Sample records for package closure control

  1. 21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD..., and Closures § 212.40 How must I control the components I use to produce PET drugs and the containers... not use in PET drug production any lot that does not meet its specifications, including any expiration...

  2. 21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD..., and Closures § 212.40 How must I control the components I use to produce PET drugs and the containers... not use in PET drug production any lot that does not meet its specifications, including any expiration...

  3. 21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD..., and Closures § 212.40 How must I control the components I use to produce PET drugs and the containers... not use in PET drug production any lot that does not meet its specifications, including any expiration...

  4. 21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD..., and Closures § 212.40 How must I control the components I use to produce PET drugs and the containers... not use in PET drug production any lot that does not meet its specifications, including any expiration...

  5. CRP - VD Tube & Closure -  Unit Non-Reclosable Packaging Rigid

    EPA Pesticide Factsheets

    This is a unit-dose non-reclosable rigid package. The package consists of a tube and a closure that is permanently attached to the tube neck. The package is opened by pushing down on the closure and simultaneously turning it counterclockwise.

  6. 49 CFR 173.24a - Additional general requirements for non-bulk packagings and packages.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... design. Except as provided in § 172.312 of this subchapter: (1) Inner packaging closures. A combination... packed, secured and cushioned to prevent their breakage or leakage and to control their shifting within... Group I packaging may be used for a Packing Group II material with a specific gravity not exceeding the...

  7. 49 CFR 173.24a - Additional general requirements for non-bulk packagings and packages.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... design. Except as provided in § 172.312 of this subchapter: (1) Inner packaging closures. A combination... packed, secured and cushioned to prevent their breakage or leakage and to control their shifting within... Group I packaging may be used for a Packing Group II material with a specific gravity not exceeding the...

  8. 21 CFR 113.60 - Containers.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Containers. 113.60 Section 113.60 Food and Drugs... CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS Control of Components, Food Product Containers, Closures, and In-Process Materials § 113.60 Containers. (a) Closures...

  9. 21 CFR 113.60 - Containers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Containers. 113.60 Section 113.60 Food and Drugs... CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS Control of Components, Food Product Containers, Closures, and In-Process Materials § 113.60 Containers. (a) Closures...

  10. 21 CFR 113.60 - Containers.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Containers. 113.60 Section 113.60 Food and Drugs... CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS Control of Components, Food Product Containers, Closures, and In-Process Materials § 113.60 Containers. (a) Closures...

  11. 21 CFR 113.60 - Containers.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Containers. 113.60 Section 113.60 Food and Drugs... CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS Control of Components, Food Product Containers, Closures, and In-Process Materials § 113.60 Containers. (a) Closures...

  12. 21 CFR 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false How must I control the components I use to produce PET drugs and the containers and closures I package them in? 212.40 Section 212.40 Food and Drugs FOOD... GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) Control of...

  13. Identification of Selected Child-Resistant Closures (Continuous Thread, Lug-Bayonet, and Snap Closures).

    ERIC Educational Resources Information Center

    Gross, Rosalind L.; White, Harry E.

    This publication describes a selected group of child-resistant closures used in packaging five categories of medicine and household products. The material in the document was collected to train survey personnel to identify closures for a planned household study of the effectiveness of child-resistant packaging. The 39 closures described are of…

  14. Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy.

    PubMed

    Victor, Ken G; Levac, Lauren; Timmins, Michael; Veale, James

    2017-01-01

    USP <1207.1> Section 3.5 states that "A deterministic leak test method having the ability to detect leaks at the product's maximum allowable leakage limit is preferred when establishing the inherent integrity of a container-closure system." Ideally, container closure integrity of parenteral packaging would be evaluated by measuring a physical property that is sensitive to the presence of any package defect that breaches package integrity by increasing its leakage above its maximum allowable leakage limit. The primary goals of the work presented herein were to demonstrate the viability of the nondestructive, deterministic method known as laser-based gas headspace analysis for evaluating container closure integrity and to provide a physical model for predicting leak rates for a variety of container volumes, headspace conditions, and defect sizes. The results demonstrate that laser-based headspace analysis provides sensitive, accurate, and reproducible measurements of the gas ingress into glass vial-stopper package assemblies that are under either diffusive or effusive leak conditions. Two different types of positive controls were examined. First, laser-drilled micro-holes in thin metal disks that were crimped on top of 15R glass vials served as positive controls with a well-characterized defect geometry. For these, a strong correlation was observed between the measured ingress parameter and the size of the defect for both diffusive and effusive conditions. Second, laser-drilled holes in the wall of glass vials served as controls that more closely simulate real-world defects. Due to their complex defect geometries, their diffusive and effusive ingress parameters did not necessarily correlate; this is an important observation that has significant implications for standardizing the characterization of container defects. Regardless, laser-based headspace analysis could readily differentiate positive and negative controls for all leak conditions, and the results provide a guide for method development of container closure integrity tests. LAY ABSTRACT: The new USP 39 <1207>, "Package Integrity Evaluation-Sterile Products", states in section 3.4.1: "tracer gas tests performed using … laser-based gas headspace analysis [have] been shown to be sensitive enough to quantitatively analyze leakage through the smallest leak paths found to pose the smallest chance of liquid leakage or microbial ingress in rigid packaging." In addition, USP <1207> also states that "for such methods, the limit of detection can be mathematically predicted on the basis of gas flow kinetics." Using the above statements as a foundation, this paper presents a theoretical basis for predicting the gas ingress through well-defined defects in product vials sealed under a variety of headspace conditions. These calculated predictions were experimentally validated by comparing them to measurements of changes in the headspace oxygen content or total pressure for several different positive controls using laser-based headspace analysis. The results demonstrated that laser-based headspace analysis can, by readily differentiating between negative controls and positive controls with a range of defect sizes on the micron scale, be used to assess container closure integrity. The work also demontrated that caution must be used when attempting to correlate a leak rate to an idealized defect-size parameter. © PDA, Inc. 2017.

  15. 75 FR 5375 - Hazardous Material; Miscellaneous Packaging Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ...In this final rule, PHMSA is amending packaging requirements in the Hazardous Materials Regulations to enhance compliance flexibility, improve clarity, and reduce regulatory burdens. Specifically, we are revising several packaging related definitions; adding provisions to allow more flexibility when preparing and transmitting closure instructions, including conditions under which closure instructions may be transmitted electronically; adding a requirement for shippers to retain packaging closure instructions; incorporating new language that will allow for a practicable means of stenciling the ``UN'' symbol on packagings; and clarifying a requirement to document the methodology used when determining whether a change in packaging configuration requires retesting as a new design or may be considered a variation of a previously tested design. This final rule also incorporates requirements for construction, maintenance, and use of Large Packagings.

  16. 21 CFR 211.186 - Master production and control records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... description of the drug product containers, closures, and packaging materials, including a specimen or copy of... form; (2) The name and weight or measure of each active ingredient per dosage unit or per unit of...

  17. 21 CFR 211.186 - Master production and control records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... description of the drug product containers, closures, and packaging materials, including a specimen or copy of... form; (2) The name and weight or measure of each active ingredient per dosage unit or per unit of...

  18. A Fruit of Yucca Mountain: The Remote Waste Package Closure System

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kevin Skinner; Greg Housley; Colleen Shelton-Davis

    2011-11-01

    Was the death of the Yucca Mountain repository the fate of a technical lemon or a political lemon? Without caution, this debate could lure us away from capitalizing on the fruits of the project. In March 2009, Idaho National Laboratory (INL) successfully demonstrated the Waste Package Closure System, a full-scale prototype system for closing waste packages that were to be entombed in the now abandoned Yucca Mountain repository. This article describes the system, which INL designed and built, to weld the closure lids on the waste packages, nondestructively examine the welds using four different techniques, repair the welds if necessary,more » mitigate crack initiating stresses in the surfaces of the welds, evacuate and backfill the packages with an inert gas, and perform all of these tasks remotely. As a nation, we now have a proven method for securely sealing nuclear waste packages for long term storage—regardless of whether or not the future destination for these packages will be an underground repository. Additionally, many of the system’s features and concepts may benefit other remote nuclear applications.« less

  19. Container system for enabling commercial production of cryopreserved cell therapy products.

    PubMed

    Woods, Erik J; Bagchi, Aniruddha; Goebel, W Scott; Vilivalam, Vinod D; Vilivalam, Vinod D

    2010-07-01

    The expansion of cellular therapeutics will require large-scale manufacturing processes to expand and package cell products, which may not be feasible with current blood-banking bag technology. This study investigated the potential for freezing, storing and shipping cell therapy products using novel pharmaceutical-grade Crystal Zenith((R)) (CZ) plastic vials. CZ vials (0.5, 5 and 30 ml volume) with several closure systems were filled with mesenchymal stem cells and stored at either -85 or -196 degrees C for 6 months. Vials were tested for their ability to maintain cell viability, proliferative and differentiation capacity, as well as durability and integrity utilizing a 1-m drop test. As controls, 2 ml polypropylene vials were investigated under the same conditions. Post-thaw viability utilizing a dye exclusion assay was over 95% in all samples. Stored cells exhibited rapid recovery 2 h post-thaw and cultures were approximately 70% confluent within 5-7 days, consistent with nonfrozen controls and indicative of functional recovery. Doubling times were consistent over all vials. The doubling rate for cells from CZ vials were 2.14 + or - 0.83 days (1 week), 1.84 + or - 0.68 days (1 month) and 1.79 + or - 0.71 days (6 months), which were not significantly different compared with frozen and fresh controls. Cells recovered from the vials exhibited trilineage differentiation consistent with controls. As part of vial integrity via drop testing, no evidence of external damage was found on vial surfaces or on closure systems. Furthermore, the filled vials stored for 6 months were tested for container closure integrity. Vials removed from freezer conditions were transported to the test laboratory on dry ice and tested using pharmaceutical packaging tests, including dye ingress and microbial challenge. The results of all stoppered vials indicated container closure integrity with no failures. Pharmaceutical-grade plastic CZ vials, which are commercially used to package pharmaceutical products, are suitable for low-temperature storage and transport of mesenchymal stem cells, and are a scalable container system for commercial manufacturing and fill-finish operation of cell therapy products.

  20. WASTE PACKAGE REMEDIATION SYSTEM DESCRIPTION DOCUMENT

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    N.D. Sudan

    2000-06-22

    The Waste Package Remediation System remediates waste packages (WPs) and disposal containers (DCs) in one of two ways: preparation of rejected DC closure welds for repair or opening of the DC/WP. DCs are brought to the Waste Package Remediation System for preparation of rejected closure welds if testing of the closure weld by the Disposal Container Handling System indicates an unacceptable, but repairable, welding flaw. DC preparation of rejected closure welds will require removal of the weld in such a way that the Disposal Container Handling System may resume and complete the closure welding process. DCs/WPs are brought to themore » Waste Package Remediation System for opening if the Disposal Container Handling System testing of the DC closure weld indicates an unrepairable welding flaw, or if a WP is recovered from the subsurface repository because suspected damage to the WP or failure of the WP has occurred. DC/WP opening will require cutting of the DC/WP such that a temporary seal may be installed and the waste inside the DC/WP removed by another system. The system operates in a Waste Package Remediation System hot cell located in the Waste Handling Building that has direct access to the Disposal Container Handling System. One DC/WP at a time can be handled in the hot cell. The DC/WP arrives on a transfer cart, is positioned within the cell for system operations, and exits the cell without being removed from the cart. The system includes a wide variety of remotely operated components including a manipulator with hoist and/or jib crane, viewing systems, machine tools for opening WPs, and equipment used to perform pressure and gas composition sampling. Remotely operated equipment is designed to facilitate DC/WP decontamination and hot cell equipment maintenance, and interchangeable components are provided where appropriate. The Waste Package Remediation System interfaces with the Disposal Container Handling System for the receipt and transport of WPs and DCs. The Waste Handling Building System houses the system, and provides the facility, safety, and auxiliary systems required to support operations. The system receives power from the Waste Handling Building Electrical System. The system also interfaces with the various DC systems.« less

  1. Status of Progress Made Toward Preliminary Design Concepts for the Inventory in Select Media for DOE-Managed HLW/SNF

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Matteo, Edward N.; Hardin, Ernest L.; Hadgu, Teklu

    As the title suggests, this report provides a summary of the status and progress for the Preliminary Design Concepts Work Package. Described herein are design concepts and thermal analysis for crystalline and salt host media. The report concludes that thermal management of defense waste, including the relatively small subset of high thermal output waste packages, is readily achievable. Another important conclusion pertains to engineering feasibility, and design concepts presented herein are based upon established and existing elements and/or designs. The multipack configuration options for the crystalline host media pose the greatest engineering challenges, as these designs involve large, heavy wastemore » packages that pose specific challenges with respect to handling and emplacement. Defense-related Spent Nuclear Fuel (DSNF) presents issues for post-closure criticality control, and a key recommendation made herein relates to the need for special packaging design that includes neutron-absorbing material for the DSNF. Lastly, this report finds that the preliminary design options discussed are tenable for operational and post-closure safety, owing to the fact that these concepts have been derived from other published and well-studied repository designs.« less

  2. 21 CFR 113.60 - Containers.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Containers. 113.60 Section 113.60 Food and Drugs... CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS Control of Components, Food Product Containers, Closures, and In-Process Materials § 113.60 Containers. Link to an...

  3. Vacuum decay container closure integrity leak test method development and validation for a lyophilized product-package system.

    PubMed

    Patel, Jayshree; Mulhall, Brian; Wolf, Heinz; Klohr, Steven; Guazzo, Dana Morton

    2011-01-01

    A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated for container-closure integrity verification of a lyophilized product in a parenteral vial package system. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity check, and for testing product stored on stability in lieu of sterility tests. Method development and optimization challenge studies incorporated artificially defective packages representing a range of glass vial wall and sealing surface defects, as well as various elastomeric stopper defects. Method validation required 3 days of random-order replicate testing of a test sample population of negative-control, no-defect packages and positive-control, with-defect packages. Positive-control packages were prepared using vials each with a single hole laser-drilled through the glass vial wall. Hole creation and hole size certification was performed by Lenox Laser. Validation study results successfully demonstrated the vacuum decay leak test method's ability to accurately and reliably detect those packages with laser-drilled holes greater than or equal to approximately 5 μm in nominal diameter. All development and validation studies were performed at Whitehouse Analytical Laboratories in Whitehouse, NJ, under the direction of consultant Dana Guazzo of RxPax, LLC, using a VeriPac 455 Micro Leak Test System by Packaging Technologies & Inspection (Tuckahoe, NY). Bristol Myers Squibb (New Brunswick, NJ) fully subsidized all work. A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated to detect defects in stoppered vial packages containing lyophilized product for injection. This nondestructive leak test method is intended for use in manufacturing as an in-process package integrity check, and for testing product stored on stability in lieu of sterility tests. Test method validation study results proved the method capable of detecting holes laser-drilled through the glass vial wall greater than or equal to 5 μm in nominal diameter. Total test time is less than 1 min per package. All method development and validation studies were performed at Whitehouse Analytical Laboratories in Whitehouse, NJ, under the direction of consultant Dana Guazzo of RxPax, LLC, using a VeriPac 455 Micro Leak Test System by Packaging Technologies & Inspection (Tuckahoe, NY). Bristol Myers Squibb (New Brunswick, NJ) fully subsidized all work.

  4. 21 CFR 212.50 - What production and process controls must I have?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... containers, closures, and packaging materials, including a specimen or copy of each label and all other..., the name and radioactivity or other measurement of each active pharmaceutical ingredient and each... active pharmaceutical ingredient and each inactive ingredient per batch or per unit of radioactivity or...

  5. 21 CFR 212.50 - What production and process controls must I have?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... containers, closures, and packaging materials, including a specimen or copy of each label and all other... radioactivity or other measurement of each active pharmaceutical ingredient and each inactive ingredient per... active pharmaceutical ingredient and each inactive ingredient per batch or per unit of radioactivity or...

  6. 49 CFR 178.955 - General requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... void space(s) and to prevent significant movement of the inner packagings. (h) Proof of compliance. In... subchapter. Variations are permitted in inner packagings of a tested Large Packaging, without further testing... determine that the inner packaging, including closure, maintains an equivalent level of performance is...

  7. 49 CFR 178.955 - General requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... void space(s) and to prevent significant movement of the inner packagings. (h) Proof of compliance. In... subchapter. Variations are permitted in inner packagings of a tested Large Packaging, without further testing... determine that the inner packaging, including closure, maintains an equivalent level of performance is...

  8. 49 CFR 178.955 - General requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... void space(s) and to prevent significant movement of the inner packagings. (h) Proof of compliance. In... subchapter. Variations are permitted in inner packagings of a tested Large Packaging, without further testing... determine that the inner packaging, including closure, maintains an equivalent level of performance is...

  9. 49 CFR 178.955 - General requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... void space(s) and to prevent significant movement of the inner packagings. (h) Proof of compliance. In... subchapter. Variations are permitted in inner packagings of a tested Large Packaging, without further testing... determine that the inner packaging, including closure, maintains an equivalent level of performance is...

  10. Permanent Closure of MFC Biodiesel Underground Storage Tank 99ANL00013

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kerry L. Nisson

    2012-10-01

    This closure package documents the site assessment and permanent closure of the Materials and Fuels Complex biodiesel underground storage tank 99ANL00013 in accordance with the regulatory requirements established in 40 CFR 280.71, “Technical Standards and Corrective Action Requirements for Owners and Operators of Underground Storage Tanks: Out-of-Service UST Systems and Closure.”

  11. Open abdomen treatment for septic patients with gastrointestinal fistula: from fistula control to definitive closure.

    PubMed

    Ren, Jianan; Yuan, Yujie; Zhao, Yunzhao; Gu, Guosheng; Wang, Gefei; Chen, Jun; Fan, Chaogang; Wang, Xinbo; Li, Jieshou

    2014-04-01

    The use of open abdomen in the management of gastrointestinal fistula complicated with severe intra-abdominal infection is uncommon. This study was designed to evaluate outcomes of our staged approach for the infected open abdomen. Patients who had gastrointestinal fistula and underwent open abdomen treatment were retrospectively reviewed. Various materials such as polypropylene mesh and a modified sandwich package were used to achieve temporary abdominal closure followed by skin grafting when the granulation bed matured. A delayed definitive operation was performed for final abdominal closure without implant of prosthetic mesh. Between 1999 and 2009, 56 (68.3%) of 82 patients survived through this treatment. Among them, 42 patients achieved final abdominal closure. Spontaneous fistula closure occurred in 16 patients with secondary fistula recorded in six patients. Besides, wound complications occurred in 13 patients with two cases for pulmonary infection. Within a 12-month follow-up period after definitive closure, no additional fistula was recorded excluding planned ventral hernia repair. Open abdomen treatment was effective for gastrointestinal fistula complicated by severe intra-abdominal infection. A delayed and deliberate operative strategy aiming at fistula excision and fascial closure, with simultaneous abdominal wall reconstruction, was required for the infected open abdomen.

  12. 49 CFR 173.167 - Consumer commodities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... exceed 30 kg (66 pounds) gross weight as prepared for shipment. (2) Closures. Friction-type closures must...) prescribed in § 173.27(c) of this part. The capability of a packaging to withstand an internal pressure...

  13. Seal welded cast iron nuclear waste container

    DOEpatents

    Filippi, Arthur M.; Sprecace, Richard P.

    1987-01-01

    This invention identifies methods and articles designed to circumvent metallurgical problems associated with hermetically closing an all cast iron nuclear waste package by welding. It involves welding nickel-carbon alloy inserts which are bonded to the mating plug and main body components of the package. The welding inserts might be bonded in place during casting of the package components. When the waste package closure weld is made, the most severe thermal effects of the process are restricted to the nickel-carbon insert material which is far better able to accommodate them than is cast iron. Use of nickel-carbon weld inserts should eliminate any need for pre-weld and post-weld heat treatments which are a problem to apply to nuclear waste packages. Although the waste package closure weld approach described results in a dissimilar metal combination, the relative surface area of nickel-to-iron, their electrochemical relationship, and the presence of graphite in both materials will act to prevent any galvanic corrosion problem.

  14. 21 CFR 178.3290 - Chromic chloride complexes.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... square inch of closure area. (b) The packaging container which has its closure area treated with the release agent shall have a capacity of not less than 120 grams of food per square inch of such treated...

  15. Microbial barrier assessment of Tyvek stopper packaging for rubber closures.

    PubMed

    Moldenhauer, J E; Bass, S A; Kupinski, M J; Walters, M L; Rubio, S L

    1996-01-01

    Two types of Tyvek and high density polyethylene or polypropylene packaging used for sterilization of rubber closures were evaluated for Microbial Barrier properties. The packaging evaluated was "Ready to Sterilize" (1) stoppers and a second test package (Test 2) which was designated as appropriate for a clean room, filled with washed and siliconized stoppers and then heat sealed. Each type of packaging was subjected to three different sterilization temperatures (125 degrees C, 128 degrees C and 131 degrees C) in a production sterilizer (15-18 psi). Following sterilization, a microbial barrier assessment was performed, using Bacillus subtilis niger (ATCC 9372), to determine whether the packaging could maintain a sterile barrier following sterilization. Results of the testing indicated that a microbial barrier was maintained for products in "Ready to Sterilize" packages at 125 degrees C and 128 degrees C. For products sterilized in the Test 2 container a microbial barrier could not be maintained at 128 degrees C, and no further testing was performed. Following sterilization at 131 degrees C physical defects were noted for the "Ready to Sterilize" bag and a microbial barrier could not be maintained.

  16. Temperature-package power correlations for open-mode geologic disposal concepts.

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hardin, Ernest.

    2013-02-01

    Logistical simulation of spent nuclear fuel (SNF) management in the U.S. combines storage, transportation and disposal elements to evaluate schedule, cost and other resources needed for all major operations leading to final geologic disposal. Geologic repository reference options are associated with limits on waste package thermal power output at emplacement, in order to meet limits on peak temperature for certain key engineered and natural barriers. These package power limits are used in logistical simulation software such as CALVIN, as threshold requirements that must be met by means of decay storage or SNF blending in waste packages, before emplacement in amore » repository. Geologic repository reference options include enclosed modes developed for crystalline rock, clay or shale, and salt. In addition, a further need has been addressed for open modes in which SNF can be emplaced in a repository, then ventilated for decades or longer to remove heat, prior to permanent repository closure. For each open mode disposal concept there are specified durations for surface decay storage (prior to emplacement), repository ventilation, and repository closure operations. This study simulates those steps for several timing cases, and for SNF with three fuel-burnup characteristics, to develop package power limits at which waste packages can be emplaced without exceeding specified temperature limits many years later after permanent closure. The results are presented in the form of correlations that span a range of package power and peak postclosure temperature, for each open-mode disposal concept, and for each timing case. Given a particular temperature limit value, the corresponding package power limit for each case can be selected for use in CALVIN and similar tools.« less

  17. Sealing Mustard Jars with Plastic Linerless Closures

    DTIC Science & Technology

    1985-10-01

    Recommendations 15 Literature cited 16 Appendices: A . Levels of Packaging 19 B. Value Engineering Correspondence 2 3 V ILLUSTRATIVE DATA Page...Analytical Progress Total Dietary Fiber Another Look, 1984, Vol 2,■No. 1, Minneapolis, MN 16 APPENDIXES A : Levels of Packaging B: Value...Engineering Correspondence 17 APPENDIX A : Levels of Packaging 19 APPENDIX A : Levels of Packaging Excerpt from: AR 700-15/NAVSUPINST 4030.28B/AFR 71~6

  18. MEANS: python package for Moment Expansion Approximation, iNference and Simulation

    PubMed Central

    Fan, Sisi; Geissmann, Quentin; Lakatos, Eszter; Lukauskas, Saulius; Ale, Angelique; Babtie, Ann C.; Kirk, Paul D. W.; Stumpf, Michael P. H.

    2016-01-01

    Motivation: Many biochemical systems require stochastic descriptions. Unfortunately these can only be solved for the simplest cases and their direct simulation can become prohibitively expensive, precluding thorough analysis. As an alternative, moment closure approximation methods generate equations for the time-evolution of the system’s moments and apply a closure ansatz to obtain a closed set of differential equations; that can become the basis for the deterministic analysis of the moments of the outputs of stochastic systems. Results: We present a free, user-friendly tool implementing an efficient moment expansion approximation with parametric closures that integrates well with the IPython interactive environment. Our package enables the analysis of complex stochastic systems without any constraints on the number of species and moments studied and the type of rate laws in the system. In addition to the approximation method our package provides numerous tools to help non-expert users in stochastic analysis. Availability and implementation: https://github.com/theosysbio/means Contacts: m.stumpf@imperial.ac.uk or e.lakatos13@imperial.ac.uk Supplementary information: Supplementary data are available at Bioinformatics online. PMID:27153663

  19. MEANS: python package for Moment Expansion Approximation, iNference and Simulation.

    PubMed

    Fan, Sisi; Geissmann, Quentin; Lakatos, Eszter; Lukauskas, Saulius; Ale, Angelique; Babtie, Ann C; Kirk, Paul D W; Stumpf, Michael P H

    2016-09-15

    Many biochemical systems require stochastic descriptions. Unfortunately these can only be solved for the simplest cases and their direct simulation can become prohibitively expensive, precluding thorough analysis. As an alternative, moment closure approximation methods generate equations for the time-evolution of the system's moments and apply a closure ansatz to obtain a closed set of differential equations; that can become the basis for the deterministic analysis of the moments of the outputs of stochastic systems. We present a free, user-friendly tool implementing an efficient moment expansion approximation with parametric closures that integrates well with the IPython interactive environment. Our package enables the analysis of complex stochastic systems without any constraints on the number of species and moments studied and the type of rate laws in the system. In addition to the approximation method our package provides numerous tools to help non-expert users in stochastic analysis. https://github.com/theosysbio/means m.stumpf@imperial.ac.uk or e.lakatos13@imperial.ac.uk Supplementary data are available at Bioinformatics online. © The Author 2016. Published by Oxford University Press.

  20. Impact of Different Standard Type A7A Drum Closure-Ring Practices on Gasket Contraction and Bolt Closure Distance– 15621

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ketusky, Edward; Blanton, Paul; Bobbitt, John H.

    The Department of Energy, the Savannah River National Laboratory, several manufacturers of specification drums, and the United States Department of Transportation (DOT) are collaborating in the development of a guidance document for DOE contractors and vendors who wish to qualify containers to DOT 7A Type A requirements. Currently, the effort is focused on DOT 7A Type A 208-liter (55-gallons) drums with a standard 12-gauge bolted closure ring. The U.S. requirements, contained in Title 49, Part 178.350 “Specification 7A; general packaging, Type A specifies a competent authority review of the packaging is not required for the transport of (Class 7) radioactivemore » material containing less than Type A quantities of radioactive material. For Type AF drums, a 4 ft. regulatory free drop must be performed, such that the drum “suffers maximum damage.” Although the actual orientation is not defined by the specification, recent studies suggest that maximum damage would result from a shallow angle top impact, where kinetic energy is transferred to the lid, ultimately causing heavy damage to the lid, or even worse, causing the lid to come off. Since each vendor develops closure recommendations/procedures for the drums they manufacture, key parameters applied to drums during closing vary based on vendor. As part of the initial phase of the collaboration, the impact of the closure variants on the ability of the drum to suffer maximum damage is investigated. Specifically, closure testing is performed varying: 1) the amount of torque applied to the closure ring bolt; and, 2) stress relief protocol, including: a) weight of hammer; and, b) orientation that the hammer hits the closure ring. After closure, the amount of drum lid gasket contraction and the distance that the closure bolt moves through the closure ring is measured.« less

  1. 49 CFR 178.960 - Preparation of Large Packagings for testing.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., including inner packagings. All closures must be installed using proper techniques and torques. (b) For the...). Average values should fall within these limits. Short-term fluctuations and measurement limitations may cause individual measurements to vary by up to ± 5 percent relative humidity without significant...

  2. 49 CFR 178.960 - Preparation of Large Packagings for testing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., including inner packagings. All closures must be installed using proper techniques and torques. (b) For the...). Average values should fall within these limits. Short-term fluctuations and measurement limitations may cause individual measurements to vary by up to ± 5 percent relative humidity without significant...

  3. 49 CFR 178.960 - Preparation of Large Packagings for testing.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., including inner packagings. All closures must be installed using proper techniques and torques. (b) For the...). Average values should fall within these limits. Short-term fluctuations and measurement limitations may cause individual measurements to vary by up to ±5 percent relative humidity without significant...

  4. 49 CFR 178.960 - Preparation of Large Packagings for testing.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., including inner packagings. All closures must be installed using proper techniques and torques. (b) For the...). Average values should fall within these limits. Short-term fluctuations and measurement limitations may cause individual measurements to vary by up to ±5 percent relative humidity without significant...

  5. 49 CFR 178.960 - Preparation of Large Packagings for testing.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., including inner packagings. All closures must be installed using proper techniques and torques. (b) For the...). Average values should fall within these limits. Short-term fluctuations and measurement limitations may cause individual measurements to vary by up to ±5 percent relative humidity without significant...

  6. The pharmaceutical vial capping process: Container closure systems, capping equipment, regulatory framework, and seal quality tests.

    PubMed

    Mathaes, Roman; Mahler, Hanns-Christian; Buettiker, Jean-Pierre; Roehl, Holger; Lam, Philippe; Brown, Helen; Luemkemann, Joerg; Adler, Michael; Huwyler, Joerg; Streubel, Alexander; Mohl, Silke

    2016-02-01

    Parenteral drug products are protected by appropriate primary packaging to protect against environmental factors, including potential microbial contamination during shelf life duration. The most commonly used CCS configuration for parenteral drug products is the glass vial, sealed with a rubber stopper and an aluminum crimp cap. In combination with an adequately designed and controlled aseptic fill/finish processes, a well-designed and characterized capping process is indispensable to ensure product quality and integrity and to minimize rejections during the manufacturing process. In this review, the health authority requirements and expectations related to container closure system quality and container closure integrity are summarized. The pharmaceutical vial, the rubber stopper, and the crimp cap are described. Different capping techniques are critically compared: The most common capping equipment with a rotating capping plate produces the lowest amount of particle. The strength and challenges of methods to control the capping process are discussed. The residual seal force method can characterize the capping process independent of the used capping equipment or CCS. We analyze the root causes of several cosmetic defects associated with the vial capping process. Copyright © 2015 Elsevier B.V. All rights reserved.

  7. Peering down the barrel of a bacteriophage portal: the genome packaging and release valve in p22.

    PubMed

    Tang, Jinghua; Lander, Gabriel C; Olia, Adam S; Olia, Adam; Li, Rui; Casjens, Sherwood; Prevelige, Peter; Cingolani, Gino; Baker, Timothy S; Johnson, John E

    2011-04-13

    The encapsidated genome in all double-strand DNA bacteriophages is packaged to liquid crystalline density through a unique vertex in the procapsid assembly intermediate, which has a portal protein dodecamer in place of five coat protein subunits. The portal orchestrates DNA packaging and exit, through a series of varying interactions with the scaffolding, terminase, and closure proteins. Here, we report an asymmetric cryoEM reconstruction of the entire P22 virion at 7.8 Å resolution. X-ray crystal structure models of the full-length portal and of the portal lacking 123 residues at the C terminus in complex with gene product 4 (Δ123portal-gp4) obtained by Olia et al. (2011) were fitted into this reconstruction. The interpreted density map revealed that the 150 Å, coiled-coil, barrel portion of the portal entraps the last DNA to be packaged and suggests a mechanism for head-full DNA signaling and transient stabilization of the genome during addition of closure proteins. Copyright © 2011 Elsevier Ltd. All rights reserved.

  8. Heterogeneous Concurrent Modeling and Design in Java (Volume 2: Ptolemy II Software Architecture)

    DTIC Science & Technology

    2008-04-01

    file (EPS) suitable for inclusion in word processors. The image in figure 7.3 is such an EPS file imported into FrameMaker . At this time, the EPS...can be imported into word processors. This figure was imported into FrameMaker . 152 Ptolemy II Plot Package 7.2.4 Modifying the format You can control...FixToken class 57 FrameMaker 149 full name 4 function closures 59 function dependency 48 FunctionDependency class 48 FunctionToken 122 FunctionToken

  9. Rock mechanics evaluation of potential repository sites in the Paradox, Permian, and Gulf Coast Basins: Volume 1

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1987-09-01

    Thermal and thermomechanical analyses of a conceptual radioactive waste repository containing commercial and defense high-level wastes and spent fuel have been performing using finite element models. The thermal and thermomechanical responses of the waste package, disposal room, and repository regions were evaluated. four bedded salt formations, in Davis and Lavender Canyons in the Paradox Basin of southeastern Utah and in Deaf Smith and Swisher counties in the Permian Basin of northwestern Texas, and three salt domes, Vacherie Dome in northwestern Louisiana and Richton and Cypress Creek Domes in southeastern Mississippi, located in the Gulf Coast Basin, were examined. In themore » Paradox Basin, the pressure exerted on the waste package overpack was much greater than the initial in situ stress. The disposal room closure was less than 10 percent after 5 years. Surface uplift was nominal, and no significant thermomechanical perturbation of the aquitards was observed. In the Permian Basin, the pressure exerted on the waste package overpack was greater than the initial in situ stress. The disposal room closures were greater than 10 percent in less than 5 years. Surface uplift was nominal, and no significant thermomechanical perturbation of the aquitards was observed. In the Gulf Coast Basin, the pressure exerted on the waste package overpack was greater than the initial in situ stress. The disposal room closures were greater than 10 percent in less than 5 years. No significant thermomechanical perturbation of the overlying geology was observed. 40 refs., 153 figs., 32 tabs.« less

  10. The impact of primary packaging on the quality of parenteral products.

    PubMed

    Solomun, Ljiljana; Ibric, Svetlana; Boltic, Zorana; Djuric, Zorica; Stupar, Biljana

    2008-11-04

    The unique approach in manufacturing of pharmaceutical dosage forms of active substances known to be unstable in aqueous solution is the introduction of lyophilization process. Nevertheless, these products must be reconstituted using the diluent from a separate container before application. The possible solution for this problem is the application of dual chamber vials comprising the freeze-dried product in a lower compartment of the vial and the solution for reconstitution in the upper chamber. The main issue in development of such product is the choice of contact packaging (rubber closures, glass vials and the container closure system as a whole). The most important parameter used for evaluation of the influence of contact material on product quality was the pH value. The results have shown that the type of vials (moulded or tubular glass) has no impact on pH shift of the solution for reconstitution (tested solution-TS), while significant differences in pH value of the TS were observed depending on the rubber closures formulation used (with some formulations, the pH shift during the test was 6.5-9.14). Benzyl alcohol assay during the tests remained unchanged. Integrity tests of the container closure system (CCS) have demonstrated the adequacy of the selected packaging system. The quality of the CCS of choice was confirmed in the course of stability studies, only parameters directly influenced by CCS being presented in this work: loss on drying and pH value. On the basis of these results, no changes in loss on drying were connected to CCS, and the pH value of the reconstituted solution remains unchanged in samples tested both ex-tempore and after in-use period of 48 h.

  11. Contamination of injectable solutions with 2-mercaptobenzothiazole leached from rubber closures.

    PubMed

    Reepmeyer, J C; Juhl, Y H

    1983-11-01

    An impurity, discovered in a sample of digoxin injectable solution commercially packaged in a syringe for single-dose delivery, was found to originate from the rubber closure of the syringe and was identified as 2-mercaptobenzothiazole, a common accelerator for rubber vulcanization. Several similarly packaged injectable solutions of a variety of drugs from various manufacturers were examined and over half contained 2-mercaptobenzothiazole. The compound was identified by UV spectrophotometry (including a pH-dependent shift in its absorbance maximum), by mass spectrometry, and by comparison with standard 2-mercaptobenzothiazole using silica gel and reverse-phase high-performance liquid chromatography (HPLC). The presence of this impurity in injectable solutions may have implications with regard to toxicity and may interfere with the assay of digoxin injectable solution by HPLC.

  12. Summary of Uranium Solubility Studies in Concrete Waste Forms and Vadose Zone Environments

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Golovich, Elizabeth C.; Wellman, Dawn M.; Serne, R. Jeffrey

    2011-09-30

    One of the methods being considered for safely disposing of Category 3 low-level radioactive wastes is to encase the waste in concrete. Concrete encasement would contain and isolate the waste packages from the hydrologic environment and act as an intrusion barrier. The current plan for waste isolation consists of stacking low-level waste packages on a trench floor, surrounding the stacks with reinforced steel, and encasing these packages in concrete. These concrete-encased waste stacks are expected to vary in size with maximum dimensions of 6.4 m long, 2.7 m wide, and 4 m high. The waste stacks are expected to havemore » a surrounding minimum thickness of 15 cm of concrete encasement. These concrete-encased waste packages are expected to withstand environmental exposure (solar radiation, temperature variations, and precipitation) until an interim soil cover or permanent closure cover is installed and to remain largely intact thereafter. Any failure of concrete encasement may result in water intrusion and consequent mobilization of radionuclides from the waste packages. This report presents the results of investigations elucidating the uranium mineral phases controlling the long-term fate of uranium within concrete waste forms and the solubility of these phases in concrete pore waters and alkaline, circum-neutral vadose zone environments.« less

  13. Space Station evolution study oxygen loop closure

    NASA Technical Reports Server (NTRS)

    Wood, M. G.; Delong, D.

    1993-01-01

    In the current Space Station Freedom (SSF) Permanently Manned Configuration (PMC), physical scars for closing the oxygen loop by the addition of oxygen generation and carbon dioxide reduction hardware are not included. During station restructuring, the capability for oxygen loop closure was deferred to the B-modules. As such, the ability to close the oxygen loop in the U.S. Laboratory module (LAB A) and the Habitation A module (HAB A) is contingent on the presence of the B modules. To base oxygen loop closure of SSF on the funding of the B-modules may not be desirable. Therefore, this study was requested to evaluate the necessary hooks and scars in the A-modules to facilitate closure of the oxygen loop at or subsequent to PMC. The study defines the scars for oxygen loop closure with impacts to cost, weight and volume and assesses the effects of byproduct venting. In addition, the recommended scenarios for closure with regard to topology and packaging are presented.

  14. BRAC, What Will it Cost

    DTIC Science & Technology

    1992-04-10

    Devens - Fort Huachuca FY 91 FY 95 Fort McClellan FY 92 FY 96 Fort Chaffee FY 92 FY 97 Cameron Station FY 91 FY 95 53 Stand Alone Housing Sites FY 90 FY...Army, Headquarters Forces Command, &as Realianment and Closure Implementation Plan - Fort Devens Closure Package, Implementation Plan, Fort McPherson, GA...Classification) RAC , What Will It Cost? 12. PERSONAL AUTHOR(S) TLIN, Robert B. LTC, USA 13. TYPE OF REPORT 13b. TIME COVERED 14. DATE OF REPORT (Year

  15. Closure development for high-level nuclear waste containers for the tuff repository; Phase 1, Final report

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Robitz, E.S. Jr.; McAninch, M.D. Jr.; Edmonds, D.P.

    1990-09-01

    This report summarizes Phase 1 activities for closure development of the high-level nuclear waste package task for the tuff repository. Work was conducted under U.S. Department of Energy (DOE) Contract 9172105, administered through the Lawrence Livermore National Laboratory (LLNL), as part of the Yucca Mountain Project (YMP), funded through the DOE Office of Civilian Radioactive Waste Management (OCRWM). The goal of this phase was to select five closure processes for further evaluation in later phases of the program. A decision tree methodology was utilized to perform an objective evaluation of 15 potential closure processes. Information was gathered via a literaturemore » survey, industrial contacts, and discussions with project team members, other experts in the field, and the LLNL waste package task staff. The five processes selected were friction welding, electron beam welding, laser beam welding, gas tungsten arc welding, and plasma arc welding. These are felt to represent the best combination of weldment material properties and process performance in a remote, radioactive environment. Conceptual designs have been generated for these processes to illustrate how they would be implemented in practice. Homopolar resistance welding was included in the Phase 1 analysis, and developments in this process will be monitored via literature in Phases 2 and 3. Work was conducted in accordance with the YMP Quality Assurance Program. 223 refs., 20 figs., 9 tabs.« less

  16. Detection of seal contamination in heat-sealed food packaging based on active infrared thermography

    NASA Astrophysics Data System (ADS)

    D'huys, Karlien; Saeys, Wouter; De Ketelaere, Bart

    2015-05-01

    In the food industry packaging is often applied to protect the product from the environment, assuring quality and safety throughout shelf life if properly performed. Packaging quality depends on the material used and the closure (seal). The material is selected based on the specific needs of the food product to be wrapped. However, proper closure of the package is often harder to achieve. One problem possibly jeopardizing seal quality is the presence of food particles between the seal. Seal contamination can cause a decreased seal strength and thus an increased packaging failure risk. It can also trigger the formation of microchannels through which air and microorganisms can enter and spoil the enclosed food. Therefore, early detection and removal of seal-contaminated packages from the production chain is essential. In this work, a pulsed-type active thermography method using the heat of the sealing bars as an excitation source was studied for detecting seal contamination. The cooling profile of contaminated seals was recorded. The detection performance of four processing methods (based on a single frame, a fit of the cooling profile, pulsed phase thermography and a matched filter) was compared. High resolution digital images served as a reference to quantify contamination. The lowest detection limit (equivalent diameter of 0.63 mm) and the lowest processing time (0.42 s per sample) were obtained for the method based on a single frame. Presumably, practical limitations in the recording stage prevented the added value of active thermography to be fully reflected in this application.

  17. Recognizing Potential Buprenorphine Medication Misuse: Product Packaging Does Not Degrade With Laundering.

    PubMed

    Gunderson, Erik W

    2015-01-01

    Expanded office-based buprenorphine opioid dependence treatment is associated with medication misuse and diversion consequences. Recurrent early refill requests may indicate misuse or diversion, although further research is needed on how to effectively recognize and address the issue in clinical practice. In the current study, patient report of damaged medication from laundering prompted evaluation of laundering on degradation of buprenorphine-containing product packages and contents. Four buprenorphine product packaging approaches were assessed: 3 buprenorphine/naloxone placebo demonstration products (Suboxone and Bunavail film in foil wrappers and Zubsolv tablet in a blister pack) and Rexam-manufactured Screw-Loc closure pill container filled with a chewable aspirin as a surrogate for generic buprenorphine and buprenorphine/naloxone products. Two experimental laundering conditions, wash machine alone (W) and washer/dryer (W+D), were compared with unlaundered control (C) condition. Standard laundering settings were based on patient presentation. Products from the 2 experimental conditions and the control condition were labeled A, B, or C with counterbalanced assignment prior to visual examination of packaging and contents by the investigator who was blinded to condition. Packaging and contents remained intact for all products across experimental conditions, with only minor cosmetic effects compared with control. The W+D Suboxone film had 1-2 mm curling of the wrapper corners. Zubsolv blister packs had slight paper label fading (W+D > W). Bunavail W+D foil had an indentation outlining the inner film. The W+D bottle tablet had a ˜1 mm nick on one edge. No other differences were noted. After implementing more structured treatment and reviewing the results with the patient, he endorsed fabricating the laundering story to get additional medication. Laundering is an unlikely cause of damaged buprenorphine-containing medication packaged in foil wrappers (Suboxone, Bunavail), blister pack (Zubsolv), or prescription pill bottle (generic buprenorphine or buprenorphine/naloxone products). Patient reports of such may indicate medication misuse or diversion.

  18. Leaflet Area as a Determinant of Tricuspid Regurgitation Severity in Patients with Pulmonary Hypertension

    PubMed Central

    Afilalo, Jonathan; Grapsa, Julia; Nihoyannopoulos, Petros; Beaudoin, Jonathan; Gibbs, J. Simon R.; Channick, Richard N.; Langleben, David; Rudski, Lawrence G.; Hua, Lanqi; Handschumacher, Mark D.; Picard, Michael H.; Levine, Robert A.

    2015-01-01

    Background Tricuspid regurgitation (TR) is a risk factor for mortality in pulmonary hypertension (PH). TR severity varies among patients with comparable degrees of PH and right ventricular (RV) remodeling. The contribution of leaflet adaptation to the pathophysiology of TR has yet to be examined. We hypothesized that tricuspid leaflet area (TLA) is increased in PH, and that its size relative to RV remodeling determines TR severity. Methods and Results A prospective cohort of 255 patients with PH from pre- and post-capillary etiologies was assembled from two centers. Patients underwent a 3-D echocardiogram focused on the tricuspid apparatus. TLA was measured with the Omni custom software package. Compared with normal controls, PH patients had a twofold increase in RV volumes, 62% increase in annulus area, and 49% increase in TLA. Those with severe TR demonstrated inadequate increase in TLA relative to the closure area, such that the ratio of TLA-to-closure area <1.78 was highly predictive of severe TR (odds ratio 68.7; 95% CI 16.2, 292.7). The median vena contracta width was 8.5 mm in the group with small TLA and large closure area as opposed to 4.8 mm in the group with large TLA and large closure area. Conclusions TLA plays a significant role in determining which patients with PH develop severe functional TR. The ratio of TLA-to-closure area, reflecting the balance between leaflet adaptation vs. annular dilation and tethering forces, is an indicator of TR severity that may identify which patients stand to benefit from leaflet augmentation during tricuspid valve repair. PMID:25977303

  19. Closure Plan for the Area 5 Radioactive Waste Management Site at the Nevada Test Site

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NSTec Environmental Management

    The Area 5 Radioactive Waste Management Site (RMWS) at the Nevada Test Site (NTS) is managed and operated by National Security Technologies, LLC (NSTec), for the U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Site Office (NNSA/NSO). This document is the first update of the preliminary closure plan for the Area 5 RWMS at the NTS that was presented in the Integrated Closure and Monitoring Plan (DOE, 2005a). The major updates to the plan include a new closure schedule, updated closure inventory, updated site and facility characterization data, the Title II engineering cover design, and the closure processmore » for the 92-Acre Area of the RWMS. The format and content of this site-specific plan follows the Format and Content Guide for U.S. Department of Energy Low-Level Waste Disposal Facility Closure Plans (DOE, 1999a). This interim closure plan meets closure and post-closure monitoring requirements of the order DOE O 435.1, manual DOE M 435.1-1, Title 40 Code of Federal Regulations (CFR) Part 191, 40 CFR 265, Nevada Administrative Code (NAC) 444.743, and Resource Conservation and Recovery Act (RCRA) requirements as incorporated into NAC 444.8632. The Area 5 RWMS accepts primarily packaged low-level waste (LLW), low-level mixed waste (LLMW), and asbestiform low-level waste (ALLW) for disposal in excavated disposal cells.« less

  20. Final closure of a low level waste disposal facility

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Potier, J.M.

    1995-12-31

    The low-level radioactive waste disposal facility operated by the Agence Nationale pour la Gestion des Dechets Radioactifs near La Hague, France was opened in 1969 and is scheduled for final closure in 1996. The last waste package was received in June 1994. The total volume of disposed waste is approximately 525,000 m{sup 3}. The site closure consists of covering the disposal structures with a multi-layer impervious cap system to prevent rainwater from infiltrating the waste isolation system. A monitoring system has been set up to verify the compliance of infiltration rates with hydraulic performance objectives (less than 10 liters permore » square meter and per year).« less

  1. 49 CFR 173.418 - Authorized packages-pyrophoric Class 7 (radioactive) materials.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... must not be fissile unless excepted by § 173.453; (b) Contained in sealed and corrosion resistant receptacles with positive closures (friction or slip-fit covers or stoppers are not authorized); (c) Free of...

  2. Determination of the Porosity Surfaces of the Disposal Room Containing Various Waste Inventories for WIPP PA

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Park, Byoung Yoon; Hansen, Francis D.

    2005-07-01

    This report develops a series of porosity surfaces for the Waste Isolation Pilot Plant. The concept of a porosity surface was developed for performance assessment and comprises calculation of room closure as salt creep processes are mitigated by gas generation and back stress created by the waste packages within the rooms. The physical and mechanical characteristics of the waste packaging that has already been disposed--such as the pipe overpack--and new waste packaging--such as the advanced mixed waste compaction--are appreciably different than the waste form upon which the original compliance was based and approved. This report provides structural analyses of roommore » closure with various waste inventories. All of the underlying assumptions pertaining to the original compliance certification including the same finite element code are implemented; only the material parameters describing the more robust waste packages are changed from the certified baseline. As modeled, the more rigid waste tends to hold open the rooms and create relatively more void space in the underground than identical calculations run on the standard waste packages, which underpin the compliance certification. The several porosity surfaces quantified within this report provide possible ranges of pressure and porosity for performance assessment analyses.3 Intentionally blank4 AcknowledgementsThis research is funded by WIPP programs administered by the U.S. Department of Energy. The authors would like to acknowledge the valuable contributions to this work provided by others. Dr. Joshua S. Stein helped explain the hand off between these finite element porosity surfaces and implementation in the performance calculations. Dr. Leo L. Van Sambeek of RESPEC Inc. helped us understand the concepts of room closure under the circumstances created by a rigid waste inventory. Dr. T. William Thompson and Tom W. Pfeifle provided technical review and Mario J. Chavez provided a Quality Assurance review. The paper has been improved by these individuals.Sandia is a multiprogram laboratory operated by Sandia Corporation, a Lockheed Martin Company, for the United States Department of Energy under Contract DE-AC04-94Al850005 Intentionally Blank6« less

  3. 75 FR 27273 - Hazardous Materials; Packages Intended for Transport by Aircraft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-14

    ...PHMSA proposes to amend requirements in the Hazardous Materials Regulations to enhance the integrity of inner packagings or receptacles of combination packagings containing liquid hazardous material by ensuring they remain intact when subjected to the reduced pressure and other forces encountered in air transportation. In order to substantially decrease the likelihood of a hazardous materials release, the proposed amendments: prescribe specific test protocols and standards for determining whether an inner packaging or receptacle is capable of meeting the pressure differential requirements specified in the regulations and, consistent with the 2011-2012 edition of the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Aircraft (ICAO Technical Instructions), require the closures on all inner packagings containing liquids within a combination packaging to be secured by a secondary means or, under certain circumstances, permit the use of a liner.

  4. 49 CFR 173.188 - White or yellow phosphorus.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) Inner water-tight metal cans containing not over 0.5 kg (1 pound) of phosphorus with screw-top closures... each. (b) When dry, it must be cast solid and shipped in packagings as follows: (1) Steel, aluminum or...

  5. 49 CFR 173.188 - White or yellow phosphorus.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) Inner water-tight metal cans containing not over 0.5 kg (1 pound) of phosphorus with screw-top closures... each. (b) When dry, it must be cast solid and shipped in packagings as follows: (1) Steel, aluminum or...

  6. Vacuum decay container/closure integrity testing technology. Part 2. Comparison to dye ingress tests.

    PubMed

    Wolf, Heinz; Stauffer, Tony; Chen, Shu-Chen Y; Lee, Yoojin; Forster, Ronald; Ludzinski, Miron; Kamat, Madhav; Mulhall, Brian; Guazzo, Dana Morton

    2009-01-01

    Part 1 of this series demonstrated that a container closure integrity test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method using a VeriPac 325/LV vacuum decay leak tester by Packaging Technologies & Inspection, LLC (PTI) is capable of detecting leaks > or = 5.0 microm (nominal diameter) in rigid, nonporous package systems, such as prefilled glass syringes. The current study compared USP, Ph.Eur. and ISO dye ingress integrity test methods to PTI's vacuum decay technology for the detection of these same 5-, 10-, and 15-microm laser-drilled hole defects in 1-mL glass prefilled syringes. The study was performed at three test sites using several inspectors and a variety of inspection conditions. No standard dye ingress method was found to reliably identify all holed syringes. Modifications to these standard dye tests' challenge conditions increased the potential for dye ingress, and adjustments to the visual inspection environment improved dye ingress detection. However, the risk of false positive test results with dye ingress tests remained. In contrast, the nondestructive vacuum decay leak test method reliably identified syringes with holes > or = 5.0 microm.

  7. Examination of Shipping Packages 9975-02694 and 9975-02729

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Daugherty, W.

    SRNL has assisted in the examination of two 9975 shipping packages (9975-02694 and 9975-02729) following their use for storage of nuclear material in K-Area Complex (KAC). Both of these were targeted for examination because they were exposed to water from a leaking expansion joint during storage. When first opened in KAC, the axial gap was found to be in excess of the 1 inch maximum criterion, signaling the potential for degradation of the fiberboard overpack and drum. Within each package the highest fiberboard moisture levels were observed in the bottom layers, but no mold was observed in either package. Themore » fiberboard in each package appeared to retain good integrity consistent with non-degraded material. Minor corrosion was also observed on these drums along the lower stitch welds and on several closure bolts.« less

  8. Leaflet area as a determinant of tricuspid regurgitation severity in patients with pulmonary hypertension.

    PubMed

    Afilalo, Jonathan; Grapsa, Julia; Nihoyannopoulos, Petros; Beaudoin, Jonathan; Gibbs, J Simon R; Channick, Richard N; Langleben, David; Rudski, Lawrence G; Hua, Lanqi; Handschumacher, Mark D; Picard, Michael H; Levine, Robert A

    2015-05-01

    Tricuspid regurgitation (TR) is a risk factor for mortality in pulmonary hypertension (PH). TR severity varies among patients with comparable degrees of PH and right ventricular remodeling. The contribution of leaflet adaptation to the pathophysiology of TR has yet to be examined. We hypothesized that tricuspid leaflet area (TLA) is increased in PH, and that the adequacy of this increase relative to right ventricular remodeling determines TR severity. A prospective cohort of 255 patients with PH from pre and postcapillary pathogeneses was assembled from 2 centers. Patients underwent a 3-dimensional echocardiogram focused on the tricuspid apparatus. TLA was measured with the Omni 4D software package. Compared with normal controls, patients with PH had a 2-fold increase in right ventricular volumes, 62% increase in annular area, and 49% increase in TLA. Those with severe TR demonstrated inadequate increase in TLA relative to the closure area, such that the ratio of TLA:closure area <1.78 was highly predictive of severe TR (odds ratio, 68.7; 95% confidence interval, 16.2-292.7). The median vena contracta width was 8.5 mm in the group with small TLA and large closure area as opposed to 4.8 mm in the group with large TLA and large closure area. TLA plays a significant role in determining which patients with PH develop severe functional TR. The ratio of TLA:closure area, reflecting the balance between leaflet adaptation versus annular dilation and tethering forces, is an indicator of TR severity that may identify which patients stand to benefit from leaflet augmentation during tricuspid valve repair. © 2015 American Heart Association, Inc.

  9. 49 CFR 173.188 - White or yellow phosphorus.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... pound) of phosphorus with screw-top closures; or (2) Steel drums (1A1) not over 250 L (66 gallons... solid and shipped in packagings as follows: (1) Steel drums (1A2) not over 115 L (30 gallons) capacity...

  10. USING A CONTAINMENT VESSEL LIFTING APPARATUS FOR REMOTE OPERATIONS OF SHIPPING PACKAGES

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Loftin, Bradley; Koenig, Richard

    2013-08-08

    The 9977 and the 9975 shipping packages are used in various nuclear facilities within the Department of Energy. These shipping packages are often loaded in designated areas with designs using overhead cranes or A-frames with lifting winches. However, there are cases where loading operations must be performed in remote locations where these facility infrastructures do not exist. For these locations, a lifting apparatus has been designed to lift the containment vessels partially out of the package for unloading operations to take place. Additionally, the apparatus allows for loading and closure of the containment vessel and subsequent pre-shipment testing. This papermore » will address the design of the apparatus and the challenges associated with the design, and it will describe the use of the apparatus.« less

  11. VALVES FOR THE HIGH PRESSURE-HIGH TEMPERATURE (HP-HT) FLUORINATION SYSTEM. (Engineering Materials)

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    None

    1963-10-31

    This package contains two drawings of valves which eliminate errors in the gravimetric oxide dilution procedure of U/sup 235/ measurement. Isotopic contaminatioNonen in the high pressure fluorination reactor was corrected by changing the manner in which the Cu tubing joins the valve and by modification of the bellows. The compact inlet system was modified to improve the precision of the spectrometer analyses. Changes were raade in the basic leak and the air operator, which is a diaphragm-type valve, so that the setting of the flow level is controlled by the closure spring adjustment screw. This capillary-type leak has increased controlmore » range and sraooth control characteristics. It is simple to construct, is remotely operated and is free from corrosion failure. (F.S.)« less

  12. Packaging Considerations for Biopreservation

    PubMed Central

    Woods, Erik J.; Thirumala, Sreedhar

    2011-01-01

    Summary The packaging system chosen for biopreservation is critical for many reasons. An ideal biopreservation container system must provide for closure integrity, sample stability and ready access to the preserved material. This means the system needs to be hermetically sealed to ensure integrity of the specimen is maintained throughout processing, storage and distribution; the system must remain stable over long periods of time as many biobanked samples may be stored indefinitely; and functionally closed access systems must be used to avoid contamination upon sample withdraw. This study reviews the suitability of a new commercially available vial configuration container utilizing blood bag style closure and access systems that can be hermetically sealed and remain stable through cryopreservation and biobanking procedures. This vial based systems allow for current good manufacturing/tissue practice (cGTP) requirements during processing of samples and may provide the benefit of ease of delivery by a care giver. In this study, the CellSeal® closed system cryovial was evaluated and compared to standard screw cap vials. The CellSeal system was evaluated for durability, closure integrity through transportation and maintenance of functional viability of a cryopreserved mesenchymal stem cell model. The results of this initial proof-of-concept study indicated that the CellSeal vials are highly suitable for biopreservation and biobanking, and provide a suitable container system for clinical and commercial cell therapy products frozen in small volumes. PMID:21566715

  13. 10 CFR 71.87 - Routine determinations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

  14. 10 CFR 71.87 - Routine determinations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

  15. 10 CFR 71.87 - Routine determinations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

  16. 10 CFR 71.87 - Routine determinations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

  17. 10 CFR 71.87 - Routine determinations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

  18. 49 CFR 178.601 - General requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... proportion to the reduction in volume. (4) Variation 4. Variations are permitted in outer packagings of a... steel; (viii) An increase greater than 10% or any decrease in the steel thickness of the head, body, or... body), type (e.g., mechanically seamed or welded flange), and materials of closure (other than the...

  19. 49 CFR 178.601 - General requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... proportion to the reduction in volume. (4) Variation 4. Variations are permitted in outer packagings of a... steel; (viii) An increase greater than 10% or any decrease in the steel thickness of the head, body, or... body), type (e.g., mechanically seamed or welded flange), and materials of closure (other than the...

  20. 49 CFR 178.601 - General requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... proportion to the reduction in volume. (4) Variation 4. Variations are permitted in outer packagings of a... steel; (viii) An increase greater than 10% or any decrease in the steel thickness of the head, body, or... body), type (e.g., mechanically seamed or welded flange), and materials of closure (other than the...

  1. Technical and Regulatory Considerations in Using Freight Containers as Industrial Packages

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hawk, Mark B; Opperman, Erich; Natali, Ronald

    2008-01-01

    The US Department of Energy (DOE), Office of Environmental Management (EM), is actively pursuing activities to reduce the radiological risk and clean up the environmental legacy of the nation's nuclear weapons programmes. The EM has made significant progress in recent years in the clean-up and closure of sites and is also focusing on longer term activities necessary for the completion of the clean-up programme. The packaging and transportation of contaminated demolition debris and low level waste materials in a safe and cost effective manner are essential in completing this mission. Toward this end, the US Department of Transportation's Final Rulemore » on Hazardous Materials Regulation issued on 26 January 2004, included a new provision authorising the use of freight containers (e.g. 20 and 40 ft ISO containers) as industrial packages type 2 or 3. This paper will discuss the technical and regulatory considerations in using these newly authorised and large packages for the packaging and transportation of low level waste materials.« less

  2. 49 CFR 178.603 - Drop test.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... aluminum boxes, Composite packagings which are in the shape of a box Five—(one for each drop) First drop... impact. Where more than one orientation is possible for a given drop test, the orientation most likely to... example a closure or, for some 7 cylindrical drums, the welded longitudinal seam of the drum body. Boxes...

  3. 10 CFR 60.134 - Design of seals for shafts and boreholes.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... boreholes shall be designed so that following permanent closure they do not become pathways that compromise... pathway for groundwater to contact the waste packages or (2) For radionuclide migration through existing pathways. [48 FR 28222, June 21, 1983, as amended at 50 FR 29648, July 22, 1985] Design Criteria for the...

  4. 10 CFR 60.134 - Design of seals for shafts and boreholes.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... boreholes shall be designed so that following permanent closure they do not become pathways that compromise... pathway for groundwater to contact the waste packages or (2) For radionuclide migration through existing pathways. [48 FR 28222, June 21, 1983, as amended at 50 FR 29648, July 22, 1985] Design Criteria for the...

  5. 10 CFR 60.134 - Design of seals for shafts and boreholes.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... boreholes shall be designed so that following permanent closure they do not become pathways that compromise... pathway for groundwater to contact the waste packages or (2) For radionuclide migration through existing pathways. [48 FR 28222, June 21, 1983, as amended at 50 FR 29648, July 22, 1985] Design Criteria for the...

  6. 9 CFR 354.244 - Temperatures and cooling and freezing procedures.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... wrapped or packaged in water-vapor resistant cartons or the containers should be lined with heavy water... carcasses and to permit unsealed closure or sealing in such a manner that water-vapor loss from the product... cooling tank containing running cold tap water to remove the animal heat from the carcass. Carcasses shall...

  7. 9 CFR 354.244 - Temperatures and cooling and freezing procedures.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... wrapped or packaged in water-vapor resistant cartons or the containers should be lined with heavy water... carcasses and to permit unsealed closure or sealing in such a manner that water-vapor loss from the product... cooling tank containing running cold tap water to remove the animal heat from the carcass. Carcasses shall...

  8. 9 CFR 354.244 - Temperatures and cooling and freezing procedures.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... wrapped or packaged in water-vapor resistant cartons or the containers should be lined with heavy water... carcasses and to permit unsealed closure or sealing in such a manner that water-vapor loss from the product... cooling tank containing running cold tap water to remove the animal heat from the carcass. Carcasses shall...

  9. 9 CFR 354.244 - Temperatures and cooling and freezing procedures.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... wrapped or packaged in water-vapor resistant cartons or the containers should be lined with heavy water... carcasses and to permit unsealed closure or sealing in such a manner that water-vapor loss from the product... cooling tank containing running cold tap water to remove the animal heat from the carcass. Carcasses shall...

  10. Underground Architecture and Layout for the Belgian High-Level and Long-Lived Intermediate-Level Radioactive Waste Disposal Facility- 12116

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Van Cotthem, Alain; Van Humbeeck, Hughes; Biurrun, Enrique

    The underground architecture and layout of the proposed Belgian high-level (HLW) and long-lived, intermediate-level radioactive wastes (ILW-LL) disposal system (repository) is mainly based on lessons learned during the development and 30-year-long operation of an underground research laboratory (URL) ('HADES') located adjacent to the city of Mol at a depth of 225 m in a 100-m-thick, Tertiary clay formation; the Boom clay. The following main operational and safety challenges are addressed in the proposed architecture and layout: 1. Following excavation, the underground openings needed to be promptly supported to minimize the extent of the excavation damaged zone (EDZ). 2. The sizemore » and unsupported stand-up time at tunnel crossings/intersections also needed to be minimized to minimize the extent of the related EDZ. 3. Steel components had to be minimized to limit the related long-term (post-closure) corrosion and hydrogen production. 4. The shafts and all equipment had to go down through a 180-m-thick aquifer and handle up to 65-Ton payloads. 5. The shaft seals had to be placed in the underlying clay layer. The currently proposed layout minimizes the excavated volume based on strict long-term-safety criteria and optimizes operational safety. Operational safety is further enhanced by a remote-controlled waste-package-handling system transporting the waste packages from their respective surface location down to their respective disposal location with no intermediate operation. The related on-site preparation and thenceforth use of cement-based, waste package- transportation containers are integral operational-safety components. In addition to strengthening the waste packages and providing radiation protection, these containers also provide long-term corrosion protection of the internal 'primary' steel packages. (authors)« less

  11. Transition and closeout of the Fernald Closure Project

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Bilson, H.E.; Terry, T.; Reising, J.

    The U.S. Department of Energy (DOE) and Fluor Fernald have completed the majority of the cleanup of the Fernald Site. The over 1,000 acre complex for processing uranium has been demolished and soil contamination has been remediated. With acres of wetlands and prairies replacing the buildings and waste pits. At the end of the project the focus shifted to developing demonstrating the completion of the project and the contract, as well as ensuring a smooth transition of the facility from the DOE's Environmental Management (EM) Program to the DOE's Legacy Management (LM) Program. Working with the DOE, each portion ofmore » the closure contract was examined for specific closure definition. From this negotiation effort the Comprehensive Exit and Transition Plan (CE/T Plan) was written. The CE/T Plan is intended to assist DOE in the analysis that the site is ready for transfer into long-term stewardship (LTS) (also referred to as legacy management) and that Fluor Fernald, Inc. has satisfactorily completed the closure contract statement of work elements. Following the Lessons Learned from the closure of the Rocky Flats Site, the DOE's Legacy Management Program created a matrix of Transition Elements required to ensure adequate information was in place to allow the new prime contractor to perform the Legacy Management scope of work. The transition plan included over 1,000 elements broken down into functional areas and relied on specific Fernald Responsibility Transition Packages (RTPs) for detailed transition actions. The template for Closure and Transition Planning used at the Fernald Site was developed using the best Lessons Learned from across the DOE Complex. The template could be used for other sites, and lessons learned from this closure and transition will be appropriate for all closure projects. (authors)« less

  12. 21 CFR 212.1 - What are the meanings of the technical terms used in these regulations?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... permit the use of a component, container and closure, in-process material, packaging material, or..., and Cosmetic Act, as amended (21 U.S.C. 321 et seq.). Active pharmaceutical ingredient means a... ingredient means any intended component of the PET drug other than the active pharmaceutical ingredient. In...

  13. Positive Catch & Economic Benefits of Periodic Octopus Fishery Closures: Do Effective, Narrowly Targeted Actions 'Catalyze' Broader Management?

    PubMed

    Oliver, Thomas A; Oleson, Kirsten L L; Ratsimbazafy, Hajanaina; Raberinary, Daniel; Benbow, Sophie; Harris, Alasdair

    2015-01-01

    Eight years of octopus fishery records from southwest Madagascar reveal significant positive impacts from 36 periodic closures on: (a) fishery catches and (b) village fishery income, such that (c) economic benefits from increased landings outweigh costs of foregone catch. Closures covered ~20% of a village's fished area and lasted 2-7 months. Octopus landings and catch per unit effort (CPUE) significantly increased in the 30 days following a closure's reopening, relative to the 30 days before a closure (landings: +718%, p<0.0001; CPUE: +87%, p<0.0001; n = 36). Open-access control sites showed no before/after change when they occurred independently of other management ("no ban", n = 17/36). On the other hand, open-access control sites showed modest catch increases when they extended a 6-week seasonal fishery shutdown ("ban", n = 19/36). The seasonal fishery shutdown affects the entire region, so confound all potential control sites. In villages implementing a closure, octopus fishery income doubled in the 30 days after a closure, relative to 30 days before (+132%, p<0.001, n = 28). Control villages not implementing a closure showed no increase in income after "no ban" closures and modest increases after "ban" closures. Villages did not show a significant decline in income during closure events. Landings in closure sites generated more revenue than simulated landings assuming continued open-access fishing at that site (27/36 show positive net earnings; mean +$305/closure; mean +57.7% monthly). Benefits accrued faster than local fishers' time preferences during 17-27 of the 36 closures. High reported rates of illegal fishing during closures correlated with poor economic performance. We discuss the implications of our findings for broader co-management arrangements, particularly for catalyzing more comprehensive management.

  14. The role of a detailed aqueous phase source release model in the LANL area G performance assessment

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Vold, E.L.; Shuman, R.; Hollis, D.K.

    1995-12-31

    A preliminary draft of the Performance Assessment for the Los Alamos National Laboratory (LANL) low-level radioactive waste disposal facility at Area G is currently being completed as required by Department of Energy orders. A detailed review of the inventory data base records and the existing models for source release led to the development of a new modeling capability to describe the liquid phase transport from the waste package volumes. Nuclide quantities are sorted down to four waste package release categories for modeling: rapid release, soil, concrete/sludge, and corrosion. Geochemistry for the waste packages was evaluated in terms of the equilibriummore » coefficients, Kds, and elemental solubility limits, Csl, interpolated from the literature. Percolation calculations for the base case closure cover show a highly skewed distribution with an average of 4 mm/yr percolation from the disposal unit bottom. The waste release model is based on a compartment representation of the package efflux, and depends on package size, percolation rate or Darcy flux, retardation coefficient, and moisture content.« less

  15. TECHNICAL AND REGULATORY CONSIDERATIONS IN USING FREIGHT CONTAINERS AS INDUSTRIAL PACKAGES

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Opperman, E; Mark Hawk, M; Ron Natali, R

    2007-10-16

    The United States (US) Department of Energy (DOE), Office of Environmental Management (EM), is actively pursuing activities to reduce the radiological risk and clean up the environmental legacy of the nation's nuclear weapons programs. EM has made significant progress in recent years in the clean-up and closure of sites and is also focusing on longer-term activities necessary for the completion of the clean-up program. The packaging and transportation of contaminated demolition debris and low-level waste (LLW) materials in a safe and cost-effective manner are essential in completing this mission. Toward this end, the US Department of Transportation's (DOT) Final Rulemore » on Hazardous Materials Regulation Final Rule issued January 26, 2004, included a new provision authorizing the use of Freight Containers (e.g., 20 and 40-foot ISO Containers) as Industrial Packages Type 1, 2, or 3 (IP-1, IP-2, and IP-3). This paper will discuss the technical and regulatory considerations in using these newly authorized and large packages for the packaging and transportation of LLW materials.« less

  16. Groundwater Data Package for Hanford Assessments

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Thorne, Paul D.; Bergeron, Marcel P.; Williams, Mark D.

    2006-01-31

    This report presents data and interpreted information that supports the groundwater module of the System Assessment Capability (SAC) used in Hanford Assessments. The objective of the groundwater module is to predict movement of radioactive and chemical contaminants through the aquifer to the Columbia River or other potential discharge locations. This data package is being revised as part of the deliverables under the Characterization of Systems Project (#49139) aimed at providing documentation for assessments being conducted under the Hanford Assessments Project (#47042). Both of these projects are components of the Groundwater Remediation and Closure Assessments Projects, managed by the Management andmore » Integration Project (#47043).« less

  17. KSC-05PD-1449

    NASA Technical Reports Server (NTRS)

    2005-01-01

    KENNEDY SPACE CENTER, FLA. At Launch Pad 39B, the Orbiter Boom Sensor System (OBSS) sensor package is viewed before the orbiter's payload bay doors are closed for launch. Payload bay door closure is a significant milestone in the preparations of Discovery for the first Return to Flight mission, STS-114. This sensor package will provide surface area and depth defect inspection for all the surfaces of the orbiter. It includes an intensified television camera (ITVC) and a laser dynamic range imager, which are mounted on a pan and tilt unit, and a laser camera system (LCS) mounted on a stationary bracket. The package is part of the new safety measures added for all future Space Shuttle missions. During its 12-day mission, Discoverys seven- person crew will test new hardware and techniques to improve Shuttle safety, as well as deliver supplies to the International Space Station. Discoverys payloads include the Multi-Purpose Logistics Module Raffaello, the Lightweight Multi-Purpose Experiment Support Structure Carrier (LMC), and the External Stowage Platform-2 (ESP-2). Raffaello will deliver supplies to the International Space Station including food, clothing and research equipment. The LMC supports a replacement Control Moment Gyroscope and a tile repair sample box. The ESP-2 is outfitted with replacement parts. Launch of mission STS-114 was set for July 13 at the conclusion of the Flight Readiness Review yesterday.

  18. Report to Congress on the potential use of lead in the waste packages for a geologic repository at Yucca Mountain, Nevada

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    1989-12-01

    In the Report of the Senate Committee on Appropriations accompanying the Energy and Water Appropriation Act for 1989, the Committee directed the Department of Energy (DOE) to evaluate the use of lead in the waste packages to be used in geologic repositories for spent nuclear fuel and high-level waste. The evaluation that was performed in response to this directive is presented in this report. This evaluation was based largely on a review of the technical literature on the behavior of lead, reports of work conducted in other countries, and work performed for the waste-management program being conducted by the DOE.more » The initial evaluation was limited to the potential use of lead in the packages to be used in the repository. Also, the focus of this report is post closure performance and not on retrievability and handling aspects of the waste package. 100 refs., 8 figs., 15 tabs.« less

  19. TRACE Model for Simulation of Anticipated Transients Without Scram in a BWR

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Cheng L. Y.; Baek J.; Cuadra,A.

    2013-11-10

    A TRACE model has been developed for using theTRACE/PARCS computational package [1, 2] to simulate anticipated transients without scram (ATWS) events in a boiling water reactor (BWR). The model represents a BWR/5 housed in a Mark II containment. The reactor and the balance of plant systems are modeled in sufficient detail to enable the evaluation of plant responses and theeffectiveness of automatic and operator actions tomitigate this beyond design basis accident.The TRACE model implements features thatfacilitate the simulation of ATWS events initiated by turbine trip and closure of the main steam isolation valves (MSIV). It also incorporates control logic tomore » initiate actions to mitigate the ATWS events, such as water levelcontrol, emergency depressurization, and injection of boron via the standby liquid control system (SLCS). Two different approaches have been used to model boron mixing in the lower plenum of the reactor vessel: modulate coolant flow in the lower plenum by a flow valve, and use control logic to modular.« less

  20. Qualitative evaluation of the iris and ciliary body by ultrasound biomicroscopy in subjects with angle closure.

    PubMed

    Ku, Judy Y; Nongpiur, Monisha E; Park, Judy; Narayanaswamy, Arun K; Perera, Shamira A; Tun, Tin A; Kumar, Rajesh S; Baskaran, Mani; Aung, Tin

    2014-12-01

    To qualitatively analyze anterior chamber structures imaged by ultrasound biomicroscopy (UBM) in primary angle-closure patients. Subjects diagnosed as primary angle-closure suspect (PACS), primary angle-closure glaucoma (PACG), and previous acute primary angle closure (APAC) were recruited prospectively along with a group of normal controls. UBM was performed under standardized dark room conditions and qualitative assessment was carried out using a set of reference photographs of standard UBM images to categorize the various anatomic features related to angle configuration. These included overall and basal iris thicknesses, iris convexity, iris angulation, ciliary body size, and ciliary sulcus. A total of 60 PACS, 114 PACG, 41 APAC, and 33 normal controls were included. Patients were predominantly older Chinese females. After controlling the confounding effect of age and sex, eyes with overall thicker irides [medium odds ratio (OR) 3.58, thick OR 2.84] when compared with thin irides have a significantly higher likelihood of having PACS/PACG/APAC versus controls. Thicker basal iris component (medium OR 4.13, thick OR 3.39) also have higher likelihood of having angle closure when compared with thin basal iris thickness. Subjects with basal iris insertion, mild iris angulation, and large ciliary body have a higher OR of having angle closure. In contrast, the presence/absence of a ciliary sulcus did not influence the likelihood of angle closure. Eyes with thicker overall and basal iris thicknesses are more likely to have angle closure than controls. Other features that increase the likelihood of angle closure include basal iris insertion, mild iris angulation, and large ciliary body.

  1. Positive Catch & Economic Benefits of Periodic Octopus Fishery Closures: Do Effective, Narrowly Targeted Actions ‘Catalyze’ Broader Management?

    PubMed Central

    Oliver, Thomas A.; Oleson, Kirsten L. L.; Ratsimbazafy, Hajanaina; Raberinary, Daniel; Benbow, Sophie; Harris, Alasdair

    2015-01-01

    Overview Eight years of octopus fishery records from southwest Madagascar reveal significant positive impacts from 36 periodic closures on: (a) fishery catches and (b) village fishery income, such that (c) economic benefits from increased landings outweigh costs of foregone catch. Closures covered ~20% of a village’s fished area and lasted 2-7 months. Fishery Catches from Each Closed Site Octopus landings and catch per unit effort (CPUE) significantly increased in the 30 days following a closure’s reopening, relative to the 30 days before a closure (landings: +718%, p<0.0001; CPUE: +87%, p<0.0001; n = 36). Open-access control sites showed no before/after change when they occurred independently of other management (“no ban”, n = 17/36). On the other hand, open-access control sites showed modest catch increases when they extended a 6-week seasonal fishery shutdown (“ban”, n = 19/36). The seasonal fishery shutdown affects the entire region, so confound all potential control sites. Fishery Income in Implementing Villages In villages implementing a closure, octopus fishery income doubled in the 30 days after a closure, relative to 30 days before (+132%, p<0.001, n = 28). Control villages not implementing a closure showed no increase in income after “no ban” closures and modest increases after “ban” closures. Villages did not show a significant decline in income during closure events. Net Economic Benefits from Each Closed Site Landings in closure sites generated more revenue than simulated landings assuming continued open-access fishing at that site (27/36 show positive net earnings; mean +$305/closure; mean +57.7% monthly). Benefits accrued faster than local fishers’ time preferences during 17-27 of the 36 closures. High reported rates of illegal fishing during closures correlated with poor economic performance. Broader Co-Management We discuss the implications of our findings for broader co-management arrangements, particularly for catalyzing more comprehensive management. PMID:26083862

  2. Flammability Analysis For Actinide Oxides Packaged In 9975 Shipping Containers

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Laurinat, James E.; Askew, Neal M.; Hensel, Steve J.

    2013-03-21

    Packaging options are evaluated for compliance with safety requirements for shipment of mixed actinide oxides packaged in a 9975 Primary Containment Vessel (PCV). Radiolytic gas generation rates, PCV internal gas pressures, and shipping windows (times to reach unacceptable gas compositions or pressures after closure of the PCV) are calculated for shipment of a 9975 PCV containing a plastic bottle filled with plutonium and uranium oxides with a selected isotopic composition. G-values for radiolytic hydrogen generation from adsorbed moisture are estimated from the results of gas generation tests for plutonium oxide and uranium oxide doped with curium-244. The radiolytic generation ofmore » hydrogen from the plastic bottle is calculated using a geometric model for alpha particle deposition in the bottle wall. The temperature of the PCV during shipment is estimated from the results of finite element heat transfer analyses.« less

  3. 76 FR 17964 - Renewal of Agency Information Collection for Home-Living Programs and School Closure and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-31

    ... School Closure and Consolidation, currently authorized by OMB Control Number 1076-0164, to the Office of... do so. III. Data OMB Control Number: 1076-0164. Title: Home-living Programs and School Closure and...

  4. Vacuum decay container/closure integrity testing technology. Part 1. ASTM F2338-09 precision and bias studies.

    PubMed

    Wolf, Heinz; Stauffer, Tony; Chen, Shu-Chen Y; Lee, Yoojin; Forster, Ronald; Ludzinski, Miron; Kamat, Madhav; Godorov, Phillip; Guazzo, Dana Morton

    2009-01-01

    ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method is applicable for leak-testing rigid and semi-rigid non-lidded trays; trays or cups sealed with porous barrier lidding materials; rigid, nonporous packages; and flexible, nonporous packages. Part 1 of this series describes the precision and bias studies performed in 2008 to expand this method's scope to include rigid, nonporous packages completely or partially filled with liquid. Round robin tests using three VeriPac 325/LV vacuum decay leak testers (Packaging Technologies & Inspection, LLC, Tuckahoe, NY) were performed at three test sites. Test packages were 1-mL glass syringes. Positive controls had laser-drilled holes in the barrel ranging from about 5 to 15 microm in nominal diameter. Two different leak tests methods were performed at each site: a "gas leak test" performed at 250 mbar (absolute) and a "liquid leak test" performed at about 1 mbar (absolute). The gas leak test was used to test empty, air-filled syringes. All defects with holes > or = 5.0 microm and all no-defect controls were correctly identified. The only false negative result was attributed to a single syringe with a < 5.0-microm hole. Tests performed using a calibrated air leak supported a 0.10-cm3 x min(-1) (ccm) sensitivity limit (99/99 lower tolerance limit). The liquid leak test was used to test both empty, air-filled syringes and water-filled syringes. Test results were 100% accurate for all empty and water-filled syringes, both without holes and with holes (5, 10, and 15 microm). Tests performed using calibrated air flow leaks of 0, 0.05, and 0.10 ccm were also 100% accurate; data supported a 0.10-ccm sensitivity limit (99/99 lower tolerance limit). Quantitative differential pressure results strongly correlated to hole size using either liquid or gas vacuum decay leak tests. The higher vacuum liquid leak test gave noticeably higher pressure readings when water was present in the defect. Both the ASTM F2338-09 test method and the precision and bias study report are available by contacting ASTM International in West Conshohocken, PA, USA (www.astm.org).

  5. Silicone-oil-based subvisible particles: their detection, interactions, and regulation in prefilled container closure systems for biopharmaceuticals.

    PubMed

    Felsovalyi, Flora; Janvier, Sébastien; Jouffray, Sébastien; Soukiassian, Hervé; Mangiagalli, Paolo

    2012-12-01

    Recent increased regulatory scrutiny concerning subvisible particulates (SbVPs) in parenteral formulations of biologics has led to the publication of numerous articles about the sources, characteristics, implications, and approaches to monitoring and detecting SbVPs. Despite varying opinions on the level of associated risks and method of regulation, nearly all industry scientists and regulators agree on the need for monitoring and reporting visible and subvisible particles. As prefillable drug delivery systems have become a prominent packaging option, silicone oil, a common primary packaging lubricant, may play a role in the appearance of particles. The goal of this article is to complement the current SbVP knowledge base with new insights into the evolution of silicone-oil-related particulates and their interactions with components in prefillable systems. We propose a "toolbox" for improved silicone-oil-related particulate detection and enumeration, and discuss the benefits and limitations of approaches for lowering and controlling silicone oil release in parenterals. Finally, we present surface cross-linking of silicone as the recommended solution for achieving significant SbVP reduction without negatively affecting functional performance. Copyright © 2012 Wiley Periodicals, Inc.

  6. Adequacy of a Small Quantity Site RH-TRU Waste Program in Meeting Proposed WIPP Characterization Objectives

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Biedscheid, J.; Stahl, S.; Devarakonda, M.

    2002-02-26

    The first remote-handled transuranic (RH-TRU) waste is expected to be permanently disposed of at the Waste Isolation Pilot Plant (WIPP) during Fiscal Year (FY) 2003. The first RH-TRU waste shipments are scheduled from the Battelle Columbus Laboratories (BCL) to WIPP in order to facilitate compliance with BCL Decommissioning Project (BCLDP) milestones. Milestones requiring RH-TRU waste containerization and removal from the site by 2004 in order to meet a 2006 site closure goal, established by Congress in the Defense Facilities Closure Projects account, necessitated the establishment and implementation of a site-specific program to direct the packaging of BCLDP RH-TRU waste priormore » to the finalization of WIPP RH-TRU waste characterization requirements. The program was designed to collect waste data, including audio and videotape records of waste packaging, such that upon completion of waste packaging, comprehensive data records exist from which compliance with final WIPP RH-TRU waste characterization requirements can be demonstrated. With the BCLDP data records generated to date and the development by the U.S. Department of Energy (DOE)-Carlsbad Field Office (CBFO) of preliminary documents proposing the WIPP RH-TRU waste characterization program, it is possible to evaluate the adequacy of the BCLDP program with respect to meeting proposed characterization objectives. The BCLDP characterization program uses primarily acceptable knowledge (AK) and visual examination (VE) during waste packaging to characterize RH-TRU waste. These methods are used to estimate physical waste parameters, including weight percentages of metals, cellulosics, plastics, and rubber in the waste, and to determine the absence of prohibited items, including free liquids. AK combined with computer modeling is used to estimate radiological waste parameters, including total activity on a waste container basis, for the majority of BCLDP RH-TRU waste. AK combined with direct analysis is used to characterize radiological parameters for the small populations of the RH-TRU waste generated by the BCLDP. All characterization based on AK is verified. Per its design for comprehensive waste data collection, the BCLDP characterization program using AK and waste packaging procedures, including VE during packaging, meets the proposed WIPP RH-TRU waste characterization objectives. The conservative program design implemented generates certification data that will be adequate to meet any additional program requirements that may be imposed by the CBFO.« less

  7. Container Closure Integrity Testing of Prefilled Syringes.

    PubMed

    Peláez, Sarah S; Mahler, Hanns-Christian; Matter, Anja; Koulov, Atanas; Singh, Satish K; Germershaus, Oliver; Mathaes, Roman

    2018-04-05

    Prefilled syringes (PFSs) are increasingly preferred over vials as container closure systems (CCSs) for injectable drug products when facilitated or self-administration is required. However, PFSs are more complex compared to CCSs consisting of vial, rubber stopper, and crimp cap. Container closure integrity (CCI) assurance and verification has been a specific challenge for PFSs as they feature several sealing areas. A comprehensive understanding of the CCS is necessary for an appropriate CCI assessment as well as for packaging development and qualification. A comprehensive CCI assessment of 6 different PFSs from 3 different manufacturers (including 1 polymeric PFS) was conducted using helium leak testing. PFS components were manipulated to systematically assess the contribution of the different sealing areas to CCI, namely rigid needle shield (RNS)/needle, RNS/tip cone, and the individual ribs of a syringe plunger. The polymeric PFS required an equilibrium measurement for accurate container closure integrity testing. The different sealing areas and a single plunger rib were shown to provide adequate CCI. Acceptable tip cap movement until the point of CCI failure was estimated. The assessment of acceptable tip cap movement demonstrated the importance of considering the RNS/tip cone seal design to ensure CCI of the PFS upon post assembly possesses and shipment. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  8. KymoKnot: A web server and software package to identify and locate knots in trajectories of linear or circular polymers.

    PubMed

    Tubiana, Luca; Polles, Guido; Orlandini, Enzo; Micheletti, Cristian

    2018-06-07

    The KymoKnot software package and web server identifies and locates physical knots or proper knots in a series of polymer conformations. It is mainly intended as an analysis tool for trajectories of linear or circular polymers, but it can be used on single instances too, e.g. protein structures in PDB format. A key element of the software package is the so-called minimally interfering chain closure algorithm that is used to detect physical knots in open chains and to locate the knotted region in both open and closed chains. The web server offers a user-friendly graphical interface that identifies the knot type and highlights the knotted region on each frame of the trajectory, which the user can visualize interactively from various viewpoints. The dynamical evolution of the knotted region along the chain contour is presented as a kymograph. All data can be downloaded in text format. The KymoKnot package is licensed under the BSD 3-Clause licence. The server is publicly available at http://kymoknot.sissa.it/kymoknot/interactive.php .

  9. Primary closure versus delayed closure for non bite traumatic wounds within 24 hours post injury.

    PubMed

    Eliya-Masamba, Martha C; Banda, Grace W

    2013-10-22

    Acute traumatic wounds are one of the common reasons why people present to the emergency department. Primary closure has traditionally been reserved for traumatic wounds presenting within six hours of injury and considered 'clean' by the attending surgeon, with the rest undergoing delayed primary closure as a means of controlling wound infection. Primary closure has the potential benefit of rapid wound healing but poses the potential threat of increased wound infection. There is currently no evidence to guide clinical decision-making on the best timing for closure of traumatic wounds. To determine the effect on time to healing of primary closure versus delayed closure for non bite traumatic wounds presenting within 24 hours post injury. To explore the adverse effects of primary closure compared with delayed closure for non bite traumatic wounds presenting within 24 hours post injury. In May 2013, for this first update we searched the Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions with respect to language, date of publication or study setting. Randomised controlled trials comparing primary closure with delayed closure of non bite traumatic wounds. Two review authors independently evaluated the results of the searches against the inclusion criteria. No studies met the inclusion criteria for this review. Since no studies met the inclusion criteria, neither a meta-analysis nor a narrative description of studies was possible. There is currently no systematic evidence to guide clinical decision-making regarding the timing for closure of traumatic wounds. There is a need for robust research to investigate the effect of primary closure compared with delayed closure for non bite traumatic wounds presenting within 24 hours of injury.

  10. Control of aperture closure during reach-to-grasp movements in parkinson’s disease

    PubMed Central

    Rand, M. K.; Smiley-Oyen, A. L.; Shimansky, Y. P.; Bloedel, J. R.; Stelmach, G. E.

    2007-01-01

    This study examined whether the pattern of coordination between arm-reaching toward an object (hand transport) and the initiation of aperture closure for grasping is different between PD patients and healthy individuals, and whether that pattern is affected by the necessity to quickly adjust the reach-to-grasp movement in response to an unexpected shift of target location. Subjects reached for and grasped a vertical dowel, the location of which was indicated by illuminating one of the three dowels placed on a horizontal plane. In control conditions, target location was fixed during the trial. In perturbation conditions, target location was shifted instantaneously by switching the illumination to a different dowel during the reach. The hand distance from the target at which the subject initiated aperture closure (aperture closure distance) was similar for both the control and perturbation conditions within each group of subjects. However, that distance was significantly closer to the target in the PD group than in the control group. The timing of aperture closure initiation varied considerably across the trials in both groups of subjects. In contrast, aperture closure distance was relatively invariant, suggesting that aperture closure initiation was determined by spatial parameters of arm kinematics rather than temporal parameters. The linear regression analysis of aperture closure distance showed that the distance was highly predictable based on the following three parameters: the amplitude of maximum grip aperture, hand velocity, and hand acceleration. This result implies that a control law, the arguments of which include the above parameters, governs the initiation of aperture closure. Further analysis revealed that the control law was very similar between the subject groups under each condition as well as between the control and perturbation conditions for each group. Consequently, the shorter aperture closure distance observed in PD patients apparently is a result of the hypometria of their grip aperture and bradykinesia of hand transport movement, rather than a consequence of a deficit in transport-grasp coordination. It is also concluded that the perturbation of target location does not disrupt the transport-grasp coordination in either healthy individuals or PD patients. PMID:16307233

  11. Control of aperture closure during reach-to-grasp movements in Parkinson's disease.

    PubMed

    Rand, M K; Smiley-Oyen, A L; Shimansky, Y P; Bloedel, J R; Stelmach, G E

    2006-01-01

    This study examined whether the pattern of coordination between arm-reaching toward an object (hand transport) and the initiation of aperture closure for grasping is different between PD patients and healthy individuals, and whether that pattern is affected by the necessity to quickly adjust the reach-to-grasp movement in response to an unexpected shift of target location. Subjects reached for and grasped a vertical dowel, the location of which was indicated by illuminating one of the three dowels placed on a horizontal plane. In control conditions, target location was fixed during the trial. In perturbation conditions, target location was shifted instantaneously by switching the illumination to a different dowel during the reach. The hand distance from the target at which the subject initiated aperture closure (aperture closure distance) was similar for both the control and perturbation conditions within each group of subjects. However, that distance was significantly closer to the target in the PD group than in the control group. The timing of aperture closure initiation varied considerably across the trials in both groups of subjects. In contrast, aperture closure distance was relatively invariant, suggesting that aperture closure initiation was determined by spatial parameters of arm kinematics rather than temporal parameters. The linear regression analysis of aperture closure distance showed that the distance was highly predictable based on the following three parameters: the amplitude of maximum grip aperture, hand velocity, and hand acceleration. This result implies that a control law, the arguments of which include the above parameters, governs the initiation of aperture closure. Further analysis revealed that the control law was very similar between the subject groups under each condition as well as between the control and perturbation conditions for each group. Consequently, the shorter aperture closure distance observed in PD patients apparently is a result of the hypometria of their grip aperture and bradykinesia of hand transport movement, rather than a consequence of a deficit in transport-grasp coordination. It is also concluded that the perturbation of target location does not disrupt the transport-grasp coordination in either healthy individuals or PD patients.

  12. Recharge Data Package for Hanford Single-Shell Tank Waste Management Areas

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Fayer, Michael J.; Keller, Jason M.

    2007-09-24

    Pacific Northwest National Laboratory (PNNL) assists CH2M HILL Hanford Group, Inc., in its preparation of the Resource Conservation and Recovery Act (RCRA) Facility Investigation report. One of the PNNL tasks is to use existing information to estimate recharge rates for past and current conditions as well as future scenarios involving cleanup and closure of tank farms. The existing information includes recharge-relevant data collected during activities associated with a host of projects, including those of RCRA, the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the CH2M HILL Tank Farm Vadose Zone Project, and the PNNL Remediation and Closure Science Project.more » As new information is published, the report contents can be updated. The objective of this data package was to use published data to provide recharge estimates for the scenarios being considered in the RCRA Facility Investigation. Recharge rates were estimated for areas that remain natural and undisturbed, areas where the vegetation has been disturbed, areas where both the vegetation and the soil have been disturbed, and areas that are engineered (e.g., surface barrier). The recharge estimates supplement the estimates provided by PNNL researchers in 2006 for the Hanford Site using additional field measurements and model analysis using weather data through 2006.« less

  13. Procedures adopted by orthodontists for space closure and anchorage control.

    PubMed

    Monini, André da Costa; Gandini Júnior, Luiz Gonzaga; dos Santos-Pinto, Ary; Maia, Luiz Guilherme Martins; Rodrigues, Willian Caetano

    2013-01-01

    The aim of this study was to identify the procedures adopted by Brazilian orthodontists in the following situations: extraction space closure, anchorage control in case of necessary anchorage for group A and frequency of skeletal anchorage use, especially in the upper jaw. A questionnaire was sent to the e-mail address of all dentists registered in the Brazilian Federal Council of Dentistry. The results showed that most Brazilian orthodontists usually perform extraction space closure by means of sliding mechanics. The use of palatal bar, inclusion of second molars in the archwire and space closure performed in two phases are the most used techniques for anchorage control in the upper jaw. The skeletal anchorage is referenced by 36.5% of specialists as a routine practice for the upper arch anchorage. There is a wide variety of procedures adopted by Brazilian orthodontists for orthodontic space closure and anchorage control.

  14. An experimental-computational analysis of MHV cavitation: effects of leaflet squeezing and rebound.

    PubMed

    Makhijani, V B; Yang, H Q; Singhal, A K; Hwang, N H

    1994-04-01

    A combined experimental-computational study was performed to investigate the flow mechanics which could cause cavitation during the squeezing and rebounding phases of valve closure in the 29 mm mitral bileaflet Edwards-Duromedics (ED) mechanical heart valve (MHV). Leaflet closing motion was measured in vitro, and input into a computational fluid mechanics software package, CFD-ACE, to compute flow velocities and pressures in the small gap space between the occluder tip and valve housing. The possibility of cavitation inception was predicted when fluid pressures dropped below the saturated vapor pressure for blood plasma. The computational analysis indicated that cavitation is more likely to be induced during valve rebound rather than the squeezing phase of valve closure in the 29 mm ED-MHV. Also, there is a higher probability of cavitation at lower values of the gap width at the point of impact between the leaflet tip and housing. These predictions of cavitation inception are not likely to be significantly influenced by the water-hammer pressure gradient that develops during valve closure.

  15. ICPP tank farm closure study. Volume 2: Engineering design files

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    1998-02-01

    Volume 2 contains the following topical sections: Tank farm heel flushing/pH adjustment; Grouting experiments for immobilization of tank farm heel; Savannah River high level waste tank 20 closure; Tank farm closure information; Clean closure of tank farm; Remediation issues; Remote demolition techniques; Decision concerning EIS for debris treatment facility; CERCLA/RCRA issues; Area of contamination determination; Containment building of debris treatment facility; Double containment issues; Characterization costs; Packaging and disposal options for the waste resulting from the total removal of the tank farm; Take-off calculations for the total removal of soils and structures at the tank farm; Vessel off-gas systems; Jet-groutedmore » polymer and subsurface walls; Exposure calculations for total removal of tank farm; Recommended instrumentation during retrieval operations; High level waste tank concrete encasement evaluation; Recommended heavy equipment and sizing equipment for total removal activities; Tank buoyancy constraints; Grout and concrete formulas for tank heel solidification; Tank heel pH requirements; Tank cooling water; Evaluation of conservatism of vehicle loading on vaults; Typical vault dimensions and approximately tank and vault void volumes; Radiological concerns for temporary vessel off-gas system; Flushing calculations for tank heels; Grout lift depth analysis; Decontamination solution for waste transfer piping; Grout lift determination for filling tank and vault voids; sprung structure vendor data; Grout flow properties through a 2--4 inch pipe; Tank farm load limitations; NRC low level waste grout; Project data sheet calculations; Dose rates for tank farm closure tasks; Exposure and shielding calculations for grout lines; TFF radionuclide release rates; Documentation of the clean closure of a system with listed waste discharge; and Documentation of the ORNL method of radionuclide concentrations in tanks.« less

  16. Environmental scan of infection prevention and control practices for containment of hospital-acquired infectious disease outbreaks in acute care hospital settings across Canada.

    PubMed

    Ocampo, Wrechelle; Geransar, Rose; Clayden, Nancy; Jones, Jessica; de Grood, Jill; Joffe, Mark; Taylor, Geoffrey; Missaghi, Bayan; Pearce, Craig; Ghali, William; Conly, John

    2017-10-01

    Ward closure is a method of controlling hospital-acquired infectious diseases outbreaks and is often coupled with other practices. However, the value and efficacy of ward closures remains uncertain. To understand the current practices and perceptions with respect to ward closure for hospital-acquired infectious disease outbreaks in acute care hospital settings across Canada. A Web-based environmental scan survey was developed by a team of infection prevention and control (IPC) experts and distributed to 235 IPC professionals at acute care sites across Canada. Data were analyzed using a mixed-methods approach of descriptive statistics and thematic analysis. A total of 110 completed responses showed that 70% of sites reported at least 1 outbreak during 2013, 44% of these sites reported the use of ward closure. Ward closure was considered an "appropriate," "sometimes appropriate," or "not appropriate" strategy to control outbreaks by 50%, 45%, and 5% of participants, respectively. System capacity issues and overall risk assessment were main factors influencing the decision to close hospital wards following an outbreak. Results suggest the use of ward closure for containment of hospital-acquired infectious disease outbreaks in Canadian acute care health settings is mixed, with outbreak control methods varying. The successful implementation of ward closure was dependent on overall support for the IPC team within hospital administration. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  17. High-voltage leak detection of a parenteral proteinaceous solution product packaged in form-fill-seal plastic laminate bags. Part 1. Method development and validation.

    PubMed

    Damgaard, Rasmus; Rasmussen, Mats; Buus, Peter; Mulhall, Brian; Guazzo, Dana Morton

    2013-01-01

    In Part 1 of this three-part research series, a leak test performed using high-voltage leak detection (HVLD) technology, also referred to as an electrical conductivity and capacitance leak test, was developed and validated for container-closure integrity verification of a small-volume laminate plastic bag containing an aqueous solution for injection. The sterile parenteral product is the rapid-acting insulin analogue, insulin aspart (NovoRapid®/NovoLog®, by Novo Nordisk A/S, Bagsværd, Denmark). The aseptically filled and sealed package is designed to preserve product sterility through expiry. Method development and validation work incorporated positive control packages with a single hole laser-drilled through the laminate film of each bag. A unique HVLD method characterized by specific high-voltage and potentiometer set points was established for testing bags positioned in each of three possible orientations as they are conveyed through the instrument's test zone in each of two possible directions-resulting in a total of six different test method options. Validation study results successfully demonstrated the ability of all six methods to accurately and reliably detect those packages with laser-drilled holes from 2.5-11.2 μm in nominal diameter. Part 2 of this series will further explore HVLD test results as a function of package seal and product storage variables. The final Part 3 will report the impact of HVLD exposure on product physico-chemical stability. In this Part 1 of a three-part research series, a leak test method based on electrical conductivity and capacitance, called high voltage leak detection (HVLD), was used to find leaks in small plastic bags filled with an insulin pharmaceutical solution for human injection by Novo Nordisk A/S (Bagsværd, Denmark). To perform the test, the package is electrically grounded while being conveyed past an electrode linked to a high-voltage, low-amperage transformer. The instrument measures the current that passes from the transformer to the electrode, through the packaged product and along the package walls, to the ground. Plastic packages without defect are relatively nonconductive and yield a low voltage reading; a leaking package with electrically conductive solution located in or near the leak triggers a spike in voltage reading. Test methods were optimized and validated, enabling the detection of leaking packages with holes as small as 2.5 μm in diameter. Part 2 of this series will further explore HVLD test results as a function of package seal and product storage variables. The final Part 3 will report the impact of HVLD exposure on product stability.

  18. 75 FR 26889 - Airworthiness Directives; Arrow Falcon Exporters, Inc. (previously Utah State University) et al...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

    ... the forward tip weight retention block (tip block) or aft tip closure (tip closure), loss of the blade...) forward tip weight retention block (tip block) and the aft tip closure (tip closure) for adhesive bond... prevent loss of a tip block or tip closure, loss of a blade, and subsequent loss of control of the...

  19. 40 CFR 265.404 - Closure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

  20. 40 CFR 265.404 - Closure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

  1. 40 CFR 265.404 - Closure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

  2. 40 CFR 265.404 - Closure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

  3. 40 CFR 265.404 - Closure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

  4. Presence of Polycyclic Aromatic Hydrocarbons in Rubber Packaging Materials and in Parenteral Formulations Stored in Bottles With Rubber Stoppers.

    PubMed

    Bohrer, Denise; Viana, Carine; Barichello, Marcia M; de Moura, Juliane F; de Carvalho, Leandro M; Nascimento, Paulo C

    2017-08-01

    Rubber closures are the primary packaging material for sterile preparations intended for repeated use. Important features of rubber closures are achieved after additives are added to the elastomeric material that compounds the rubber. Among these additives is carbon black. Because of its origin, carbon black may contain polycyclic aromatic hydrocarbons (PAHs). The U.S. Environmental Protection Agency has identified 16 priority PAHs on the basis of concerns that they cause or might cause cancer in animals and humans. Regulatory agencies impose carbon black purity specifications based on limits for total PAHs (0.5 mg/kg) and benzo[a]pyrene (5 μg/kg) or benzo[a]pyrene only (250 μg/kg). PAHs in rubber packaging used for pharmaceutical formulations and in parenteral products stored in containers with rubber stoppers were investigated. To this end, the method proposed by the National Institute for Occupational Safety and Health-based on high-performance liquid chromatography with ultraviolet and fluorescence detection-was adapted to determine the levels of PAHs in rubber stoppers (gray and red) and in lipid emulsions and amino acid solutions stored in bottles with rubber stoppers. The rubber materials were shown to contain 12 PAHs, in concentrations ranging from 0.25-3.31 µg/g. Only 1 of 18 samples (11 amino acid solutions and 7 lipid emulsions) was uncontaminated. The most prevalent contaminants were pyrene, benzo[a]pyrene, and fluoranthene. The total PAH concentrations in the samples ranged from 0.11-5.96 µg/mL. Components of parenteral nutrition may be contaminated with PAHs, and rubber stoppers represent a potential source of these contaminants.

  5. Closure Report for Corrective Action Unit 127: Areas 25 and 26 Storage Tanks, Nevada Test Site, Nevada

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NSTec Environmental Restoration

    CAU 127, Areas 25 and 26 Storage Tanks, consists of twelve CASs located in Areas 25 and 26 of the NTS. The closure alternatives included no further action, clean closure, and closure in place with administrative controls. The purpose of this Closure Report is to provide a summary of the completed closure activities, documentation of waste disposal, and analytical data to confirm that the remediation goals were met.

  6. Base Realignment and Closure (BRAC) Cleanup Plan for Fort Devens, Fort Devens, Massachusetts

    DTIC Science & Technology

    1994-04-07

    Landfill (AOCs 4, 5, 18, and 40) were identified in the MEP as the highest priority (Priority 1A) for remediation. As such, these sites proceeded...Spring Brook Landfills OUs, etc. 4.1.4 Environmental Restoration Early Actions Strategy The Site Investigation (SI) Data Package concept was developed...Approach for the Shepley’ s Hill and Cold Spring Brook Landfill Sites . Fort Devens. Massachusetts, prepared for USAEC; February. Ecology & Environment

  7. A Randomized Effectiveness Trial of a Systems Level Approach to Stepped Care for War Related PTSD

    DTIC Science & Technology

    2015-09-01

    treatment options, STEPS UP includes web- based cognitive behavioral self- management, telephone cognitive-behavioral therapy , continuous RN nurse...IRB closure report packages for the Ft. Campbell and Ft. Stewart sites because study activities are no longer physically occurring at the study sites...significantly associated with decreased physical symptom burden (as measured by the PHQ-15), improved mental health functioning (as measured by the SF

  8. Assessment of Residual Stresses in 3013 Inner and Outer Containers and Teardrop Samples

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Stroud, Mary Ann; Prime, Michael Bruce; Veirs, Douglas Kirk

    2015-12-08

    This report is an assessment performed by LANL that examines packaging for plutonium-bearing materials and the resilience of its design. This report discusses residual stresses in the 3013 outer, the SRS/Hanford and RFETS/LLNL inner containers, and teardrop samples used in studies to assess the potential for SCC in 3013 containers. Residual tensile stresses in the heat affected zones of the closure welds are of particular concern.

  9. Anterior Segment Imaging Predicts Incident Gonioscopic Angle Closure.

    PubMed

    Baskaran, Mani; Iyer, Jayant V; Narayanaswamy, Arun K; He, Yingke; Sakata, Lisandro M; Wu, Renyi; Liu, Dianna; Nongpiur, Monisha E; Friedman, David S; Aung, Tin

    2015-12-01

    To investigate the incidence of gonioscopic angle closure after 4 years in subjects with gonioscopically open angles but varying degrees of angle closure detected on anterior segment optical coherence tomography (AS OCT; Visante; Carl Zeiss Meditec, Dublin, CA) at baseline. Prospective, observational study. Three hundred forty-two subjects, mostly Chinese, 50 years of age or older, were recruited, of whom 65 were controls with open angles on gonioscopy and AS OCT at baseline, and 277 were cases with baseline open angles on gonioscopy but closed angles (1-4 quadrants) on AS OCT scans. All subjects underwent gonioscopy and AS OCT at baseline (horizontal and vertical single scans) and after 4 years. The examiner performing gonioscopy was masked to the baseline and AS OCT data. Angle closure in a quadrant was defined as nonvisibility of the posterior trabecular meshwork by gonioscopy and visible iridotrabecular contact beyond the scleral spur in AS OCT scans. Gonioscopic angle closure in 2 or 3 quadrants after 4 years. There were no statistically significant differences in age, ethnicity, or gender between cases and controls. None of the control subjects demonstrated gonioscopic angle closure after 4 years. Forty-eight of the 277 subjects (17.3%; 95% confidence interval [CI], 12.8-23; P < 0.0001) with at least 1 quadrant of angle closure on AS OCT at baseline demonstrated gonioscopic angle closure in 2 or more quadrants, whereas 28 subjects (10.1%; 95% CI, 6.7-14.6; P < 0.004) demonstrated gonioscopic angle closure in 3 or more quadrants after 4 years. Individuals with more quadrants of angle closure on baseline AS OCT scans had a greater likelihood of gonioscopic angle closure developing after 4 years (P < 0.0001, chi-square test for trend for both definitions of angle closure). Anterior segment OCT imaging at baseline predicts incident gonioscopic angle closure after 4 years among subjects who have gonioscopically open angles and iridotrabecular contact on AS OCT at baseline. Copyright © 2015 American Academy of Ophthalmology. All rights reserved.

  10. CLOSURE REPORT FOR CORRECTIVE ACTION UNIT 528: POLYCHLORINATED BIPHENYLS CONTAMINATION NEVADA TEST SITE, NEVADA

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    BECHTEL NEVADA

    2006-09-01

    This Closure Report (CR) describes the closure activities performed at CAU 528, Polychlorinated Biphenyls Contamination, as presented in the Nevada Division of Environmental Protection (NDEP)-approved Corrective Action Plan (CAP) (US. Department of Energy, National Nuclear Security Administration Nevada Site Office [NNSAINSO], 2005). The approved closure alternative was closure in place with administrative controls. This CR provides a summary of the completed closure activities, documentation of waste disposal, and analytical data to confirm that the remediation goals were met.

  11. Performance characteristics of a novel blood bag in-line closure device and subsequent product quality assessment

    PubMed Central

    Serrano, Katherine; Levin, Elena; Culibrk, Brankica; Weiss, Sandra; Scammell, Ken; Boecker, Wolfgang F; Devine, Dana V

    2010-01-01

    BACKGROUND In high-volume processing environments, manual breakage of in-line closures can result in repetitive strain injury (RSI). Furthermore, these closures may be incorrectly opened causing shear-induced hemolysis. To overcome the variability of in-line closure use and minimize RSI, Fresenius Kabi developed a new in-line closure, the CompoFlow, with mechanical openers. STUDY DESIGN AND METHODS The consistency of the performance of the CompoFlow closure device was assessed, as was its effect on component quality. A total of 188 RBC units using CompoFlow blood bag systems and 43 using the standard bag systems were produced using the buffy coat manufacturing method. Twenty-six CompoFlow platelet (PLT) concentrates and 10 control concentrates were prepared from pools of four buffy coats. RBCs were assessed on Days 1, 21, and 42 for cellular variables and hemolysis. PLTs were assessed on Days 1, 3, and 7 for morphology, CD62P expression, glucose, lactate, and pH. A total of 308 closures were excised after processing and the apertures were measured using digital image analysis. RESULTS The use of the CompoFlow device significantly improved the mean extraction time with 0.46 ± 0.11 sec/mL for the CompoFlow units and 0.52 ± 0.13 sec/mL for the control units. The CompoFlow closures showed a highly reproducible aperture after opening (coefficient of variation, 15%) and the device always remained opened. PLT and RBC products showed acceptable storage variables with no differences between CompoFlow and control. CONCLUSIONS The CompoFlow closure devices improved the level of process control and processing time of blood component production with no negative effects on product quality. PMID:20529007

  12. Improving the Safety of Moving Lane Closures

    DOT National Transportation Integrated Search

    2009-06-01

    Moving lane closures are an increasingly utilized and inherently hazardous traffic control procedure for highway : maintenance and operations activities. To improve the safety of moving lane closures for workers and motorists, : this research studied...

  13. Surgical outcomes after application of a liquid adhesive ocular bandage to clear corneal incisions during cataract surgery.

    PubMed

    Uy, Harvey S; Kenyon, Kenneth R

    2013-11-01

    To compare the anatomic and refractive outcomes in eyes having phacoemulsification with 1 of 3 clear corneal incision (CCI) closure methods. Ambulatory surgical center, Makati, Philippines. Prospective randomized clinical trial. Patients having phacoemulsification cataract surgery had wound closure using no additional treatment (control), a single 10-0 nylon suture, or a liquid adhesive ocular bandage (Ocuseal). The main outcome measures were wound-edge closure rates, surgically induced astigmatism (SIA), foreign-body sensation, and intraocular pressure (IOP) 1, 3, 5, 7, and 14 days postoperatively. The study evaluated 90 eyes. There was a significant improvement in wound-edge closure rates in the suture group and the ocular bandage group compared with the control group (P<.001). A significant increase in SIA occurred in the sutured group but not in the control or ocular bandage groups (P<.001). The ocular bandage group had significantly less foreign-body sensation than the control and suture groups (P<.001). There were no significant differences in IOP between the groups (P=.515). The liquid adhesive ocular bandage resulted in improved wound-edge closure, reduced SIA, and diminished foreign-body sensation. Suturing was associated with improved wound-edge closure but increased SIA and foreign-body sensation. Unsutured incisions led to delayed wound-edge closure and increased foreign-body sensation. Copyright © 2013 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  14. Natural orifice transluminal endoscopic surgery gastrotomy closure with an over-the-endoscope clip: a randomized, controlled porcine study (with videos).

    PubMed

    von Renteln, Daniel; Schmidt, Arthur; Vassiliou, Melina C; Gieselmann, Maria; Caca, Karel

    2009-10-01

    Secure endoscopic closure of transgastric natural orifice transluminal endoscopic surgery (NOTES) access is of paramount importance. The over-the-scope clip (OTSC) system has previously been shown to be effective for NOTES gastrotomy closure. To compare OTSC gastrotomy closure with surgical closure. Randomized, controlled animal study. Animal facility laboratory. Thirty-six female domestic pigs. Gastrotomies were created by using a needle-knife and an 18-mm balloon. The animals were subsequently randomized to either open surgical repair with interrupted sutures or endoscopic repair with 12-mm OTSCs. In addition, pressurized leak tests were performed in ex vivo specimens of 18-mm scalpel incisions closed with suture (n = 14) and of intact stomachs (n = 10). The mean time for endoscopic closure was 9.8 minutes (range 3-22, SD 5.5). No complications occurred during either type of gastrotomy closure. At necropsy, examination of all OTSC and surgical closures demonstrated complete sealing of gastrotomy sites without evidence of injury to adjacent organs. Pressurized leak tests showed a mean burst pressure of 83 mm Hg (range 30-140, SD 27) for OTSC closures and 67 mm Hg (range 30-130, SD 27.7) for surgical sutures. Ex vivo hand-sewn sutures of 18-mm gastrotomies (n = 14) exhibited a mean burst pressure of 65 mm Hg (range 20-140, SD 31) and intact ex vivo stomachs (n = 10) had a mean burst pressure of 126 mm Hg (range 90-170, SD 28). The burst pressure of ex vivo intact stomachs was significantly higher compared with OTSC closures (P < .01), in vivo surgical closures (P < .01), and ex vivo hand-sewn closures (P < .01). There was a trend toward higher burst pressures in the OTSC closures compared with surgical closures (P = .063) and ex vivo hand-sewn closures (P = .094). In vivo surgical closures demonstrated similar burst pressures compared with ex vivo hand-sewn closures (P = .848). Nonsurvival setting. Endoscopic closure by using the OTSC system is comparable to surgical closure in a nonsurvival porcine model. This technique is easy to perform and is suitable for NOTES gastrotomy closure.

  15. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Eric Larsen; Art Watkins; Timothy R. McJunkin

    The U.S. Department of Energy (DOE) created the National Spent Nuclear Fuel Program (NSNFP) to manage DOE’s spent nuclear fuel (SNF). One of the NSNFP’s tasks is to prepare spent nuclear fuel for storage, transportation, and disposal at the national repository. As part of this effort, the NSNFP developed a standardized canister for interim storage and transportation of SNF. These canisters will be built and sealed to American Society of Mechanical Engineers (ASME) Section III, Division 3 requirements. Packaging SNF usually is a three-step process: canister loading, closure welding, and closure weld verification. After loading SNF into the canisters, themore » canisters must be seal welded and the welds verified using a combination of visual, surface eddy current, and ultrasonic inspection or examination techniques. If unacceptable defects in the weld are detected, the defective sections of weld must be removed, re-welded, and re-inspected. Due to the high contamination and/or radiation fields involved with this process, all of these functions must be performed remotely in a hot cell. The prototype apparatus to perform these functions is a floor-mounted carousel that encircles the loaded canister; three stations perform the functions of welding, inspecting, and repairing the seal welds. A welding operator monitors and controls these functions remotely via a workstation located outside the hot cell. The discussion describes the hardware and software that have been developed and the results of testing that has been done to date.« less

  16. Reduction of the closure time of postoperative enterocutaneous fistulas with fibrin sealant.

    PubMed

    Avalos-González, Jorge; Portilla-deBuen, Eliseo; Leal-Cortés, Caridad Aurea; Orozco-Mosqueda, Abel; Estrada-Aguilar, María del Carmen; Velázquez-Ramírez, Gabriela Abigail; Ambriz-González, Gabriela; Fuentes-Orozco, Clotilde; Guzmán-Gurrola, Aldo Emmerson; González-Ojeda, Alejandro

    2010-06-14

    To assess whether the use of fibrin sealant shortens the closure time of postoperative enterocutaneous fistulas (ECFs). The prospective case-control study included 70 patients with postoperative ECFs with an output of < 500 mL/d, a fistulous tract of > 2 cm and without any local complication. They were divided into study (n = 23) and control groups (n = 47). Esophageal, gastric and colocutaneous fistulas were monitored under endoscopic visualization, which also allowed fibrin glue application directly through the external hole. Outcome variables included closure time, time to resume oral feeding and morbidity related to nutritional support. There were no differences in mean age, fistula output, and follow-up. Closure-time for all patients of the study group was 12.5 +/- 14.2 d and 32.5 +/- 17.9 d for the control group (P < 0.001), and morbidity related to nutritional support was 8.6% and 42.5%, respectively (P < 0.01). In patients with colonic fistulas, complete closure occurred 23.5 +/- 19.5 d after the first application of fibrin glue, and spontaneous closure was observed after 36.2 +/- 22.8 d in the control group (P = 0.36). Recurrences were observed in 2 patients because of residual disease. One patient of each group died during follow-up as a consequence of septic complications related to parenteral nutrition. Closure time was significantly reduced with the use of fibrin sealant, and oral feeding was resumed faster. We suggest the use of fibrin sealant for the management of stable enterocutaneous fistulas.

  17. Early Versus Delayed Source Control in Open Abdomen Management for Severe Intra-abdominal Infections: A Retrospective Analysis on 111 Cases.

    PubMed

    Rausei, Stefano; Pappalardo, Vincenzo; Ruspi, Laura; Colella, Antonio; Giudici, Simone; Ardita, Vincenzo; Frattini, Francesco; Rovera, Francesca; Boni, Luigi; Dionigi, Gianlorenzo

    2018-03-01

    Time to source control plays a determinant prognostic role in patients having severe intra-abdominal infections (IAIs). Open abdomen (OA) management became an effective treatment option for peritonitis. Aim of this study was to analyze the correlation between time to source control and outcome in patients presenting with abdominal sepsis and treated by OA. We retrospectively analyzed 111 patients affected by abdominal sepsis and treated with OA from May 2007 to May 2015. Patients were classified according to time interval from first patient evaluation to source control. The end points were intra-hospital mortality and primary fascial closure rate. The in-hospital mortality rate was 21.6% (24/111), and the primary fascial closure rate was 90.9% (101/111). A time to source control ≥6 h resulted significantly associated with a poor prognosis and a lower fascial closure rate (mortality 27.0 vs 9.0%, p = 0.04; primary fascial closure 86 vs 100%, p = 0.02). We observed a direct increase in mortality (and a reduction in closure rate) for each 6-h delay in surgery to source control. Early source control using OA management significantly improves outcome of patients with severe IAIs. This damage control approach well fits to the treatment of time-related conditions, particularly in case of critically ill patients.

  18. 40 CFR 63.962 - Standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... shall control air emissions from the individual drain system using one or a combination of the following... closure device. (3) Junction box control requirements. Each junction box shall be equipped with controls as follows: (i) The junction box shall be equipped with a closure device (e.g., manhole cover, access...

  19. 40 CFR 63.962 - Standards.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... shall control air emissions from the individual drain system using one or a combination of the following... closure device. (3) Junction box control requirements. Each junction box shall be equipped with controls as follows: (i) The junction box shall be equipped with a closure device (e.g., manhole cover, access...

  20. 40 CFR 63.962 - Standards.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... shall control air emissions from the individual drain system using one or a combination of the following... closure device. (3) Junction box control requirements. Each junction box shall be equipped with controls as follows: (i) The junction box shall be equipped with a closure device (e.g., manhole cover, access...

  1. 40 CFR 63.962 - Standards.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... shall control air emissions from the individual drain system using one or a combination of the following... closure device. (3) Junction box control requirements. Each junction box shall be equipped with controls as follows: (i) The junction box shall be equipped with a closure device (e.g., manhole cover, access...

  2. The influence of percutaneous closure of patent ductus arteriosus on left ventricular size and function: a prospective study using two- and three-dimensional echocardiography and measurements of serum natriuretic peptides.

    PubMed

    Eerola, Anneli; Jokinen, Eero; Boldt, Talvikki; Pihkala, Jaana

    2006-03-07

    We aimed to evaluate the effect of percutaneous closure of patent ductus arteriosus (PDA) on left ventricular (LV) hemodynamics. Today, most PDAs are closed percutaneously. Little is known, however, about hemodynamic changes after the procedure. Of 37 children (ages 0.6 to 10.6 years) taken to the catheterization laboratory for percutaneous PDA closure, the PDA was closed in 33. Left ventricular diastolic and systolic dimensions, volumes, and function were examined by two-dimensional (2D) and three-dimensional (3D) echocardiography and serum concentrations of natriuretic peptides measured before PDA closure, on the following day, and 6 months thereafter. Control subjects comprised 36 healthy children of comparable ages. At baseline, LV diastolic diameter measured >+2 SD in 5 of 33 patients. In 3D echocardiography, a median LV diastolic volume measured 54.0 ml/m2 in the control subjects and 58.4 ml/m2 (p < 0.05) in the PDA group before closure and 57.2 ml/m2 (p = NS) 6 months after closure. A median N-terminal brain natriuretic peptide (pro-BNP) concentration measured 72 ng/l in the control group and 141 ng/l in the PDA group before closure (p = 0.001) and 78.5 ng/l (p = NS) 6 months after closure. Patients differed from control subjects in indices of LV systolic and diastolic function at baseline. By the end of follow-up, all these differences had disappeared. Even in the subgroup of patients with normal-sized LV at baseline, the LV diastolic volume decreased significantly during follow-up. Changes in LV volume and function caused by PDA disappear by 6 months after percutaneous closure. Even the children with normal-sized LV benefit from the procedure.

  3. Preliminary results of laser tissue welding in extravesical reimplantation of the ureters.

    PubMed

    Kirsch, A J; Dean, G E; Oz, M C; Libutti, S K; Treat, M R; Nowygrod, R; Hensle, T W

    1994-02-01

    One exciting potential use of laparoscopic technology is the extravesical reimplantation of the ureters. We have assessed the efficacy of laser-activated fibrinogen solder to close vesical muscle flaps over submucosal ureters (Lich-Gregoir technique) in a canine model. Four dogs were subjected to unilateral flap closures via a protein solder (indocyanine green and fibrinogen) applied to the bladder serosa and exposed to 808 nm. continuous wave diode laser energy. Contralateral reimplantation was performed using 4-zero vicryl muscle flap closures (controls). At 7, 14 and 28 days postoperatively, intravenous pyelograms confirmed bilateral ureteral patency. At intravesical pressures above 100 cm. H2O, there was no evidence of wound disruption in either group. Nondisrupted wound closures were sectioned and strained until ultimate breakage to determine tensile strength. At each study interval the laser-welded closures withstood greater stress than the controls. Although these data represent single tissue samples and are not amenable to statistical analysis, laser-welded closures appeared to be stronger at each study interval. In conclusion, laser-welded vesical wound closures appear at least as strong as suture closures in the canine model.

  4. Transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of perimembranous ventricular septal defects in children: a protocol for a network meta-analysis.

    PubMed

    You, Tao; Yi, Kang; Ding, Zhao-Hong; Hou, Xiao-Dong; Liu, Xing-Guang; Wang, Xin-Kuan; Ge, Long; Tian, Jin-Hui

    2017-06-21

    Both transcatheter device closure and surgical repair are effective treatments with excellent midterm outcomes for perimembranous ventricular septal defects (pmVSDs) in children. The mini-invasive periventricular device occlusion technique has become prevalent in research and application, but evidence is limited for the assessment of transcatheter closure, mini-invasive closure and open-heart surgical repair. This study comprehensively compares the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of pmVSDs in children using Bayesian network meta-analysis. A systematic search will be performed using Chinese Biomedical Literature Database, China National Knowledge Infrastructure, PubMed, EMBASE.com and the Cochrane Central Register of Controlled Trials to include random controlled trials, prospective or retrospective cohort studies comparing the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair. The risk of bias for the included prospective or retrospective cohort studies will be evaluated according to the risk of bias in non-randomised studies of interventions (ROBINS-I). For random controlled trials, we will use risk of bias tool from Cochrane Handbook version 5.1.0. A Bayesian network meta-analysis will be conducted using R-3.3.2 software. Ethical approval and patient consent are not required since this study is a network meta-analysis based on published trials. The results of this network meta-analysis will be submitted to a peer-reviewed journal for publication. CRD42016053352. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  5. Endoscopic closure of duodenal perforations by using an over-the-scope clip: a randomized, controlled porcine study.

    PubMed

    von Renteln, Daniel; Rudolph, Hans-Ulrich; Schmidt, Arthur; Vassiliou, Melina C; Caca, Karel

    2010-01-01

    Duodenal perforations during diagnostic upper endoscopy are rare; however, when therapeutic techniques are performed, the reported incidence is as great as 2.8%. Surgical repair is usually mandated, but it is associated with significant morbidity and mortality. To compare closure of duodenal perforations by using an over-the-scope clip (OTSC) with a surgical closure. Randomized, controlled animal study. Animal facility laboratory. Domestic pigs (24 females). Large (10-mm) duodenal perforations were created by using an endoscopic needle-knife. The animals were randomly assigned to either open surgical repair (n=12) or endoscopic closure by using the OTSC system (n=12). Pressurized leak tests were performed during necropsy. One major bleed occurred because of a liver injury during creation of the duodenotomy. Mean time for endoscopic closure was 5 minutes (range, 3-8 min; SD +/- 2). No complications occurred during any of the closure procedures. At necropsy, all OTSC and surgical closures demonstrated complete sealing of duodenotomy sites. Pressurized leak tests demonstrated a mean burst pressure of 166 mm Hg (range, 80-260; SD +/- 65) for OTSC closures and 143 mm Hg (range, 30-300, SD +/- 83) for surgical sutures. Ex vivo intact duodenal specimens exhibited a mean burst pressure of 247 mm Hg (range, 200-300; SD +/- 35), which was significantly higher compared with in vivo OTSC and surgical closures (P < .01). There were no significant differences between burst pressures of OTSC and surgical closures (P = .461). Nonsurvival setting. Endoscopic closure of duodenal perforations by using the OTSC system is comparable with surgical closure in a nonsurvival porcine model. This technique is easy to perform and seems suitable for repairing duodenal perforations. 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  6. EPA Facility Registry Service (FRS): Facility Interests Dataset - Intranet Download

    EPA Pesticide Factsheets

    This downloadable data package consists of location and facility identification information from EPA's Facility Registry Service (FRS) for all sites that are available in the FRS individual feature layers. The layers comprise the FRS major program databases, including:Assessment Cleanup and Redevelopment Exchange System (ACRES) : brownfields sites ; Air Facility System (AFS) : stationary sources of air pollution ; Air Quality System (AQS) : ambient air pollution data from monitoring stations; Bureau of Indian Affairs (BIA) : schools data on Indian land; Base Realignment and Closure (BRAC) facilities; Clean Air Markets Division Business System (CAMDBS) : market-based air pollution control programs; Comprehensive Environmental Response, Compensation, and Liability Information System (CERCLIS) : hazardous waste sites; Integrated Compliance Information System (ICIS) : integrated enforcement and compliance information; National Compliance Database (NCDB) : Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA); National Pollutant Discharge Elimination System (NPDES) module of ICIS : NPDES surface water permits; Radiation Information Database (RADINFO) : radiation and radioactivity facilities; RACT/BACT/LAER Clearinghouse (RBLC) : best available air pollution technology requirements; Resource Conservation and Recovery Act Information System (RCRAInfo) : tracks generators, transporters, treaters, storers, and disposers

  7. EPA Facility Registry Service (FRS): Facility Interests Dataset Download

    EPA Pesticide Factsheets

    This downloadable data package consists of location and facility identification information from EPA's Facility Registry Service (FRS) for all sites that are available in the FRS individual feature layers. The layers comprise the FRS major program databases, including:Assessment Cleanup and Redevelopment Exchange System (ACRES) : brownfields sites ; Air Facility System (AFS) : stationary sources of air pollution ; Air Quality System (AQS) : ambient air pollution data from monitoring stations; Bureau of Indian Affairs (BIA) : schools data on Indian land; Base Realignment and Closure (BRAC) facilities; Clean Air Markets Division Business System (CAMDBS) : market-based air pollution control programs; Comprehensive Environmental Response, Compensation, and Liability Information System (CERCLIS) : hazardous waste sites; Integrated Compliance Information System (ICIS) : integrated enforcement and compliance information; National Compliance Database (NCDB) : Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA); National Pollutant Discharge Elimination System (NPDES) module of ICIS : NPDES surface water permits; Radiation Information Database (RADINFO) : radiation and radioactivity facilities; RACT/BACT/LAER Clearinghouse (RBLC) : best available air pollution technology requirements; Resource Conservation and Recovery Act Information System (RCRAInfo) : tracks generators, transporters, treaters, storers, and disposers

  8. Effect of wastewater treatment facility closure on endocrine disrupting chemicals in a Coastal Plain stream

    USGS Publications Warehouse

    Bradley, Paul M.; Journey, Celeste A.; Clark, Jimmy M.

    2016-01-01

    Wastewater treatment facility (WWTF) closures are rare environmental remediation events; offering unique insight into contaminant persistence, long-term wastewater impacts, and ecosystem recovery processes. The U.S. Geological Survey assessed the fate of select endocrine disrupting chemicals (EDC) in surface water and streambed sediment one year before and one year after closure of a long-term WWTF located within the Spirit Creek watershed at Fort Gordon, Georgia. Sample sites included a WWTF-effluent control located upstream from the outfall, three downstream effluent-impacted sites located between the outfall and Spirit Lake, and one downstream from the lake's outfall. Prior to closure, the 2.2-km stream segment downstream from the WWTF outfall was characterized by EDC concentrations significantly higher (α = 0.05) than at the control site; indicating substantial downstream transport and limited in-stream attenuation of EDC, including pharmaceuticals, estrogens, alkylphenol ethoxylate (APE) metabolites, and organophosphate flame retardants (OPFR). Wastewater-derived pharmaceutical, APE metabolites, and OPFR compounds were also detected in the outflow of Spirit Lake, indicating the potential for EDC transport to aquatic ecosystems downstream of Fort Gordon under effluent discharge conditions. After the WWTF closure, no significant differences in concentrations or numbers of detected EDC compounds were observed between control and downstream locations. The results indicated EDC pseudo-persistence under preclosure, continuous supply conditions, with rapid attenuation following WWTF closure. Low concentrations of EDC at the control site throughout the study and comparable concentrations in downstream locations after WWTF closure indicated additional, continuing, upstream contaminant sources within the Spirit Creek watershed. 

  9. Reduction of the closure time of postoperative enterocutaneous fistulas with fibrin sealant

    PubMed Central

    Avalos-González, Jorge; Portilla-deBuen, Eliseo; Leal-Cortés, Caridad Aurea; Orozco-Mosqueda, Abel; del Carmen Estrada-Aguilar, María; Velázquez-Ramírez, Gabriela Abigail; Ambriz-González, Gabriela; Fuentes-Orozco, Clotilde; Guzmán-Gurrola, Aldo Emmerson; González-Ojeda, Alejandro

    2010-01-01

    AIM: To assess whether the use of fibrin sealant shortens the closure time of postoperative enterocutaneous fistulas (ECFs). METHODS: The prospective case-control study included 70 patients with postoperative ECFs with an output of < 500 mL/d, a fistulous tract of > 2 cm and without any local complication. They were divided into study (n = 23) and control groups (n = 47). Esophageal, gastric and colocutaneous fistulas were monitored under endoscopic visualization, which also allowed fibrin glue application directly through the external hole. Outcome variables included closure time, time to resume oral feeding and morbidity related to nutritional support. RESULTS: There were no differences in mean age, fistula output, and follow-up. Closure-time for all patients of the study group was 12.5 ± 14.2 d and 32.5 ± 17.9 d for the control group (P < 0.001), and morbidity related to nutritional support was 8.6% and 42.5%, respectively (P < 0.01). In patients with colonic fistulas, complete closure occurred 23.5 ± 19.5 d after the first application of fibrin glue, and spontaneous closure was observed after 36.2 ± 22.8 d in the control group (P = 0.36). Recurrences were observed in 2 patients because of residual disease. One patient of each group died during follow-up as a consequence of septic complications related to parenteral nutrition. CONCLUSION: Closure time was significantly reduced with the use of fibrin sealant, and oral feeding was resumed faster. We suggest the use of fibrin sealant for the management of stable enterocutaneous fistulas. PMID:20533600

  10. Chromatographic and Spectral Analysis of Two Main Extractable Compounds Present in Aqueous Extracts of Laminated Aluminum Foil Used for Protecting LDPE-Filled Drug Vials

    PubMed Central

    Akapo, Samuel O.; Syed, Sajid; Mamangun, Anicia; Skinner, Wayne

    2009-01-01

    Laminated aluminum foils are increasingly being used to protect drug products packaged in semipermeable containers (e.g., low-density polyethylene (LDPE)) from degradation and/or evaporation. The direct contact of such materials with primary packaging containers may potentially lead to adulteration of the drug product by extractable or leachable compounds present in the closure system. In this paper, we described a simple and reliable HPLC method for analysis of an aqueous extract of laminated aluminum foil overwrap used for packaging LDPE vials filled with aqueous pharmaceutical formulations. By means of combined HPLC-UV, GC/MS, LC/MS/MS, and NMR spectroscopy, the two major compounds detected in the aqueous extracts of the representative commercial overwraps were identified as cyclic oligomers with molecular weights of 452 and 472 and are possibly formed from poly-condensation of the adhesive components, namely, isophthalic acid, adipic acid, and diethylene glycol. Lower molecular weight compounds that might be associated with the “building blocks” of these compounds were not detected in the aqueous extracts. PMID:20140083

  11. PLUTONIUM FINISHING PLANT (PFP) 241-Z LIQUID WASTE TREATMENT FACILITY DEACTIVATION AND DEMOLITION

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    JOHNSTON GA

    2008-01-15

    Fluor Hanford, Inc. (FH) is proud to submit the Plutonium Finishing Plant (PFP) 241-Z liquid Waste Treatment Facility Deactivation and Demolition (D&D) Project for consideration by the Project Management Institute as Project of the Year for 2008. The decommissioning of the 241-Z Facility presented numerous challenges, many of which were unique with in the Department of Energy (DOE) Complex. The majority of the project budget and schedule was allocated for cleaning out five below-grade tank vaults. These highly contaminated, confined spaces also presented significant industrial safety hazards that presented some of the most hazardous work environments on the Hanford Site.more » The 241-Z D&D Project encompassed diverse tasks: cleaning out and stabilizing five below-grade tank vaults (also called cells), manually size-reducing and removing over three tons of process piping from the vaults, permanently isolating service utilities, removing a large contaminated chemical supply tank, stabilizing and removing plutonium-contaminated ventilation ducts, demolishing three structures to grade, and installing an environmental barrier on the demolition site . All of this work was performed safely, on schedule, and under budget. During the deactivation phase of the project between November 2005 and February 2007, workers entered the highly contaminated confined-space tank vaults 428 times. Each entry (or 'dive') involved an average of three workers, thus equaling approximately 1,300 individual confined -space entries. Over the course of the entire deactivation and demolition period, there were no recordable injuries and only one minor reportable skin contamination. The 241-Z D&D Project was decommissioned under the provisions of the 'Hanford Federal Facility Agreement and Consent Order' (the Tri-Party Agreement or TPA), the 'Resource Conservation and Recovery Act of 1976' (RCRA), and the 'Comprehensive Environmental Response, Compensation, and Liability Act of 1980' (CERCLA). The project completed TPA Milestone M-083-032 to 'Complete those activities required by the 241-Z Treatment and Storage Unit's RCRA Closure Plan' four years and seven months ahead of this legally enforceable milestone. In addition, the project completed TPA Milestone M-083-042 to 'Complete transition and dismantlement of the 241-2 Waste Treatment Facility' four years and four months ahead of schedule. The project used an innovative approach in developing the project-specific RCRA closure plan to assure clear integration between the 241-Z RCRA closure activities and ongoing and future CERCLA actions at PFP. This approach provided a regulatory mechanism within the RCRA closure plan to place segments of the closure that were not practical to address at this time into future actions under CERCLA. Lessons learned from th is approach can be applied to other closure projects within the DOE Complex to control scope creep and mitigate risk. A paper on this topic, entitled 'Integration of the 241-Z Building D and D Under CERCLA with RCRA Closure at the PFP', was presented at the 2007 Waste Management Conference in Tucson, Arizona. In addition, techniques developed by the 241-Z D&D Project to control airborne contamination, clean the interior of the waste tanks, don and doff protective equipment, size-reduce plutonium-contaminated process piping, and mitigate thermal stress for the workers can be applied to other cleanup activities. The project-management team developed a strategy utilizing early characterization, targeted cleanup, and close coordination with PFP Criticality Engineering to significantly streamline the waste- handling costs associated with the project . The project schedule was structured to support an early transition to a criticality 'incredible' status for the 241-Z Facility. The cleanup work was sequenced and coordinated with project-specific criticality analysis to allow the fissile material waste being generated to be managed in a bulk fashion, instead of individual waste packages. This approach negated the need for real-time assay of individual waste packages, greatly improving the efficiency of the cleanup operation. The cleanup and stabilization of the 241-2 Liquid Effluent Treatment Facility reduced radiological risks to the environment and Hanford site workers. It was recognized as a success by regulatory agencies, the media, the DOE-client, and stakeholders. The 241-Z D&D Project demonstrated management excellence in adapting to significant changes in project direction, fostered a safety culture that amassed impressive results on this high-hazard job, maintained excellent communications with the client and stakeholders, and developed and implemented unique cleanup techniques.« less

  12. High-voltage leak detection of a parenteral proteinaceous solution product packaged in form-fill-seal plastic laminate bags. Part 2. Method performance as a function of heat seal defects, product-package refrigeration, and package plastic laminate lot.

    PubMed

    Rasmussen, Mats; Damgaard, Rasmus; Buus, Peter; Mulhall, Brian; Guazzo, Dana Morton

    2013-01-01

    Part 1 of this three-part research series detailed the development and validation of a high-voltage leak detection test (HVLD, also known as an electrical conductivity and capacitance test) for verifying the container-closure integrity of a small-volume laminate plastic bag containing an aqueous solution formulation of the rapid-acting insulin analogue, insulin aspart (NovoRapid®/NovoLog®) by Novo Nordisk A/S, Bagsværd, Denmark. Leak detection capability was verified using positive controls each with a single laser-drilled hole in the bag film face. In this Part 2, HVLD leak detection capability was further explored in four separate studies. Study 1 investigated the ability of HVLD to detect weaknesses and/or gaps in the bag heat seal. Study 2 checked the HVLD detection of bag holes in packages stored 4 days at ambient conditions followed by 17 days at refrigeration. Study 3 examined HVLD test results for packages tested when cold. Study 4 compared HVLD test results as a function of bag plastic film lots. The final Part 3 of this series will report the impact of HVLD exposure on product visual appearance and chemical stability. In Part 1 of this three-part series, a leak test method based on electrical conductivity and capacitance, also called high-voltage leak detection (HVLD), was used to find leaks in small plastic bags filled with a solution for injection of the rapid-acting insulin analogue, insulin aspart (NovoRapid®/NovoLog®) by Novo Nordisk A/S, Bagsværd, Denmark. In this Part 2, HVLD leak detection capability was further explored in four separate studies. Study 1 investigated the ability of HVLD to detect bag heat seal leaks. Study 2 checked HVLD's ability to detect bag holes after a total of 21 days at ambient plus refrigerated temperatures. Study 3 looked to see if HVLD results changed for packages tested when still cold. Study 4 compared HVLD results for multiple bag plastic film lots. The final Part 3 of this series will report any evidence of drug component degradation caused by HVLD exposure.

  13. 46 CFR 108.114 - Appliances for watertight and weathertight integrity.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... watertight doors, hatches, scuttles, bolted manhole covers, or other watertight closures for openings in... and hatches, closures for air pipes, ventilators, ventilation intakes and outlets, and closures for... meet the following: (1) Each door, hatch, and scuttle must— (i) Be remotely controlled from a normally...

  14. 46 CFR 108.114 - Appliances for watertight and weathertight integrity.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... watertight doors, hatches, scuttles, bolted manhole covers, or other watertight closures for openings in... and hatches, closures for air pipes, ventilators, ventilation intakes and outlets, and closures for... meet the following: (1) Each door, hatch, and scuttle must— (i) Be remotely controlled from a normally...

  15. 46 CFR 108.114 - Appliances for watertight and weathertight integrity.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... watertight doors, hatches, scuttles, bolted manhole covers, or other watertight closures for openings in... and hatches, closures for air pipes, ventilators, ventilation intakes and outlets, and closures for... meet the following: (1) Each door, hatch, and scuttle must— (i) Be remotely controlled from a normally...

  16. 46 CFR 108.114 - Appliances for watertight and weathertight integrity.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... watertight doors, hatches, scuttles, bolted manhole covers, or other watertight closures for openings in... and hatches, closures for air pipes, ventilators, ventilation intakes and outlets, and closures for... meet the following: (1) Each door, hatch, and scuttle must— (i) Be remotely controlled from a normally...

  17. 46 CFR 108.114 - Appliances for watertight and weathertight integrity.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... watertight doors, hatches, scuttles, bolted manhole covers, or other watertight closures for openings in... and hatches, closures for air pipes, ventilators, ventilation intakes and outlets, and closures for... meet the following: (1) Each door, hatch, and scuttle must— (i) Be remotely controlled from a normally...

  18. Defense Base Realignment and Closure Budget Data for the Closure of Fort Devens, Massachusetts

    DTIC Science & Technology

    1995-08-01

    provides the results of the audit of one project, valued at $2.75 million, for the closure and realignment of Fort Devens, Massachusetts. This audit also...assessed the adequacy of the management control program as it applied to the audit objective.

  19. Effective time closures: quantifying the conservation benefits of input control for the Pacific chub mackerel fishery.

    PubMed

    Ichinokawa, Momoko; Okamura, Hiroshi; Watanabe, Chikako; Kawabata, Atsushi; Oozeki, Yoshioki

    2015-09-01

    Restricting human access to a specific wildlife species, community, or ecosystem, i.e., input control, is one of the most popular tools to control human impacts for natural resource management and wildlife conservation. However, quantitative evaluations of input control are generally difficult, because it is unclear how much human impacts can actually be reduced by the control. We present a model framework to quantify the effectiveness of input control using day closures to reduce actual fishing impact by considering the observed fishery dynamics. The model framework was applied to the management of the Pacific stock of the chub mackerel (Scomber japonicus) fishery, in which fishing was suspended for one day following any day when the total mackerel catch exceeded a threshold level. We evaluated the management measure according to the following steps: (1) we fitted the daily observed catch and fishing effort data to a generalized linear model (GLM) or generalized autoregressive state-space model (GASSM), (2) we conducted population dynamics simulations based on annual catches randomly generated from the parameters estimated in the first step, (3) we quantified the effectiveness of day closures by comparing the results of two simulation scenarios with and without day closures, and (4) we conducted additional simulations based on different sets of explanatory variables and statistical models (sensitivity analysis). In the first step, we found that the GASSM explained the observed data far better than the simple GLM. The model parameterized with the estimates from the GASSM demonstrated that the day closures implemented from 2004 to 2009 would have decreased exploitation fractions by ~10% every year and increased the 2009 stock biomass by 37-46% (median), relative to the values without day closures. The sensitivity analysis revealed that the effectiveness of day closures was particularly influenced by autoregressive processes in the fishery data and by positive relationships between fishing effort and total biomass. Those results indicated the importance of human behavioral dynamics under input control in quantifying the conservation benefit of natural resource management and the applicability of our model framework to the evaluation of the input controls that are actually implemented.

  20. Effectiveness and costs of overland skid trail BMPs

    Treesearch

    Clay Sawyers; W. Michael Aust; M. Chad Bolding; William A. Lakel III

    2012-01-01

    Forestry Best Management Practices (BMPs) are designed to protect water quality; however, little data exists comparing the efficacy and costs of different BMP options for skid trail closure. Study objectives were to evaluate erosion control effectiveness and implementation costs of five overland skid trail closure techniques. Closure techniques were: waterbar only (...

  1. Implementation of New Process Models for Tailored Polymer Composite Structures into Processing Software Packages

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Nguyen, Ba Nghiep; Jin, Xiaoshi; Wang, Jin

    2010-02-23

    This report describes the work conducted under the Cooperative Research and Development Agreement (CRADA) (Nr. 260) between the Pacific Northwest National Laboratory (PNNL) and Autodesk, Inc. to develop and implement process models for injection-molded long-fiber thermoplastics (LFTs) in processing software packages. The structure of this report is organized as follows. After the Introduction Section (Section 1), Section 2 summarizes the current fiber orientation models developed for injection-molded short-fiber thermoplastics (SFTs). Section 3 provides an assessment of these models to determine their capabilities and limitations, and the developments needed for injection-molded LFTs. Section 4 then focuses on the development of amore » new fiber orientation model for LFTs. This model is termed the anisotropic rotary diffusion - reduced strain closure (ARD-RSC) model as it explores the concept of anisotropic rotary diffusion to capture the fiber-fiber interaction in long-fiber suspensions and uses the reduced strain closure method of Wang et al. to slow down the orientation kinetics in concentrated suspensions. In contrast to fiber orientation modeling, before this project, no standard model was developed to predict the fiber length distribution in molded fiber composites. Section 5 is therefore devoted to the development of a fiber length attrition model in the mold. Sections 6 and 7 address the implementations of the models in AMI, and the conclusions drawn from this work is presented in Section 8.« less

  2. High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 3. Chemical Stability and Visual Appearance of a Protein-Based Aqueous Solution for Injection as a Function of HVLD Exposure.

    PubMed

    Rasmussen, Mats; Damgaard, Rasmus; Buus, Peter; Guazzo, Dana Morton

    2013-01-01

    This Part 3 of this three-part research series reports the impact of high-voltage leak detection (HVLD) exposure on the physico-chemical stability of the packaged product. The product, intended for human administration by injection, is an aqueous solution formulation of the rapid acting insulin analogue, insulin aspart (NovoRapid®/NovoLog®) by Novo Nordisk A/S, Bagsværd, Denmark. The package is a small-volume form-fill-seal plastic laminate bag. Product-packages exposed to HVLD were compared to unexposed product after storage for 9 months at recommended storage conditions of 5 ± 3 °C. No differences in active ingredient or degradation products assays were noted. No changes in any other stability indicating parameter results were observed. This report concludes this three-part series. Part 1 documented HVLD method development and validation work. Part 2 explored the impact of various package material, package temperature, and package storage conditions on HVLD test results. Detection of leaks in the bag seal area was investigated. In conclusion, HVLD is reported to be a validatable leak test method suitable for rapid, nondestructive container-closure integrity evaluation of the subject product-package. In Part 1 of this three-part series, a leak test method based on electrical conductivity and capacitance, also called high-voltage leak detection (HVLD), was proven to find hole leaks in small plastic bags filled with a solution of insulin aspart intended for human injection (NovoRapid®/NovoLog® by Novo Nordisk A/S, Bagsværd, Denmark). In Part 2, the ability of the HVLD method to find other types of package leaks was tested, and the impact of package material and product storage temperature on HVLD results was explored. This final Part 3 checked how well the packaged protein drug solution maintained its potency after HVLD exposure over 9 months of storage under long-term stability conditions. Results showed that HVLD caused no harm to the product.

  3. Evaluation of a novel technique for wound closure using a barbed suture.

    PubMed

    Murtha, Amy P; Kaplan, Andrew L; Paglia, Michael J; Mills, Benjie B; Feldstein, Michael L; Ruff, Gregory L

    2006-05-01

    Suture knots present several disadvantages in wound closure, because they are tedious to tie and place ischemic demands on tissue. Bulky knots may be a nidus for infection, and they may extrude through skin weeks after surgery. Needle manipulations during knot-tying predispose the surgeon to glove perforation. A barbed suture was developed that is self-anchoring, requiring no knots or slack management for wound closure. The elimination of knot tying may have advantages over conventional wound closure methods. This prospective, randomized, controlled trial was designed to show that the use of barbed suture in dermal closure of the Pfannenstiel incision during nonemergent cesarean delivery surgery produces scar cosmesis at 5 weeks that is no worse than that observed with conventional closure using 3-0 polydioxanone suture. Cosmesis was assessed by review of postoperative photographs by a blinded, independent plastic surgeon using the modified Hollander cosmesis score. Secondary endpoints included infection, dehiscence, pain, closure time, and other adverse events. The study enrolled 195 patients, of whom 188 were eligible for analysis. Cosmesis scores did not significantly differ between the barbed suture group and the control group. Rates of infection, dehiscence, and other adverse events did not significantly differ between the two groups. Closure time and pain scores were comparable between the groups. The barbed suture represents an innovative option for wound closure. With a cosmesis and safety profile that is similar to that of conventional suture technique, it avoids the drawbacks inherent to suture knots.

  4. Reducing the risk of contamination of sterile parenteral products via ready-to-use closure components.

    PubMed

    Curry, Wayne; Conway, Samuel; Goodfield, Clara; Miller, Kimberly; Mueller, Ronald L; Polini, Eugene

    2010-12-01

    The preparation of sterile parenteral products requires careful control of all ingredients, materials, and processes to ensure the final product has the identity and strength, and meets the quality and purity characteristics that it purports to possess. Contamination affecting these critical properties of parenteral products can occur in many ways and from many sources. The use of closures supplied by manufacturers in a ready-to-use state can be an effective method for reducing the risk of contamination and improving the quality of the drug product. This article will address contamination attributable to elastomeric container closure components and the regulatory requirements associated with container closure systems. Possible contaminants, including microorganisms, endotoxins, and chemicals, along with the methods by which these contaminants can enter the product will be reviewed. Such methods include inappropriate material selection, improper closure preparation processes, compromised container closure integrity, degradation of closures, and leaching of compounds from the closures.

  5. Role of vision in aperture closure control during reach-to-grasp movements.

    PubMed

    Rand, Miya K; Lemay, Martin; Squire, Linda M; Shimansky, Yury P; Stelmach, George E

    2007-08-01

    We have previously shown that the distance from the hand to the target at which finger closure is initiated during the reach (aperture closure distance) depends on the amplitude of peak aperture, as well as hand velocity and acceleration. This dependence suggests the existence of a control law according to which a decision to initiate finger closure during the reach is made when the hand distance to target crosses a threshold that is a function of the above movement-related parameters. The present study examined whether the control law is affected by manipulating the visibility of the hand and the target. Young adults made reach-to-grasp movements to a dowel under conditions in which the target or the hand or both were either visible or not visible. Reaching for and grasping a target when the hand and/or target were not visible significantly increased transport time and widened peak aperture. Aperture closure distance was significantly lengthened and wrist peak velocity was decreased only when the target was not visible. Further analysis showed that the control law was significantly different between the visibility-related conditions. When either the hand or target was not visible, the aperture closure distance systematically increased compared to its value for the same amplitude of peak aperture, hand velocity, and acceleration under full visibility. This implies an increase in the distance-related safety margin for grasping when the hand or target is not visible. It has been also found that the same control law can be applied to all conditions, if variables describing hand and target visibility were included in the control law model, as the parameters of the task-related environmental context, in addition to the above movement-related parameters. This suggests that that the CNS utilizes those variables for controlling grasp initiation based on a general control law.

  6. Role of vision in aperture closure control during reach-to-grasp movements

    PubMed Central

    Rand, Miya K.; Lemay, Martin; Squire, Linda M.; Shimansky, Yury P.; Stelmach, George E.

    2007-01-01

    We have previously shown that the distance from the hand to the target at which finger closure is initiated during the reach (aperture closure distance) depends on the amplitude of peak aperture, as well as hand velocity and acceleration. This dependence suggests the existence of a control law according to which a decision to initiate finger closure during the reach is made when the hand distance to target crosses a threshold that is a function of the above movement-related parameters. The present study examined whether the control law is affected by manipulating the visibility of the hand and the target. Young adults made reach-to-grasp movements to a dowel under conditions in which the target or the hand or both were either visible or not visible. Reaching for and grasping a target when the hand and/or target were not visible significantly increased transport time and widened peak aperture. Aperture closure distance was significantly lengthened and wrist peak velocity was decreased only when the target was not visible. Further analysis showed that the control law was significantly different between the visibility-related conditions. When either the hand or target was not visible, the aperture closure distance systematically increased compared to its value for the same amplitude of peak aperture, hand velocity, and acceleration under full visibility. This implies an increase in the distance-related safety margin for grasping when the hand or target is not visible. It has been also found that the same control law can be applied to all conditions, if variables describing hand and target visibility were included in the control law model, as the parameters of the task-related environmental context, in addition to the above movement-related parameters. This suggests that that the CNS utilizes those variables for controlling grasp initiation based on a general control law. PMID:17476491

  7. Defense Base Realignment and Closure Budget Data for the Closure of Naval Training Center San Diego, California

    DTIC Science & Technology

    1995-06-06

    provides the audit results for 4 military construction projects, valued at $14.4 million, for realignment and closure of Naval Tralning Center San Diego...California. The audit also assessed the adequacy of the management control program as it applied to the audit objective.

  8. Land use-based landscape planning and restoration in mine closure areas.

    PubMed

    Zhang, Jianjun; Fu, Meichen; Hassani, Ferri P; Zeng, Hui; Geng, Yuhuan; Bai, Zhongke

    2011-05-01

    Landscape planning and restoration in mine closure areas is not only an inevitable choice to sustain mining areas but also an important path to maximize landscape resources and to improve ecological function in mine closure areas. The analysis of the present mine development shows that many mines are unavoidably facing closures in China. This paper analyzes the periodic impact of mining activities on landscapes and then proposes planning concepts and principles. According to the landscape characteristics in mine closure areas, this paper classifies available landscape resources in mine closure areas into the landscape for restoration, for limited restoration and for protection, and then summarizes directions for their uses. This paper establishes the framework of spatial control planning and design of landscape elements from "macro control, medium allocation and micro optimization" for the purpose of managing and using this kind of special landscape resources. Finally, this paper applies the theories and methods to a case study in Wu'an from two aspects: the construction of a sustainable land-use pattern on a large scale and the optimized allocation of typical mine landscape resources on a small scale.

  9. Evaluation of innovative devices to control traffic entering from low-volume access points within a land closure.

    DOT National Transportation Integrated Search

    2014-04-01

    This report describes the methodology and results of analyses performed to identify and evaluate : alternative methods to control traffic entering a lane closure on a two-lane, two-way road from low-volume : access points. Researchers documented the ...

  10. The design of multirate digital control systems

    NASA Technical Reports Server (NTRS)

    Berg, M. C.

    1986-01-01

    The successive loop closures synthesis method is the only method for multirate (MR) synthesis in common use. A new method for MR synthesis is introduced which requires a gradient-search solution to a constrained optimization problem. Some advantages of this method are that the control laws for all control loops are synthesized simultaneously, taking full advantage of all cross-coupling effects, and that simple, low-order compensator structures are easily accomodated. The algorithm and associated computer program for solving the constrained optimization problem are described. The successive loop closures , optimal control, and constrained optimization synthesis methods are applied to two example design problems. A series of compensator pairs are synthesized for each example problem. The succesive loop closure, optimal control, and constrained optimization synthesis methods are compared, in the context of the two design problems.

  11. Cost-effectiveness analysis of different devices used for the closure of small-to-medium-sized patent ductus arteriosus in pediatric patients

    PubMed Central

    El-Saiedi, Sonia A; El Sisi, Amal M; Mandour, Rodina Sobhy; Abdel-Aziz, Doaa M; Attia, Wael A

    2017-01-01

    Aims: In this study, we examined the differences in cost and effectiveness of various devices used for the closure of small to medium sized patent ductus arteriosus (PDA). Setting and Design: We retrospectively studied 116 patients who underwent closure of small PDAs between January 2010 and January 2015. Subjects and Methods: Three types of devices were used: the Amplatzer duct occluder (ADO) II, the cook detachable coil and the Nit Occlud coil (NOC). Immediate and late complications were recorded and patients were followed up for 3 months after the procedure. Statistical Methods: All statistical calculations were performed using Statistical Package for the Social Science software. P <0.05 were considered significant. Results: We successfully deployed ADO II devices in 33 out of 35 cases, cook detachable coils in 36 out of 40 cases and NOCs in 38 out of 41 cases. In the remaining nine cases, the first device was unsuitable or embolized and required retrieval and replacement with another device. Eleven patients (9.5%) developed vascular complications and required anticoagulation therapy. Patients who had hemolysis or vascular complications remained longer in the intensive care unit, with consequently higher total cost (P = 0.016). Also, the need for a second device increased the cost per patient. Conclusions: The cook detachable coil is the most cost-effective device for closure of small-to medium-sized PDAs. Calculations of the incremental cost-effectiveness. (ICE) revealed that the Cook detachable coil had less ICE than the ADO II and NOC. The NOC was more effective with fewer complications. PMID:28566822

  12. Primary versus secondary closure of cutaneous abscesses in the emergency department: a randomized controlled trial.

    PubMed

    Singer, Adam J; Taira, Breena R; Chale, Stuart; Bhat, Rahul; Kennedy, David; Schmitz, Gillian

    2013-01-01

    Cutaneous abscesses have traditionally been treated with incision and drainage (I&D) and left to heal by secondary closure. The objective was to compare the healing rates of cutaneous abscesses following I&D after primary or secondary closure. This was a randomized, controlled, trial, balanced by center, with blocked randomization created by a random-number generator. One urban and one suburban academic emergency department (ED) participated. Subjects were randomized to primary or secondary wound closure following I&D of the abscess. Main outcome measures were the percentage of healed wounds (wound was completely closed by visual inspection; a 40% difference in wound healing was sought) and overall failure rate (need for additional intervention including suture removal, additional drainage, antibiotics, or admission within 7 days after drainage). Fifty-six adult patients with simple localized cutaneous abscesses were included; 29 were randomized to primary closure, and 27 were randomized to secondary closure. Healing rates at 7 days were similar between the primary and secondary closure groups (69.6%, 95% confidence interval [CI] = 49.1% to 84.4% vs. 59.3%, 95% CI = 40.7% to 75.5%; difference 10.3%, 95% CI = -15.8% to 34.1%). Overall failure rates at 7 days were also similar between the primary and secondary closure groups (30.4%, 95% CI = 15.6% to 50.9% vs. 28.6%, 95% CI = 15.2% to 47.1%; difference 1.8%, 95% CI = -24.2% to 28.8%). The rates of wound healing and treatment failure following I&D of simple abscesses in the ED are similar after primary or secondary closure. The authors did not detect a difference of at least 40% in healing rates between primary and secondary closure. © 2013 by the Society for Academic Emergency Medicine.

  13. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial.

    PubMed

    Diener, Markus K; Seiler, Christoph M; Rossion, Inga; Kleeff, Jörg; Glanemann, Matthias; Butturini, Giovanni; Tomazic, Ales; Bruns, Christiane J; Busch, Olivier R C; Farkas, Stefan; Belyaev, Orlin; Neoptolemos, John P; Halloran, Christopher; Keck, Tobias; Niedergethmann, Marco; Gellert, Klaus; Witzigmann, Helmut; Kollmar, Otto; Langer, Peter; Steger, Ulrich; Neudecker, Jens; Berrevoet, Frederik; Ganzera, Silke; Heiss, Markus M; Luntz, Steffen P; Bruckner, Thomas; Kieser, Meinhard; Büchler, Markus W

    2011-04-30

    The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53–1·33; p=0·56). One patient died within the fi rst 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome. German Federal Ministry of Education and Research.

  14. Rupture loop annex ion exchange RLAIX vault deactivation

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ham, J.E.; Harris, D.L., Westinghouse Hanford

    This engineering report documents the deactivation, stabilization and final conditions of the Rupture Loop Annex Ion Exchange (RLAIX) Vault located northwest of the 309 Building`s Plutonium Recycle Test Reactor (PRTR). Twelve ion exchange columns, piping debris, and column liquid were removed from the vault, packaged and shipped for disposal. The vault walls and floor were decontaminated, and portions of the vault were painted to fix loose contamination. Process piping and drains were plugged, and the cover blocks and rain cover were installed. Upon closure,the vault was empty, stabilized, isolated.

  15. 40 CFR 266.102 - Permit standards for burners.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... subpart G (Closure and post-closure), §§ 264.111-264.115; (viii) In subpart H (Financial requirements... prescribed in paragraph (e)(6) of this section; (C) Appropriate controls of the hazardous waste firing system...; (C) Appropriate controls on operation and maintenance of the hazardous waste firing system and any...

  16. 40 CFR 266.102 - Permit standards for burners.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... subpart G (Closure and post-closure), §§ 264.111-264.115; (viii) In subpart H (Financial requirements... prescribed in paragraph (e)(6) of this section; (C) Appropriate controls of the hazardous waste firing system...; (C) Appropriate controls on operation and maintenance of the hazardous waste firing system and any...

  17. 40 CFR 266.102 - Permit standards for burners.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... subpart G (Closure and post-closure), §§ 264.111-264.115; (viii) In subpart H (Financial requirements... prescribed in paragraph (e)(6) of this section; (C) Appropriate controls of the hazardous waste firing system...; (C) Appropriate controls on operation and maintenance of the hazardous waste firing system and any...

  18. 40 CFR 266.102 - Permit standards for burners.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... subpart G (Closure and post-closure), §§ 264.111-264.115; (viii) In subpart H (Financial requirements... prescribed in paragraph (e)(6) of this section; (C) Appropriate controls of the hazardous waste firing system...; (C) Appropriate controls on operation and maintenance of the hazardous waste firing system and any...

  19. 40 CFR 266.102 - Permit standards for burners.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... subpart G (Closure and post-closure), §§ 264.111-264.115; (viii) In subpart H (Financial requirements... prescribed in paragraph (e)(6) of this section; (C) Appropriate controls of the hazardous waste firing system...; (C) Appropriate controls on operation and maintenance of the hazardous waste firing system and any...

  20. 49 CFR 173.474 - Quality control for construction of packaging.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 2 2011-10-01 2011-10-01 false Quality control for construction of packaging. 173...-GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS Class 7 (Radioactive) Materials § 173.474 Quality control for construction of packaging. Prior to the first use of any packaging for the shipment of Class 7...

  1. 49 CFR 173.474 - Quality control for construction of packaging.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Quality control for construction of packaging. 173...-GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS Class 7 (Radioactive) Materials § 173.474 Quality control for construction of packaging. Prior to the first use of any packaging for the shipment of Class 7...

  2. Thinning guidelines from crown area relationships for young hardwood plantations

    Treesearch

    Jeffrey W. Stringer; Luke Cecil

    2010-01-01

    Crown closure in hardwood plantations signals the first opportunity to apply density control treatments such as thinning or release. The proper timing of these treatments is a function of stocking levels and is generally scheduled within several years after initial crown closure. Predicting crown closure for a plantation provides practitioners with the ability to plan...

  3. ECCD-induced tearing mode stabilization in coupled IPS/NIMROD/GENRAY HPC simulations

    NASA Astrophysics Data System (ADS)

    Jenkins, Thomas; Kruger, S. E.; Held, E. D.; Harvey, R. W.; Elwasif, W. R.

    2012-03-01

    We summarize ongoing developments toward an integrated, predictive model for determining optimal ECCD-based NTM stabilization strategies in ITER. We demonstrate the capability of the SWIM Project's Integrated Plasma Simulator (IPS) framework to choreograph multiple executions of, and data exchanges between, physics codes modeling various spatiotemporal scales of this coupled RF/MHD problem on several thousand HPC processors. As NIMROD evolves fluid equations to model bulk plasma behavior, self-consistent propagation/deposition of RF power in the ensuing plasma profiles is calculated by GENRAY. Data from both codes is then processed by computational geometry packages to construct the RF-induced quasilinear diffusion tensor; moments of this tensor (entering as additional terms in NIMROD's fluid equations due to the disparity in RF/MHD spatiotemporal scales) influence the dynamics of current, momentum, and energy evolution as well as the MHD closures. Initial results are shown to correctly capture the physics of magnetic island stabilization; we also discuss the development of a numerical plasma control system for active feedback stabilization of tearing modes.

  4. Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke: Meta-Analysis of Five Randomized Controlled Trials with 3440 Patients

    PubMed Central

    Sá, Michel Pompeu Barros Oliveira; de Oliveira Neto, Luiz de Albuquerque Pereira; do Nascimento, Gabriella Caroline Sales; Vieira, Erik Everton da Silva; Martins, Gabriel Lopes; Rodrigues, Karine Coelho; Nascimento, Giulia Cioffi; de Menezes, Alexandre Motta; Lins, Ricardo Felipe de Albuquerque; Silva, Frederico Pires Vasconcelos; Lima, Ricardo Carvalho

    2018-01-01

    Objective We aimed to determine whether patent foramen ovale closure reduces the risk of stroke, also assessing some safety outcomes. Introduction The clinical benefit of closing a patent foramen ovale after a cryptogenic stroke has been an open question for several decades, so that it is necessary to review the current state of published medical data in this regard. Methods MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LI-LACS, Google Scholar and reference lists of relevant articles were searched for randomized controlled trials that reported any of the following outcomes: stroke, death, major bleeding or atrial fibrillation. Five studies fulfilled our eligibility criteria and included 3440 patients (1829 for patent foramen ovale closure and 1611 for medical therapy). Results The risk ratio (RR) for stroke in the "device closure" group compared with the "medical therapy" showed a statistically significant difference between the groups, favouring the "device closure" group (RR 0.400; 95% CI 0.183-0.873, P=0.021). There was no statistically significant difference between the groups regarding the safety outcomes death and major bleeding, but we observed an increase in the risk of atrial fibrillation in the "device closure group (RR 4.000; 95% CI 2.262-7.092, P<0.001). We also observed that the larger the proportion of effective closure, the lower the risk of stroke. Conclusion This meta-analysis found that stroke rates are lower with percutaneously implanted device closure than with medical therapy alone, being these rates modulated by the rates of effective closure. PMID:29617507

  5. Closure of skin incisions in rabbits by laser soldering: I: Wound healing pattern.

    PubMed

    Simhon, David; Brosh, Tamar; Halpern, Marisa; Ravid, Avi; Vasilyev, Tamar; Kariv, Naam; Katzir, Abraham; Nevo, Zvi

    2004-01-01

    Temperature-controlled tissue laser soldering is an innovative sutureless technique awaiting only solid experimental data to become the gold-standard surgical procedure for incision closure. The goals of the current study were: (1) to define the optimal laser soldering conditions, (2) to explore the immediate skin reparative healing events after sealing the wound, and (3) to determine the long-term trajectory of skin wound healing. Skin incisions were generated over rabbit dorsa and were closed using different wound-closure interventions, in three groups: (a) closure, using a temperature-controlled infrared fiberoptic CO2 laser system, employing 47% bovine serum albumin as a solder; (b) wound closure by cyanoacrylate glues; and (c) wound closure by sutures. The reparative outcomes were evaluated macroscopically and microscopically, employing semi-quantitative grading indices. Laser soldering of incisions at T = 65 degrees C emerged as the optimal method achieving immediate wound sealing. This in turn induced accelerated reparative events characterized by a reduced inflammatory reaction, followed by minimal scarring and leading to a fine quality healing. Temperature-controlled laser soldering offers an accelerated wound reparative process with numerous advantages over the conventional methods. Further investigations may reveal additional benefits in the spectrum of advantages that this innovative surgical technology has to offer. This can introduce new scientific insight that will pave the way for clinical use.

  6. 40 CFR 265.111 - Closure performance standard.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) Controls, minimizes or eliminates, to the extent necessary to protect human health and the environment, post-closure escape of hazardous waste, hazardous constituents, leachate, contaminated run-off, or...

  7. Post-Closure Strategy for Use-Restricted Sites on the Nevada National Security Site, Nevada Test and Training Range, and Tonopah Test Range, Nevada

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Silvas, A. J.

    The purpose of this Post-Closure Strategy is to provide a consistent methodology for continual evaluation of post-closure requirements for use-restricted areas on the Nevada National Security Site (NNSS), Nevada Test and Training Range (NTTR), and Tonopah Test Range (TTR) to consolidate, modify, or streamline the program. In addition, this document stipulates the creation of a single consolidated Post-Closure Plan that will detail the current post-closure requirements for all active use restrictions (URs) and outlines its implementation and subsequent revision. This strategy will ensure effective management and control of the post-closure sites. There are currently over 200 URs located on themore » NNSS, NTTR, and TTR. Post-closure requirements were initially established in the Closure Report for each site. In some cases, changes to the post-closure requirements have been implemented through addenda, errata sheets, records of technical change, or letters. Post-closure requirements have been collected from these multiple sources and consolidated into several formats, such as summaries and databases. This structure increases the possibility of inconsistencies and uncertainty. As more URs are established and the post-closure program is expanded, the need for a comprehensive approach for managing the program will increase. Not only should the current requirements be obtainable from a single source that supersedes all previous requirements, but the strategy for modifying the requirements should be standardized. This will enable more effective management of the program into the future. This strategy document and the subsequent comprehensive plan are to be implemented under the assumption that the NNSS and outlying sites will be under the purview of the U.S. Department of Energy, National Nuclear Security Administration for the foreseeable future. This strategy was also developed assuming that regulatory control of the sites remains static. The comprehensive plan is not intended to be a permanent long-term stewardship plan. However, it is intended to clarify requirements and identify components to effectively manage the sites until regulatory requirements are met or management of the site changes. The Environmental Management Program is required to manage these sites until the NNSS Environmental Restoration program is completed, currently planned for 2030. Prior to completion of the Environmental Restoration program, additional planning will be conducted to ensure that long-term stewardship of the sites is maintained. A comprehensive post-closure plan can be transitioned effectively into any future site-wide long-term stewardship program that may be developed. Therefore, the post-closure plan will include current aspects of the post-closure program that are also important aspects of long-term stewardship, including the following: • Management of physical and engineering controls such as fences, signs, and soil covers • Management of institutional and administrative controls such as use restrictions and real estate systems • Management of monitoring and maintenance programs • Management of information related to the sites such as geographic information system data and related documentation The strategy will also allow for periodic review and modification of any aspect of the program to ensure continued effectiveness.« less

  8. Self-testing security sensor for monitoring closure of vault doors and the like

    DOEpatents

    Cawthorne, Duane C.

    1997-05-27

    A self-testing device is provided for a monitoring system for monitoring whether a closure member such as a door or window is closed. The monitoring system includes a switch unit mounted on the frame of the closure member being monitored and including magnetically biased switches connected in one or more electrical monitoring circuits, and a door magnet unit mounted on the closure member being monitored. The door magnet includes one or more permanent magnets that produce a magnetic field which, when the closure member is closed, cause said switches to assume a first state. When the closure member is opened, the switches switch to a second, alarm state. The self-testing device is electrically controllable from a remote location and produces a canceling or diverting magnetic field which simulates the effect of movement of the closure member from the closed position thereof without any actual movement of the member.

  9. Self-testing security sensor for monitoring closure of vault doors and the like

    DOEpatents

    Cawthorne, D.C.

    1997-05-27

    A self-testing device is provided for a monitoring system for monitoring whether a closure member such as a door or window is closed. The monitoring system includes a switch unit mounted on the frame of the closure member being monitored and including magnetically biased switches connected in one or more electrical monitoring circuits, and a door magnet unit mounted on the closure member being monitored. The door magnet includes one or more permanent magnets that produce a magnetic field which, when the closure member is closed, cause said switches to assume a first state. When the closure member is opened, the switches switch to a second, alarm state. The self-testing device is electrically controllable from a remote location and produces a canceling or diverting magnetic field which simulates the effect of movement of the closure member from the closed position thereof without any actual movement of the member. 5 figs.

  10. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ...: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin... Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin... intended for the topical approximation of skin may comply with the requirement of special controls for...

  11. 49 CFR Appendix A to Part 180 - Internal Self-closing Stop Valve Emergency Closure Test for Liquefied Compressed Gases

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Part 180—Internal Self-closing Stop Valve Emergency Closure Test for Liquefied Compressed Gases 1. In performing this test, all internal self-closing stop valves must be opened. Each emergency discharge control... 49 Transportation 3 2011-10-01 2011-10-01 false Internal Self-closing Stop Valve Emergency Closure...

  12. Nasalance Scores of Children with Repaired Cleft Palate Who Exhibit Normal Velopharyngeal Closure during Aerodynamic Testing

    ERIC Educational Resources Information Center

    Zajac, David J.

    2013-01-01

    Purpose: To determine if children with repaired cleft palate and normal velopharyngeal (VP) closure as determined by aerodynamic testing exhibit greater acoustic nasalance than control children without cleft palate. Method: Pressure-flow procedures were used to identify 2 groups of children based on VP closure during the production of /p/ in the…

  13. 43 CFR 4710.5 - Closure to livestock grazing.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) PROTECTION, MANAGEMENT, AND CONTROL OF WILD FREE-ROAMING HORSES AND BURROS Management Considerations § 4710.5 Closure to livestock grazing. (a) If...

  14. 43 CFR 4710.5 - Closure to livestock grazing.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) PROTECTION, MANAGEMENT, AND CONTROL OF WILD FREE-ROAMING HORSES AND BURROS Management Considerations § 4710.5 Closure to livestock grazing. (a) If...

  15. 43 CFR 4710.5 - Closure to livestock grazing.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) PROTECTION, MANAGEMENT, AND CONTROL OF WILD FREE-ROAMING HORSES AND BURROS Management Considerations § 4710.5 Closure to livestock grazing. (a) If...

  16. 43 CFR 4710.5 - Closure to livestock grazing.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) PROTECTION, MANAGEMENT, AND CONTROL OF WILD FREE-ROAMING HORSES AND BURROS Management Considerations § 4710.5 Closure to livestock grazing. (a) If...

  17. Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study)

    PubMed Central

    2014-01-01

    Background Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure. Methods/Design In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. Discussion The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia. Trail registration number NCT01927497 (Clinicaltrial.gov). PMID:25163547

  18. School closures during the 2009 influenza pandemic: national and local experiences

    PubMed Central

    2014-01-01

    Background School closure is a non-pharmaceutical intervention that was considered in many national pandemic plans developed prior to the start of the influenza A(H1N1)pdm09 pandemic, and received considerable attention during the event. Here, we retrospectively review and compare national and local experiences with school closures in several countries during the A(H1N1)pdm09 pandemic. Our intention is not to make a systematic review of country experiences; rather, it is to present the diversity of school closure experiences and provide examples from national and local perspectives. Methods Data were gathered during and following a meeting, organized by the European Centres for Disease Control, on school closures held in October 2010 in Stockholm, Sweden. A standard data collection form was developed and sent to all participants. The twelve participating countries and administrative regions (Bulgaria, China, France, Hong Kong Special Administrative Region (SAR), Italy, Japan, New Zealand, Serbia, South Africa, Thailand, United Kingdom, and United States) provided data. Results Our review highlights the very diverse national and local experiences on school closures during the A(H1N1)pdm09 pandemic. The processes including who was in charge of making recommendations and who was in charge of making the decision to close, the school-based control strategies, the extent of school closures, the public health tradition of responses and expectations on school closure varied greatly between countries. Our review also discusses the many challenges associated with the implementation of this intervention and makes recommendations for further practical work in this area. Conclusions The single most important factor to explain differences observed between countries may have been the different public health practises and public expectations concerning school closures and influenza in the selected countries. PMID:24739814

  19. Impact of Mucorales and Other Invasive Molds on Clinical Outcomes of Polymicrobial Traumatic Wound Infections

    PubMed Central

    Shaikh, Faraz; Weintrob, Amy C.; Rodriguez, Carlos J.; Murray, Clinton K.; Lloyd, Bradley A.; Ganesan, Anuradha; Aggarwal, Deepak; Carson, M. Leigh; Tribble, David R.

    2015-01-01

    Combat trauma wounds with invasive fungal infections (IFIs) are often polymicrobial with fungal and bacterial growth, but the impact of the wound microbiology on clinical outcomes is uncertain. Our objectives were to compare the microbiological features between IFI and non-IFI wounds and evaluate whether clinical outcomes differed among IFI wounds based upon mold type. Data from U.S. military personnel injured in Afghanistan with IFI wounds were examined. Controls were matched by the pattern/severity of injury, including blood transfusion requirements. Wound closure timing was compared between IFI and non-IFI control wounds (with/without bacterial infections). IFI wound closure was also assessed according to mold species isolation. Eighty-two IFI wounds and 136 non-IFI wounds (63 with skin and soft tissue infections [SSTIs] and 73 without) were examined. The time to wound closure was longer for the IFI wounds (median, 16 days) than for the non-IFI controls with/without SSTIs (medians, 12 and 9 days, respectively; P < 0.001). The growth of multidrug-resistant Gram-negative rods was reported among 35% and 41% of the IFI and non-IFI wounds with SSTIs, respectively. Among the IFI wounds, times to wound closure were significantly longer for wounds with Mucorales growth than for wounds with non-Mucorales growth (median, 17 days versus 13 days; P < 0.01). When wounds with Mucorales and Aspergillus spp. growth were compared, there was no significant difference in wound closure timing. Trauma wounds with SSTIs were often polymicrobial, yet the presence of invasive molds (predominant types: order Mucorales, Aspergillus spp., and Fusarium spp.) significantly prolonged the time to wound closure. Overall, the times to wound closure were longest for the IFI wounds with Mucorales growth. PMID:25972413

  20. Impact of Mucorales and Other Invasive Molds on Clinical Outcomes of Polymicrobial Traumatic Wound Infections.

    PubMed

    Warkentien, Tyler E; Shaikh, Faraz; Weintrob, Amy C; Rodriguez, Carlos J; Murray, Clinton K; Lloyd, Bradley A; Ganesan, Anuradha; Aggarwal, Deepak; Carson, M Leigh; Tribble, David R

    2015-07-01

    Combat trauma wounds with invasive fungal infections (IFIs) are often polymicrobial with fungal and bacterial growth, but the impact of the wound microbiology on clinical outcomes is uncertain. Our objectives were to compare the microbiological features between IFI and non-IFI wounds and evaluate whether clinical outcomes differed among IFI wounds based upon mold type. Data from U.S. military personnel injured in Afghanistan with IFI wounds were examined. Controls were matched by the pattern/severity of injury, including blood transfusion requirements. Wound closure timing was compared between IFI and non-IFI control wounds (with/without bacterial infections). IFI wound closure was also assessed according to mold species isolation. Eighty-two IFI wounds and 136 non-IFI wounds (63 with skin and soft tissue infections [SSTIs] and 73 without) were examined. The time to wound closure was longer for the IFI wounds (median, 16 days) than for the non-IFI controls with/without SSTIs (medians, 12 and 9 days, respectively; P < 0.001). The growth of multidrug-resistant Gram-negative rods was reported among 35% and 41% of the IFI and non-IFI wounds with SSTIs, respectively. Among the IFI wounds, times to wound closure were significantly longer for wounds with Mucorales growth than for wounds with non-Mucorales growth (median, 17 days versus 13 days; P < 0.01). When wounds with Mucorales and Aspergillus spp. growth were compared, there was no significant difference in wound closure timing. Trauma wounds with SSTIs were often polymicrobial, yet the presence of invasive molds (predominant types: order Mucorales, Aspergillus spp., and Fusarium spp.) significantly prolonged the time to wound closure. Overall, the times to wound closure were longest for the IFI wounds with Mucorales growth. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  1. 49 CFR 178.338-11 - Discharge control devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... water capacity, remote means of automatic closure must be installed at the ends of the cargo tank in at... control system. (ii) On a cargo tank motor vehicle of 3,500 gallons water capacity or less, at least one remote means of automatic closure must be installed on the end of the cargo tank farthest away from the...

  2. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  3. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  4. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  5. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  6. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  7. The impact of the fecal stream and stasis on immunologic reactions in ileal pouch after restorative proctocolectomy for ulcerative colitis: a prospective, pilot study.

    PubMed

    Yamamoto, Takayuki; Umegae, Satoru; Kitagawa, Tatsushi; Matsumoto, Koichi

    2005-10-01

    The etiology of pouch inflammation after restorative proctocolectomy is unknown. The fecal stream and immunological reactions are potential pathological factors. This study was performed to examine the impact of the fecal stream and stasis on immunological reactions in the pouch. Patients who underwent a restorative proctocolectomy with a covering ileostomy for ulcerative colitis were studied. Mucosal biopsy specimens were obtained from both the pouch and the proximal ileum at the time of ileostomy closure, and 3, 6, and 12 months after ileostomy closure. As a control group, normal ileal biopsies were obtained from patients with colonic polyps. At the time of ileostomy closure, mucosal interleukin-1beta, interleukin-6, interleukin-8, and tumor necrosis factor-alpha levels in the pouch and the proximal ileum were not significantly different from those in the normal control group. At 3 months after ileostomy closure, the mucosal cytokine levels in the pouch increased significantly compared with those at ileostomy closure, and their levels were significantly higher than those in the proximal ileum. At 6 and 12 months after ileostomy closure, the mucosal cytokine levels in the pouch did not change significantly compared with those at 3 months after ileostomy closure. The mucosal cytokine levels in the proximal ileum did not change significantly during the entire study. The immunological reactions in the pouch occurred soon after ileostomy closure, and continued for at least 1 yr. The fecal stream and stasis play an important part in the pathogenesis of immunological reactions in the ileal pouch.

  8. Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data.

    PubMed

    Hakeem, Abdul; Cilingiroglu, Mehmet; Katramados, Angelos; Boudoulas, Konstantinos Dean; Iliescu, Cezar; Gundogdu, Betul; Marmagkiolis, Konstantinos

    2018-01-14

    To evaluate the safety and efficacy of percutaneous device closure of patent foramen ovale (PFO) for secondary prevention of ischemic stroke BACKGROUND: Stroke remains the leading cause of serious long-term disability in the United States. The effectiveness of a percutaneous PFO closure in the prevention of recurrent cryptogenic strokes has not been established. We performed a literature search using PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Google Scholar, and Internet-based sources from January 2003 to September 2017. Randomized controlled trails (RCTs) comparing percutaneous PFO closure to medical therapy alone. Five RCTs (CLOSURE I, PC Trial, REDUCE, RESPECT, and CLOSE) with 1,829 patients in the device group and 1,611 patients in the medical group met inclusion criteria. The cumulative incidence of recurrent stroke was 2.02% in the PFO closure arm and 4.4% in the medical therapy group (RR 0.42, 95%CI 0.20, 0.91; P = 0.03). There was no difference in the incidence of death [0.7% vs. 0.9%; RR 0.76 (95% CI 0.35, 1.64), P = 0.49] or adverse events during the follow-up period [24.6% vs. 23.7% (RR 1.03; 95% CI 0.91, 1.16), P = 0.65] between the closure and medical therapy groups. Incidence of atrial fibrillation was significantly higher in closure group compared to medical therapy [4% vs. 0.6% (RR 4.73; 95% CI 2.09, 10.70), P = 0.0002]. The comparative effectiveness of PFO closure (compared to medical therapy) was significantly more pronounced in those younger than 45 years, males, larger shunts and disc design platforms (P < 0.05). Based on the results of this analysis of randomized trial data, percutaneous PFO closure appears to be a safe and effective therapeutic option for the secondary prevention of ischemic stroke in patients with PFO and cryptogenic stroke. © 2018 Wiley Periodicals, Inc.

  9. Contemporary Approach to the Diagnosis and Management of Primary Angle-Closure Disease.

    PubMed

    Razeghinejad, M Reza; Myers, Jonathan S

    2018-05-16

    Primary angle closure disease spectrum varies from a narrow angle to advanced glaucoma. A variety of imaging technologies may assist the clinician in determining the pathophysiology and diagnosis of primary angle closure, but gonioscopy remains a mainstay of clinical evaluation. Laser iridotomy effectively eliminates the pupillary block component of angle closure; however, studies show that in many patients the iridocorneal angle remains narrow from underlying anatomic issues, and increasing lens size often leads to further narrowing over time. Recent studies have further characterized the role of the lens in angle closure disease, and cataract or clear lens extraction is increasingly used earlier in its management. As a first surgical step in angle closure glaucoma, lens extraction alone often effectively controls the pressure with less risk of complications than concurrent or stand alone glaucoma surgery, but may not be sufficient in more advanced or severe disease. We provide a comprehensive review on the primary angle-closure disease nomenclature, imaging, and current laser and surgical management. Copyright © 2018. Published by Elsevier Inc.

  10. Valve for controlling solids flow

    DOEpatents

    Feldman, David K.

    1980-01-01

    A fluidized solids control valve is disclosed that is particularly well adapted for use with a flow of coal or char that includes both large particles and fines. The particles may or may not be fluidized at various times during the operation. The valve includes a tubular body that terminates in a valve seat covered by a normally closed closure plate. The valve body at the seat and the closure plate is provided with aligned longitudinal slots that receive a pivotally supported key plate. The key plate is positionable by an operator in inserted, intermediate and retracted positions respecting the longitudinal slot in the valve body. The key plate normally closes the slot within the closure plate but is shaped and aligned obliquely to the longitudinal slot within the valve body to provide progressively increasing slot openings between the inserted and retracted positions. Transfer members are provided between the operator, key plate and closure plate to move the closure plate into an open position only when the key plate is retracted from the longitudinal slot within the valve body.

  11. Food packing optimization

    NASA Technical Reports Server (NTRS)

    1981-01-01

    The development of a universal closure lid for the space shuttle food package is reported. The revised lid needs a folded configuration which, when unfolded, fully conforms to the interior surfaces of the food cup. Experimental thermoform molds were fabricated and test lids formed. The lid material not in contact with the food conformed to the cup interior without wrinkles, permitting full nesting of the cups. The final lid design was established and thermoform tooling designed and fabricated. Lids formed on these molds were tested for strength. The heating elements were replaced and repositioned to eliminate any hot spots which may cause warpage.

  12. Reactor refueling containment system

    DOEpatents

    Gillett, J.E.; Meuschke, R.E.

    1995-05-02

    A method of refueling a nuclear reactor is disclosed whereby the drive mechanism is disengaged and removed by activating a jacking mechanism that raises the closure head. The area between the barrier plate and closure head is exhausted through the closure head penetrations. The closure head, upper drive mechanism, and bellows seal are lifted away and transported to a safe area. The barrier plate acts as the primary boundary and each drive and control rod penetration has an elastomer seal preventing excessive tritium gases from escaping. The individual instrumentation plugs are disengaged allowing the corresponding fuel assembly to be sealed and replaced. 2 figs.

  13. Reactor refueling containment system

    DOEpatents

    Gillett, James E.; Meuschke, Robert E.

    1995-01-01

    A method of refueling a nuclear reactor whereby the drive mechanism is disengaged and removed by activating a jacking mechanism that raises the closure head. The area between the barrier plate and closure head is exhausted through the closure head penetrations. The closure head, upper drive mechanism, and bellows seal are lifted away and transported to a safe area. The barrier plate acts as the primary boundary and each drive and control rod penetration has an elastomer seal preventing excessive tritium gases from escaping. The individual instrumentation plugs are disengaged allowing the corresponding fuel assembly to be sealed and replaced.

  14. Integration of actomyosin contractility with cell-cell adhesion during dorsal closure.

    PubMed

    Duque, Julia; Gorfinkiel, Nicole

    2016-12-15

    In this work, we combine genetic perturbation, time-lapse imaging and quantitative image analysis to investigate how pulsatile actomyosin contractility drives cell oscillations, apical cell contraction and tissue closure during morphogenesis of the amnioserosa, the main force-generating tissue during the dorsal closure in Drosophila We show that Myosin activity determines the oscillatory and contractile behaviour of amnioserosa cells. Reducing Myosin activity prevents cell shape oscillations and reduces cell contractility. By contrast, increasing Myosin activity increases the amplitude of cell shape oscillations and the time cells spend in the contracted phase relative to the expanded phase during an oscillatory cycle, promoting cell contractility and tissue closure. Furthermore, we show that in AS cells, Rok controls Myosin foci formation and Mbs regulates not only Myosin phosphorylation but also adhesion dynamics through control of Moesin phosphorylation, showing that Mbs coordinates actomyosin contractility with cell-cell adhesion during amnioserosa morphogenesis. © 2016. Published by The Company of Biologists Ltd.

  15. High expression of A-type lamin in the leading front is required for Drosophila thorax closure.

    PubMed

    Kosakamoto, Hina; Fujisawa, Yuya; Obata, Fumiaki; Miura, Masayuki

    2018-05-05

    Tissue closure involves the coordinated unidirectional movement of a group of cells without loss of cell-cell contact. However, the molecular mechanisms controlling the tissue closure are not fully understood. Here, we demonstrate that Lamin C, the sole A-type lamin in Drosophila, contributes to the process of thorax closure in pupa. High expression of Lamin C was observed at the leading front of the migrating wing imaginal discs. Live imaging analysis revealed that knockdown of Lamin C in the thorax region affected the coordinated movement of the leading front, resulting in incomplete tissue fusion required for formation of the adult thorax. The closure defect due to knockdown of Lamin C correlated with insufficient accumulation of F-actin at the front. Our study indicates a link between A-type lamin and the cell migration behavior during tissue closure. Copyright © 2018 Elsevier Inc. All rights reserved.

  16. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial.

    PubMed

    Lee, Janet T; Marquez, Thao T; Clerc, Daniel; Gie, Olivier; Demartines, Nicolas; Madoff, Robert D; Rothenberger, David A; Christoforidis, Dimitrios

    2014-11-01

    Surgical site infection after stoma reversal is common. The optimal skin closure technique after stoma reversal has been widely debated in the literature. We hypothesized that pursestring near-complete closure of the stoma site would lead to fewer surgical site infections compared with conventional primary closure. This study was a parallel prospective multicenter randomized controlled trial. This study was conducted at 2 university medical centers. Patients (N = 122) presenting for elective colostomy or ileostomy reversal were selected. Pursestring versus conventional primary closure of stoma sites were compared. Stoma site surgical site infection within 30 days of surgery, overall surgical site infection, delayed healing (open wound for >30 days), time to wound epithelialization, and patient satisfaction were the primary outcomes measured. The pursestring group had a significantly lower stoma site infection rate (2% vs 15%, p = 0.01). There was no difference in delayed healing or patient satisfaction between groups. Time to epithelialization was measured in only 51 patients but was significantly longer in the pursestring group (34.6 ± 20 days vs 24.1 ± 17 days, p = 0.02). This study was limited by the variability in procedures and surgeons, the limited follow-up after 30 days, and the inability to perform blinding. Pursestring closure after stoma reversal has a lower risk of stoma site surgical site infection than conventional primary closure, although wounds may take longer to heal with the use of this approach. NCT01713452 (www.clinicaltrials.gov).

  17. Skull Base Cerebrospinal Fluid Leakage Control with a Fibrin-Based Composite Tissue Adhesive

    PubMed Central

    Rock, Jack P.; Sierra, David H.; Castro-Moure, Frederico; Jiang, Feng

    1996-01-01

    Cerebrospinal fluid (CSF) leaks can be responsible for significant patient morbidity and mortality. While the majority of leaks induced after head trauma will seal without intervention, spontaneous or surgically-induced leaks often require operative repair. Many modifications on standard surgical technique are available for repair of CSF fistulae, but none assures adequate closure. We have studied the efficacy of a novel fibrin-based composite tissue adhesive (CTA) for closure of experimentally-induced CSF leaks in rats. Fistulae were created in two groups of animals. Two weeks after creation of the leaks, the animals were sacrificed and analyzed for persistence of leak. A 58% leakage rate was noted in the control group (n = 12), and no leaks were noted in the experimental group closed after application of CTA to the surgical defect followed by skin closure (n = 11). Comparing the control group to the experimental group, results were statistically significant (p = 0.015). These data suggest that CTA may be effective as an adjunct for the closure of CSF fistulae. ImagesFigure 2Figure 3 PMID:17170969

  18. Transcatheter Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Darmoch, Fahed; Al-Khadra, Yasser; Soud, Mohamad; Fanari, Zaher; Alraies, M Chadi

    2018-01-01

    Patent foramen ovale (PFO) with atrial septal aneurysm is suggested as an important potential source for cryptogenic strokes. Percutaneous PFO closure to reduce the recurrence of stroke compared to medical therapy has been intensely debated. The aim of this study is to assess whether PFO closure in patients with cryptogenic stroke is safe and effective compared with medical therapy. A search of PubMed, Medline, and Cochrane Central Register from January 2000 through September 2017 for randomized controlled trails (RCT), which compared PFO closure to medical therapy in patients with cryptogenic stroke was conducted. We used the items "PFO or patent foramen ovale", "paradoxical embolism", "PFO closure" and "stroke". Data were pooled for the primary outcome measure using the random-effects model as pooled rate ratio (RR). The primary outcome was reduction in recurrent strokes. Among 282 studies, 5 were selected. Our analysis included 3,440 patients (mean age 45 years, 55% men, mean follow-up 2.9 years), 1,829 in the PFO closure group and 1,611 in the medical therapy group. The I2 heterogeneity test was found to be 48%. A random effects model combining the results of the included studies demonstrated a statistically significant risk reduction in risk of recurrent stroke in the PFO closure group when compared with medical therapy (RR 0.42; 95% CI 0.20-0.91, p = 0.03). Pooled data from 5 large RCTs showed that PFO closure in patients with cryptogenic stroke is safe and effective intervention for prevention of stroke recurrence compared with medical therapy. © 2018 S. Karger AG, Basel.

  19. Association of aortic stiffness to brain natriuretic peptide in children before and after device closure of patent ductus arteriosus

    PubMed Central

    Mahfouz, Ragab A.; Alzaiat, Ahmad; Gad, Marwa

    2014-01-01

    Objectives We evaluated the influence of device closure for patent ductus arteriosus (PDA) on the aortic stiffness index (ASI) and brain natriuretic peptide (BNP) and their association with cardiac function. Patients and methods ASI and echocardiography assessment before and after treatment (16 ± 9 months) in 48 children with PDA (mean age 10 ± 4.5) and 52 control children (mean age 9.7 ± 4.6). BNP level was measured pre-closure for all children, and was measured six months after closure only for children with PDA. Results ASI was higher in PDA patients than in controls (P < 0.001). ASI correlated with age (P < 0.05), LVEF% (P < 0.01), E/E′ (<0.03), pulmonary artery pressure (P < 0.001), and BNP (P < 0.001). ASI and BNP significantly decreased after closure (P < 0.001). ASI and BNP were independent predictors for post-closure systolic dysfunction (P < 0.001and <0.005, respectively). Receiver operating curve (ROC) analysis showed that ASI ⩾ 13.5, BNP level ⩾75 pg/ml and basal mean pulmonary artery pressure (PAP) ⩾ 23 were powerful predictors for post-closure systolic function. Conclusion ASI is significantly associated with BNP and basal PAP in children with PDA. After device closure, aortic distensibility improved significantly and was associated with significant improvement in both systolic and diastolic functions. ASI can be used for monitoring the course of patients with PDA, and may give opportunities for early intervention. PMID:25544819

  20. The open abdomen and temporary abdominal closure systems--historical evolution and systematic review.

    PubMed

    Quyn, A J; Johnston, C; Hall, D; Chambers, A; Arapova, N; Ogston, S; Amin, A I

    2012-08-01

    Several techniques for temporary abdominal closure have been developed. We systematically review the literature on temporary abdominal closure to ascertain whether the method can be tailored to the indication. Medline, Embase, the Cochrane Central Register of Controlled Trials and relevant meeting abstracts until December 2009 were searched using the following headings: open abdomen, laparostomy, VAC (vacuum assisted closure), TNP (topical negative pressure), fascial closure, temporary abdominal closure, fascial dehiscence and deep wound dehiscence. The data were analysed by closure technique and aetiology. The primary end-points included delayed fascial closure and in-hospital mortality. The secondary end-points were intra-abdominal complications. The search identified 106 papers for inclusion. The techniques described were VAC (38 series), mesh/sheet (30 series), packing (15 series), Wittmann patch (eight series), Bogotá bag (six series), dynamic retention sutures (three series), zipper (15 series), skin only and locking device (one series each). The highest facial closure rates were seen with the Wittmann patch (78%), dynamic retention sutures (71%) and VAC (61%). Temporary abdominal closure has evolved from simple packing to VAC based systems. In the absence of sepsis Wittmann patch and VAC offered the best outcome. In its presence VAC had the highest delayed primary closure and the lowest mortality rates. However, due to data heterogeneity only limited conclusions can be drawn from this analysis. © 2012 The Authors. Colorectal Disease © 2012 The Association of Coloproctology of Great Britain and Ireland.

  1. Randomized clinical trial of intestinal ostomy takedown comparing pursestring wound closure vs conventional closure to eliminate the risk of wound infection.

    PubMed

    Camacho-Mauries, Daniel; Rodriguez-Díaz, José Luis; Salgado-Nesme, Noel; González, Quintín H; Vergara-Fernández, Omar

    2013-02-01

    The use of temporary stomas has been demonstrated to reduce septic complications, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection, anastomotic leaks, and intestinal obstruction. To compare the rates of superficial wound infection and patient satisfaction after pursestring closure of ostomy wound vs conventional linear closure. Patients undergoing colostomy or ileostomy closure between January 2010 and February 2011 were randomly assigned to linear closure (n = 30) or pursestring closure (n = 31) of their ostomy wound. Wound infection within 30 days of surgery was defined as the presence of purulent discharge, pain, erythema, warmth, or positive culture for bacteria. Patient satisfaction, healing time, difficulty managing the wound, and limitation of activities were analyzed with the Likert questionnaire. The infection rate for the control group was 36.6% (n = 11) vs 0% in the pursestring closure group (p < 0.0001). Healing time was 5.9 weeks in the linear closure group and 3.8 weeks in the pursestring group (p = 0.0002). Seventy percent of the patients with pursestring closure were very satisfied in comparison with 20% in the other group (p = 0.0001). This study was limited by the heterogeneity in the type of stoma in both groups. The pursestring method resulted in the absence of infection after ostomy wound closure (shorter healing time and improved patient satisfaction).

  2. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing.

    PubMed

    Mathaes, Roman; Mahler, Hanns-Christian; Roggo, Yves; Huwyler, Joerg; Eder, Juergen; Fritsch, Kamila; Posset, Tobias; Mohl, Silke; Streubel, Alexander

    2016-01-01

    Capping equipment used in good manufacturing practice manufacturing features different designs and a variety of adjustable process parameters. The overall capping result is a complex interplay of the different capping process parameters and is insufficiently described in literature. It remains poorly studied how the different capping equipment designs and capping equipment process parameters (e.g., pre-compression force, capping plate height, turntable rotating speed) contribute to the final residual seal force of a sealed container closure system and its relation to container closure integrity and other drug product quality parameters. Stopper compression measured by computer tomography correlated to residual seal force measurements.In our studies, we used different container closure system configurations from different good manufacturing practice drug product fill & finish facilities to investigate the influence of differences in primary packaging, that is, vial size and rubber stopper design on the capping process and the capped drug product. In addition, we compared two large-scale good manufacturing practice manufacturing capping equipment and different capping equipment settings and their impact on product quality and integrity, as determined by residual seal force.The capping plate to plunger distance had a major influence on the obtained residual seal force values of a sealed vial, whereas the capping pre-compression force and the turntable rotation speed showed only a minor influence on the residual seal force of a sealed vial. Capping process parameters could not easily be transferred from capping equipment of different manufacturers. However, the residual seal force tester did provide a valuable tool to compare capping performance of different capping equipment. No vial showed any leakage greater than 10(-8)mbar L/s as measured by a helium mass spectrometry system, suggesting that container closure integrity was warranted in the residual seal force range tested for the tested container closure systems. Capping equipment used in good manufacturing practice manufacturing features different designs and a variety of adjustable process parameters. The overall capping result is a complex interplay of the different capping process parameters and is insufficiently described in the literature. It remains poorly studied how the different capping equipment designs and capping equipment process parameters contribute to the final capping result.In this study, we used different container closure system configurations from different good manufacturing process drug product fill & finish facilities to investigate the influence of the vial size and the rubber stopper design on the capping process. In addition, we compared two examples of large-scale good manufacturing process capping equipment and different capping equipment settings and their impact on product quality and integrity, as determined by residual seal force. © PDA, Inc. 2016.

  3. Debris control design achievements of the booster separation motors

    NASA Technical Reports Server (NTRS)

    Smith, G. W.; Chase, C. A.

    1985-01-01

    The stringent debris control requirements imposed on the design of the Space Shuttle booster separation motor are described along with the verification program implemented to ensure compliance with debris control objectives. The principal areas emphasized in the design and development of the Booster Separation Motor (BSM) relative to debris control were the propellant formulation and nozzle closures which protect the motors from aerodynamic heating and moisture. A description of the motor design requirements, the propellant formulation and verification program, and the nozzle closures design and verification are presented.

  4. Assessment of platelet-derived growth factor using A splinted full thickness dermal wound model in bearded dragons (Pogona vitticeps).

    PubMed

    Keller, Krista A; Paul-Murphy, Joanne; Weber, E P Scott; Kass, Philip H; Guzman, Sanchez-Migallon David; Park, Shin Ae; Raghunathan, Vijay Krishna; Gustavsen, Kate A; Murphy, Christopher J

    2014-12-01

    Wounds in reptiles are a common reason for presentation to a veterinarian. At this time there is limited information on effective topical medications to aid in wound closure. The objectives of this study were to translate the splinted, full-thickness dermal wound model, validated in mice, to the bearded dragon (Pogona vitticeps) and to determine the effect of topical becaplermin (BP), a platelet-derived growth factor (0.01%), on the rate of wound closure. Ten bearded dragons were anesthetized and two full-thickness cutaneous wounds were made on the dorsum of each lizard. Encircling splints were applied surrounding each wound and subsequently covered by a semi-occlusive dressing. Five lizards had one wound treated with BP and the adjacent wound treated with a vehicle control. Five additional lizards had one wound treated with saline and the second wound treated with a vehicle control. Wounds were imaged daily, and the wound area was measured using digital image analysis. The change in percentage wound closure over 17 days and the time to 50% wound closure was compared among the four treatment groups. There was no significant difference in wound closure rates between BP-treated and saline-treated wounds or in the time to 50% wound closure between any treatments. Vehicle-treated wounds adjacent to saline-treated wounds closed significantly slower than did BP (P < 0.010), saline (P < 0.001), and vehicle-treated wounds adjacent to BP-treated wounds (P < 0.013). Our preliminary study indicates that the splinted wound model, with modifications, may be used to determine wound closure rates in bearded dragons. When compared with saline, BP did not have a significant effect on wound closure rates, while the vehicle alone delayed wound closure. Histologic analysis of experimentally created wounds throughout the wound healing process is needed to further evaluate the effects of these treatments on reptile dermal wound healing.

  5. Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis.

    PubMed

    Wolfrum, Mathias; Froehlich, Georg M; Knapp, Guido; Casaubon, Leanne K; DiNicolantonio, James J; Lansky, Alexandra J; Meier, Pascal

    2014-03-01

    The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence. Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptogenic strokes as compared to best medical therapy (BMT). Trials were identified through a literature search until 28 May 2013. Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT. Main end point of interest was stroke. A random effects model was used to calculate the pooled relative risks (RR) with 95% CIs. A total of 14 studies (three randomised controlled trials (RCT) and 11 non-randomised observational studies (non-RCT)), and a total of 4335 patients were included for this analysis. There was no significant treatment effect of PFO closure regarding stroke among the RCT (RR 0.66, 95% CI 0.37 to 1.19, p=0.171). However, among non-RCT stroke was reduced (RR 0.37, 95% CI 0.20 to 0.67, p<0.001) after PFO closure. A time-to-event (stroke) analysis, combining all three RCT and the two non-RCT which applied strict multivariate adjustments, showed a borderline significant risk reduction after PFO closure (HR 0.58, 95% CI 0.33 to 0.99, p=0.047). Neither risk of bleeding nor mortality differed significantly between the groups. However, there was a higher incidence of new onset atrial fibrillation in the closure group (RR 3.50, 95% CI 1.47 to 8.35, p=0.005). Percutaneous closure of PFO in patients with cryptogenic stroke does not appear superior to medical therapy according to currently available randomised data. Furthermore, it is associated with an increased incidence of atrial fibrillation. However, there are signals pointing towards a potential benefit and more research should be strongly encouraged.

  6. 76 FR 4720 - Renewal of Agency Information Collection for Homeliving Programs and School Closure and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-26

    ... Number 1076-0164, which expires on March 31, 2011. DATES: Interested persons are invited to submit... able to do so. III. Data OMB Control Number: 1076-0164. Title: Homeliving Programs and School Closure...

  7. 21 CFR 211.130 - Packaging and labeling operations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control § 211.130 Packaging and labeling operations. There shall be written procedures designed to... manufacture and control of the batch. (d) Examination of packaging and labeling materials for suitability and...

  8. Granite disposal of U.S. high-level radioactive waste.

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Freeze, Geoffrey A.; Mariner, Paul E.; Lee, Joon H.

    This report evaluates the feasibility of disposing U.S. high-level radioactive waste in granite several hundred meters below the surface of the earth. The U.S. has many granite formations with positive attributes for permanent disposal. Similar crystalline formations have been extensively studied by international programs, two of which, in Sweden and Finland, are the host rocks of submitted or imminent repository license applications. This report is enabled by the advanced work of the international community to establish functional and operational requirements for disposal of a range of waste forms in granite media. In this report we develop scoping performance analyses, basedmore » on the applicable features, events, and processes (FEPs) identified by international investigators, to support generic conclusions regarding post-closure safety. Unlike the safety analyses for disposal in salt, shale/clay, or deep boreholes, the safety analysis for a mined granite repository depends largely on waste package preservation. In crystalline rock, waste packages are preserved by the high mechanical stability of the excavations, the diffusive barrier of the buffer, and favorable chemical conditions. The buffer is preserved by low groundwater fluxes, favorable chemical conditions, backfill, and the rigid confines of the host rock. An added advantage of a mined granite repository is that waste packages would be fairly easy to retrieve, should retrievability be an important objective. The results of the safety analyses performed in this study are consistent with the results of comprehensive safety assessments performed for sites in Sweden, Finland, and Canada. They indicate that a granite repository would satisfy established safety criteria and suggest that a small number of FEPs would largely control the release and transport of radionuclides. In the event the U.S. decides to pursue a potential repository in granite, a detailed evaluation of these FEPs would be needed to inform site selection and safety assessment.« less

  9. Effectiveness of Active Packaging on Control of Escherichia Coli O157:H7 and Total Aerobic Bacteria on Iceberg Lettuce.

    PubMed

    Lu, Haixia; Zhu, Junli; Li, Jianrong; Chen, Jinru

    2015-06-01

    Contaminated leafy green vegetables have been linked to several outbreaks of human gastrointestinal infections. Antimicrobial interventions that are adoptable by the fresh produce industry for control of pathogen contamination are in great demand. This study was undertaken to evaluate the efficacy of sustained active packaging on control of Escherichia coli O157:H7 and total aerobic bacteria on lettuce. Commercial Iceberg lettuce was inoculated with a 3-strain mixture of E. coli O157:H7 at 10(2) or 10(4) CFU/g. The contaminated lettuce and un-inoculated controls were placed respectively in 5 different active packaging structures. Traditional, nonactive packaging structure was included as controls. Packaged lettuce was stored at 4, 10, or 22 °C for 3 wk and sampled weekly for the population of E. coli O157:H7 and total aerobic bacteria. Results showed that packaging structures with ClO2 generator, CO2 generator, or one of the O2 scavengers effectively controlled the growth of E. coli O157:H7 and total aerobic bacteria under all storage conditions. Packaging structure with the ClO2 generator was most effective and no E. coli O157:H7 was detected in samples packaged in this structure except for those that were inoculated with 4 log CFU/g of E. coli O157:H7 and stored at 22 °C. Packaging structures with an oxygen scavenger and the allyl isothiocyanate generator were mostly ineffective in control of the growth of the bacteria on Iceberg lettuce. The research suggests that some of the packaging structures evaluated in the study can be used to control the presence of foodborne pathogens on leafy green vegetables. © 2015 Institute of Food Technologists®

  10. 10 CFR 71.107 - Package design control.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Package design control. 71.107 Section 71.107 Energy... Assurance § 71.107 Package design control. (a) The licensee, certificate holder, and applicant for a CoC... identification and control of design interfaces and for coordination among participating design organizations...

  11. 10 CFR 71.107 - Package design control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Package design control. 71.107 Section 71.107 Energy... Assurance § 71.107 Package design control. (a) The licensee, certificate holder, and applicant for a CoC... identification and control of design interfaces and for coordination among participating design organizations...

  12. 10 CFR 71.107 - Package design control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Package design control. 71.107 Section 71.107 Energy... Assurance § 71.107 Package design control. (a) The licensee, certificate holder, and applicant for a CoC... identification and control of design interfaces and for coordination among participating design organizations...

  13. 10 CFR 71.107 - Package design control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Package design control. 71.107 Section 71.107 Energy... Assurance § 71.107 Package design control. (a) The licensee, certificate holder, and applicant for a CoC... identification and control of design interfaces and for coordination among participating design organizations...

  14. 10 CFR 71.107 - Package design control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Package design control. 71.107 Section 71.107 Energy... Assurance § 71.107 Package design control. (a) The licensee, certificate holder, and applicant for a CoC... identification and control of design interfaces and for coordination among participating design organizations...

  15. 75 FR 59086 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... package printing entitled ``Control Techniques Guidelines for Flexible Package Printing'' (Publication No... adoption of the EPA CTG for flexible packaging printing. EPA develops CTGs as guidance on control... Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control Techniques Guidelines for...

  16. Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer. Trial registration German Clinical Trial Register Number: DRKS00000040 PMID:21303515

  17. The healing effects of autologous platelet gel on acute human skin wounds.

    PubMed

    Hom, David B; Linzie, Bradley M; Huang, Trevor C

    2007-01-01

    To compare the healing of full-thickness skin punch wounds treated with topical autologous platelet gel (APG) vs conventional therapy (antibiotic ointment and/or occlusive dressings) in healthy volunteers. A prospective, single-blind, pilot study comprising 80 full-thickness skin punch wounds (4 mm diameter) was conducted on the thighs of 8 healthy volunteers. With each subject serving as his or her own control (5 punch sites per leg), APG was applied topically on one thigh, and an antibiotic ointment and/or a semiocclusive dressing was applied on the other thigh. Healing was monitored for spontaneous wound closure by clinical assessment and by digital photographs over 6 months. Over 35 days, 64 serial dermal biopsy specimens (6 mm diameter) were analyzed (using hematoxylin-eosin, Mason trichrome, CD-34, and Ki-67 stains) to measure differences between treated and control sites for cellularity, granulation formation, vascularity, epithelialization, and cellular replication. Over a 42-day period, the APG-treated sites had statistically increased wound closure compared with controls by visual clinical assessment and by digital planimetry photographic measurements (P

  18. Prevalence of patent foramen ovale and usefulness of percutaneous closure device in carcinoid heart disease.

    PubMed

    Mansencal, Nicolas; Mitry, Emmanuel; Pillière, Rémy; Lepère, Céline; Gérardin, Benoît; Petit, Jérôme; Gandjbakhch, Iradj; Rougier, Philippe; Dubourg, Olivier

    2008-04-01

    The aim of this study was to assess (1) the incidence of patent foramen ovale (PFO) in carcinoid syndrome (CS) and (2) the feasibility of percutaneous closure procedure in selected patients with CS. One hundred eight patients were prospectively studied: 54 with CS and an age- and gender-matched control group. All patients underwent conventional and contrast echocardiography. Patients with clinical signs of dyspnea (New York Heart Association class > or =III), cyanosis, carcinoid heart disease (CHD), and severe PFO were referred for the percutaneous closure of PFO. The prevalence of PFO was 41% in patients with CS and 22% in the control group (p = 0.03) and was significantly higher in patients with CHD (59%, p = 0.009). Four patients (14% of those with CHD) were referred for the percutaneous closure of PFO, and 3 patients ultimately underwent PFO closure (using Amplatzer septal occluders). At 6-month follow-up, New York Heart Association class was improved in all patients, as well as arterial blood gas results (p = 0.04) and 6-minute walking distance (p = 0.03), but all patients presented residual right-to-left shunts. In conclusion, this prospective study demonstrates that in patients with CHD, the prevalence of PFO is high and that percutaneous closure of PFO is feasible, with a reduction in symptoms but with residual shunting.

  19. Independent exercise for glottal incompetence to improve vocal problems and prevent aspiration pneumonia in the elderly: a randomized controlled trial.

    PubMed

    Fujimaki, Yoko; Tsunoda, Koichi; Kobayashi, Rika; Tonghyo, Chong; Tanaka, Fujinobu; Kuroda, Hiroyuki; Numata, Tsutomu; Ishii, Toyota; Kuroda, Reiko; Masuda, Sawako; Hashimoto, Sho; Misawa, Hayato; Shindo, Naoko; Mori, Takahiro; Mori, Hiroko; Uchiyama, Naoki; Kamei, Yuichirou; Tanaka, Masashi; Hamaya, Hironobu; Funatsuki, Shingo; Usui, Satoko; Ito, Ikuno; Hamada, Kohei; Shindo, Akihito; Tokumaru, Yutaka; Morita, Yoko; Ueha, Rumi; Nito, Takaharu; Kikuta, Shu; Sekimoto, Sotaro; Kondo, Kenji; Sakamoto, Takashi; Itoh, Kenji; Yamasoba, Tatsuya; Matsumoto, Sumio

    2017-08-01

    To evaluate the effect of a self-controlled vocal exercise in elderly people with glottal closure insufficiency. Parallel-arm, individual randomized controlled trial. Patients who visited one of 10 medical centers under the National Hospital Organization group in Japan for the first time, aged 60 years or older, complaining of aspiration or hoarseness, and endoscopically confirmed to have glottal closure insufficiency owing to vocal cord atrophy, were enrolled in this study. They were randomly assigned to an intervention or a control group. The patients of the intervention group were given guidance and a DVD about a self-controlled vocal exercise. The maximum phonation time which is a measure of glottal closure was evaluated, and the number of patients who developed pneumonia during the six months was compared between the two groups. Of the 543 patients enrolled in this trial, 259 were allocated into the intervention group and 284 into the control; 60 of the intervention group and 75 of the control were not able to continue the trial. A total of 199 patients (age 73.9 ±7.25 years) in the intervention group and 209 (73.3 ±6.68 years) in the control completed the six-month trial. Intervention of the self-controlled vocal exercise extended the maximum phonation time significantly ( p < 0.001). There were two hospitalizations for pneumonia in the intervention group and 18 in the control group, representing a significant difference ( p < 0.001). The self-controlled vocal exercise allowed patients to achieve vocal cord adduction and improve glottal closure insufficiency, which reduced the rate of hospitalization for pneumonia significantly. gov Identifier-UMIN000015567.

  20. Priming with a combination of proangiogenic growth factors improves wound healing in normoglycemic mice

    PubMed Central

    Ackermann, Maximilian; Wolloscheck, Tanja; Wellmann, Axel; Li, Vincent W.; Li, William W.; Konerding, Moritz A.

    2012-01-01

    Growth factors and/or angiogenic factors are supposed to improve wound healing. The aim of our study was to evaluate the effects of subcutaneous pretreatment with combinatory proangiogenic factors on wound closure, mechanical properties, vessel density, and morphology. Twenty-eight Balb/c mice were divided equally into two groups. A mixture of VEGF (35.0 μg), bFGF (2.5 μg), and PDGF (3.5 μg) was administered 3, 5, and 7 days subcutaneously to 14 mice before full thickness skin punch biopsy wounding, whereas 14 control animals received three times 0.2 ml saline solution. Wound sizes were assessed daily and the repaired tissues were harvested 7 days after complete wound closure. Complete closure (≥95% healing of initial wound area) was reached in all proangiogenic pretreated animals on day 10, whereas controls needed 13 days for complete closure. Tensile strengths were nearly twofold higher than in the controls (p≤0.01). The punch biopsy material revealed 4.2 fold higher vessel densities in the proangiogenic pretreated group. On day 17, the vessel densities in the proangiogenic pretreated wounds were also 3.2 fold higher than in the untreated controls. No significant differences were seen in the collagen ratio. Pretreatment with proangiogenic factors revealed several significant effects on wound healing: faster time to closure, a higher vessel density, better functional outcome. These results suggest a beneficial effect of pretreatment with combinatory growth factors in mouse skin wounds without impaired wound healing. This might be exploited in further investigations in diabetic healing as a therapeutic approach for elective surgery. PMID:21373751

  1. PED/PEA-15 Controls Fibroblast Motility and Wound Closure by ERK1/2-Dependent Mechanisms

    PubMed Central

    Buonomo, Roberta; Giacco, Ferdinando; Vasaturo, Angela; Caserta, Sergio; Guido, Stefano; Pagliara, Valentina; Garbi, Corrado; Mansueto, Gelsomina; Cassese, Angela; Perruolo, Giuseppe; Oriente, Francesco; Miele, Claudia; Beguinot, Francesco; Formisano, Pietro

    2012-01-01

    Cell migration is dependent on the control of signaling events that play significant roles in creating contractile force and in contributing to wound closure. We evaluated wound closure in fibroblasts from mice overexpressing (TgPED) or lacking ped/pea-15 (KO), a gene overexpressed in patients with type 2 diabetes. Cultured skin fibroblasts isolated from TgPED mice showed a significant reduction in the ability to recolonize wounded area during scratch assay, compared to control fibroblasts. This difference was observed both in the absence and in the presence of mytomicin C, an inhibitor of mitosis. In time-lapse experiments, TgPED fibroblasts displayed about twofold lower velocity and diffusion coefficient, as compared to controls. These changes were accompanied by reduced spreading and decreased formation of stress fibers and focal adhesion plaques. At the molecular level, TgPED fibroblasts displayed decreased RhoA activation and increased abundance of phosphorylated extracellular signal-regulated kinase 1/2 (ERK1/2). Inhibition of ERK1/2 activity by PD98059 restored RhoA activation, cytoskeleton organization and cell motility, and almost completely rescued wound closure of TgPED fibroblasts. Interestingly, skin fibroblasts isolated from KO mice displayed an increased wound closure ability. In vivo, healing of dorsal wounds was delayed in TgPED and accelerated in KO mice. Thus, PED/PEA-15 may affect fibroblast motility by a mechanism, at least in part, mediated by ERK1/2. J. Cell. Physiol. 227: 2106–2116, 2012. © 2011 Wiley Periodicals, Inc. PMID:21780113

  2. Nasal symptoms and clinical findings in adult patients treated for unilateral cleft lip and palate.

    PubMed

    Morén, Staffan; Mani, Maria; Lundberg, Kristina; Holmström, Mats

    2013-10-01

    The aim of the study was to investigate self-experienced nasal symptoms among adults treated for UCLP and the association to clinical findings, and to evaluate whether palate closure in one-stage or two-stages affected the symptoms or clinical findings. All people with UCLP born between 1960-1987, treated at Uppsala University Hospital, were considered for participation in this cross-sectional population study with long-term follow-up. Eighty-three patients (76% participation rate) participated, a mean of 37 years after the first operation. Fifty-two patients were treated with one-stage palate closure and 31 with two-stage palate closure. An age-matched group of 67 non-cleft controls completed the same study protocol, which included a questionnaire regarding nasal symptoms, nasal inspection, anterior rhinoscopy, and nasal endoscopy. Patients reported a higher frequency of nasal symptoms compared with the control group, e.g., nasal obstruction (81% compared with 60%) and mouth breathing (20% compared with 5%). Patients also rated their nasal symptoms as having a more negative impact on their daily life and physical activities than controls. Nasal examination revealed higher frequencies of nasal deformities among patients. No positive correlation was found between nasal symptoms and severity of findings at nasal examination. No differences were identified between patients treated with one-stage and two-stage palate closure regarding symptoms or nasal findings. Adult patients treated for UCLP suffer from more nasal symptoms than controls. However, symptoms are not associated with findings at clinical nasal examination or method of palate closure.

  3. Preliminary experience with a new device for delayed sternal closure strategy in cardiac surgery.

    PubMed

    Santini, Francesco; Onorati, Francesco; Telesca, Mariassunta; Faggian, Giuseppe; Mazzucco, Alessandro

    2012-06-01

    Open chest management with delayed sternal closure (DSC) is a valuable strategy in the management of patients with postcardiotomy hemodynamic instability or severe coagulopathy. The conventional extemporized material available for off-label sternal stenting however may limit its efficacy. We evaluated outcomes of patients with refractory severe postcardiotomy cardiogenic shock (SPCCS) treated with DSC using a novel temporary sternal spreader (NTSS) which allows myocardial recovery by progressive controlled approximation of the sternal edges. Seven patients (4 male, mean age 66.5 ± 5 years) with refractory SPCCS showing acute hemodynamic instability at sternal closure, were implanted with the NTSS, consisting of stainless-steel branches linked to 2 diverging plates of polyether-ether ketone, whose progressive opening/closing mechanism can be controlled from outside the chest with a rotating steel wire. The sternal wound was closed by an elastic membrane to achieve a sterile field. Swan-Ganz monitoring was employed, and clinical outcomes evaluated. The device was successfully implanted in all patients without device-related complications or failures. Progressive approximation of sternal edges, titrated on cardiac index values, was successfully completed allowing subsequent uneventful sternal closure in all. Mean time from SPCCS to sternal closure was 70 ± 21 hours. No patient developed infective complications or late hemodynamic instability after device removal and sternal closure. One patient (14%) died of multiorgan failure on postoperative day 9. Despite the limited number of patients enrolled, the NTSS proved safe and effective in allowing complete myocardial recovery after SPCCS, avoiding hemodynamic instability related to abrupt sternal closure, with no occurrence of infective complications.

  4. Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: a systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Rengifo-Moreno, Pablo; Palacios, Igor F; Junpaparp, Parichart; Witzke, Christian F; Morris, D Lynn; Romero-Corral, Abel

    2013-11-01

    In patients with cryptogenic stroke, transcatheter (TC) closure of a patent foramen ovale (PFO) has not been shown to better prevent recurrent vascular events than medical therapy. However, randomized controlled trials (RCT) to date have included few vascular events, and lack of power has been raised as an important concern. To conduct a systematic review and meta-analysis of existing RCT published studies assessing the recurrence of vascular events after TC PFO closure when compared to medical therapy. Using the search terms "patent foramen ovale", "PFO", "stroke", "percutaneous closure" and "transcatheter closure", Medline, Pubmed, Embase, and Cochrane databases were reviewed from inception through April 2013, with no language restrictions. Only studies in adult humans were considered. Additional references were obtained from the bibliographies of studies reviewed. The following criteria were used for study selection: 1) randomized controlled trial, 2) subjects were adult patients with cryptogenic stroke who were randomized to TC PFO closure or medical treatment (antiplatelet therapy and/or anticoagulation), and 3) reported outcomes included cardiac death, all death, stroke, transient ischemic attack, and peripheral embolism. Methodological and descriptive data, adverse events (including raw data and risk estimates), as well as procedural success and complications were abstracted in duplicate from each study independently, and agreement was tested. We followed rigorously the recommended guidelines for reporting and conducting and assessing quality of meta-analysis of RCT. The primary endpoints pre-specified in advance were recurrent vascular events, and composite endpoint of death, and recurrent vascular events. Three studies were identified as meeting selection criteria. These included a total of 2,303 patients, with 1,150 patients randomized to TC PFO closure and 1,153 patients randomized to medical therapy. Mean follow-up was 3.5 years. Baseline characteristics (age, sex, and cardiovascular risk factors) were similar across studies. Intention-to-treat analyses showed a statistically significant risk reduction in stroke and/or transient ischemic attack in the TC PFO closure group when compared to medical treatment, pooled HR = 0.59, 95%CI (0.36-0.97), P = 0.04. The combined outcome of death, and vascular events, showed a borderline statistically significant benefit for TC PFO closure when compared to medical treatment, pooled HR = 0.67, 95%CI (0.44-1.00), P = 0.05 Subjects with a substantial PFO shunt seem to benefit the most with TC PFO closure, pooled HR = 0.35, 95%CI (0.12-1.03), P = 0.06, however, it did not reach statistical significance. These results suggest that in patients with cryptogenic stroke, TC PFO closure may be beneficial in reducing the risk of recurrent vascular events when compared to medical treatment. The benefit of TC PFO closure may be greater in patients with a substantial shunt.

  5. Effectiveness of closure of public places with time delay in disease control.

    PubMed

    Wang, Zhenggang; Szeto, Kwok Yip; Leung, Frederick Chi-Ching

    2008-08-25

    A theoretical basis for the evaluation of the effciency of quarantine measure is developed in a SIR model with time delay. In this model, the effectiveness of the closure of public places such as schools in disease control, modeled as a high degree node in a social network, is evaluated by considering the effect of the time delay in the identification of the infected. In the context of the SIR model, the relation between the number of infectious individuals who are identified with time delay and then quarantined and those who are not identified and continue spreading the virus are investigated numerically. The social network for the simulation is modeled by a scale free network. Closure measures are applied to those infected nodes with high degrees. The effectiveness of the measure can be controlled by the present value of the critical degree K(C): only those nodes with degree higher than K(C) will be quarantined. The cost C(Q) incurred for the closure measure is assumed to be proportional to the total links rendered inactive as a result of the measure, and generally decreases with K(C), while the medical cost C(Q) incurred for virus spreading increases with K(C). The total social cost (C(M) + C(Q)) will have a minimum at a critical K(*), which depends on the ratio of medical cost coeffcient alpha(M) and closure cost coeffcient alpha(Q). Our simulation results demonstrate a mathematical procedure to evaluate the effciency of quarantine measure. Although the numerical work is based on a scale free network, the procedure can be readily generalized and applied to a more realistic social network to determine the proper closure measure in future epidemics.

  6. Engineered Barrier System performance requirements systems study report. Revision 02

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Balady, M.A.

    This study evaluates the current design concept for the Engineered Barrier System (EBS), in concert with the current understanding of the geologic setting to assess whether enhancements to the required performance of the EBS are necessary. The performance assessment calculations are performed by coupling the EBS with the geologic setting based on the models (some of which were updated for this study) and assumptions used for the 1995 Total System Performance Assessment (TSPA). The need for enhancements is determined by comparing the performance assessment results against the EBS related performance requirements. Subsystem quantitative performance requirements related to the EBS includemore » the requirement to allow no more than 1% of the waste packages (WPs) to fail before 1,000 years after permanent closure of the repository, as well as a requirement to control the release rate of radionuclides from the EBS. The EBS performance enhancements considered included additional engineered components as well as evaluating additional performance available from existing design features but for which no performance credit is currently being taken.« less

  7. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kupar, J.; Hasek, M.

    The Sanitary Landfill Corrective Action Plan proposes a two pronged approach to remediation. The first part of the total remediation strategy is the placement of a RCRA style closure cap to provide source control of contaminants into the groundwater. The second part of the proposed remediation package is a phased approach primarily using an in situ bioremediation system for groundwater clean up of the Constituents of Concern (COCs) that exceed their proposed Alternate Concentration Limits (ACL). The phased in approach of groundwater clean up will involve operation of the in situ bioremediation system, followed by evaluation of the Phase 1more » system and, if necessary, additional phased remediation strategies. This document presents pertinent information on operations, well locations, anticipated capture zones, monitoring strategies, observation wells and other information which will allow a decision on the acceptability of the remedial strategy as an interim corrective action prior to permit application approval. The proposed interim phase of the remediation program will position two horizontal bioremediation wells such that the respective zones of influence will intersect the migration path for the highest concentrations of each plume.« less

  8. Effects of load and thermal histories on mechanical behavior of materials; Proceedings of the Symposium, Denver, CO, Feb. 25, 26, 1987

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Liaw, P.K.; Nicholas, T.

    This volume includes topics on fatigue crack propagation; isothermal and thermal-mechanical fatigue; and microstructure, fracture, and damage. Papers are presented on transients in fatigue crack growth, elevated-temperature fatigue crack propagation, the role of crack closure in crack retardation in P/M and I/M aluminum alloys, the acoustic interrogation of fatigue overload effects, and the effects of frequency and environment on crack growth in Inconel 718. Special attention is given to isothermal fatigue failure mechanisms in low-tin lead-based solder, the stress and strain controlled low-cycle fatigue of Pb-Sn solder for electronic packaging applications, load sequence effects on the deformation of isolated microplasticmore » grains, and thermal fatigue of stainless steel. Other papers are on the influence of thermal aging on the creep crack growth behavior of a Cr-Mo steel, the effect of cyclic loading on the fracture toughness of a modified 4340 steel, and the effects of hot rolling condition and boron microalloying on phase transformation and microstructure in niobium-bearing interstitial free steel.« less

  9. A comparison of two endoscopic closures: over-the-scope clip (OTSC) versus KING closure (endoloop + clips) in a randomized long-term experimental study.

    PubMed

    Dolezel, R; Ryska, O; Kollar, M; Juhasova, J; Kalvach, J; Ryska, M; Martinek, J

    2016-11-01

    Both over-the-scope clip (OTSC) and KING (endoloop + clips) closures provide reliable and safe full-thickness endoscopic closure. Nevertheless, OTSC clip demonstrated significantly inferior histological healing in the short-term follow-up. To compare OTSC versus KING closure of a perforation with regard to long-term effectiveness and macroscopic and histological quality of healing. We performed a randomized experimental study with 16 mini-pigs (mean weight 43.2 ± 11.2 kg). A standardized perforation was performed on the anterior sigmoid wall. KING closure (n = 8) was attained by approximation of an endoloop fixed to the margins of a perforation with endoclips. OTSC closure (n = 8) was performed by deploying OTSC (OVESCO) over the defect. Pigs underwent a control sigmoidoscopy 8 months after the closure to assess the macroscopic quality of healing. Then, autopsy was performed and the rectosigmoid was sent for histopathological assessment. All closures were completed successfully without air leaks. The duration of closure was similar in both techniques (OTSC 17.8 ± 7.6 min vs. KING 19.6 ± 8.8 min). At autopsy, all KING closures (100 %) were healed with a flat scar without signs of leakage. Microscopically, no inflammatory changes were observed after KING closure. In the OTSC group, microscopic ulcers were present in two pigs (25 %), cryptal abscesses in three pigs (38 %) and significant neutrophil accumulation in all eight pigs (P < 0.01). Giant cell granulomas, dysplasia or abundant scarification was not observed in either group. Both OTSC and KING closures offer a long-term reliable seal of a gastrointestinal perforation without stenosis or fistulas. KING closure provides long-term histologically superior healing.

  10. The TopClosure® 3S System, for skin stretching and a secure wound closure.

    PubMed

    Topaz, Moris; Carmel, Narin-Nard; Silberman, Adi; Li, Ming Sen; Li, Yong Zhong

    2012-07-01

    The principle of stretching wound margins for primary wound closure is commonly practiced and used for various skin defects, leading at times to excessive tension and complications during wound closure. Different surgical techniques, skin stretching devices and tissue expanders have been utilized to address this issue. Previously designed skin stretching devices resulted in considerable morbidity. They were invasive by nature and associated with relatively high localized tissue pressure, frequently leading to necrosis, damage and tearing of skin at the wound margins. To assess the clinical effectiveness and performance and, to determine the safety of TopClosure® for gradual, controlled, temporary, noninvasive and invasive applications for skin stretching and secure wound closing, the TopClosure® device was applied to 20 patients for preoperative skin lesion removal and to secure closure of a variety of wound sizes. TopClosure® was reinforced with adhesives, staples and/or surgical sutures, depending on the circumstances of the wound and the surgeon's judgment. TopClosure® was used prior to, during and/or after surgery to reduce tension across wound edges. No significant complications or adverse events were associated with its use. TopClosure® was effectively used for preoperative skin expansion in preparation for dermal resection (e.g., congenital nevi). It aided closure of large wounds involving significant loss of skin and soft tissue by mobilizing skin and subcutaneous tissue, thus avoiding the need for skin grafts or flaps. Following surgery, it was used to secure closure of wounds under tension, thus improving wound aesthetics. A sample case study will be presented. We designed TopClosure®, an innovative device, to modify the currently practiced concept of wound closure by applying minimal stress to the skin, away from damaged wound edges, with flexible force vectors and versatile methods of attachment to the skin, in a noninvasive or invasive manner.

  11. Hospital closures had no measurable impact on local hospitalization rates or mortality rates, 2003-11.

    PubMed

    Joynt, Karen E; Chatterjee, Paula; Orav, E John; Jha, Ashish K

    2015-05-01

    The Affordable Care Act (ACA) set in motion payment changes that could put pressure on hospital finances and lead some hospitals to close. Understanding the impact of closures on patient care and outcomes is critically important. We identified 195 hospital closures in the United States between 2003 and 2011. We found no significant difference between the change in annual mortality rates for patients living in hospital service areas (HSAs) that experienced one or more closures and the change in rates in matched HSAs without a closure (5.5 percent to 5.2 percent versus 5.4 percent to 5.4 percent, respectively). Nor was there a significant difference in the change in all-cause mortality rates following hospitalization (9.1 percent to 8.2 percent in HSAs with a closure versus 9.0 percent to 8.4 percent in those without a closure). HSAs with a closure had a drop in readmission rates compared to controls (19.4 percent to 18.2 percent versus 18.8 percent to 18.3 percent). Overall, we found no evidence that hospital closures were associated with worse outcomes for patients living in those communities. These findings may offer reassurance to policy makers and clinical leaders concerned about the potential acceleration of hospital closures as a result of health care reform. Project HOPE—The People-to-People Health Foundation, Inc.

  12. Closure Report for Corrective Action Unit 139: Waste Disposal Sites, Nevada Test Site, Nevada

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NSTec Environmental Restoration

    2009-07-31

    Corrective Action Unit (CAU) 139 is identified in the Federal Facility Agreement and Consent Order (FFACO) as 'Waste Disposal Sites' and consists of the following seven Corrective Action Sites (CASs), located in Areas 3, 4, 6, and 9 of the Nevada Test Site: CAS 03-35-01, Burn Pit; CAS 04-08-02, Waste Disposal Site; CAS 04-99-01, Contaminated Surface Debris; CAS 06-19-02, Waste Disposal Site/Burn Pit; CAS 06-19-03, Waste Disposal Trenches; CAS 09-23-01, Area 9 Gravel Gertie; and CAS 09-34-01, Underground Detection Station. Closure activities were conducted from December 2008 to April 2009 according to the FFACO (1996, as amended February 2008) andmore » the Corrective Action Plan for CAU 139 (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, 2007b). The corrective action alternatives included No Further Action, Clean Closure, and Closure in Place with Administrative Controls. Closure activities are summarized. CAU 139, 'Waste Disposal Sites,' consists of seven CASs in Areas 3, 4, 6, and 9 of the NTS. The closure alternatives included No Further Action, Clean Closure, and Closure in Place with Administrative Controls. This CR provides a summary of completed closure activities, documentation of waste disposal, and confirmation that remediation goals were met. The following site closure activities were performed at CAU 139 as documented in this CR: (1) At CAS 03-35-01, Burn Pit, soil and debris were removed and disposed as LLW, and debris was removed and disposed as sanitary waste. (2) At CAS 04-08-02, Waste Disposal Site, an administrative UR was implemented. No postings or post-closure monitoring are required. (3) At CAS 04-99-01, Contaminated Surface Debris, soil and debris were removed and disposed as LLW, and debris was removed and disposed as sanitary waste. (4) At CAS 06-19-02, Waste Disposal Site/Burn Pit, no work was performed. (5) At CAS 06-19-03, Waste Disposal Trenches, a native soil cover was installed, and a UR was implemented. (6) At CAS 09-23-01, Area 9 Gravel Gertie, a UR was implemented. (7) At CAS 09-34-01, Underground Detection Station, no work was performed.« less

  13. Low-frequency pulsed electromagnetic fields significantly improve time of closure and proliferation of human tendon fibroblasts

    PubMed Central

    2014-01-01

    Background The promotion of the healing process following musculoskeletal injuries comprises growth factor signalling, migration, proliferation and apoptosis of cells. If these processes could be modulated, the healing of tendon tissue may be markedly enhanced. Here, we report the use of the Somagen™ device, which is certified for medical use according to European laws. It generates low-frequency pulsed electromagnetic fields that trigger effects of a nature that are yet to be determined. Methods A 1.5-cm wide, linear scrape was introduced into patellar tendon fibroblast cultures (N = 5 donors). Treatment was carried out every second day. The regimen was applied three times in total with 30 minutes comprising pulsed electromagnetic field packages with two fundamental frequencies (10 minutes of 33 Hz, 20 minutes of 7.8 Hz). Control cells remained untreated. All samples were analyzed for gap closure time, proliferation and apoptosis one week after induction of the scrape wound. Results The mean time for bridging the gap in the nontreated cells was 5.05 ± 0.33 days, and in treated cells, it took 3.35 ± 0.38 days (P <0.001). For cell cultures with scrape wounds, a mean value for BrdU incorporation of OD = 0.70 ± 0.16 was found. Whereas low-frequency pulsed electromagnetic fields treated samples showed OD = 1.58 ± 0.24 (P <0.001). However, the percentage of apoptotic cells did not differ between the two groups. Conclusions Our data demonstrate that low-frequency pulsed electromagnetic fields emitted by the Somagen™ device influences the in vitro wound healing of patellar tendon fibroblasts and, therefore, possibly increases wound healing potential. PMID:24996421

  14. Hospital closure: a review of current and proposed research.

    PubMed Central

    Hernandez, S R; Kaluzny, A D

    1983-01-01

    This paper reviews available data describing issues and research findings with implications for hospital closings. Factors contributing to fiscal problems of hospitals (e.g., inadequate reimbursement, inflation, management problems, organizational structure, societal factors) are discussed. Selected studies offering examples of hospital and community characteristics associated with closure are presented. This review suggests that future directions for research should focus not only on hospital cost control but also on insuring equity in the distribution of hospital services. Specifically, research is needed that further describes the hospital closure phenomenon, the effects of closure, and the policy choices that might be pursued to insure equity in the continuation of hospital services to disadvantaged populations. PMID:6360954

  15. A blinded, prospective, randomized controlled trial of topical negative pressure wound closure in India.

    PubMed

    Mody, Gita N; Nirmal, Ida Anita; Duraisamy, Sulochana; Perakath, Benjamin

    2008-12-01

    Wound closure using topical negative pressure (TNP) has been reported to be effective, but equipment costs can be prohibitive in resource-challenged countries. Because nonhealing wounds are exceedingly common in developing countries such as India, the ability to optimize wound care with limited resources is very important. To investigate the feasibility and efficacy of providing TNP in an Indian medical referral center, a randomized controlled trial comparing a locally constructed TNP device (treatment) to wet-to-dry gauze dressings (control) was conducted. Eligible study participants (N = 48) were recruited from the inpatient wards. Wound etiologies included diabetic foot ulcers (15), pressure ulcers (11), cellulitis/fasciitis (11), and "other" (11). Following enrollment, wound size was assessed using computer-aided measurements of digital photographs and block-randomized to the study arms using a concealed allocation table. Wounds in both treatment groups were débrided before dressing application and patients were followed until wound closure or being lost to follow-up for an average of 26.3 days (+/- 18.5) in the control and 33.1 days (+/- 37.3) in the treatment group. No statistically significant differences in time to closure between the two treatment groups were observed except in a subset analysis of pressure ulcers (mean 10 +/- 7.11 days for treatment and 27 +/- 10.6 days in control group, P = 0.05). Direct costs to close a pressure ulcer also were lower in the TNP than in the control group. A review of the literature suggests the outcomes obtained using a locally constructed TNP device are similar to those obtained using commercially available devices. As a result of this study, a dedicated tissue viability team has been established to identify wounds suitable for TNP, oversee treatment, monitor the need for surgical débridement, and employ wound healing principles and technology appropriately. These results suggest that inexpensive materials can be utilized for TNP wound closure in a developing country.

  16. Eye care for patients receiving neuromuscular blocking agents or propofol during mechanical ventilation.

    PubMed

    Lenart, S B; Garrity, J A

    2000-05-01

    The presence of a corneal reflex and the ability to maintain eye closure are instrumental in protecting the cornea. Use of neuromuscular blocking agents or propofol can result in impaired eyelid closure and loss of corneal reflex, leading to corneal exposure. The cornea is then at risk for drying, infection, and scarring, which may lead to permanent visual loss. To determine whether applying artificial tear ointment to the eyes of paralyzed or heavily sedated patients receiving mechanical ventilation decreases the prevalence of exposure keratitis more than does passive closure of the eyelid. A prospective, randomized control trial was done. The sample was 50 patients in the intensive care unit receiving either neuromuscular blocking agents or propofol during mechanical ventilation. In each patient, artificial tear ointment was applied to one eye; passive closure of the eyelid was used for the other eye (control eye). Nine patients had evidence of exposure keratitis in the untreated eye, and 2 had corneal abrasions in both the treated and the control eyes. The remaining 39 patients did not have corneal abrasions in either eye. Use of the artificial tear ointment was more effective in preventing corneal exposure than was passive eyelid closure (P = .004). Eye care with a lubricating ointment on a regular, set schedule can effectively reduce the prevalence of corneal abrasions in patients who are either paralyzed or heavily sedated and thus can help prevent serious complications such as corneal ulceration, infection, and visual loss.

  17. 10 CFR 60.51 - License amendment for permanent closure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... description of the program for post-permanent closure monitoring of the geologic repository. (2) A detailed... postclosure controlled area and geologic repository operations area by monuments that have been designed... tests, experiments, and any other analyses relating to backfill of excavated areas, shaft sealing, waste...

  18. 10 CFR 60.51 - License amendment for permanent closure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... description of the program for post-permanent closure monitoring of the geologic repository. (2) A detailed... postclosure controlled area and geologic repository operations area by monuments that have been designed... tests, experiments, and any other analyses relating to backfill of excavated areas, shaft sealing, waste...

  19. 10 CFR 60.51 - License amendment for permanent closure.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... description of the program for post-permanent closure monitoring of the geologic repository. (2) A detailed... postclosure controlled area and geologic repository operations area by monuments that have been designed... tests, experiments, and any other analyses relating to backfill of excavated areas, shaft sealing, waste...

  20. 10 CFR 60.51 - License amendment for permanent closure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... description of the program for post-permanent closure monitoring of the geologic repository. (2) A detailed... postclosure controlled area and geologic repository operations area by monuments that have been designed... tests, experiments, and any other analyses relating to backfill of excavated areas, shaft sealing, waste...

  1. 10 CFR 60.51 - License amendment for permanent closure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... description of the program for post-permanent closure monitoring of the geologic repository. (2) A detailed... postclosure controlled area and geologic repository operations area by monuments that have been designed... tests, experiments, and any other analyses relating to backfill of excavated areas, shaft sealing, waste...

  2. Stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy.

    PubMed

    Probst, Pascal; Hüttner, Felix J; Klaiber, Ulla; Knebel, Phillip; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

    2015-11-06

    Resections of the pancreatic body and tail reaching to the left of the superior mesenteric vein are defined as distal pancreatectomy. Most distal pancreatectomies are elective treatments for chronic pancreatitis, benign or malignant diseases, and they have high morbidity rates of up to 40%. Pancreatic fistula formation is the main source of postoperative morbidity, associated with numerous further complications. Researchers have proposed several surgical resection and closure techniques of the pancreatic remnant in an attempt to reduce these complications. The two most common techniques are scalpel resection followed by hand-sewn closure of the pancreatic remnant and stapler resection and closure. To compare the rates of pancreatic fistula in people undergoing distal pancreatectomy using scalpel resection followed by hand-sewn closure of the pancreatic remnant versus stapler resection and closure. We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Biosis and Science Citation Index from database inception to October 2015. We included randomised controlled trials (RCTs) comparing stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy (irrespective of language or publication status). Two authors independently assessed trials for inclusion and extracted the data. Taking into consideration the clinical heterogeneity between the trials (e.g. different endpoint definitions), we analysed data using a random-effects model with Review Manager (RevMan), calculating risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). In two eligible trials, a total of 381 participants underwent distal pancreatic resection and were randomised to closure of the pancreatic remnant either with stapler (n = 191) or scalpel resection followed by hand-sewn closure (n = 190). One was a single centre pilot RCT and the other was a multicentre blinded RCT. The single centre pilot RCT evaluated 69 participants in five intervention arms (stapler, hand-sewn, fibrin glue, mesh and pancreaticojejunostomy), although we only assessed the stapler and hand-sewn closure groups (14 and 15 participants, respectively). The multicentre RCT had two interventional arms: stapler (n = 177) and hand-sewn closure (n = 175). The rate of postoperative pancreatic fistula was the main outcome, and it occurred in 79 of 190 participants in the hand-sewn group compared to 65 of 191 participants in the stapler group. Neither the individual trials nor the meta-analysis showed a significant difference between resection techniques (RR 0.90; 95% CI 0.55 to 1.45; P = 0.66). In the same way, postoperative mortality and operation time did not differ significantly. The single centre RCT had an unclear risk of bias in the randomisation, allocation and both blinding domains. However, the much larger multicentre RCT had a low risk of bias in all domains. Due to the small number of events and the wide confidence intervals that cannot exclude clinically important benefit or harm with stapler versus hand-sewn closure, there is a serious possibility of imprecision, making the overall quality of evidence moderate. The quality of evidence is moderate and mainly based on the high weight of the results of one multicentre RCT. Unfortunately, there are no other completed RCTs on this topic except for one relevant ongoing trial. Neither stapler nor scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy showed any benefit compared to the other method in terms of postoperative pancreatic fistula, overall postoperative mortality or operation time. Currently, the choice of closure is left up to the preference of the individual surgeon and the anatomical characteristics of the patient. Another (non-European) multicentre trial (e.g. with an equality or non-inferiority design) would help to corroborate the findings of this meta-analysis. Future trials assessing novel methods of stump closure should compare them either with stapler or hand-sewn closure as a control group to ensure comparability of results.

  3. Randomized Controlled Trial of Pancreaticojejunostomy versus Stapler Closure of the Pancreatic Stump During Distal Pancreatectomy to Reduce Pancreatic Fistula.

    PubMed

    Kawai, Manabu; Hirono, Seiko; Okada, Ken-Ichi; Sho, Masayuki; Nakajima, Yoshiyuki; Eguchi, Hidetoshi; Nagano, Hiroaki; Ikoma, Hisashi; Morimura, Ryou; Takeda, Yutaka; Nakahira, Shin; Suzumura, Kazuhiro; Fujimoto, Jiro; Yamaue, Hiroki

    2016-07-01

    The aim of this study was to evaluate in a multicenter randomized controlled trial (RCT) whether pancreaticojejunostomy (PJ) of pancreatic stump decreases the incidence of pancreatic fistula after distal pancreatectomy (DP) compared with stapler closure. Several studies reported that PJ of pancreatic stump reduces the incidence of pancreatic fistula after DP. However, no RCT has confirmed the efficacy of PJ of pancreatic stump. One hundred thirty-six patients scheduled for DP were enrolled in this study between June 2011 and March 2014 at 6 high-volume surgical centers in Japan. Enrolled patients were randomized to either stapler closure or PJ. The primary endpoint was the incidence of pancreatic fistula based on the International Study Group on Pancreatic Fistula criteria. This RCT was registered with ClinicalTrials.gov (NCT01384617). Sixty-one patients randomized to stapler and 62 patients randomized to PJ were analyzed by intention-to-treat. Pancreatic fistula occurred in 23 patients (37.7%) in the stapler closure group and 24 (38.7%) in the PJ group (P = 0.332) in intention-to-treat analysis. The incidence of clinically relevant pancreatic fistula (grade B or C) was 16.4% for stapler closure and 9.7% for PJ (P = 0.201). Mortality was zero in both groups. In a subgroup analysis for thickness of pancreas greater than 12 mm, the incidence of clinically relevant pancreatic fistula occurred in 22.2% of the patients in the stapler closure group and in 6.2% of the PJ group (P = 0.080). PJ of the pancreatic stump during DP does not reduce pancreatic fistula compared with stapler closure.

  4. Randomized Controlled Trial of Pancreaticojejunostomy versus Stapler Closure of the Pancreatic Stump During Distal Pancreatectomy to Reduce Pancreatic Fistula

    PubMed Central

    Kawai, Manabu; Hirono, Seiko; Okada, Ken-ichi; Sho, Masayuki; Nakajima, Yoshiyuki; Eguchi, Hidetoshi; Nagano, Hiroaki; Ikoma, Hisashi; Morimura, Ryou; Takeda, Yutaka; Nakahira, Shin; Suzumura, Kazuhiro; Fujimoto, Jiro; Yamaue, Hiroki

    2016-01-01

    Objectives: The aim of this study was to evaluate in a multicenter randomized controlled trial (RCT) whether pancreaticojejunostomy (PJ) of pancreatic stump decreases the incidence of pancreatic fistula after distal pancreatectomy (DP) compared with stapler closure. Background: Several studies reported that PJ of pancreatic stump reduces the incidence of pancreatic fistula after DP. However, no RCT has confirmed the efficacy of PJ of pancreatic stump. Methods: One hundred thirty-six patients scheduled for DP were enrolled in this study between June 2011 and March 2014 at 6 high-volume surgical centers in Japan. Enrolled patients were randomized to either stapler closure or PJ. The primary endpoint was the incidence of pancreatic fistula based on the International Study Group on Pancreatic Fistula criteria. This RCT was registered with ClinicalTrials.gov (NCT01384617). Results: Sixty-one patients randomized to stapler and 62 patients randomized to PJ were analyzed by intention-to-treat. Pancreatic fistula occurred in 23 patients (37.7%) in the stapler closure group and 24 (38.7%) in the PJ group (P = 0.332) in intention-to-treat analysis. The incidence of clinically relevant pancreatic fistula (grade B or C) was 16.4% for stapler closure and 9.7% for PJ (P = 0.201). Mortality was zero in both groups. In a subgroup analysis for thickness of pancreas greater than 12 mm, the incidence of clinically relevant pancreatic fistula occurred in 22.2% of the patients in the stapler closure group and in 6.2% of the PJ group (P = 0.080). Conclusions: PJ of the pancreatic stump during DP does not reduce pancreatic fistula compared with stapler closure. PMID:26473652

  5. ‘Beauty Is No Quality in Things Themselves’: Epistemic Motivation Affects Implicit Preferences for Art

    PubMed Central

    Chirumbolo, Antonio; Brizi, Ambra; Mastandrea, Stefano; Mannetti, Lucia

    2014-01-01

    Art preferences are affected by a number of subjective factors. This paper reports two studies which investigated whether need for closure shapes implicit art preferences. It was predicted that higher need for closure would negatively affect implicit preferences for abstract art. In study one, 60 participants were tested for dispositional need for closure and then completed an Implicit Association Test (IAT) task to measure their implicit preference for abstract (vs. figurative) paintings. In study two, 54 participants completed the same IAT task. In this experiment need for closure was both manipulated by cognitive load and tapped as a dispositional trait. Results of the studies converged in showing that after controlling for other important individual factors such as participants'expertise and cognitive ability, need for closure, both as a dispositional trait and as a situationally induced motivational state, was negatively associated with implicit preference for abstract art. PMID:25360697

  6. 'Beauty is no quality in things themselves': epistemic motivation affects implicit preferences for art.

    PubMed

    Chirumbolo, Antonio; Brizi, Ambra; Mastandrea, Stefano; Mannetti, Lucia

    2014-01-01

    Art preferences are affected by a number of subjective factors. This paper reports two studies which investigated whether need for closure shapes implicit art preferences. It was predicted that higher need for closure would negatively affect implicit preferences for abstract art. In study one, 60 participants were tested for dispositional need for closure and then completed an Implicit Association Test (IAT) task to measure their implicit preference for abstract (vs. figurative) paintings. In study two, 54 participants completed the same IAT task. In this experiment need for closure was both manipulated by cognitive load and tapped as a dispositional trait. Results of the studies converged in showing that after controlling for other important individual factors such as participants'expertise and cognitive ability, need for closure, both as a dispositional trait and as a situationally induced motivational state, was negatively associated with implicit preference for abstract art.

  7. Autocracy bias in informal groups under need for closure.

    PubMed

    Pierro, Antonio; Mannetti, Lucia; De Grada, Eraldo; Livi, Stefano; Kruglanski, Arie W

    2003-03-01

    Two experiments investigated the tendency of groups with members under high (vs. low) need for cognitive closure to develop an autocratic leadership structure in which some members dominate the discussion, constitute the "hubs" of communication, and influence the group more than other members. The first experiment found that high (vs. low) need for closure groups, as assessed via dispositional measure of the need for closure, manifested greater asymmetry of conversational floor control, such that members with autocratic interactional style were more conversationally dominant and influential than less autocratic members. The second experiment manipulated the need for closure via time pressure and utilized a social network analysis. Consistent with expectation, groups under time pressure (vs. no pressure) showed a greater asymmetry of participation, of centrality, and of prestige among the group members, such that the more focal members were perceived to exert the greater influence over the groups' decisions.

  8. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

  9. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

  10. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

  11. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

  12. 40 CFR 63.906 - Inspection and monitoring requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... between the roof and the tank wall; broken, cracked, or otherwise damaged seals or gaskets on closure devices; and broken or missing hatches, access covers, caps, or other closure devices. (2) The owner or... air pollution control equipment designated as such a written explanation of the reasons why the...

  13. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

  14. Patent Foramen Ovale Closure in the Setting of Cryptogenic Stroke: A Meta-Analysis of Five Randomized Trials.

    PubMed

    Garg, Lohit; Haleem, Affan; Varade, Shweta; Sivakumar, Keithan; Shah, Mahek; Patel, Brijesh; Agarwal, Manyoo; Agrawal, Sahil; Leary, Megan; Kluck, Bryan

    2018-05-24

    The clinical benefit of patent foramen ovale (PFO) closure after cryptogenic stroke has been a topic of debate for decades. Recently, 3 randomized controlled trials of PFO closure in patients with cryptogenic stroke demonstrated a significantly reduced risk of recurrent stroke compared with standard medical therapy alone. This meta-analysis was performed to clarify the efficacy of PFO closure for future stroke prevention in this population. A systematic literature search was undertaken. Published pooled data from 5 large randomized clinical trials (CLOSE, RESPECT, Gore REDUCE, CLOSURE I, and PC) were combined and then subsequently analyzed. Enrolled patients with cryptogenic stroke were assigned to receive standard medical care or to undergo endovascular PFO closure, with a primary outcome of reduction in stroke recurrence rate. Secondary outcomes included rates of transient ischemic attack (TIA), composite outcome of stroke, TIA, and death from all causes, and rates of atrial fibrillation events. We analyzed data for 3412 patients. Transcatheter PFO closure resulted in a statistically significant reduced rate of recurrent stroke, compared with medication alone. Patients undergoing closure were 58% less likely to have another stroke. The number needed to treat with PFO closure to reduce recurrent stroke for 1 patient was 40. Endovascular PFO closure was associated with a reduced risk of recurrent stroke in patients with a prior cryptogenic cerebral infarct. Although the absolute stroke reduction was small, these findings are clinically significant, given the young age of this patient population and the patients' lifetime risk of recurrent stroke. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  15. Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.

    PubMed

    Simonetti, Andrea; Amari, Filippo

    2015-01-01

    In reaction to the limitations of the traditional sterility test methods, in 2008, the U.S. Food and Drug Administration issued the guidance "Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products" encouraging sterile drug manufacturers to use properly validated physical methods, apart from conventional microbial challenge testing, to confirm container closure integrity as part of the stability protocol. The case study presented in this article investigated the capability of four container closure integrity testing methods to detect simulated defects of different sizes and types on glass syringes, prefilled both with drug product intended for parenteral administration and sterile water. The drug product was a flu vaccine (Agrippal, Novartis Vaccines, Siena, Italy). Vacuum decay, pharmacopoeial dye ingress test, Novartis specific dye ingress test, and high-voltage leak detection were, in succession, the methods involved in the comparative studies. The case study execution was preceded by the preparation of two independent sets of reference prefilled syringes, classified, respectively, as examples of conforming to closure integrity requirements (negative controls) and as defective (positive controls). Positive controls were, in turn, split in six groups, three of with holes laser-drilled through the prefilled syringe glass barrel, while the other three with capillary tubes embedded in the prefilled syringe plunger. These reference populations were then investigated by means of validated equipment used for container closure integrity testing of prefilled syringe commercial production; data were collected and analyzed to determine the detection rate and the percentage of false results. Results showed that the vacuum decay method had the highest performance in terms of detection sensitivity and also ensured the best reliability and repeatability of measurements. An innovative technical solution, preventing possible prefilled syringe plunger movement during container closure integrity testing execution, is presented as well. The growing need to meet sterile drug products' regulatory, quality, and safety expectations has progressively driven new developments and improvements both in container closure integrity testing methods and in the respective equipment, over the last years. Indeed, container closure integrity testing establishes the container closure system capability to provide required protection to the drug product and to demonstrate maintenance of product sterility over its shelf life. This article describes the development of four container closure integrity testing approaches for the evaluation of glass prefilled syringe closure integrity, including two destructive (pharmacopoeial and Novartis specific dye ingress test) and two non-destructive (vacuum decay and high-voltage leak detection) methods. The important finding from the validation of comparative studies was that the vacuum decay method resulted in the most effective, reliable and repeatable detection of defective samples, whether the defect was exposed to sterile water, to drug product, or to air. Complete sets of known defects were created for this purpose (5 μm, 10 μm, 20 μm certified leakages by laser drilled holes and capillary tubes). All investigations and studies were conducted at Bonfiglioli Engineering S.r.l. (Vigarano Pieve, Ferrara, Italy) and at Novartis Vaccines (Sovicille, Siena, Italy). © PDA, Inc. 2015.

  16. Laser tissue melding: use of 1.32-μm computerized Nd:YAG laser, results of leak/burst strength studies in microsurgical procedures

    NASA Astrophysics Data System (ADS)

    Anderson, Dallas W.; Hsu, Tung M.; Halpern, Steven J.; Honaker, Arnold

    1993-07-01

    The ProClosureTM System (PCS) consists of a low power 1.32micrometers Nd:YAG laser coupled to a handheld disposable fiber optic device. The system has been designed to perform a wide range of tissue welding applications such as cosmetic skin closure,vascular surgery, and minimally invasive surgical procedures normally performed with sutures and staples. Utilizing a wavelength for tissue fusion that is least distracted by medium in the surgical field coupled with a computerized delivery system allows for a more precise application (+/- 5%) of laser energy to the tissue. The study design involved the micro-surgical anastomosis of twenty Sprague-Dawley rats (vas deferens) and twenty-one Sprague-Dawley rats (femoral arteries). Each rat is its own contralateral control. Laser repair time is approximately one-third that of conventional suturing. Postoperative dissection and burst strength testing was conducted at day 0, 1, 7, and 14. At each postoperative interval, the mean leak/burst strength for laser-assisted closure v. control, was markedly higher. The precise application of energy fluence resulting from ProClosure's computerized system yields an initial strength and a fluid static seal that is superior to conventional suture closure.

  17. Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

    PubMed

    Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

    2015-10-07

    The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

  18. Freshness maintenance of cherries ready for consumption using convenient, microperforated, bio-based packaging.

    PubMed

    Koutsimanis, Georgios; Harte, Janice; Almenar, Eva

    2015-03-30

    Current consumer demand for high-quality ready-to-eat fresh fruit in convenient bio-based packaging was met utilizing sanitized stem-free sweet cherries and a polylactic acid (PLA) cup with a PLA peelable microperforated lid. The newly developed packaging system was compared with the petroleum-based macroperforated bag currently used for retail. After 27 days of storage at 1 °C, the PLA package maintained the cherry firmness, compared with a 50% reduction of the controls. No fungal decay was detected in the cherries stored in PLA, while the controls were non-marketable after 21 days. The PLA package allowed minimal weight loss (0.8%), compared with a weight loss of approximately 16% in the controls. Differences in the cherry aroma, color, acidity, soluble solids content, pH and quality index were also caused by the packaging type. A consumer sensory evaluation showed that cherries stored in PLA packages were more acceptable than those of the controls for appearance, texture, flavor and overall acceptability. The new package matched both the consumer demand for high-quality fresh fruit ready for consumption in convenient bio-based packaging and the extended fruit marketability and consumer satisfaction desired by industry. © 2014 Society of Chemical Industry.

  19. Design requirements for SRB production control system. Volume 3: Package evaluation, modification and hardware

    NASA Technical Reports Server (NTRS)

    1981-01-01

    The software package evaluation was designed to analyze commercially available, field-proven, production control or manufacturing resource planning management technology and software package. The analysis was conducted by comparing SRB production control software requirements and conceptual system design to software package capabilities. The methodology of evaluation and the findings at each stage of evaluation are described. Topics covered include: vendor listing; request for information (RFI) document; RFI response rate and quality; RFI evaluation process; and capabilities versus requirements.

  20. Research and Development of Fully Automatic Alien Smoke Stack and Packaging System

    NASA Astrophysics Data System (ADS)

    Yang, Xudong; Ge, Qingkuan; Peng, Tao; Zuo, Ping; Dong, Weifu

    2017-12-01

    The problem of low efficiency of manual sorting packaging for the current tobacco distribution center, which developed a set of safe efficient and automatic type of alien smoke stack and packaging system. The functions of fully automatic alien smoke stack and packaging system adopt PLC control technology, servo control technology, robot technology, image recognition technology and human-computer interaction technology. The characteristics, principles, control process and key technology of the system are discussed in detail. Through the installation and commissioning fully automatic alien smoke stack and packaging system has a good performance and has completed the requirements for shaped cigarette.

  1. The effects of school closures on influenza outbreaks and pandemics: systematic review of simulation studies.

    PubMed

    Jackson, Charlotte; Mangtani, Punam; Hawker, Jeremy; Olowokure, Babatunde; Vynnycky, Emilia

    2014-01-01

    School closure is a potential intervention during an influenza pandemic and has been investigated in many modelling studies. To systematically review the effects of school closure on influenza outbreaks as predicted by simulation studies. We searched Medline and Embase for relevant modelling studies published by the end of October 2012, and handsearched key journals. We summarised the predicted effects of school closure on the peak and cumulative attack rates and the duration of the epidemic. We investigated how these predictions depended on the basic reproduction number, the timing and duration of closure and the assumed effects of school closures on contact patterns. School closures were usually predicted to be most effective if they caused large reductions in contact, if transmissibility was low (e.g. a basic reproduction number <2), and if attack rates were higher in children than in adults. The cumulative attack rate was expected to change less than the peak, but quantitative predictions varied (e.g. reductions in the peak were frequently 20-60% but some studies predicted >90% reductions or even increases under certain assumptions). This partly reflected differences in model assumptions, such as those regarding population contact patterns. Simulation studies suggest that school closure can be a useful control measure during an influenza pandemic, particularly for reducing peak demand on health services. However, it is difficult to accurately quantify the likely benefits. Further studies of the effects of reactive school closures on contact patterns are needed to improve the accuracy of model predictions.

  2. Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

    PubMed Central

    2011-01-01

    Background For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. Objective The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. Methods During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Results Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Conclusions Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety. PMID:21324833

  3. Packaging and labeling of pharmaceutical products obtained from the internet.

    PubMed

    Veronin, Michael

    2011-02-15

    For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.

  4. Tank waste remediation system retrieval and disposal mission readiness-to-proceed responses to internal independent assessment

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Schaus, P.S.

    1998-01-06

    The US Department of Energy (DOE) is planning to make critical decisions during fiscal year (FY) 1998 regarding privatization contracts for the treatment of Hanford tank waste. Specifically, DOE, Richland Operations Office (RL), will make decisions related to proceeding with Phase 1 Privatization. In support of these decisions, the management and integration (M+I) contractor must be able to meet the requirements to support the Phase 1 privatization contractors. As part of the assessment of the Tank Waste Retrieval (TWR) Readiness-To-Proceed (RTP), an independent review of their process and products was required by the RL letter of August 8, 1997. Themore » Independent Review Team reviewed the adequacy of the planning that has been done by the M+I contractor to validate that, if the plans are carried out, there is reasonable assurance of success. Overall, the RTP Independent Review Team concluded that, if the planning by the M+I contractor team is carried out with adequate funding, there is reasonable assurance that the M+I contractor will be able to deliver waste to the privatization contractor for the duration of Phase 1. This conclusion was based on addressing the recommendations contained in the Independent Review Team`s Final Report and in the individual Criteria and Review Approach (CRA) forms completed during the assessment. The purpose of this report is to formally document the independent assessment and the RTP team responses to the Independent Review Team recommendations. It also provides closure logics for selected recommendations from a Lockheed Martin Hanford Corporation (LMHC) internal assessment of the Technical Basis Review (TBR) packages. This report contains the RTP recommendation closure process (Section 2.0); the closure tables (Section 3.0) which provide traceability between each review team recommendation and its corresponding Project Hanford Management Contract closure logic; and two attachments that formally document the Independent Review Team Final Report and the Internal Assessment Final Report.« less

  5. Is adhesive paper-tape closure of video assisted thoracoscopic port-sites safe?

    PubMed

    Luckraz, Heyman; Rammohan, Kandadai S; Phillips, Mabel; O'Keefe, Peter A

    2007-07-01

    Video assisted thoracoscopic surgery (VATS) is used in lung surgery for diagnostic, staging, curative and palliative purposes. The port-sites are usually sutured with dissolvable sutures. The use of adhesive paper-tape for port-site closure was assessed by a prospective randomised double-blind control trial comparing sutured to adhesive paper-tape closure. The following outcomes were assessed: incidence of clinically significant pneumothorax, wound healing using the ASEPSIS score, patient's comfort (pain score using a visual analog score), the time difference between the two techniques of wound closure and cost savings. Thirty patients were recruited in each group. No clinically significant pneumothoraces occurred in either group. There were no significant differences between the two groups in terms of immediate post-operative pain scores, wound cosmesis and wound complications. It was quicker to close the wound with adhesive paper-tape with a mean time of closure per unit length of wound of 9.3 and 2.2s/mm for the groups, respectively. The cost for wound closure (per patient) was $0.8 for the adhesive paper-tape group and $4.00 for the sutures.

  6. Spoilage and safety characteristics of ground beef packaged in traditional and modified atmosphere packages.

    PubMed

    Brooks, J C; Alvarado, M; Stephens, T P; Kellermeier, J D; Tittor, A W; Miller, M F; Brashears, M M

    2008-02-01

    Two separate studies, one with pathogen-inoculated product and one with noninoculated product, were conducted to determine the safety and spoilage characteristics of modified atmosphere packaging (MAP) and traditional packaging of ground beef patties. Ground beef patties were allotted to five packaging treatments (i) control (foam tray with film overwrap; traditional), (ii) high-oxygen MAP (80% 02, 20% CO2), (iii) high-oxygen MAP with added rosemary extract, (iv) low-oxygen carbon monoxide MAP (0.4% CO, 30% CO2, 69.6% N2), and (v) low-oxygen carbon monoxide MAP with added rosemary extract. Beef patties were evaluated for changes over time (0, 1, 3, 5, 7, 14, and 21 days) during lighted display. Results indicated low-oxygen carbon monoxide gas flush had a stabilizing effect on meat color after the formation of carboxymyoglobin and was effective for preventing the development of surface discoloration. Consumers indicated that beef patties packaged in atmospheres containing carbon monoxide were more likely to smell fresh at 7, 14, and 21 days of display, but the majority would probably not consume these products after 14 days of display because of their odor. MAP suppressed the growth of psychrophilic aerobic bacteria when compared with control packages. Generally, control packages had significantly higher total aerobic bacteria and Lactobacillus counts than did modified atmosphere packages. In the inoculated ground beef (approximately 10(5) CFU/g) in MAP, Escherichia coli O157 populations ranged from 4.51 to 4.73 log CFU/g with no differences among the various packages, but the total E. coli O157:H7 in the ground beef in the control packages was significantly higher at 5.61 log CFU/g after 21 days of storage. On days 14 and 21, the total Salmonella in the ground beef in control packages was at 5.29 and 5.27 log CFU/g, respectively, which was significantly higher than counts in the modified atmosphere packages (3.99 to 4.31 log CFU/g on day 14 and 3.76 to 4.02 log CFU/g on day 21). Data from these studies indicate that MAP suppresses pathogen growth compared with controls and that spoilage characteristics developed in MAP packages.

  7. Space Station environmental control and life support system distribution and loop closure studies

    NASA Technical Reports Server (NTRS)

    Humphries, William R.; Reuter, James L.; Schunk, Richard G.

    1986-01-01

    The NASA Space Station's environmental control and life support system (ECLSS) encompasses functional elements concerned with temperature and humidity control, atmosphere control and supply, atmosphere revitalization, fire detection and suppression, water recovery and management, waste management, and EVA support. Attention is presently given to functional and physical module distributions of the ECLSS among these elements, with a view to resource requirements and safety implications. A strategy of physical distribution coupled with functional centralization is for the air revitalization and water reclamation systems. Also discussed is the degree of loop closure desirable in the initial operational capability status Space Station's oxygen and water reclamation loops.

  8. Control Systems

    NASA Technical Reports Server (NTRS)

    1984-01-01

    Boeing Commercial Airplane Company's Flight Control Department engineers relied on Langley developed software package known as ORACLS to develop an advanced control synthesis package for both continuous and discrete control system. Package was used by Boeing for computerized analysis of new system designs. Resulting applications include a multiple input/output control system for the terrain-following navigation equipment of the Air Forces B-1 Bomber, and another for controlling in flight changes of wing camber on an experimental airplane. ORACLS is one of 1,300 computer programs available from COSMIC.

  9. "Plain packaging" regulations for tobacco products: the impact of standardizing the color and design of cigarette packs.

    PubMed

    Hammond, David

    2010-01-01

    Tobacco packaging and labeling policies have emerged as prominent and cost-effective tobacco control measures. Although packaging policies have primarily focused on health warnings, there is growing recognition of the importance of packaging as a marketing tool for the tobacco industry. The current paper reviews evidence on the potential impact of standardizing the color and design of tobacco packages -so called "plain" packaging. The evidence indicates three primary benefits of plain packaging: increasing the effectiveness of health warnings, reducing false health beliefs about cigarettes, and reducing brand appeal especially among youth and young adults. Overall, the research to date suggests that "plain" packaging regulations would be an effective tobacco control measure, particularly in jurisdictions with comprehensive restrictions on other forms of marketing.

  10. Purse-string double-layer closure: a novel technique for repairing the uterine incision during cesarean section.

    PubMed

    Turan, Cem; Büyükbayrak, Esra Esim; Yilmaz, Aylin Onan; Karsidag, Yasemin Karageyim; Pirimoglu, Meltem

    2015-04-01

    To compare the classical double-layer uterine closure to a double-layer purse-string uterine closure (Turan technique) in cesarean section regarding short- and long-term results. Patients were randomized into either the double-layer purse-string uterine closure arm (study group, 84 patients) or the classical double-layer uterine closure arm (control group, 84 patients). For short-term comparison, a detailed transvaginal ultrasound examination was planned in all patients 6 weeks after the operation and a wedge-shaped defect in the uterine incision scar was accepted as uterine scar defect and recorded. For the long-term comparison, subsequent pregnancies of these patients were followed up for any complication. The number of patients with ultrasonographically visible uterine scar defect was 12 (23.5% of all scar defects) in the study group whereas it was 39 (76.5% of all scar defects) in the control group (P < 0.001, χ(2) = 15.42). Demographic data, operation time, hospitalization time, preoperative and postoperative hemoglobin values were not significantly different between the groups. During the 2-year of the follow-up period, five patients in the study group and six patients in the control group became pregnant again. No complication during their pregnancies and second cesarean operation were encountered. With the Turan technique, the uterine incision length becomes shorter, and the frequency of uterine scar defect is lower regarding short-term results. More data is needed for long-term results. ClinicalTrials.gov NCT01287611. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

  11. Open abdomen in gastrointestinal surgery: Which technique is the best for temporary closure during damage control?

    PubMed Central

    Ribeiro Junior, Marcelo A F; Barros, Emily Alves; de Carvalho, Sabrina Marques; Nascimento, Vinicius Pereira; Cruvinel Neto, José; Fonseca, Alexandre Zanchenko

    2016-01-01

    AIM To compare the 3 main techniques of temporary closure of the abdominal cavity, vacuum assisted closure (vacuum-assisted closure therapy - VAC), Bogota bag and Barker technique, in damage control surgery. METHODS After systematic review of the literature, 33 articles were selected to compare the efficiency of the three procedures. Criteria such as cost, infections, capacity of reconstruction of the abdominal wall, diseases associated with the technique, among others were analyzed. RESULTS The Bogota bag and Barker techniques present as advantage the availability of material and low cost, what is not observed in the VAC procedure. The VAC technique is the most efficient, not only because it reduces the tension on the boarders of the lesion, but also removes stagnant fluids and debris and acts at cellular level increasing cell proliferation and division. Bogota bag presents the higher rates of skin laceration and evisceration, greater need for a stent for draining fluids and wash-ups, higher rates of intestinal adhesion to the abdominal wall. The Barker technique presents lack of efficiency in closing the abdominal wall and difficulty on maintaining pressure on the dressing. The VAC dressing can generate irritation and dermatitis when the drape is applied, in addition to pain, infection and bleeding, as well as toxic shock syndrome, anaerobic sepsis and thrombosis. CONCLUSION The VAC technique, showed to be superior allowing a better control of liquid on the third space, avoiding complications such as fistula with small mortality, low infection rate, and easier capability on primary closure of the abdominal cavity. PMID:27648164

  12. Corrective Action Decision Document/Corrective Action Plan for the 92-Acre Area and Corrective Action Unit 111: Area 5 WMD Retired Mixed Waste Pits, Nevada National Security Site, Nevada

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NSTec Environmental Restoration

    This Corrective Action Decision Document/Corrective Action Plan (CADD/CAP) has been prepared for the 92-Acre Area, the southeast quadrant of the Radioactive Waste Management Site, located in Area 5 of the Nevada National Security Site (NNSS). The 92-Acre Area includes Corrective Action Unit (CAU) 111, 'Area 5 WMD Retired Mixed Waste Pits.' Data Quality Objectives (DQOs) were developed for the 92-Acre Area, which includes CAU 111. The result of the DQO process was that the 92-Acre Area is sufficiently characterized to provide the input data necessary to evaluate corrective action alternatives (CAAs) without the collection of additional data. The DQOs aremore » included as Appendix A of this document. This CADD/CAP identifies and provides the rationale for the recommended CAA for the 92-Acre Area, provides the plan for implementing the CAA, and details the post-closure plan. When approved, this CADD/CAP will supersede the existing Pit 3 (P03) Closure Plan, which was developed in accordance with Title 40 Code of Federal Regulations (CFR) Part 265, 'Interim Status Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities.' This document will also serve as the Closure Plan and the Post-Closure Plan, which are required by 40 CFR 265, for the 92-Acre Area. After closure activities are complete, a request for the modification of the Resource Conservation and Recovery Act Permit that governs waste management activities at the NNSS will be submitted to the Nevada Division of Environmental Protection to incorporate the requirements for post-closure monitoring. Four CAAs, ranging from No Further Action to Clean Closure, were evaluated for the 92-Acre Area. The CAAs were evaluated on technical merit focusing on performance, reliability, feasibility, safety, and cost. Based on the evaluation of the data used to develop the conceptual site model; a review of past, current, and future operations at the site; and the detailed and comparative analysis of the potential CAAs, Closure in Place with Administrative Controls is the preferred CAA for the 92-Acre Area. Closure activities will include the following: (1) Constructing an engineered evapotranspiration cover over the 92-Acre Area; (2) Installing use restriction (UR) warning signs, concrete monuments, and subsidence survey monuments; (3) Establishing vegetation on the cover; (4) Implementing a UR; and (5) Implementing post-closure inspections and monitoring. The Closure in Place with Administrative Controls alternative meets all requirements for the technical components evaluated, fulfills all applicable federal and state regulations for closure of the site, and will minimize potential future exposure pathways to the buried waste at the site.« less

  13. Corrective Action Decision Document/Corrective Action Plan for the 92-Acre Area and Corrective Action Unit 111: Area 5 WMD Retired Mixed Waste Pits, Nevada Test Site, Nevada

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NSTec Environmental Restoration

    2009-07-31

    This Corrective Action Decision Document/Corrective Action Plan (CADD/CAP) has been prepared for the 92-Acre Area, the southeast quadrant of the Radioactive Waste Management Site, located in Area 5 of the Nevada Test Site (NTS). The 92-Acre Area includes Corrective Action Unit (CAU) 111, 'Area 5 WMD Retired Mixed Waste Pits.' Data Quality Objectives (DQOs) were developed for the 92-Acre Area, which includes CAU 111. The result of the DQO process was that the 92-Acre Area is sufficiently characterized to provide the input data necessary to evaluate corrective action alternatives (CAAs) without the collection of additional data. The DQOs are includedmore » as Appendix A of this document. This CADD/CAP identifies and provides the rationale for the recommended CAA for the 92-Acre Area, provides the plan for implementing the CAA, and details the post-closure plan. When approved, this CADD/CAP will supersede the existing Pit 3 (P03) Closure Plan, which was developed in accordance with Title 40 Code of Federal Regulations (CFR) Part 265, 'Interim Status Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities.' This document will also serve as the Closure Plan and the Post-Closure Plan, which are required by 40 CFR 265, for the 92-Acre Area. After closure activities are complete, a request for the modification of the Resource Conservation and Recovery Act Permit that governs waste management activities at the NTS will be submitted to the Nevada Division of Environmental Protection to incorporate the requirements for post-closure monitoring. Four CAAs, ranging from No Further Action to Clean Closure, were evaluated for the 92-Acre Area. The CAAs were evaluated on technical merit focusing on performance, reliability, feasibility, safety, and cost. Based on the evaluation of the data used to develop the conceptual site model; a review of past, current, and future operations at the site; and the detailed and comparative analysis of the potential CAAs, Closure in Place with Administrative Controls is the preferred CAA for the 92-Acre Area. Closure activities will include the following: (1) Constructing an engineered evapotranspiration cover over the 92-Acre Area; (2) Installing use restriction (UR) warning signs, concrete monuments, and subsidence survey monuments; (3) Establishing vegetation on the cover; (4) Implementing a UR; and (5) Implementing post-closure inspections and monitoring. The Closure in Place with Administrative Controls alternative meets all requirements for the technical components evaluated, fulfills all applicable federal and state regulations for closure of the site, and will minimize potential future exposure pathways to the buried waste at the site.« less

  14. A combination of subcuticular suture and sterile Micropore tape compared with conventional interrupted sutures for skin closure. A controlled trial.

    PubMed Central

    Taube, M.; Porter, R. J.; Lord, P. H.

    1983-01-01

    We have conducted a controlled trial to compare skin closure using conventional interrupted sutures with a combination of subcuticular suture and sterile Micropore tape in 169 patients undergoing appendicectomy, inguinal herniorrhaphy, or saphenofemoral ligation. We have found that the combination technique consistently gives a better cosmetic result and that the tape acts well as a dressing, is convenient, and is well tolerated by patients. Images Fig. 1 Fig. 2 Fig. 3 Fig. 4 PMID:6344732

  15. Simulated precipitation diurnal cycles over East Asia using different CAPE-based convective closure schemes in WRF model

    NASA Astrophysics Data System (ADS)

    Yang, Ben; Zhou, Yang; Zhang, Yaocun; Huang, Anning; Qian, Yun; Zhang, Lujun

    2018-03-01

    Closure assumption in convection parameterization is critical for reasonably modeling the precipitation diurnal variation in climate models. This study evaluates the precipitation diurnal cycles over East Asia during the summer of 2008 simulated with three convective available potential energy (CAPE) based closure assumptions, i.e. CAPE-relaxing (CR), quasi-equilibrium (QE), and free-troposphere QE (FTQE) and investigates the impacts of planetary boundary layer (PBL) mixing, advection, and radiation on the simulation by using the weather research and forecasting model. The sensitivity of precipitation diurnal cycle to PBL vertical resolution is also examined. Results show that the precipitation diurnal cycles simulated with different closures all exhibit large biases over land and the simulation with FTQE closure agrees best with observation. In the simulation with QE closure, the intensified PBL mixing after sunrise is responsible for the late-morning peak of convective precipitation, while in the simulation with FTQE closure, convective precipitation is mainly controlled by advection cooling. The relative contributions of different processes to precipitation formation are functions of rainfall intensity. In the simulation with CR closure, the dynamical equilibrium in the free troposphere still can be reached, implying the complex cause-effect relationship between atmospheric motion and convection. For simulations in which total CAPE is consumed for the closures, daytime precipitation decreases with increased PBL resolution because thinner model layer produces lower convection starting layer, leading to stronger downdraft cooling and CAPE consumption. The sensitivity of the diurnal peak time of precipitation to closure assumption can also be modulated by changes in PBL vertical resolution. The results of this study help us better understand the impacts of various processes on the precipitation diurnal cycle simulation.

  16. CLOSURE REPORT FOR CORRECTIVE ACTION UNIT165: AREA 25 AND 26 DRY WELL AND WASH DOWN AREAS, NEVADA TEST SITE, NEVADA

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    BECHTEL NEVADA

    This Closure Report (CR) documents the closure activities for Corrective Action Unit (CAU) 165, Area 25 and 26 Dry Well and Washdown Areas, according to the Federal Facility Agreement and Consent Order (FFACO) of 1996. CAU 165 consists of 8 Corrective Action Sites (CASs) located in Areas 25 and 26 of the Nevada Test Site (NTS). The NTS is located approximately 105 kilometers (65 miles) northwest of Las Vegas, nevada. Site closure activities were performed according to the Nevada Division of Environmental Protection (NDEP)-approved Corrective Action Plan (CAP) for CAU 165. CAU 165 consists of the following CASs: (1) CASmore » 25-07-06, Train Decontamination Area; (2) CAS 25-07-07, Vehicle Washdown; (3) CAS 25-20-01, Lab Drain Dry Well; (4) CAS 25-47-01, Reservoir and French Drain; (5) CAS 25-51-02, Drywell; (6) CAS 25-59-01, Septic System; (7) CAS 26-07-01, Vehicle Washdown Station; and (8) CAS 26-59-01, Septic System. CAU 165, Area 25 and 26 Dry Well and Washdown Areas, consists of eight CASs located in Areas 25 and 26 of the NTS. The approved closure alternatives included No Further Action, Clean Closure, and Closure in Place with Administrative Controls.« less

  17. The modern staged repair of classic bladder exstrophy: a detailed postoperative management strategy for primary bladder closure.

    PubMed

    Stec, Andrew A; Baradaran, Nima; Schaeffer, Anthony; Gearhart, John P; Matthews, Ranjiv I

    2012-10-01

    Successful primary bladder closure of classic bladder exstrophy sets the stage for development of adequate bladder capacity and eventual voided continence. The postoperative pathway following primary bladder closure at the authors' institution is quantitatively and qualitatively detailed. Sixty-five consecutive newborns (47 male) undergoing primary closure of classic bladder exstrophy were identified and data were extracted relating to immediate postoperative care. Overall success rate was utilized to validate the pathway. Mean age at time of primary closure was 4.6 days and mean hospital stay was 35.8 days. Osteotomy was performed in 19 patients (mean age 8.8 days), and was not required in 39 infants (mean age 2.9 days). All patients were immobilized for 4 weeks. Tunneled epidural analgesia was employed in 61/65 patients. All patients had ureteral catheters and a suprapubic tube, along with a comprehensive antibiotic regimen. Postoperative total parenteral nutrition was commonly administered, and enteral feedings started around day 4.6. Our success rate of primary closure was 95.4%. A detailed and regimented plan for bladder drainage, immobilization, pain control, nutrition, antimicrobial prophylaxis, and adequate healing time is a cornerstone for the postoperative management of the primary closure of bladder exstrophy. Copyright © 2011 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

  18. Critical review of controlled release packaging to improve food safety and quality.

    PubMed

    Chen, Xi; Chen, Mo; Xu, Chenyi; Yam, Kit L

    2018-03-19

    Controlled release packaging (CRP) is an innovative technology that uses the package to release active compounds in a controlled manner to improve safety and quality for a wide range of food products during storage. This paper provides a critical review of the uniqueness, design considerations, and research gaps of CRP, with a focus on the kinetics and mechanism of active compounds releasing from the package. Literature data and practical examples are presented to illustrate how CRP controls what active compounds to release, when and how to release, how much and how fast to release, in order to improve food safety and quality.

  19. Effects of Laser Etching on the Corrosion Susceptibility of SAVY 4000 and Hagan Containers

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hyer, Holden Christopher; Duque, Juan; Smith, Paul Herrick

    Since the late 1990’s, the Hagan container was used as the primary container for packaging of plutonium-bearing materials. The Hagan design consisted of a threaded closure, a Viton® ORing, a carbon-carbon filter, and a 304L stainless steel (SS) body. Over the years, Hagans have shown vulnerability in their design [1]. In 2008, The Department of Energy (DOE) issued DOE M 441.1-1, Nuclear Material Packaging Manual, which detailed an approach to obtain highconfidence in containers by including specific design requirements, material contents and an approach to determine life span from said contents, and surveillance techniques [2]. In response to both themore » vulnerability issues with the Hagan and DOE M 441.1-1, the SAVY 4000 container with its twist style closure, Viton® O-Ring, Fiberfrax-Gortex filter, and annealed 316L SS body, was designed as the replacement for Hagan containers, but only for a short term lifespan of 5 years [1]. However, both the Hagan and SAVY 4000 are being pushed to maintain a lifespan of 40 years. Therefore, proper confidence must be placed on each component of each container to last a minimum of 40 years. So far, the biggest concern found during surveillance of these containers is corrosion and the potential for failure by corrosion. One concern is that the containers fail due to stress corrosion cracking (SCC), especially around the weld between the collar and the body as welds leave residual stresses. One advantage the SAVY 4000 has is that the body is annealed, but its weld is still susceptible as it was welded after annealing [3, 4]. Moreover, 316L SS is known to have a higher pitting resistance (pits are a precursor to SCC and can also lead to extensive failure of the material), than 304L SS [4]. During recent surveillance activities, two SAVY 4000’s containing Solution Assay Instrument (SAI) solutions were opened. The SAI SAVY 4000’s contained plutonium (Pu) in 3M HCl solution in plastic volumetric flasks placed inside of polyethylene bags. Historically, a SAVY 4000 containing an SAI solution is packaged for 3 weeks, however, these particular containers were not reopened until 14 months later. When opened, brown-red corrosion product was found all over the inside of the container as shown in Figure 1.« less

  20. Effective school actions for mitigating seasonal influenza outbreaks in Niigata, Japan.

    PubMed

    Sugisaki, Koshu; Seki, Nao; Tanabe, Naohito; Saito, Reiko; Sasaki, Asami; Sasaki, Satoshi; Suzuki, Hiroshi

    2013-01-01

    Japan has implemented various school actions during seasonal influenza outbreaks since the 1950's under the School Health Law. However, the effective duration, extent, and timing of closures remain unresolved. We conducted a retrospective study on the relationship between elementary class closures and influenza outbreak control during four consecutive influenza seasons from the 2004-2005 to 2007-2008 school years in Joetsu, Niigata, Japan. Among a total of 1,061 classes of 72 schools, 624 cases of influenza outbreaks were documented among 61 schools. Class closures were carried out in a total of 62 cases in response to influenza outbreak, which was defined as a student absentee rate of greater than 10% due to influenza or influenza-like illness. Of these cases, two-day class closures were conducted the day after reaching a 10% student absentee rate in 28 cases and other types of closures were initiated in 34 cases. A markedly higher number of outbreak cases ended within one week for two-day class closures compared to the other types of closures (82.1% vs. 20.6%, respectively). The significant association between two-day class closures and interruption of an outbreak within one week was confirmed using a multivariable model adjusted for the season, grade, day of the week of an outbreak start, and absentee rate on the day of an outbreak start (OR, 3.18; 95% CI, 1.12-9.07; p = 0.030). Our results suggest that a two-day class closure carried out the day after reaching a 10% absentee rate is an effective approach for mitigating influenza outbreaks in elementary schools.

  1. Comparison of rate of surgical wound infection, length of hospital stay and patient convenience in complicated appendicitis between primary closure and delayed primary closure.

    PubMed

    Khan, Khizar Ishtiaque; Mahmood, Shahid; Akmal, Muhammad; Waqas, Ahmed

    2012-06-01

    To compare the difference in the rate of surgical wound infection, patient's convenience and length of hospital stay between Primary Closure and Delayed Primary Closure in cases of complicated appendicitis in adults. This randomised control trial was conducted at the Combined Military Hospital, Kharian and Malir from June 5, 2006, to September 10, 2009. Patients > or = 15 years of both gender who underwent appendectomy through grid iron or Lanz incision and having complicated appendicitis were included. The 100 patients who were included in the study out of the initial size of 393, were randomised into two equal groups of 50 each (Group A: Primary Closure; Group B: Delayed Primary Closure) using a computer-generated table. All the surgeries were done by the same surgeon and the operative steps and antibiotic coverage were standardised. The rate of surgical wound infection, patient's convenience (on visual analogue scale in mm) and the length of hospital stay were recorded. Data was analysed using SPSS version 11, and p value was calculated. Demographic data, comorbids and medication of both the groups was comparable. There was no significant difference in rate of surgical wound infection (p > 0.05). The difference in patient's convenience and length of hospital stay were significant (p < 0.05), showing superiority of Primary Closure over Delayed Primary Closure with no added morbidity/mortality. Primary Closure in complicated appendicitis not only reduces the cost of treatment, but is also more convenient and satisfying for the patients, with no added risk of surgical wound infection.

  2. Does the bracket–ligature combination affect the amount of orthodontic space closure over three months? A randomized controlled trial

    PubMed Central

    Wong, Henry; Collins, Jill; Tinsley, David; Sandler, Jonathan; Benson, Philip

    2013-01-01

    Objective: To investigate the effect of bracket–ligature combination on the amount of orthodontic space closure over three months. Design: Randomized clinical trial with three parallel groups. Setting: A hospital orthodontic department (Chesterfield Royal Hospital, UK). Participants: Forty-five patients requiring upper first premolar extractions. Methods: Informed consent was obtained and participants were randomly allocated into one of three groups: (1) conventional pre-adjusted edgewise brackets and elastomeric ligatures; (2) conventional pre-adjusted edgewise brackets and Super Slick® low friction elastomeric ligatures; (3) Damon 3MX® passive self-ligating brackets. Space closure was undertaken on 0·019×0·025-inch stainless steel archwires with nickel–titanium coil springs. Participants were recalled at four weekly intervals. Upper alginate impressions were taken at each visit (maximum three). The primary outcome measure was the mean amount of space closure in a 3-month period. Results: A one-way ANOVA was undertaken [dependent variable: mean space closure (mm); independent variable: group allocation]. The amount of space closure was very similar between the three groups (1 mm per 28 days); however, there was a wide variation in the rate of space closure between individuals. The differences in the amount of space closure over three months between the three groups was very small and non-significant (P = 0·718). Conclusion: The hypothesis that reducing friction by modifying the bracket/ligature interface increases the rate of space closure was not supported. The major determinant of orthodontic tooth movement is probably the individual patient response. PMID:23794696

  3. Online Work Force Analyzes Social Media to Identify Consequences of an Unplanned School Closure - Using Technology to Prepare for the Next Pandemic.

    PubMed

    Rainey, Jeanette J; Kenney, Jasmine; Wilburn, Ben; Putman, Ami; Zheteyeva, Yenlik; O'Sullivan, Megan

    During an influenza pandemic, the United States Centers for Disease Control and Prevention (CDC) may recommend school closures. These closures could have unintended consequences for students and their families. Publicly available social media could be analyzed to identify the consequences of an unplanned school closure. As a proxy for an unplanned, pandemic-related school closure, we used the district-wide school closure due to the September 10-18, 2012 teachers' strike in Chicago, Illinois. We captured social media posts about the school closure using the Radian6 social media-monitoring platform. An online workforce from Amazon Mechanical Turk categorized each post into one of two groups. The first group included relevant posts that described the impact of the closure on students and their families. The second group included irrelevant posts that described the political aspects of the strike or topics unrelated to the school closure. All relevant posts were further categorized as expressing a positive, negative, or neutral sentiment. We analyzed patterns of relevant posts and sentiment over time and compared our findings to household surveys conducted after other unplanned school closures. We captured 4,546 social media posts about the district-wide school closure using our search criteria. Of these, 930 (20%) were categorized as relevant by the online workforce. Of the relevant posts, 619 (67%) expressed a negative sentiment, 51 (5%) expressed a positive sentiment, and 260 (28%) were neutral. The number of relevant posts, and especially those with a negative sentiment, peaked on day 1 of the strike. Negative sentiment expressed concerns about childcare, missed school lunches, and the lack of class time for students. This was consistent with findings from previously conducted household surveys. Social media are publicly available and can readily provide information on the impact of an unplanned school closure on students and their families. Using social media to assess the impact of an unplanned school closure due to a public health event would be informative. An online workforce can effectively assist with the review process.

  4. Online Work Force Analyzes Social Media to Identify Consequences of an Unplanned School Closure – Using Technology to Prepare for the Next Pandemic

    PubMed Central

    Rainey, Jeanette J.; Kenney, Jasmine; Wilburn, Ben; Putman, Ami; Zheteyeva, Yenlik; O’Sullivan, Megan

    2016-01-01

    Background During an influenza pandemic, the United States Centers for Disease Control and Prevention (CDC) may recommend school closures. These closures could have unintended consequences for students and their families. Publicly available social media could be analyzed to identify the consequences of an unplanned school closure. Methods As a proxy for an unplanned, pandemic-related school closure, we used the district-wide school closure due to the September 10–18, 2012 teachers’ strike in Chicago, Illinois. We captured social media posts about the school closure using the Radian6 social media-monitoring platform. An online workforce from Amazon Mechanical Turk categorized each post into one of two groups. The first group included relevant posts that described the impact of the closure on students and their families. The second group included irrelevant posts that described the political aspects of the strike or topics unrelated to the school closure. All relevant posts were further categorized as expressing a positive, negative, or neutral sentiment. We analyzed patterns of relevant posts and sentiment over time and compared our findings to household surveys conducted after other unplanned school closures. Results We captured 4,546 social media posts about the district-wide school closure using our search criteria. Of these, 930 (20%) were categorized as relevant by the online workforce. Of the relevant posts, 619 (67%) expressed a negative sentiment, 51 (5%) expressed a positive sentiment, and 260 (28%) were neutral. The number of relevant posts, and especially those with a negative sentiment, peaked on day 1 of the strike. Negative sentiment expressed concerns about childcare, missed school lunches, and the lack of class time for students. This was consistent with findings from previously conducted household surveys. Conclusion Social media are publicly available and can readily provide information on the impact of an unplanned school closure on students and their families. Using social media to assess the impact of an unplanned school closure due to a public health event would be informative. An online workforce can effectively assist with the review process. PMID:27655229

  5. Separating Active and Passive Influences on Stomatal Control of Transpiration[OPEN

    PubMed Central

    McAdam, Scott A.M.; Brodribb, Timothy J.

    2014-01-01

    Motivated by studies suggesting that the stomata of ferns and lycophytes do not conform to the standard active abscisic acid (ABA) -mediated stomatal control model, we examined stomatal behavior in a conifer species (Metasequoia glyptostroboides) that is phylogenetically midway between the fern and angiosperm clades. Similar to ferns, daytime stomatal closure in response to moderate water stress seemed to be a passive hydraulic process in M. glyptostroboides immediately alleviated by rehydrating excised shoots. Only after prolonged exposure to more extreme water stress did active ABA-mediated stomatal closure become important, because foliar ABA production was triggered after leaf turgor loss. The influence of foliar ABA on stomatal conductance and stomatal aperture was highly predictable and additive with the passive hydraulic influence. M. glyptostroboides thus occupies a stomatal behavior type intermediate between the passively controlled ferns and the characteristic ABA-dependent stomatal closure described in angiosperm herbs. These results highlight the importance of considering phylogeny as a major determinant of stomatal behavior. PMID:24488969

  6. Separating active and passive influences on stomatal control of transpiration.

    PubMed

    McAdam, Scott A M; Brodribb, Timothy J

    2014-04-01

    Motivated by studies suggesting that the stomata of ferns and lycophytes do not conform to the standard active abscisic acid (ABA) -mediated stomatal control model, we examined stomatal behavior in a conifer species (Metasequoia glyptostroboides) that is phylogenetically midway between the fern and angiosperm clades. Similar to ferns, daytime stomatal closure in response to moderate water stress seemed to be a passive hydraulic process in M. glyptostroboides immediately alleviated by rehydrating excised shoots. Only after prolonged exposure to more extreme water stress did active ABA-mediated stomatal closure become important, because foliar ABA production was triggered after leaf turgor loss. The influence of foliar ABA on stomatal conductance and stomatal aperture was highly predictable and additive with the passive hydraulic influence. M. glyptostroboides thus occupies a stomatal behavior type intermediate between the passively controlled ferns and the characteristic ABA-dependent stomatal closure described in angiosperm herbs. These results highlight the importance of considering phylogeny as a major determinant of stomatal behavior.

  7. Life Support System Technologies for NASA Exploration Missions

    NASA Technical Reports Server (NTRS)

    Ewert, Michael K.

    2007-01-01

    The Lunar Mars Life Support Test series successfully demonstrated integration and operation of advanced technologies for closed-loop life support systems, including physicochemical and biological subsystems. Increased closure was obtained when targeted technologies, such as brine dewatering subsystems, were added to further process life support system byproducts to recover resources. Physicochemical and biological systems can be integrated satisfactorily to achieve desired levels of closure. Imbalances between system components, such as differences in metabolic quotients between human crews and plants, must be addressed. Each subsystem or component that is added to increase closure will likely have added costs, ranging from initial launch mass, power, thermal, crew time, byproducts, etc., that must be factored into break even analysis. Achieving life support system closure while maintaining control of total mass and system complexity will be a challenge.

  8. Integrated Design and Engineering Analysis (IDEA) Environment - Propulsion Related Module Development and Vehicle Integration

    NASA Technical Reports Server (NTRS)

    Kamhawi, Hilmi N.

    2013-01-01

    This report documents the work performed during the period from May 2011 - October 2012 on the Integrated Design and Engineering Analysis (IDEA) environment. IDEA is a collaborative environment based on an object-oriented, multidisciplinary, distributed framework using the Adaptive Modeling Language (AML). This report will focus on describing the work done in the areas of: (1) Integrating propulsion data (turbines, rockets, and scramjets) in the system, and using the data to perform trajectory analysis; (2) Developing a parametric packaging strategy for a hypersonic air breathing vehicles allowing for tank resizing when multiple fuels and/or oxidizer are part of the configuration; and (3) Vehicle scaling and closure strategies.

  9. Gap Resolution

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Labutti, Kurt; Foster, Brian; Lapidus, Alla

    Gap Resolution is a software package that was developed to improve Newbler genome assemblies by automating the closure of sequence gaps caused by repetitive regions in the DNA. This is done by performing the follow steps:1) Identify and distribute the data for each gap in sub-projects. 2) Assemble the data associated with each sub-project using a secondary assembler, such as Newbler or PGA. 3) Determine if any gaps are closed after reassembly, and either design fakes (consensus of closed gap) for those that closed or lab experiments for those that require additional data. The software requires as input a genomemore » assembly produce by the Newbler assembler provided by Roche and 454 data containing paired-end reads.« less

  10. Early Complications and Outcomes in Combat Injury Related Invasive Fungal Wound Infections: A Case-Control Analysis

    PubMed Central

    Lewandowski, Louis R.; Weintrob, Amy C.; Tribble, David R.; Rodriguez, Carlos J.; Petfield, Joseph; Lloyd, Bradley A.; Murray, Clinton K.; Stinner, Daniel; Aggarwal, Deepak; Shaikh, Faraz; Potter, Benjamin K.

    2015-01-01

    Objective Clinicians have anecdotally noted that combat-related invasive fungal wound infections (IFIs) lead to residual limb shortening, additional days and operative procedures prior to initial wound closure, and high early complication rates. We evaluated the validity of these observations and identified risk factors that may impact time to initial wound closure. Design Retrospective review and case-control analysis. Setting Military hospitals. Patients/Participants United States military personnel injured during combat operations (2009–2011). The IFI cases were identified based upon the presence of recurrent, necrotic extremity wounds with mold growth in culture and/or histopathologic fungal evidence. Non-IFI controls were matched on injury pattern and severity. In a supplemental matching analysis, non-IFI controls were also matched by blood volume transfused within 24 hours of injury. Intervention None. Main Outcome Measurements Amputation revision rate and loss of functional levels. Results Seventy-one IFI cases (112 fungal-infected extremity wounds) were identified and matched to 160 control patients (315 non-IFI extremity wounds). The IFI wounds resulted in significantly more changes in amputation level (p<0.001). Additionally, significantly (p<0.001) higher number of operative procedures and longer duration to initial wound closure was associated with IFI. A shorter duration to initial wound closure was significantly associated with wounds lacking IFIs (Hazard ratio: 1.53; 95% CI: 1.17, 2.01). The supplemental matching analysis found similar results. Conclusions Our analysis indicates that IFIs adversely impact wound healing and patient recovery, requiring more frequent proximal amputation revisions and leading to higher early complication rates. PMID:26360542

  11. Border Forces and Friction Control Epithelial Closure Dynamics

    PubMed Central

    Cochet-Escartin, Olivier; Ranft, Jonas; Silberzan, Pascal; Marcq, Philippe

    2014-01-01

    We study the closure dynamics of a large number of well-controlled circular apertures within an epithelial monolayer, where the collective cell migration responsible for epithelization is triggered by the removal of a spatial constraint rather than by scratching. Based on experimental observations, we propose a physical model that takes into account border forces, friction with the substrate, and tissue rheology. Border protrusive activity drives epithelization despite the presence of a contractile actomyosin cable at the periphery of the wound. The closure dynamics is quantified by an epithelization coefficient, defined as the ratio of protrusive stress to tissue-substrate friction, that allows classification of different phenotypes. The same analysis demonstrates a distinct signature for human cells bearing the oncogenic RasV12 mutation, demonstrating the potential of the approach to quantitatively characterize metastatic transformations. PMID:24411238

  12. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment

    PubMed Central

    Ribeiro, Gerson Luiz Ulema; Jacob, Helder B.

    2016-01-01

    ABSTRACT Introduction: Space closure is one of the most challenging processes in Orthodontics and requires a solid comprehension of biomechanics in order to avoid undesirable side effects. Understanding the biomechanical basis of space closure better enables clinicians to determine anchorage and treatment options. In spite of the variety of appliance designs, space closure can be performed by means of friction or frictionless mechanics, and each technique has its advantages and disadvantages. Friction mechanics or sliding mechanics is attractive because of its simplicity; the space site is closed by means of elastics or coil springs to provide force, and the brackets slide on the orthodontic archwire. On the other hand, frictionless mechanics uses loop bends to generate force to close the space site, allowing differential moments in the active and reactive units, leading to a less or more anchorage control, depending on the situation. Objective: This article will discuss various theoretical aspects and methods of space closure based on biomechanical concepts. PMID:27275623

  13. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment.

    PubMed

    Ribeiro, Gerson Luiz Ulema; Jacob, Helder B

    2016-01-01

    Space closure is one of the most challenging processes in Orthodontics and requires a solid comprehension of biomechanics in order to avoid undesirable side effects. Understanding the biomechanical basis of space closure better enables clinicians to determine anchorage and treatment options. In spite of the variety of appliance designs, space closure can be performed by means of friction or frictionless mechanics, and each technique has its advantages and disadvantages. Friction mechanics or sliding mechanics is attractive because of its simplicity; the space site is closed by means of elastics or coil springs to provide force, and the brackets slide on the orthodontic archwire. On the other hand, frictionless mechanics uses loop bends to generate force to close the space site, allowing differential moments in the active and reactive units, leading to a less or more anchorage control, depending on the situation. This article will discuss various theoretical aspects and methods of space closure based on biomechanical concepts.

  14. Auditory skills of figure-ground and closure in air traffic controllers.

    PubMed

    Villar, Anna Carolina Nascimento Waack Braga; Pereira, Liliane Desgualdo

    2017-12-04

    To investigate the auditory skills of closure and figure-ground and factors associated with health, communication, and attention in air traffic controllers, and compare these variables with those of other civil and military servants. Study participants were sixty adults with normal audiometric thresholds divided into two groups matched for age and gender: study group (SG), comprising 30 air traffic controllers and control group (CG), composed of 30 other military and civil servants. All participants were asked a number of questions regarding their health, communication, and attention, and underwent the Speech-in-Noise Test (SIN) to assess their closure skills and the Synthetic Sentence Identification Test - Ipsilateral Competitive Message (SSI-ICM) in monotic listening to evaluate their figure-ground abilities. Data were compared using nonparametric statistical tests and logistic regression analysis. More individuals in the SG reported fatigue and/or burnout and work-related stress and showed better performance than that of individuals in the CG for the figure-ground ability. Both groups performed similarly and satisfactorily in the other hearing tests. The odds ratio for participants belonging in the SG was 5.59 and 1.24 times regarding work-related stress and SSI-ICM (right ear), respectively. Results for the variables auditory closure, self-reported health, attention, and communication were similar in both groups. The SG presented significantly better performance in auditory figure-ground compared with that of the CG. Self-reported stress and right-ear SSI-ICM were significant predictors of individuals belonging to the SG.

  15. Anterior segment optical coherence tomography parameters in phacomorphic angle closure and mature cataracts.

    PubMed

    Mansouri, Mohammadreza; Ramezani, Farshid; Moghimi, Sasan; Tabatabaie, Ali; Abdi, Fatemeh; He, Mingguang; Lin, Shan C

    2014-10-21

    To describe anterior segment optical coherence tomography (AS-OCT) parameters in phacomorphic angle closure eyes, mature cataract eyes, and their fellow eyes, and identify those parameters that could be used to differentiate phacomorphic angle closure eyes from those with mature cataract and no phacomorphic angle closure. In this cross-sectional study, a total of 33 phacomorphic angle closure subjects and 34 control patients with unilateral mature cataracts were enrolled. All patients underwent AS-OCT imaging and A-scan biometry of both eyes. Anterior chamber depth (ACD), anterior chamber area (ACA), iris thickness, iris curvature, lens vault (LV), and angle parameters, including angle opening distance (AOD750) and trabecular-iris space area (TISA750), were measured in qualified images using customized software and compared among eyes with phacomorphic angle closure, mature cataract eyes, and their fellow eyes. There was no significant difference in axial length among the four groups. Phacomorphic angle closure had the smallest angle (AOD750, TISA750) and anterior chamber parameters (ACD, ACA, anterior chamber width) and the greatest LV among the groups. This pattern was similar when comparing fellow eyes of mature cataract patients and fellow eyes of phacomorphic angle closure. Anterior chamber area less than 18.62 mm(2), ACD less than 2.60 mm, LV greater than 532.0 μm, and AOD750 less than 0.218 mm had the highest odds ratios (ORs) for distinguishing fellow eyes of phacomorphic angle closure versus fellow eyes of mature cataracts, with OR values of 9.90, 8.31, 7.91, and 7.91, respectively. Logistic regression showed that ACA less than 18.62 was the major parameter associated with fellow eyes of phacomorphic angle closure (OR = 10.96, P < 0.001). Anterior chamber depth, ACA, AOD750, and LV are powerful indicators in differentiating phacomorphic angle closure eyes from those with mature cataract and their fellow eyes. Copyright 2014 The Association for Research in Vision and Ophthalmology, Inc.

  16. Best management practices for erosion control from bladed skid trails

    Treesearch

    Charles R. Wade; W. Michael Aust; M. Chad Bolding; William A. Lakel III

    2012-01-01

    Sediment from forest operations is primarily associated with roads and skid trails. We evaluated five skid trail closure treatments applied to bladed skid trails in the Virginia Piedmont. Closure treatments were Waterbars, Seed, Mulch, Pine slash, and Hardwood slash. Sediment traps were used to collect monthly sediment samples for one year. The Mulch, Pine slash, and...

  17. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  18. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  19. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  20. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  1. 21 CFR 211.86 - Use of approved components, drug product containers, and closures.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

  2. Impacts of tree height on leaf hydraulic architecture and stomatal control in Douglas-fir.

    Treesearch

    D.R. Woodruff; K.A. McCulloh; J.M. Warren; F.C. Meinzer; B.L. Gartner

    2007-01-01

    We investigated the mechanisms involved in the regulation of stomatal closure in Douglas-fir and evaluated the potential compensatory adjustments in response to increasing tree height. Stomatal closure was initiated at values of leaf water potential corresponding to nearly complete loss of leaf hydraulic conductance. Cryogenic scanning electron microscopic images...

  3. Effect of the ripening time under vacuum and packaging film permeability on processing and quality characteristics of low-fat fermented sausages.

    PubMed

    Liaros, N G; Katsanidis, E; Bloukas, J G

    2009-12-01

    The effect of vacuum ripening of low-fat fermented sausages packaged in films with different permeabilities on their microbiological, physicochemical and sensorial characteristics was studied. High-fat control sausages were produced with 30% initial fat and low-fat sausages with 10% initial fat. The low-fat sausages were separated into: (a) non-packaged (control) and (b) packaged under vacuum on 7th, 12th and 17th day of processing, remaining under vacuum during the ripening period for 21, 16 and 11days, respectively, in three different oxygen (100, 38 and⩽5cm(3)/m(2)/24h/1atm) and water vapour (4.5, <2.5 and 1g/m(2)24h) permeability plastic bags. Vacuum packaging reduced (p<0.05) the weight loss, the hardness and extent of lipid oxidation in the sausages, increased (p<0.05) their lightness, but had no effect (p>0.05) on the redness, compared to the control sausages. Packaging low-fat fermented sausages under vacuum for the last 11days of ripening in packaging film with high permeability increased (p<0.05) the lactic acid bacteria count. The same product packaged in film with medium permeability had a higher (p<0.05) Micrococcaceae count and the same (p>0.05) hardness and overall acceptability as the high-fat control sausages. A ripening time of 11days and the medium packaging film permeability were the most appropriate conditions for the vacuum packaging of low-fat fermented sausages.

  4. 21 CFR 820.130 - Device packaging.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device packaging. 820.130 Section 820.130 Food and... QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the...

  5. Primary packaging considerations in developing medicines for children: oral liquid and powder for constitution.

    PubMed

    Campbell, Gossett A; Vallejo, Erick

    2015-01-01

    The packaging presentation of oral liquid pediatric medicines is a critical step in maintaining chemical and physical stability, compliance, adherence, and proper handling by the target patient population, guardians, caregivers, and health-care professionals. The common packaging presentations for commercial oral liquid pediatric drug products are glass bottle, plastic bottle, sachet, and stick pack configurations. The type of pack presentation selected is driven by the quality target product profile (QTPP) that is designed around the physicochemical properties of the drug substance and the desired drug product suitability for the target population. The QTPP defines the intended use of the drug product, drug product quality criteria, dose strength, dosage form, container closure system, storage conditions, stability criteria, dosing device, shelf life, and attributes affecting the pharmacokinetic characteristics. Oral liquid pediatric formulations are typically prepared from a powder that is constituted at the time of use as a suspension or a solution for single or multiple use depending on the stability of the constituted formulation. Active ingredients with high aqueous solubility can be developed as a powder for oral solution and presented in a bottle for multiple use product and a stick pack, packet, or sachet for single-use product. Active ingredients with low aqueous solubility can be developed as a powder for oral suspension and presented in a bottle for multiple use product and a stick pack or sachet for single-use product. A secondary package may be used in cases where the primary pack failed to provide adequate protection against light degradation. This work will help formulation scientists select the most appropriate pack presentation in the early stages of pediatric clinical development. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  6. Significant skin-tightening by closure of fractional ablative laser holes.

    PubMed

    Russe, Elisabeth; Purschke, Martin; Limpiangkanan, Wikunda; Farinelli, William A; Wang, Ying; Doukas, Apostolos G; Sakamoto, Fernanda H; Wechselberger, Gottfried; Anderson, Richard Rox

    2018-01-01

    Ablative fractional laser treatment uses thousands of very small laser beam wounds to damage a fraction of the skin, which stimulates tissue remodeling. Each open micro-wound heals without scarring, but the amount of skin tightening achieved is limited. This animal study was performed to test the hypothesis that immediate temporary closure of fractional laser wounds could increase skin tightening after fractional ablative laser treatment. Four adult swine were used for the study; 98 square test sites (3 × 3 cm) were tattooed on the abdomen and flanks of each pig. An ablative fractional Erbium:YAG laser (Sciton Profile, Sciton Inc, Palo Alto, CA) was used to treat the test areas. A laser micro-spot fluence of 375 J/cm 2 was delivered in 150-250 microseconds pulses, resulting in an array of ablation channels extending 1.5 mm deep into the skin, with a spot size of 250 µm, with 10% treatment density. Immediately following laser exposure the resulting holes were closed using a stretched elastic adhesive dressing, which, when applied, recoiled and compressed the diameter of the ablation holes. The compressive dressings were removed after 7 days. This procedure was compared to removing the same amount of skin (10%) mechanically by specially designed 19 gauge coring needles, as well as to the same laser and coring methods without compression closure. Area and shape of test sites were measured by digital photography before and 28 days after treatment. Data analysis included compensation for animal growth, as measured by increase in the area of the untreated control sites. All treated and control sites healed within a week, without scarring evident at 28 days. Laser treatment combined with compressive wound closure caused significant shrinkage at 28 days compared with untreated control sites. The treated skin area was reduced by 11.5% (P = 0.0001). Needle coring with wound closure produced similar, significant shrinkage (8%, P < 0.0021), whereas laser and needle coring treatment without closure did not result in significant area reduction (P = 0.1289) compared with untreated control sites. Significant skin tightening can be achieved by immediate temporary non-invasive wound closure after short pulse Er:YAG fractional ablative laser treatment, as well as after mechanically removing skin with a coring needle. This approach may improve skin tightening after ablative laser treatments. Further clinical studies are necessary to confirm successful application in humans. Lasers Surg. Med. 50:64-69, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  7. Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial.

    PubMed

    Tobis, Jonathan M; Charles, Andrew; Silberstein, Stephen D; Sorensen, Sherman; Maini, Brijeshwar; Horwitz, Phillip A; Gurley, John C

    2017-12-05

    Migraine is a prevalent and disabling disorder. Patent foramen ovale (PFO) has been associated with migraine, but its role in the disorder remains poorly understood. This study examined the efficacy of percutaneous PFO closure as a therapy for migraine with or without aura. The PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management) was a double-blind study investigating migraine characteristics over 1 year in subjects randomized to medical therapy with a sham procedure (right heart catheterization) versus medical therapy and PFO closure with the Amplatzer PFO Occluder device (St. Jude Medical, St. Paul, Minnesota). Subjects had 6 to 14 days of migraine per month, had failed at least 3 migraine preventive medications, and had significant right-to-left shunt defined by transcranial Doppler. Primary endpoints were responder rate defined as 50% reduction in migraine attacks and adverse events. Secondary endpoints included reduction in migraine days and efficacy in patients with versus without aura. Of 1,653 subjects consented, 230 were enrolled. There was no difference in responder rate in the PFO closure (45 of 117) versus control (33 of 103) groups. One serious adverse event (transient atrial fibrillation) occurred in 205 subjects who underwent PFO closure. Subjects in the PFO closure group had a significantly greater reduction in headache days (-3.4 vs. -2.0 days/month, p = 0.025). Complete migraine remission for 1 year occurred in 10 patients (8.5%) in the treatment group versus 1 (1%) in the control group (p = 0.01). PFO closure did not meet the primary endpoint of reduction in responder rate in patients with frequent migraine. (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management [PREMIUM]; NCT00355056). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  8. Study design of the CLOSURE I Trial: a prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale.

    PubMed

    Furlan, Anthony J; Reisman, Mark; Massaro, Joseph; Mauri, Laura; Adams, Harold; Albers, Gregory W; Felberg, Robert; Herrmann, Howard; Kar, Saibal; Landzberg, Michael; Raizner, Albert; Wechsler, Lawrence

    2010-12-01

    Some strokes of unknown etiology may be the result of a paradoxical embolism traversing through a nonfused foramen ovale (patent foramen ovale [PFO]). The utility of percutaneously placed devices for treatment of patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO is unknown. In addition, there are no clear data about the utility of medical interventions or other surgical procedures in this situation. Despite limited data, many patients are being treated with PFO closure devices. Thus, there is a strong need for clinical trials that test the potential efficacy of PFO occlusive devices in this situation. To address this gap in medical knowledge, we designed the CLOSURE I trial, a randomized, clinical trial comparing the use of a percutaneously placed PFO occlusive device and best medical therapy versus best medical therapy alone for prevention of recurrent ischemic neurologic symptoms among persons with TIA or ischemic stroke. This prospective, multicenter, randomized, controlled trial has finished enrollment. Two-year follow-up for all 910 patients is required. The primary end point is the 2-year incidence of stroke or TIA, all-cause mortality for the first 30 days, and neurologic mortality from ≥ 31 days of follow-up, as adjudicated by a panel of physicians who are unaware of treatment allocation. This article describes the rationale and study design of CLOSURE I. This trial should provide information as to whether the STARFlex septal closure system is safe and more effective than best medical therapy alone in preventing recurrent stroke/TIA and mortality in patients with PFO and whether the STARFlex septal closure device can demonstrate superiority compared with best medical therapy alone. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00201461.

  9. Sinonasal Epithelial Wound Resealing in an In Vitro Model: Inhibition of Wound Closure with IL-4 Exposure

    PubMed Central

    Wise, Sarah K.; Den Beste, Kyle A.; Hoddeson, Elizabeth K.; Parkos, Charles A.; Nusrat, Asma

    2013-01-01

    Background Prolonged healing and persistent inflammation following surgery for rhinosinusitis impacts patient satisfaction and healthcare resources. Cytokines interleukin (IL)-4, 5, and 13 are important mediators in Th2 inflammatory rhinosinusitis. Decreased wound healing has been demonstrated with Th2 cytokine exposure, but this has not been extensively studied in sinonasal epithelium. We hypothesized that in vitro exposure of primary sinonasal epithelial cell cultures to Th2 inflammatory cytokine IL-4 and IL-13 would impair wound resealing and decrease expression of annexin A2 at the wound edge. Methods Following 24-hour exposure to IL-4, 5, or 13 versus controls, sterile linear mechanical wounds were created in primary sinonasal epithelial cultures (n = 12 wounds per condition). Wounds were followed for 36 hours or until complete closure and residual wound areas were calculated by image analysis. Group differences in annexin A2 were assessed by immunofluorescence labeling, confocal microscopy, and Western blots. Results Significant wound closure differences were identified across cytokine exposure groups (p<0.001). Mean percentage wound closure at the completion of the 36-hour timecourse was 98.41% ± 3.43% for control wounds versus 85.02% ± 18.46% for IL-4 exposed wounds. IL-13 did not significantly impair sinonasal epithelial wound resealing in vitro. Annexin A2 protein levels were decreased in IL-4 treated wounds when compared to control wounds (p<0.01). Conclusions Th2 cytokine IL-4 decreases sinonasal epithelial wound closure in vitro. Annexin A2 is also diminished with IL-4 exposure. This supports the hypothesis that IL-4 exposure impairs sinonasal epithelial wound healing and may contribute to prolonged healing in Th2 inflammatory rhinosinusitis. PMID:23468432

  10. Speech in Adults Treated for Unilateral Cleft Lip and Palate: Long-Term Follow-Up After One- or Two-Stage Palate Repair.

    PubMed

    Morén, Staffan; Mani, Maria; Lilian, Stålhammar; Lindestad, Per Åke; Holmström, Mats

    2017-11-01

      To evaluate speech in adults treated for unilateral cleft lip and palate with one-stage or two-stage palate closure and compare the speech of the patients with that of a noncleft control group.   Cross-sectional study with long-term follow-up.   All unilateral cleft lip and palate patients born from 1960 to 1987 and treated at Uppsala University Hospital, Sweden, were invited (n = 109). Participation rate was 67% (n = 73) at a mean of 35 years after primary surgery. Forty-seven had been treated according to one-stage palate closure and 26 according to two-stage palate closure. Pharyngeal flap surgery had been performed in 11 of the 73 patients (15%). The noncleft control group consisted of 63 age-matched volunteers.   Speech-language pathologists rated perceptual speech characteristics from blinded audio recordings.   Among patients, seven (10%) presented with hypernasality, 12 (16%) had audible nasal emission and/or nasal turbulence, five (7%) had consonant production errors, one (2%) had glottal reinforcements/substitutions, and one (2%) had reduced intelligibility. Controls had no audible signs of velopharyngeal insufficiency and no quantifiable problems with the other speech production variables. No significant differences were identified between patients treated with one-stage and two-stage palate closure for any of the variables.   The prevalence of speech outcome indicative of velopharyngeal insufficiency among adult patients treated for unilateral cleft lip and palate was low but higher compared with individuals without cleft. Whether palatal closure is performed in one or two stages does not seem to affect the speech outcome at a mean age of 35 years.

  11. Deep inferior epigastric artery perforator flap donor-site closure with cannula-assisted, limited undermining, and progressive high-tension sutures versus standard abdominoplasty: complications, sensitivity, and cosmetic outcomes.

    PubMed

    Visconti, Giuseppe; Tomaselli, Federica; Monda, Anna; Barone-Adesi, Liliana; Salgarello, Marzia

    2015-01-01

    In deep inferior epigastric artery perforator (DIEP) flap breast reconstruction, abdominal donor-site cosmetic and sensibility outcomes and the closure technique have drawn little attention in the literature, with many surgeons still following the principles of standard abdominoplasty. In this article, the authors report their experience with the cannula-assisted, limited undermining, and progressive high-tension suture ("CALP") technique of DIEP donor-site closure compared with standard abdominoplasty. Between December of 2008 and January of 2013, 137 consecutive women underwent DIEP flap breast reconstruction. Of these, 82 patients (between December of 2008 and November of 2011) underwent DIEP flap donor-site closure by means of standard abdominoplasty (control group) and 55 patients (from December of 2011 to January of 2013) by means of cannula-assisted, limited undermining, and progressive high-tension suture (study group). The abdominal drainage daily output, donor-site complications, abdominal skin sensitivity at 1-year follow-up, cosmetic outcomes, and patient satisfaction were recorded and analyzed statistically. Daily drainage output was significantly lower in the study group. Donor-site complications were significantly higher in the control group (37.8 percent versus 9 percent). Seroma and wound healing problems were experienced in the control group. Abdominal skin sensibility was better preserved in the study group. Overall, abdominal wall aesthetic outcomes were similar in both groups, except for scar quality (better in the study group). According to the authors' experience, cannula-assisted, limited undermining, and progressive high-tension suture should be always preferred to standard abdominoplasty for DIEP donor-site closure to reduce the complication rate to improve abdominal skin sensitivity and scar quality. Therapeutic, II.

  12. Paperless Work Package Application

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kilgore, Jr., William R.; Morrell, Jr., Otto K.; Morrison, Dan

    2014-07-31

    Paperless Work Package (PWP) System is a computer program process that takes information from Asset Suite, provides a platform for other electronic inputs, Processes the inputs into an electronic package that can be downloaded onto an electronic work tablet or laptop computer, provides a platform for electronic inputs into the work tablet, and then transposes those inputs back into Asset Suite and to permanent SRS records. The PWP System will basically eliminate paper requirements from the maintenance work control system. The program electronically relays the instructions given by the planner to work on a piece of equipment which is currentlymore » relayed via a printed work package. The program does not control/approve what is done. The planner will continue to plan the work package, the package will continue to be routed, approved, and scheduled. The supervisor reviews and approves the work to be performed and assigns work to individuals or to a work group. (The supervisor conducts pre job briefings with the workers involved in the job) The Operations Manager (Work Controlling Entity) approves the work package electronically for the work that will be done in his facility prior to work starting. The PWP System will provide the package in an electronic form. All the reviews, approvals, and safety measures taken by people outside the electronic package does not change from the paper driven work packages.« less

  13. Controllable Magnetization Processes Induced by Nucleation Sites in Permalloy Rings

    NASA Astrophysics Data System (ADS)

    Chen, Ying-Jiun; Hsu, Chia-Jung; Liao, Chun-Neng; Huang, Hao-Ting; Lee, Chiun-Peng; Chiu, Yi-Hsun; Tung, Tzu-Yun; Lai, Mei-Feng

    2010-02-01

    Different arrangements of notches as nucleation sites are demonstrated experimentally and numerically to effectively control the magnetization processes of permalloy rings. In the ring with notches at the same side with respect to field direction, two same-helicity vortex domain walls in the onion state lead to two-step switching going through flux-closure state; in the ring with diagonal notches two opposite-helicity vortex domain walls lead to one-step switching skipping flux-closure state. The switching processes are repeatable in contrast to rings without notches where helicites of two vortex domain walls are random so the switching processes can not be controlled.

  14. Fuzzy based attitude controller for flexible spacecraft with on/off thrusters

    NASA Astrophysics Data System (ADS)

    Knapp, Roger G.; Adams, Neil J.

    A fuzzy-based attitude controller is designed for attitude control of a generic spacecraft with on/off thrusters. The controller is comprised of packages of rules dedicated to addressing different objectives (e.g., disturbance rejection, low fuel consumption, avoiding the excitation of flexible appendages, etc.). These rule packages can be inserted or removed depending on the requirements of the particular spacecraft and are parameterized based on vehicle parameters such as inertia or operational parameters such as the maneuvering rate. Individual rule packages can be 'weighted' relative to each other to emphasize the importance of one objective relative to another. Finally, the fuzzy controller and rule packages are demonstrated using the high-fidelity Space Shuttle Interactive On-Orbit Simulator (IOS) while performing typical on-orbit operations and are subsequently compared with the existing shuttle flight control system performance.

  15. Fuzzy based attitude controller for flexible spacecraft with on/off thrusters

    NASA Astrophysics Data System (ADS)

    Knapp, Roger Glenn

    1993-05-01

    A fuzzy-based attitude controller is designed for attitude control of a generic spacecraft with on/off thrusters. The controller is comprised of packages of rules dedicated to addressing different objectives (e.g., disturbance rejection, low fuel consumption, avoiding the excitation of flexible appendages, etc.). These rule packages can be inserted or removed depending on the requirements of the particular spacecraft and are parameterized based on vehicle parameters such as inertia or operational parameters such as the maneuvering rate. Individual rule packages can be 'weighted' relative to each other to emphasize the importance of one objective relative to another. Finally, the fuzzy controller and rule packages are demonstrated using the high-fidelity Space Shuttle Interactive On-Orbit Simulator (IOS) while performing typical on-orbit operations and are subsequently compared with the existing shuttle flight control system performance.

  16. High-pressure processing and antimicrobial biodegradable packaging to control Listeria monocytogenes during storage of cooked ham.

    PubMed

    Marcos, Begonya; Aymerich, Teresa; Monfort, Josep M; Garriga, Margarita

    2008-02-01

    The efficiency of combining high-pressure processing (HPP) and active packaging technologies to control Listeria monocytogenes growth during the shelf life of artificially inoculated cooked ham was assessed. Three lots of cooked ham were prepared: control, packaging with alginate films, and packaging with antimicrobial alginate films containing enterocins. After packaging, half of the samples were pressurized. Sliced cooked ham stored at 6 degrees C experienced a quick growth of L. monocytogenes. Both antimicrobial packaging and pressurization delayed the growth of the pathogen. However, at 6 degrees C the combination of antimicrobial packaging and HPP was necessary to achieve a reduction of inoculated levels without recovery during 60 days of storage. Further storage at 6 degrees C of pressurized antimicrobial packed cooked ham resulted in L. monocytogenes levels below the detection limit (day 90). On the other hand, storage at 1 degrees C controlled the growth of the pathogen until day 39 in non-pressurized ham, while antimicrobial packaging and storage at 1 degrees C exerted a bacteriostatic effect for 60 days. All HPP lots stored at 1 degrees C led to counts <100CFU/g at day 60. Similar results were observed when combining both technologies. After a cold chain break no growth of L. monocytogenes was observed in pressurized ham packed with antimicrobial films, showing the efficiency of combining both technologies.

  17. Delaying microbial proliferation in freshly peeled shallots by active packaging incorporating ethanol vapour-controlled release sachets and low storage temperature.

    PubMed

    Utto, Weerawate; Preutikul, Rittirong; Malila, Patcharee; Noomhorm, Athapol; Bronlund, John E

    2018-03-01

    This research was conducted to investigate effects of ethanol vapour released in active packaging and storage temperatures on the quality of freshly peeled shallots. The package tested was a solid polypropylene tray incorporating an ethanol vapour-controlled release sachet. The sachet was made of an aluminium foil film on one side and either low-density polyethylene or nylon/polyethylene on the other. Individual sachets contained silica gel adsorbent as the carrier pre-loaded with ethanol. One sachet was placed in each tray containing the peeled shallots and the tray was heat sealed with the low-density polyethylene film lid. Packages were stored at either 10 or 25 ℃ for 10 d. Trays containing only peeled shallots were designated as controls. High storage temperature stimulated quality changes in the shallots. Although ethanol vapour accumulated in the active package headspace, the extent to which ethanol concentrations increased within the shallots was not significantly different from that in the control packages. Microbial proliferation in terms of yeast and mould counts could be delayed through a combination of 10 ℃ and ethanol vapour released from the low-density polyethylene sachet. The ethanol vapour accumulated in the packages did not have a significant effect on mass loss, firmness, and colour changes in the peeled shallots, or on the concentrations of oxygen and carbon dioxide in the packages.

  18. Integrating environmental management into food safety and food packaging in Malaysia: review of the food regulation 1985

    NASA Astrophysics Data System (ADS)

    Nordin, N. H.; Hara, H.; Kaida, N.

    2017-05-01

    Food safety is an important issue that is related to public safety to prevent the toxicity threats of the food. Management through legal approach has been used in Malaysia as one of the predominant approaches to manage the environment. In this regard, the Food Regulation 1985 has been one of the mechanisms of environmental management through legal approach in controlling the safety of packaged food in food packaging industry in Malaysia. The present study aims to analyse and to explain the implementation of the Food Regulation 1985 in controlling the safety of packaged food in Malaysia and to integrate the concept of environmental management into the food safety issue. Qualitative analysis on the regulation document revealed that there are two main themes, general and specific, while their seven sub themes are included harmful packages, safety packages, reuse packages, polyvinyl chloride (PVC), alcoholic bottle, toys, money and others and iron powder. The implementation of the Food Regulation 1985 in controlling the safety of packaged food should not be regarded solely for regulation purposes but should be further developed for a broader sense of food safety from overcoming the food poisoning.

  19. Concomitant surgical closure of left atrial appendage: A systematic review and meta-analysis.

    PubMed

    Ando, Masahiko; Funamoto, Masaki; Cameron, Duke E; Sundt, Thoralf M

    2018-03-12

    Although percutaneous closure of the left atrial appendage is supported as a potential alternative to lifelong anticoagulation in patients with atrial fibrillation, comprehensive evidence on surgical left atrial appendage closure in heart surgery is limited. We conducted a meta-analysis of studies comparing patients who underwent open cardiac surgery with or without left atrial appendage closure. A literature search was performed on PubMed, Embase, and Cochrane Trials databases. Outcomes of interest were 30-day/in-hospital mortality and cerebrovascular accident. I 2 statistics were used to evaluate heterogeneity, and publication bias was evaluated by Begg's and Egger's tests. We reviewed 1284 articles and selected for main analysis 7 articles including 3897 patients (1963 in the left atrial appendage closure group and 1934 in the non-left atrial appendage closure group). Among the 7 studies, 3 were randomized-controlled studies, 3 were propensity-matched studies, and 1 was a case-matching study. At 30-day/in-hospital follow-up, left atrial appendage closure was significantly associated with decreased risk of mortality and cerebrovascular accident (odds ratio, 0.384, 95% confidence interval, 0.233-0.631 for mortality, and odds ratio, 0.622, 95% confidence interval, 0.388-0.998 for cerebrovascular accident). Stratified analysis demonstrated that this association was more prominent in preoperative atrial fibrillation strata. Concomitant surgical left atrial appendage closure should be considered at the time of open cardiac surgery, particularly among those in atrial fibrillation preoperatively. The benefit of left atrial appendage closure for patients not in atrial fibrillation and for those undergoing nonvalvular surgery is still unclear. Further prospective investigations are indicated. Copyright © 2018. Published by Elsevier Inc.

  20. [The plain packaging of tobacco products: a new strategy for tobacco control].

    PubMed

    Rey-Pino, Juan Miguel; Nerín, Isabel; Lacave-García, Ma Blanca

    There is evidence that global tobacco smoking control policies contribute to decrease the prevalence of smoking among populations, so there is a need to effectively implement different measures in a coordinated way. The plain packaging and labelling of tobacco products is one of the measures proposed by the World Health Organisation Framework Convention on Tobacco Control. At the moment, leading countries are implementing this tobacco control measure, which involves a plain packaging for all tobacco products, i.e., the absence of any promotional or communication tool in the packaging, except the name of the brand, appearing with a standardised font, size, colour and placing in the pack. Australia was the first country to implement this measure in 2012 and recently other countries are legislating and approving it. In Spain, tobacco legislation (2005 and 2010), was an important advance in tobacco control policies. The introduction of plain packaging in Spain would mean the next step in the development of a global strategy for fighting this significant health problem. The aim of this article is to synthesise in a structured manner the role that the packaging of tobacco products has within marketing and communication strategies, as well as to describe the potential effects that the plain packaging has on some aspects of smoking behaviour, according to current literature. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  1. Effects of box liner perforation area on methyl bromide diffusion into table grape packages during fumigation

    USDA-ARS?s Scientific Manuscript database

    Plastic liners are used inside boxes of table grapes to retard moisture loss from the grapes and to contain sulfur dioxide gas released inside the packages to control postharvest decay. However, to control organisms of quarantine concern, regulators specify exported packages must be fumigated with m...

  2. 49 CFR 173.224 - Packaging and control and emergency temperatures for self-reactive materials.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 2 2014-10-01 2014-10-01 false Packaging and control and emergency temperatures... temperatures for self-reactive materials. (a) General. When the § 172.101 table of this subchapter specifies... packagings meeting Packing Group I are not authorized. Self-reactive materials which require temperature...

  3. 49 CFR 173.224 - Packaging and control and emergency temperatures for self-reactive materials.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Packaging and control and emergency temperatures... temperatures for self-reactive materials. (a) General. When the § 172.101 table of this subchapter specifies... packagings meeting Packing Group I are not authorized. Self-reactive materials which require temperature...

  4. 49 CFR 173.224 - Packaging and control and emergency temperatures for self-reactive materials.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 2 2011-10-01 2011-10-01 false Packaging and control and emergency temperatures... temperatures for self-reactive materials. (a) General. When the § 172.101 table of this subchapter specifies... packagings meeting Packing Group I are not authorized. Self-reactive materials which require temperature...

  5. 49 CFR 173.224 - Packaging and control and emergency temperatures for self-reactive materials.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 2 2012-10-01 2012-10-01 false Packaging and control and emergency temperatures... temperatures for self-reactive materials. (a) General. When the § 172.101 table of this subchapter specifies... packagings meeting Packing Group I are not authorized. Self-reactive materials which require temperature...

  6. 49 CFR 173.224 - Packaging and control and emergency temperatures for self-reactive materials.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 2 2013-10-01 2013-10-01 false Packaging and control and emergency temperatures... temperatures for self-reactive materials. (a) General. When the § 172.101 table of this subchapter specifies... packagings meeting Packing Group I are not authorized. Self-reactive materials which require temperature...

  7. Orthodontic Replacement of Lost Permanent Molar with Neighbor Molar: A Six-Year Follow-Up

    PubMed Central

    Shintcovsk, Ricardo Lima; Knop, Luegya Amorim Henriques; Sampaio, Luana Paz

    2017-01-01

    Extraction is very frequent indication in orthodontic planning, especially when there are crowding, biprotrusion, and aesthetically unpleasant profiles. Next to extraction comes space closure, which represents a challenge for orthodontists because of extended treatment time, discomfort created for the patient, tissue tolerance, and stability concerns. When it comes to what mechanics to choose for space closure, loops present two major advantages in relation to sliding mechanics: absence of abrasion and possibility to reach pure dental translation. A case is presented where an adult female patient with early loss of the first lower permanent molars, minor lower crowding, and tooth biprotrusion was treated with upper first bicuspids extraction along with upper and lower space closure done with T-loops to promote best space closure control in order to correct the malocclusion and enhance facial aesthetics. PMID:29318054

  8. Abbreviated closure for remote damage control laparotomy in extreme environments: A randomized trial of sutures versus wound clamps comparing terrestrial and weightless conditions.

    PubMed

    Kirkpatrick, Andrew W; McKee, Jessica Lynn; Tien, Colonel Homer; LaPorta, Anthony J; Lavell, Kit; Leslie, Tim; McBeth, Paul B; Roberts, Derek J; Ball, Chad G

    2017-05-01

    Far-Forward Damage Control Laparotomies (DCLs) might provide direct-compression of visceral hemorrhage, however, suturing is a limiting factor, especially for non-physicians. We thus compared abbreviated skin closures comparing skin-suture (SS) versus wound-clamp (WC), on-board a research aircraft in weightlessness (0g) and normal gravity (1g). Surgeons conducted DCLs on a surgical-simulator; onboard the hangered-aircraft (1g), or during parabolic flight (0g), randomized to either WC or SS. Ten surgeons participated. Two (40%) surgeons randomized to suture in 0g were incapacitated with motion-sickness, and none were able to close in either 1 or 0g. With WC, two completely closed in 1g as did three in 0g, despite having longer incisions (p = 0.016). Overall skin-closure with WC was significantly greater in both 1g (p = 0.016) and 0g (p = 0.008). WC was more effective in 1g and particularly 0g. Future studies should address the utility of abbreviated WC abdominal closure to facilitate potential Far-Forward DCL. ID ISRCTN/77929274. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. The combined effects of storage temperature and packaging on the sensory, chemical, and physical properties of a Cabernet Sauvignon wine.

    PubMed

    Hopfer, Helene; Buffon, Peter A; Ebeler, Susan E; Heymann, Hildegarde

    2013-04-03

    A Californian Cabernet Sauvignon was stored for 6 months at three different constant temperatures to study the combined effects of storage temperature and packaging configuration. Glass bottles with natural cork, synthetic cork, and screw cap closure, as well as two Bag-in-Box treatments, were used in the experiment. A trained sensory panel was able to detect significant changes in aroma, flavor, taste, mouthfeel, and color attributes among the samples, differences that were found also with various chemical and physical measurements (volatile profile, polyphenol pattern, enological parameters, color space). Additionally, two commonly used polyphenol assays were compared to each other in terms of their ability to detect the changes in the polyphenol profile. Generally, sample changes were more pronounced due to the different storage temperatures, with 30 sensory attributes differing significantly among the three different storage temperatures, while only 17 sensory attributes showed a significant packaging effect. With increasing storage temperature the packaging effect became more pronounced, resulting in the largest changes in the Bag-in-Box samples stored at the highest temperature of 40 °C. At the highest storage temperature, all wines showed oxidized characters, independent of the wine packaging configurations, but to a varying degree. Generally, wines that received highest oxygen amounts and storage temperatures were much lighter, less red, and more brown-yellow at the end of the 6-month storage period, compared to their counterparts stored at 10 °C. These changes in color and polyphenols, respectively, were also detected with the two spectrophotometric assays. With increasing storage temperature both assays measured reduced concentrations in total phenols and total anthocyanins, while total tannins, degree of ionized anthocyanins, and color density increased. Various volatile compounds differed significantly among the samples, with largest relative concentration changes in acetates, organic acids, and alcohols, in good agreement with previous literature reports, with some being well correlated to specific sensory attributes too; for example, various acetates correlated to cherry and fruit aromas and flavors. The study shows that storage at elevated temperatures could be a valuable tool for wine packaging screening and testing new and improved wine packaging types under the worst conditions, which are unfortunately not unrealistic.

  10. Advanced Manufacturing Systems in Food Processing and Packaging Industry

    NASA Astrophysics Data System (ADS)

    Shafie Sani, Mohd; Aziz, Faieza Abdul

    2013-06-01

    In this paper, several advanced manufacturing systems in food processing and packaging industry are reviewed, including: biodegradable smart packaging and Nano composites, advanced automation control system consists of fieldbus technology, distributed control system and food safety inspection features. The main purpose of current technology in food processing and packaging industry is discussed due to major concern on efficiency of the plant process, productivity, quality, as well as safety. These application were chosen because they are robust, flexible, reconfigurable, preserve the quality of the food, and efficient.

  11. Image dissector control and data system, part 1. [instrument packages and equipment specifications

    NASA Technical Reports Server (NTRS)

    1974-01-01

    A general description of the image dissector control and data system is presented along with detailed design information, operating instructions, and maintenance and trouble-shooting procedures for the four instrumentation packages. The four instrumentation packages include a 90 inch telescope, a simplified telescope module for use on the 90 inch or other telescopes, a photographic plate scanner module which permits the scanning of astronomical photographic plates in the laboratory, and the lunar experiment package module.

  12. Temperature controlled CO(2) laser welding of soft tissues: urinary bladder welding in different animal models (rats, rabbits, and cats).

    PubMed

    Lobel, B; Eyal, O; Kariv, N; Katzir, A

    2000-01-01

    Laser welding of tissues is a method of closure of surgical incisions that, in principle, may have advantages over conventional closure methods. It is a noncontact technique that introduces no foreign body, the closure is continuous and watertight, and the procedure is faster and requires less skill to master. However, in practice, there have been difficulties in obtaining strong and reliable welding. We assumed that the quality of the weld depends on the ability to monitor and control the surface temperature of the welded zone during the procedure. Our objective was to develop a "smart" fiberoptic laser system for controlled temperature welding. We have developed a welding system based on a CO(2) laser and on infrared transmitting AgClBr fibers. This fiberoptic system plays a double role: transmitting laser power for tissue heating and noncontact (radiometric) temperature monitoring and control. The "true" temperature of the heated tissue was determined by using an improved calibration method. We carried out long-studies of CO(2) laser welding of urinary bladders in various animal models. Cystotomies were performed on the animals, and complete closure of the bladder was obtained with a surface temperature of 55 +/- 5 degrees C at the welding site. In early experiments on 31 rats, the success rate was 73%. In later experiments with 10 rabbits and 3 cats, there was an 80% and a 100% success rate, respectively. The success rate in these preliminary experiments and the quality of the weld, as determined histologically, demonstrate that temperature controlled CO(2) laser welding can produce effective welding of tissues. The fiberoptic system can be adapted for endoscopic laser welding. Copyright 2000 Wiley-Liss, Inc.

  13. [WHO Framework Convention on Tobacco Control (FCTC) Article 11: packaging and labelling of tobacco products].

    PubMed

    Bekki, Kanae; Inaba, Yohei; Kunugita, Naoki

    2015-01-01

    The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) requires member countries to implement measures aimed at reducing the demand for tobacco products. FCTC article 11 describes the important forms of health communication and packaging regulations. And this article recommends on large pictorial health warnings and encourages more effective forms of disclosure on constituents and emissions. Furthermore, article 11 recognizes the importance of the package as a promotional vehicle for tobacco companies and requires the removal of potentially misleading packaging information, including the terms "light" and "mild." The Conference of the Parties (COP) adopted guidelines for implementation of article 11 on "Packaging and labelling of Tobacco Products". Some countries, such as Canada, the U.S.A., Australia, EU countries etc. positively promoted tobacco control by implementing countermeasures such as the graphic health warning labels and plain packages. These countermeasures showed the significant effects of decreasing smoking rate and preventing smoking initiation in young people. Furthermore, these warning labels were effective for the literally challenged. However, the Japanese government has not implemented these countermeasures, and only limited texts are shown on Japanese tobacco packaging. Therefore, Japan should emulate approaches taken by other countries, and promote the tobacco control policy in accordance with FCTC.

  14. Tissue adhesives for closure of surgical incisions.

    PubMed

    Dumville, Jo C; Coulthard, Paul; Worthington, Helen V; Riley, Philip; Patel, Neil; Darcey, James; Esposito, Marco; van der Elst, Maarten; van Waes, Oscar J F

    2014-11-28

    Sutures (stitches), staples and adhesive tapes have been used for many years as methods of wound closure, but tissue adhesives have entered clinical practice more recently. Closure of wounds with sutures enables the closure to be meticulous, but the sutures may show tissue reactivity and can require removal. Tissue adhesives offer the advantages of an absence of risk of needlestick injury and no requirement to remove sutures later. Initially, tissue adhesives were used primarily in emergency room settings, but this review looks at the use of tissue adhesives in the operating room/theatre where surgeons are using them increasingly for the closure of surgical skin incisions. To determine the effects of various tissue adhesives compared with conventional skin closure techniques for the closure of surgical wounds. In March 2014 for this second update we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We did not restrict the search and study selection with respect to language, date of publication or study setting. Only randomised controlled trials were eligible for inclusion. We conducted screening of eligible studies, data extraction and risk of bias assessment independently and in duplicate. We expressed results as random-effects models using mean difference for continuous outcomes and risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes. We investigated heterogeneity, including both clinical and methodological factors. This second update of the review identified 19 additional eligible trials resulting in a total of 33 studies (2793 participants) that met the inclusion criteria. There was low quality evidence that sutures were significantly better than tissue adhesives for reducing the risk of wound breakdown (dehiscence; RR 3.35; 95% CI 1.53 to 7.33; 10 trials, 736 participants that contributed data to the meta-analysis). The number needed to treat for an additional harmful outcome was calculated as 43. For all other outcomes - infection, patient and operator satisfaction and cost - there was no evidence of a difference for either sutures or tissue adhesives. No evidence of differences was found between tissue adhesives and tapes for minimising dehiscence, infection, patients' assessment of cosmetic appearance, patient satisfaction or surgeon satisfaction. However there was evidence in favour of using tape for surgeons' assessment of cosmetic appearance (mean difference (VAS 0 to 100) 9.56 (95% CI 4.74 to 14.37; 2 trials, 139 participants). One trial compared tissue adhesives with a variety of methods of wound closure and found both patients and clinicians were significantly more satisfied with the alternative closure methods than the adhesives. There appeared to be little difference in outcome for different types of tissue adhesives. One study that compared high viscosity with low viscosity adhesives found that high viscosity adhesives were less time-consuming to use than low viscosity tissue adhesives, but the time difference was small. Sutures are significantly better than tissue adhesives for minimising dehiscence. In some cases tissue adhesives may be quicker to apply than sutures. Although surgeons may consider the use of tissue adhesives as an alternative to other methods of surgical site closure in the operating theatre, they need to be aware that sutures minimise dehiscence. There is a need for more well designed randomised controlled trials comparing tissue adhesives with alternative methods of closure. These trials should include people whose health may interfere with wound healing and surgical sites of high tension.

  15. Development of a score and probability estimate for detecting angle closure based on anterior segment optical coherence tomography.

    PubMed

    Nongpiur, Monisha E; Haaland, Benjamin A; Perera, Shamira A; Friedman, David S; He, Mingguang; Sakata, Lisandro M; Baskaran, Mani; Aung, Tin

    2014-01-01

    To develop a score along with an estimated probability of disease for detecting angle closure based on anterior segment optical coherence tomography (AS OCT) imaging. Cross-sectional study. A total of 2047 subjects 50 years of age and older were recruited from a community polyclinic in Singapore. All subjects underwent standardized ocular examination including gonioscopy and imaging by AS OCT (Carl Zeiss Meditec). Customized software (Zhongshan Angle Assessment Program) was used to measure AS OCT parameters. Complete data were available for 1368 subjects. Data from the right eyes were used for analysis. A stepwise logistic regression model with Akaike information criterion was used to generate a score that then was converted to an estimated probability of the presence of gonioscopic angle closure, defined as the inability to visualize the posterior trabecular meshwork for at least 180 degrees on nonindentation gonioscopy. Of the 1368 subjects, 295 (21.6%) had gonioscopic angle closure. The angle closure score was calculated from the shifted linear combination of the AS OCT parameters. The score can be converted to an estimated probability of having angle closure using the relationship: estimated probability = e(score)/(1 + e(score)), where e is the natural exponential. The score performed well in a second independent sample of 178 angle-closure subjects and 301 normal controls, with an area under the receiver operating characteristic curve of 0.94. A score derived from a single AS OCT image, coupled with an estimated probability, provides an objective platform for detection of angle closure. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. Fuzzy based attitude controller for flexible spacecraft with on/off thrusters. M.S. Thesis - M.I.T., 1993

    NASA Technical Reports Server (NTRS)

    Knapp, Roger Glenn

    1993-01-01

    A fuzzy-based attitude controller is designed for attitude control of a generic spacecraft with on/off thrusters. The controller is comprised of packages of rules dedicated to addressing different objectives (e.g., disturbance rejection, low fuel consumption, avoiding the excitation of flexible appendages, etc.). These rule packages can be inserted or removed depending on the requirements of the particular spacecraft and are parameterized based on vehicle parameters such as inertia or operational parameters such as the maneuvering rate. Individual rule packages can be 'weighted' relative to each other to emphasize the importance of one objective relative to another. Finally, the fuzzy controller and rule packages are demonstrated using the high-fidelity Space Shuttle Interactive On-Orbit Simulator (IOS) while performing typical on-orbit operations and are subsequently compared with the existing shuttle flight control system performance.

  17. Impact of adding a second layer to a single unlocked closure of a Cesarean uterine incision: randomized controlled trial.

    PubMed

    Bennich, G; Rudnicki, M; Wilken-Jensen, C; Lousen, T; Lassen, P D; Wøjdemann, K

    2016-04-01

    To investigate short- and long-term effects on residual myometrial thickness (RMT) of adding a second layer to a single unlocked closure of a Cesarean uterine incision. This was a randomized double-blind controlled trial. Healthy nulliparous women scheduled for first-time elective Cesarean delivery were operated on using a modified version of the Misgav Ladach surgical technique. The women were examined by transabdominal ultrasound before discharge from the maternity ward and by transvaginal saline contrast sonohysterography at a minimum of 5 months postpartum. Seventy-six nulliparae met the criteria and agreed to participate in the study. Thirty-five women were assigned to the single-layer technique and 38 to the double-layer unlocked closure technique. Groups were comparable regarding gestational age at delivery, duration of surgery and perioperative blood loss. There was no difference in RMT between the two groups, both at time of discharge (mean ± SD, 20.2 ± 8.0 mm vs 21.0 ± 9.7 mm) and after 5 months postpartum (mean, 5.7 ± 2.9 mm vs 5.7 ± 2.2 mm). RMT was approximately half that of the normal myometrium at both examinations. The results of this study suggest that double-layer closure of a Cesarean uterine incision does not increase RMT compared with single-layer closure when an unlocked technique is used. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

  18. The BIG protein distinguishes the process of CO2 -induced stomatal closure from the inhibition of stomatal opening by CO2.

    PubMed

    He, Jingjing; Zhang, Ruo-Xi; Peng, Kai; Tagliavia, Cecilia; Li, Siwen; Xue, Shaowu; Liu, Amy; Hu, Honghong; Zhang, Jingbo; Hubbard, Katharine E; Held, Katrin; McAinsh, Martin R; Gray, Julie E; Kudla, Jörg; Schroeder, Julian I; Liang, Yun-Kuan; Hetherington, Alistair M

    2018-04-01

    We conducted an infrared thermal imaging-based genetic screen to identify Arabidopsis mutants displaying aberrant stomatal behavior in response to elevated concentrations of CO 2 . This approach resulted in the isolation of a novel allele of the Arabidopsis BIG locus (At3g02260) that we have called CO 2 insensitive 1 (cis1). BIG mutants are compromised in elevated CO 2 -induced stomatal closure and bicarbonate activation of S-type anion channel currents. In contrast with the wild-type, they fail to exhibit reductions in stomatal density and index when grown in elevated CO 2 . However, like the wild-type, BIG mutants display inhibition of stomatal opening when exposed to elevated CO 2 . BIG mutants also display wild-type stomatal aperture responses to the closure-inducing stimulus abscisic acid (ABA). Our results indicate that BIG is a signaling component involved in the elevated CO 2 -mediated control of stomatal development. In the control of stomatal aperture by CO 2 , BIG is only required in elevated CO 2 -induced closure and not in the inhibition of stomatal opening by this environmental signal. These data show that, at the molecular level, the CO 2 -mediated inhibition of opening and promotion of stomatal closure signaling pathways are separable and BIG represents a distinguishing element in these two CO 2 -mediated responses. © 2018 The Authors. New Phytologist © 2018 New Phytologist Trust.

  19. Design and Evaluation of an Integrated Online Motion Control Training Package

    ERIC Educational Resources Information Center

    Buiu, C.

    2009-01-01

    The aim of this paper is to present an integrated Internet-based package for teaching the fundamentals of motion control by using a wide range of resources: theory, videos, simulators, games, quizzes, and a remote lab. The package is aimed at automation technicians, pupils at vocational schools and students taking an introductory course in…

  20. Redundant electronic circuit provides fail-safe control

    NASA Technical Reports Server (NTRS)

    Archer, J. W.

    1970-01-01

    Circuit using dual control amplifiers and dual position demand potentiometers powered from separate sources is used for reliable hydraulic valve controller that prevents closure of valve when control circuits fail, and maintains valve control to close tolerance for more common modes of controller failure.

  1. Use of antimicrobial biodegradable packaging to control Listeria monocytogenes during storage of cooked ham.

    PubMed

    Marcos, Begonya; Aymerich, Teresa; Monfort, Josep M; Garriga, Margarita

    2007-11-30

    The antimicrobial effect against L. monocytogenes of biodegradable films (alginate, zein and polyvinyl alcohol) containing enterocins was investigated. Survival of the pathogen was studied by means of challenge tests performed at 6 degrees C during 8 and 29 days, for air-packed and vacuum-packed sliced cooked ham, respectively. Air packaging was tested with two concentrations of enterocins (200 and 2000 AU/cm2). Control air-packed cooked ham showed an increase of L. monocytogenes from 10(4) to 10(7) CFU/g after 8 days. By contrast, packaging with antimicrobial films effectively slowed down the pathogen's growth, leading to final counts lower than in control lots. Air-packaging with alginate films containing 2000 AU/cm2 of enterocins effectively controlled L. monocytogenes for 8 days. An increase of only 1 log unit was observed in zein and polyvinyl alcohol lots at the same enterocin concentration. Vacuum packaging with films containing enterocins (2000 AU/cm2) also delayed the growth of the pathogen. No increase from inoculated levels was observed during 15 days in antimicrobial alginate films. After 29 days of storage, the lowest counts were obtained in samples packed with zein and alginate films containing enterocins, as well as with zein control films. The most effective treatment for controlling L. monocytogenes during 6 degrees C storage was vacuum-packaging of sliced cooked ham with alginate films containing 2000 AU/cm2 of enterocins. From the results obtained it can concluded that antimicrobial packaging can improve the safety of sliced cooked ham by delaying and reducing the growth of L. monocytogenes.

  2. Modelling turbulent vertical mixing sensitivity using a 1-D version of NEMO

    NASA Astrophysics Data System (ADS)

    Reffray, G.; Bourdalle-Badie, R.; Calone, C.

    2014-08-01

    Through two numerical experiments, a 1-D vertical model called NEMO1D was used to investigate physical and numerical turbulent-mixing behaviour. The results show that all the turbulent closures tested (k + l from Blanke and Delecluse, 1993 and two equation models: Generic Lengh Scale closures from Umlauf and Burchard, 2003) are able to correctly reproduce the classical test of Kato and Phillips (1969) under favourable numerical conditions while some solutions may diverge depending on the degradation of the spatial and time discretization. The performances of turbulence models were then compared with data measured over a one-year period (mid-2010 to mid-2011) at the PAPA station, located in the North Pacific Ocean. The modelled temperature and salinity were in good agreement with the observations, with a maximum temperature error between -2 and 2 °C during the stratified period (June to October). However the results also depend on the numerical conditions. The vertical RMSE varied, for different turbulent closures, from 0.1 to 0.3 °C during the stratified period and from 0.03 to 0.15 °C during the homogeneous period. This 1-D configuration at the PAPA station (called PAPA1D) is now available in NEMO as a reference configuration including the input files and atmospheric forcing set described in this paper. Thus, all the results described can be recovered by downloading and launching PAPA1D. The configuration is described on the NEMO site (http://www.nemo-ocean.eu/Using-NEMO/Configurations/C1D_PAPA). This package is a good starting point for further investigation of vertical processes.

  3. Modelling turbulent vertical mixing sensitivity using a 1-D version of NEMO

    NASA Astrophysics Data System (ADS)

    Reffray, G.; Bourdalle-Badie, R.; Calone, C.

    2015-01-01

    Through two numerical experiments, a 1-D vertical model called NEMO1D was used to investigate physical and numerical turbulent-mixing behaviour. The results show that all the turbulent closures tested (k+l from Blanke and Delecluse, 1993, and two equation models: generic length scale closures from Umlauf and Burchard, 2003) are able to correctly reproduce the classical test of Kato and Phillips (1969) under favourable numerical conditions while some solutions may diverge depending on the degradation of the spatial and time discretization. The performances of turbulence models were then compared with data measured over a 1-year period (mid-2010 to mid-2011) at the PAPA station, located in the North Pacific Ocean. The modelled temperature and salinity were in good agreement with the observations, with a maximum temperature error between -2 and 2 °C during the stratified period (June to October). However, the results also depend on the numerical conditions. The vertical RMSE varied, for different turbulent closures, from 0.1 to 0.3 °C during the stratified period and from 0.03 to 0.15 °C during the homogeneous period. This 1-D configuration at the PAPA station (called PAPA1D) is now available in NEMO as a reference configuration including the input files and atmospheric forcing set described in this paper. Thus, all the results described can be recovered by downloading and launching PAPA1D. The configuration is described on the NEMO site (http://www.nemo-ocean.eu/Using-NEMO/Configurations/C1D_PAPA). This package is a good starting point for further investigation of vertical processes.

  4. Efficacy of stapler pharyngeal closure after total laryngectomy: A systematic review.

    PubMed

    Aires, Felipe T; Dedivitis, Rogério A; Castro, Mario Augusto F; Bernardo, Wanderley Marques; Cernea, Claudio Roberto; Brandão, Lenine Garcia

    2014-05-01

    Some primary studies compare manual and mechanical pharyngeal closures after total laryngectomy. The purpose of this study was to evaluate the advantages of the mechanical suture in pharyngeal closure. The literature survey included research in MEDLINE, EMBASE, and LILACS. The intervention analyzed was stapler-assisted pharyngeal closure, whereas the control group was manual suture pharyngeal closure. The survey resulted in 319 studies. However, 4 studies were selected (417 patients). In the group of patients in whom the stapler was used, the incidence of pharyngocutaneous fistula was 8.7%, whereas in the other, it was 22.9%, with an absolute risk reduction of 15% (95% confidence interval [CI], 0.02-0.28; p = .02; I(2) = 66%). Regarding the surgical time, the average difference was 80 minutes in favor of the stapler group (95% CI, 23.16-136.58 minutes; p < .006). The difference for starting oral feeding was 8 days in favor of the mechanical suture (95% CI, 4.01-11.73 days; p < .001). Patients who underwent mechanical suture had a shorter hospitalization period. Copyright © 2013 Wiley Periodicals, Inc.

  5. Angle closure glaucoma in congenital ectropion uvea.

    PubMed

    Wang, Grace M; Thuente, Daniel; Bohnsack, Brenda L

    2018-06-01

    Congenital ectropion uvea is a rare anomaly, which is associated with open, but dysplastic iridocorneal angles that cause childhood glaucoma. Herein, we present 3 cases of angle-closure glaucoma in children with congenital ectropion uvea. Three children were initially diagnosed with unilateral glaucoma secondary to congenital ectropion uvea at 7, 8 and 13 years of age. The three cases showed 360° of ectropion uvea and iris stromal atrophy in the affected eye. In one case, we have photographic documentation of progression to complete angle closure, which necessitated placement of a glaucoma drainage device 3 years after combined trabeculotomy and trabeculectomy. The 2 other cases, which presented as complete angle closure, also underwent glaucoma drainage device implantation. All three cases had early glaucoma drainage device encapsulation (within 4 months) and required additional surgery (cycloablation or trabeculectomy). Congenital ectropion uvea can be associated with angle-closure glaucoma, and placement of glaucoma drainage devices in all 3 of our cases showed early failure due to plate encapsulation. Glaucoma in congenital ectropion uvea requires attention to angle configuration and often requires multiple surgeries to obtain intraocular pressure control.

  6. [New technology for prevention of embolic events in atrial fibrillation: a systematic review on percutaneous endovascular left atrial appendage closure].

    PubMed

    Danna, Paolo; Sagone, Antonio; Proietti, Riccardo; Arensi, Andrea; Viecca, Maurizio; Santangeli, Pasquale; Di Biase, Luigi; Natale, Andrea

    2012-09-01

    Atrial fibrillation (AF) is the most common cardiac arrhythmia. The mortality rate of patients with AF is doubled as compared to non-fibrillating controls. The most relevant complication of AF is a major increase in the risk of stroke. The gold standard in reducing cerebrovascular events in AF is warfarin therapy, which is not free from contraindications and limitations. The left atrial appendage (LAA) is the main source of emboli causing stroke in AF. LAA closure is a seducing approach to stroke risk reduction in AF without anticoagulation. Since 1949, heart surgeons have performed LAA closure or amputation in patients with AF. Percutaneous endovascular LAA closure is a new, less invasive, technique to reach the goal. Several devices have been used to perform this intervention, and the results of published trials are encouraging in terms of effectiveness and relative safety of this attractive technique. In this review we examine the published trials and data on percutaneous LAA closure, with particular attention to the risks and benefits of this procedure.

  7. Humid site stabilization and closure

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Cutshall, N.H.

    1981-01-01

    The purpose of the work described here is to identify and evaluate the importance of factors that are expected to dictate the nature of site stabilization and closure requirements. Subsequent efforts will plan for implementation of such requirements. Two principal areas of site stabilization and closure effort will be pursued initially - geological management and vegetation management. The geological effort will focus on chemical weathering and surficial erosion. Such catastrophic geologic events as landslides, flooding, earthquakes, volcanos, etc. are already considered in site selection and operation and these factors will not be emphasized initially. Vegetation management will be designed tomore » control erosion, to minimize nuclide mobilization by roots and to be compatible with natural successional pressures. It is anticipated that the results of this work will be important both to site selection and operation as well as the actual stabilization and closure procedure.« less

  8. An evaluation of the effectiveness of FreshCase technology to extend the storage life of whole-muscle pork and ground pork sausage.

    PubMed

    Yang, X; Woerner, D R; McCullough, K R; Hasty, J D; Geornaras, I; Smith, G C; Sofos, J N; Belk, K E

    2016-11-01

    The objective of this study was to identify the maximum time of refrigerated storage before aerobic psychrotrophic bacteria grew to a level indicative of spoilage (7 log cfu/g) or other indicators of spoilage were observed for whole-muscle pork and ground pork sausage packaged using FreshCase technology. Pork chops and pork sausage were packaged using conventional vacuum packaging without nitrite in film (Control) or using FreshCase technology and were compared with respect to microbial counts, pH, instrumental color measurements, lipid oxidation level, and sensory properties. The storage life was 45 d for pork chops stored in FreshCase packages at 1°C and 19 d for ground pork sausage stored under the same condition. Results indicated that both pork chops and sausage stored in FreshCase packages retained redder color ( < 0.05) than those stored in Control packages. No differences ( > 0.05) existed between Control and FreshCase packaged samples for any off-odor detection for either pork chops or sausage. Moreover, levels of oxidative rancidity in all packages had low thiobarbituric acid reactive substances values. The results indicated that FreshCase technology can be used to extend storage life of pork products without having adverse effects on pork quality.

  9. RANS Simulation (Actuator Disk Model[ADM]) of the NREL Phase VI wind turbine modeled as MHK Turbine

    DOE Data Explorer

    Javaherchi, Teymour

    2016-06-08

    Attached are the .cas and .dat files for the Reynolds Averaged Navier-Stokes (RANS) simulation of a single lab-scaled DOE RM1 turbine implemented in ANSYS FLUENT CFD-package. In this case study the flow field around and in the wake of the NREL Phase VI wind turbine, modeled is MHK turbine, is simulated using Actuator Disk Model (a.k.a Porous Media) by solving RANS equations coupled with a turbulence closure model. It should be highlighted that in this simulation the actual geometry of the rotor blade is not modeled. The effect of turbine rotating blades are modeled using the Actuator Disk Theory (see the stated section of attached M.Sc. thesis for more details).

  10. Near-memory data reorganization engine

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gokhale, Maya; Lloyd, G. Scott

    A memory subsystem package is provided that has processing logic for data reorganization within the memory subsystem package. The processing logic is adapted to reorganize data stored within the memory subsystem package. In some embodiments, the memory subsystem package includes memory units, a memory interconnect, and a data reorganization engine ("DRE"). The data reorganization engine includes a stream interconnect and DRE units including a control processor and a load-store unit. The control processor is adapted to execute instructions to control a data reorganization. The load-store unit is adapted to process data move commands received from the control processor via themore » stream interconnect for loading data from a load memory address of a memory unit and storing data to a store memory address of a memory unit.« less

  11. Options for reducing food waste by quality-controlled logistics using intelligent packaging along the supply chain.

    PubMed

    Heising, Jenneke K; Claassen, G D H; Dekker, Matthijs

    2017-10-01

    Optimising supply chain management can help to reduce food waste. This paper describes how intelligent packaging can be used to reduce food waste when used in supply chain management based on quality-controlled logistics (QCL). Intelligent packaging senses compounds in the package that correlate with the critical quality attribute of a food product. The information on the quality of each individual packaged food item that is provided by the intelligent packaging can be used for QCL. In a conceptual approach it is explained that monitoring food quality by intelligent packaging sensors makes it possible to obtain information about the variation in the quality of foods and to use a dynamic expiration date (IP-DED) on a food package. The conceptual approach is supported by quantitative data from simulations on the effect of using the information of intelligent packaging in supply chain management with the goal to reduce food waste. This simulation shows that by using the information on the quality of products that is provided by intelligent packaging, QCL can substantially reduce food waste. When QCL is combined with dynamic pricing based on the predicted expiry dates, a further waste reduction is envisaged.

  12. 21 CFR 820.130 - Device packaging.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device packaging. 820.130 Section 820.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer...

  13. Snap-lock bags with red band: A study of manufacturing characteristics, thermal and chemical properties.

    PubMed

    Sim, Yvonne Hui Ying; Koh, Alaric C W; Lim, Shing Min; Yew, Sok Yee

    2015-10-01

    Drug packaging is commonly submitted to the Forensic Chemistry and Physics Laboratory of the Health Sciences Authority, Singapore, for examination. The drugs seized are often packaged in plastic bags. These bags are examined for linkages to provide law enforcement with useful associations between the traffickers and drug abusers. The plastic bags submitted may include snap-lock bags, some with a red band located above the snap-lock closure and some without. Current techniques for examination involve looking at the physical characteristics (dimensions, thickness and polarising patterns) and manufacturing marks of these bags. In cases where manufacturing marks on the main body of the bags are poor or absent, the manufacturing characteristics present on the red band can be examined. A study involving approximately 1000 bags was conducted to better understand the variations in the manufacturing characteristics of the red band. This understanding is crucial in helping to determine associations/eliminations between bags. Two instrumental techniques, namely differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FT-IR) were explored to evaluate the effectiveness of examining the chemical composition to discriminate the bags. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  14. Streamlined Approach for Environmental Restoration Plan for Corrective Action Unit 574: Neptune, Nevada National Security Site, Nevada

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NSTec Environmental Restoration

    2011-08-31

    This Streamlined Approach for Environmental Restoration (SAFER) Plan identifies the activities required for closure of Corrective Action Unit (CAU) 574, Neptune. CAU 574 is included in the Federal Facility Agreement and Consent Order (FFACO) (1996 [as amended March 2010]) and consists of the following two Corrective Action Sites (CASs) located in Area 12 of the Nevada National Security Site: (1) CAS 12-23-10, U12c.03 Crater (Neptune); (2) CAS 12-45-01, U12e.05 Crater (Blanca). This plan provides the methodology for the field activities that will be performed to gather the necessary information for closure of the two CASs. There is sufficient information andmore » process knowledge regarding the expected nature and extent of potential contaminants to recommend closure of CAU 574 using the SAFER process. Based on historical documentation, personnel interviews, site process knowledge, site visits, photographs, field screening, analytical results, the results of the data quality objective (DQO) process (Section 3.0), and an evaluation of corrective action alternatives (Appendix B), closure in place with administrative controls is the expected closure strategy for CAU 574. Additional information will be obtained by conducting a field investigation to verify and support the expected closure strategy and provide a defensible recommendation that no further corrective action is necessary. This will be presented in a Closure Report that will be prepared and submitted to the Nevada Division of Environmental Protection (NDEP) for review and approval.« less

  15. [Percutaneous closure of atrial septal defects with the Amplatzer® device: 15 years of experience].

    PubMed

    Zabal-Cerdeira, Carlos; García-Montes, José Antonio; Sandoval-Jones, Juan Pablo; Calderón-Colmenero, Juan; Patiño-Bahena, Emilia; Juanico-Enríquez, Antonio; Buendía-Hernández, Alfonso

    2014-01-01

    Percutaneous closure of atrial septal defects is an alternative to surgical treatment. We report the results of percutaneous closure of atrial septal defects with the Amplatzer(®) device. We include patients taken to the catheterization laboratory from September 1997 to December 2011. We proceeded with defect closure in 721 patients and in 85 the defect was considered not suitable for closure. The stretched diameter of the defect was 23±6.7mm (limits, 5-42). All devices were positioned successfully. In 15 cases (2.1%) the device was changed due to instability and in 6 (0.8%) the device embolized within the first 24h, 4 were retrieved and repositioned (final success with intention to treat 719/806-89.2%). Immediate control showed complete closure in 247 patients (34.3%), leak through the device in 395 (54.9%), mild residual leak in 75 (10.4%) and moderate in 2 (0.3%). We have follow-up in 626 patients (87.1%) for 33±27.5 months, with headache in 54 (8.6%), new supraventricular arrhythmia in 10 (1.6%), puncture site complications in 4 (0.6%), and stroke in one (0.1%). The design of the Amplatzer(®) device allows effective closure of atrial septal defects with a simple technique and patient safety. Copyright © 2013 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

  16. Comparison of V-Loc™ 180 wound closure device and Quill™ PDO knotless tissue-closure device for intradermal closure in a porcine in vivo model: evaluation of biomechanical wound strength.

    PubMed

    Gingras, Kristen; Zaruby, Jeffrey; Maul, Don

    2012-05-01

    The objective of this study was to compare the biomechanical strength of two barbed suture devices: V-Loc™ 180 Wound Closure Device and Quill™ PDO Knotless Tissue-Closure Device following primary cosmetic skin closures in a porcine dermal model. This prospective randomized, controlled in vivo trial compared size 3/0 V-Loc™ 180 device to size 2/0 Quill™ PDO device. Both products were tested for dermal closure in adult porcine models and evaluated at five timepoints. At postoperative days 0, 3, 7, 14, and 28 sutured tissue regions were excised post mortem and tested for intradermal wound holding strength. Wounds closed with V-Loc™ 180 device were stronger than Quill™ PDO device at days 0, 3, 7, and 14 with these differences being significant (p < 0.05) at days 3 and 7. At day 3, the average maximum load of V-Loc™ 180 was 13.53 kgf and Quill™ PDO was 10.38 kgf (p = 0.002). At day 7, the average maximum load of V-Loc™ 180 was 10.4 kgf and Quill™ PDO was 7.56 kgf (p = 0.001). Throughout the duration of the study, there was no suture extrusion or tissue distortion and all wounds healed with no major complications. In this study, V-Loc™ 180 device was significantly stronger than Quill™ PDO device during the critical phases of wound healing in skin. Copyright © 2012 Wiley Periodicals, Inc.

  17. Stress-induced, time-dependent fracture closure at hydrothermal conditions

    USGS Publications Warehouse

    Beeler, N.M.; Hickman, S.H.

    2004-01-01

    Time-dependent closure of fractures in quartz was measured in situ at 22-530??C temperature and 0.1-150 MPa water pressure. Unlike previous crack healing and rock permeability studies, in this study, fracture aperture is monitored directly and continuously using a windowed pressure vessel, a long-working-distance microscope, and reflected-light interferometry. Thus the fracture volume and geometry can be measured as a function of time, temperature, and water pressure. Relatively uniform closure occurs rapidly at temperatures and pressures where quartz becomes significantly soluble in water. During closure the aperture is reduced by as much as 80% in a few hours. We infer that this closure results from the dissolution of small particles or asperities that prop the fracture open. The driving force for closure via dissolution of the prop is the sum of three chemical potential terms: (1) the dissolution potential, proportional to the logarithm of the degree of undersaturation of the solution; (2) the coarsening potential, proportional to the radius of curvature of the prop; and (3) the pressure solution potential, proportional to the effective normal stress at the contact between propping particles and the fracture wall. Our observations suggest that closure is controlled by a pressure solution-like process. The aperture of dilatant fractures and microcracks in the Earth that are similar to those in our experiments, such as ones generated from thermal stressing or brittle failure during earthquake rupture and slip, will decrease rapidly with time, especially if the macroscopic stress is nonhydrostatic.

  18. Stress-induced, time-dependent fracture closure at hydrothermal conditions

    NASA Astrophysics Data System (ADS)

    Beeler, N. M.; Hickman, S. H.

    2004-02-01

    Time-dependent closure of fractures in quartz was measured in situ at 22-530°C temperature and 0.1-150 MPa water pressure. Unlike previous crack healing and rock permeability studies, in this study, fracture aperture is monitored directly and continuously using a windowed pressure vessel, a long-working-distance microscope, and reflected-light interferometry. Thus the fracture volume and geometry can be measured as a function of time, temperature, and water pressure. Relatively uniform closure occurs rapidly at temperatures and pressures where quartz becomes significantly soluble in water. During closure the aperture is reduced by as much as 80% in a few hours. We infer that this closure results from the dissolution of small particles or asperities that prop the fracture open. The driving force for closure via dissolution of the prop is the sum of three chemical potential terms: (1) the dissolution potential, proportional to the logarithm of the degree of undersaturation of the solution; (2) the coarsening potential, proportional to the radius of curvature of the prop; and (3) the pressure solution potential, proportional to the effective normal stress at the contact between propping particles and the fracture wall. Our observations suggest that closure is controlled by a pressure solution-like process. The aperture of dilatant fractures and microcracks in the Earth that are similar to those in our experiments, such as ones generated from thermal stressing or brittle failure during earthquake rupture and slip, will decrease rapidly with time, especially if the macroscopic stress is nonhydrostatic.

  19. Leak testing in parenteral packaging: establishment of direct correlation between helium leak rate measurements and microbial ingress for two different leak types.

    PubMed

    Morrical, Bradley D; Goverde, Marcel; Grausse, Jean; Gerwig, Tanja; Vorgrimler, Lothar; Morgen, Rachel; Büttiker, Jean-Pierre

    2007-01-01

    A direct test method using helium leak detection was developed to determine microbial ingress in parenteral vial/rubber closure systems. The purpose of this study was to establish a direct correlation between the helium leak rate and the presence of ingress when vials were submersed under pressure in a broth of bacteria. Results were obtained for two different types of leaks: microholes that have been laser-drilled into thin metal plates, and thin copper wire that was placed between the rubber closure and the glass vial's sealing surface. The results from the microholes showed that the helium leak rate was a function of the square of the hole diameter and fit well with theoretical calculations. The relationship with the wire gave a far more complex dependence and was not modeled theoretically. Comparison with the microbial challenge showed that for microholes a lower size limit was found to be 2 microm with a corresponding leak rate of 1.4 x 10(-3) mbarl/s. For the fine wire experiment the lower limit was 15-microm wire and a corresponding leak rate of 1.3 x 10(-5) mbarl/s. From these tests a safe, lower limit, leak rate was established.

  20. DISPOSITION PATHS FOR ROCKY FLATS GLOVEBOXES: EVALUATING OPTIONS

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lobdell, D.; Geimer, R.; Larsen, P.

    2003-02-27

    The Kaiser-Hill Company, LLC has the responsibility for closure activities at the Rocky Flats Environmental Technology Site (RFETS). One of the challenges faced for closure is the disposition of radiologically contaminated gloveboxes. Evaluation of the disposition options for gloveboxes included a detailed analysis of available treatment capabilities, disposal facilities, and lifecycle costs. The Kaiser-Hill Company, LLC followed several processes in determining how the gloveboxes would be managed for disposition. Currently, multiple disposition paths have been chosen to accommodate the needs of the varying styles and conditions of the gloveboxes, meet the needs of the decommissioning team, and to best managemore » lifecycle costs. Several challenges associated with developing a disposition path that addresses both the radiological and RCRA concerns as well as offering the most cost-effective solution were encountered. These challenges included meeting the radiological waste acceptance criteria of available disposal facilities, making a RCRA determination, evaluating treatment options and costs, addressing void requirements associated with disposal, and identifying packaging and transportation options. The varying disposal facility requirements affected disposition choices. Facility conditions that impacted decisions included radiological and chemical waste acceptance criteria, physical requirements, and measurement for payment options. The facility requirements also impacted onsite activities including management strategies, decontamination activities, and life-cycle cost.« less

  1. Development and testing of the Junkeeper Control Corporation integrated programmable electronic controller and hydronics package

    NASA Technical Reports Server (NTRS)

    Hankins, J. D.

    1979-01-01

    Additional developmental work on the existing programmable electronic controller and hydronic package for use with solar heating and cooling systems is summarized. The controller/hydronics subsystems passed all acceptance tests and performance criteria. The subsystems were shown marketable for public use.

  2. Palate dimensions in six-year-old children with unilateral cleft lip and palate: a six-center study on dental casts.

    PubMed

    Koželj, Vesna; Vegnuti, Miljana; Drevenšek, Martina; Hortis-Dzierzbicka, Maria; Gonzalez-Landa, Gonzalo; Hanstein, Siiri; Klimova, Irena; Kobus, Kazimierz; Kobus-Zaleśna, Katarzyna; Semb, Gunvor; Shaw, Bill

    2012-11-01

    To compare palatal dimensions in 6-year-old children with unilateral cleft lip and palate (UCLP) treated by different protocols with those of noncleft children. Retrospective intercenter outcome study. Patients : Upper dental casts from 129 children with repaired UCLP and 30 controls were analyzed by the trigonometric method. Six European cleft centers. Main outcome measures : Sagittal, transverse, and vertical dimensions of the palate were observed. Palate variables were analyzed with descriptive methods and nonparametric tests. Regarding several various characteristics measured on a relatively small number of subjects, hierarchical, k-means clustering, and principal component analyses were used. Mean values of the observed dimensions for five cleft groups differed significantly from the control (p < .05). The group with one-stage closure of the cleft differed significantly from all other cleft groups in most variables (p < .05). Principal component analysis of all 159 cases identified three clusters with specific morphologic characteristics of the palate. A similar number of treated children were classified into each cluster, while all children without clefts were classified in the same cluster. The percentage of treated children from a particular group that fit this cluster ranged from 0% to 70% and increased with age at palatal closure and number of primary surgical procedures. At 6 years of age, children with stepwise repair and hard palate closure after the age of two more frequently result in palatal dimensions of noncleft control than children with earlier palatal closure and one-stage cleft repair.

  3. Design of Control System for Flexible Packaging Bags Palletizing Production Line Based on PLC

    NASA Astrophysics Data System (ADS)

    Zheng, Huiping; Chen, Lin; Zhao, Xiaoming; Liu, Zhanyang

    Flexible packaging bags palletizing production line is to put the bags in the required area according to particular order and size, in order to finish handling, storage, loading and unloading, transportation and other logistics work of goods. Flexible packaging bags palletizing line is composed of turning bags mechanism, shaping mechanism, indexing mechanism, marshalling mechanism, pushing bags mechanism, pressing bags mechanism, laminating mechanism, elevator, tray warehouse, tray conveyor and loaded tray conveyor. Whether the whole production line can smoothly run depends on each of the above equipment and precision control among them. In this paper the technological process and the control logic of flexible packaging bags palletizing production line is introduced. Palletizing process of the production line realized automation by means of a control system based on programmable logic controller (PLC). It has the advantages of simple structure, reliable and easy maintenance etc.

  4. Tissue adhesives for closure of surgical incisions.

    PubMed

    Coulthard, P; Worthington, H; Esposito, M; Elst, M; Waes, O J F

    2004-01-01

    Sutures, staples and adhesive tapes are the traditional methods of wound closure, whilst tissue adhesives have entered clinical practice more recently. Closure of wounds with sutures enables meticulous closure, but sutures may induce tissue reactivity and they usually require removal. Tissue adhesives offer the advantages there are no sutures to remove later for the patient and no risk of needlestick injury to the surgeon. Tissue adhesives have been used primarily in emergency rooms but this review looks at the use of tissue adhesives in the operating room where surgeons are increasingly using these for the closure of surgical skin incisions. To determine the relative effects of various tissue adhesives and conventional skin closure techniques on the healing of surgical wounds. The Cochrane Wounds Group Specialised Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE were searched. Bibliographies of review articles were checked for studies outside the handsearched journals and wound care product manufacturers were contacted. Randomised controlled clinical trials only. Screening of eligible studies and data extraction was conducted independently and in triplicate whilst assessment of the methodological quality of the trials was conducted independently and in duplicate. Results were expressed as random effect models using weighted mean differences for continuous outcomes and relative risk with 95% confidence intervals for dichotomous outcomes. Heterogeneity was investigated including both clinical and methodological factors. Eight RCTs were included (630 patients). No statistically significant differences were found between various tissue adhesives and sutures (8 trials) for dehiscence, infection, satisfaction with cosmetic appearance when assessed by patients' or surgeons' general satisfaction. Nor were differences found between a tissue adhesive and tapes (2 trials) for infection, patients' assessment of cosmetic appearance, patient satisfaction or surgeon satisfaction. However a statistically significant difference was found for surgeons' assessment of cosmetic appearance with mean difference 13 (95%CI 5 to 21), the higher mean rating for the tissue adhesive group. Surgeons may consider the use of tissue adhesives as an alternative to sutures or adhesive tape for the closure of incisions in the operating room. There is a need for trials in all areas but in particular to include patients that require incision closure in areas of high tension and patients of general health that may impair wound healing.

  5. 10 CFR 71.91 - Records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... licensed material in each package, and the total quantity of each shipment; (5) For each item of irradiated... the shipment; (7) For fissile packages and for Type B packages, any special controls exercised; (8... determinations required by § 71.87 and by the conditions of the package approval. (b) Each certificate holder...

  6. 10 CFR 71.91 - Records.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... licensed material in each package, and the total quantity of each shipment; (5) For each item of irradiated... the shipment; (7) For fissile packages and for Type B packages, any special controls exercised; (8... determinations required by § 71.87 and by the conditions of the package approval. (b) Each certificate holder...

  7. 10 CFR 71.91 - Records.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... licensed material in each package, and the total quantity of each shipment; (5) For each item of irradiated... the shipment; (7) For fissile packages and for Type B packages, any special controls exercised; (8... determinations required by § 71.87 and by the conditions of the package approval. (b) Each certificate holder...

  8. 10 CFR 71.91 - Records.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... licensed material in each package, and the total quantity of each shipment; (5) For each item of irradiated... the shipment; (7) For fissile packages and for Type B packages, any special controls exercised; (8... determinations required by § 71.87 and by the conditions of the package approval. (b) Each certificate holder...

  9. Pore formation and pore closure in poly(D,L-lactide-co-glycolide) films.

    PubMed

    Fredenberg, Susanne; Wahlgren, Marie; Reslow, Mats; Axelsson, Anders

    2011-03-10

    Pore formation and pore closure in poly(D,L-lactide-co-glycolide)-based drug delivery systems are two important processes as they control the release of the encapsulated drug. The phenomenon pore closure was investigated by studying the effects of the pH and the temperature of the release medium, and the properties of the polymer. Poly(D,L-lactide-co-glycolide) (PLG) films were subjected to a pore forming pre-treatment, and then pore closure was observed simultaneously with changes in glass transition temperature, wettability (contact angle), water absorption and mass remaining. To further understand the effect of pH, combined pore formation and pore closure were studied at different pH values. Pore closure was increased in a release medium with low pH, with a low-molecular-weight PLG of relatively low degree of hydrophobicity, or at high temperature. Pore closure occurred by two different mechanisms, one based on polymer-polymer interactions and one on polymer-water interactions. The mobility of the PLG chains also played an important role. The surface of the PLG films were more porous at pH 5-6 than at lower or higher pH, as pore formation was relatively fast and pore closure were less pronounced in this pH range. The pH had a significant impact on the porous structure, which should be kept in mind when evaluating experimental results, as the pH may be significantly decreased in vitro, in vivo and in situ. The results also show that the initial porosity is very important when using a high-molecular-weight PLG. Copyright © 2010 Elsevier B.V. All rights reserved.

  10. Association of iris crypts with acute primary angle closure.

    PubMed

    Koh, Victor; Chua, Jacqueline; Shi, Yuan; Thakku, Sri Gowtham; Lee, Ryan; Nongpiur, Monisha E; Baskaran, Mani; Kumar, Rajesh S; Perera, Shamira; Aung, Tin; Cheng, Ching-Yu

    2017-10-01

    To determine the relationship between iris surface features and acute primary angle closure (APAC) in eyes with angle closure. Case-control study involving Asian patients diagnosed with previous APAC, primary angle closure suspect (PACS), primary angle closure (PAC) and primary angle closure glaucoma (PACG) at an eye centre in Singapore between August 2012 and January 2015. Participants underwent ophthalmic examination and digital slit-lamp iris photography. Iris surface features were graded based on crypts, furrows and colour. Fellow eyes of APAC were compared with PACS and PAC/PACG eyes with regard to their iris surface features. Occurrence of APAC. A total of 309 patients (71 APAC, 139 PACS, 47 PAC and 52 PACG) were included (mean age: 67.7±7.2 years and 36.6% male). Compared with PACS, higher crypt grade was significantly associated with lower odds of APAC (OR=0.58 for one grade higher in crypt grade; p=0.027, adjusted for age, gender, ethnicity and pupil diameter). The results remained similar when compared with PAC/PACG group (OR=0.58 for one grade higher in crypt grade; p=0.043). We did not observe any significant associations between iris furrows or colour with presence of APAC. Our study comprising Asian eyes with angle closure suggests that the presence of a higher crypt grading may be protective for APAC. As such, assessing iris surface architecture for crypts could be a new measure for risk stratification of developing APAC in eyes with angle closure. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  11. Prospective experimental study of transrectal viscerotomy closure using transanal endoscopic suture vs. circular stapler: a step toward NOTES.

    PubMed

    Diana, M; Leroy, J; Wall, J; De Ruijter, V; Lindner, V; Dhumane, P; Mutter, D; Marescaux, J

    2012-06-01

    Endoluminal full-thickness closure of the rectal wall is critical in emerging procedures including endoscopic submucosal dissection and transrectal natural orifice transluminal endoscopic surgery (NOTES). This study aimed to compare manual suture using the transanal endoscopic operation platform (TEO; Karl Storz, Tüttlingen, Germany) with the end-to-end anastomosis hemorrhoid circular stapler (EEA; Covidien, Dublin, Ireland) for closure of the rectal viscerotomy during transrectal NOTES segmental colectomy. A total of 12 swine underwent transrectal hybrid NOTES partial colectomies. Animals were divided into two groups according to the viscerotomy closure technique: 1) TEO manual suture; 2) EEA circular stapler closure. Mean (± SD) viscerotomy closure time was 67.5 ± 59.5 minutes and 31.5 ± 19.6 minutes for TEO and EEA, respectively. There was one conversion to laparoscopy in the TEO group and a misfiring in the EEA group that required a TEO salvage suture. There was one positive air-leak test in each group. Peritoneal fluid collected at the end of the procedure tested positive for bacterial contamination in all cases. A mild stenosis was present in 4 /6 viscerotomies (67 %) in the TEO group and in 1/6 (17 %) in the EEA group on endoscopic control. Inflammatory changes were mild in 3/5 (60 %) and 4/5 (80 %) viscerotomies in the TEO and EEA groups, respectively, whereas severe inflammation was found in 2/5 (TEO) and 1 /5 (EEA). Transrectal viscerotomy closure using the EEA circular stapler technique is feasible, easy to perform, and histologically comparable to suture closure through a TEO platform. It may offer an attractive alternative for NOTES segmental colectomies and endoscopic resections. © Georg Thieme Verlag KG Stuttgart · New York.

  12. [Clinical epidemiological study of neural tube defects classified according to the five sites of closure].

    PubMed

    Sanchis Calvo, A; Martínez- Frías, M

    2001-02-01

    To identify the frequency at birth of neural tube defects (NTD) in the Spanish population. NTDs were considered as a whole as well as according to the different sites of closure failure, following the theory of multisite closure of the neural tube. To analyze the epidemiological characteristics of the different sites. Data derived from the Spanish Collaborative Study of Congenital Malformations (ECEMC), from April 1976 to March 1995. Among the 1,222,698 live births during this period, 784 infants had NTD were controlled. Among these, 784 infants had NTD. The prevalence of NTD in our population was 1.01 per 1,000 births, a frequency which is considered medium-to low. Only 5.74% of the NTD were of known etiology: 2.17% were genic, 1.27% were chromosomic and 2.29% were environmental. Excluding NTD of genetic etiology, whether genic or chromosomic, most of the remaining were isolated defects (multifactorial) and 16.78% multiple malformations. Site 1, where the closure of the neural tube starts, represented 24% of all the affected sites. However, more than 50% of the NTDs corresponded to closure failure at the junction of two sites. As in other populations with a low prevalence of NTD at birth, the prevalence of these defects in our population showed a trend to decrease with time, due to the possibility of interrupting gestation after prenatal diagnosis. All the NTD could be classified according to the theory of multisite closure of the neural tube, including 13 cases with several noncontiguous affected sites. Two types of NTD were observed: in the first, closure failed to occur and in the second, two closures failed to meet.

  13. Package architecture and component design for an implanted neural stimulator with closed loop control.

    PubMed

    Bjune, Caroline K; Marinis, Thomas F; Brady, Jeanne M; Moran, James; Wheeler, Jesse; Sriram, Tirunelveli S; Parks, Philip D; Widge, Alik S; Dougherty, Darin D; Eskandar, Emad N

    2015-08-01

    An implanted neural stimulator with closed loop control requires electrodes for stimulation pulses and recording neuron activity. Our system features arrays of 64 electrodes. Each electrode can be addressed through a cross bar switch, to enable it to be used for stimulation or recording. This electrode switch, a bank of low noise amplifiers with an integrated analog to digital converter, power conditioning electronics, and a communications and control gate array are co-located with the electrode array in a 14 millimeter diameter satellite package that is designed to be flush mounted in a skull burr hole. Our system features five satellite packages connected to a central hub processor-controller via ten conductor cables that terminate in a custom designed, miniaturized connector. The connector incorporates features of high reliability, military grade devices and utilizes three distinct seals to isolate the contacts from fluid permeation. The hub system is comprised of a connector header, hermetic electronics package, and rechargeable battery pack, which are mounted on and electrically interconnected by a flexible circuit board. The assembly is over molded with a compliant silicone rubber. The electronics package contains two antennas, a large coil, used for recharging the battery and a high bandwidth antenna that is used to download data and update software. The package is assembled from two machined alumina pieces, a flat base with brazed in, electrical feed through pins and a rectangular cover with rounded corners. Titanium seal rings are brazed onto these two pieces so that they can be sealed by laser welding. A third system antenna is incorporated in the flexible circuit board. It is used to communicate with an externally worn control package, which monitors the health of the system and allows both the user and clinician to control or modify various system function parameters.

  14. [Migraine and cadiac shunts - is there a link?].

    PubMed

    Riederer, Franz

    2012-10-17

    Recently an association between migraine and cardiac shunts (e.g. through a patent foramen ovale, PFO) has been described. There is evidence from mostly retrospective case series that PFO closure can significantly improve migraine. On the other hand an increase in attack frequency or de novo migraine after percutaneous closure of an atrial septal defect has been described. Animal experiments showed that microemboli in the cerebral circulation can trigger a cortical spreading depression, which is believed the pathophysiological substrate of migraine aura. A randomized controlled trial that investigated PFO closure for treatment resistant migraine with aura was negative. It is currently discussed whether certain subgroups, who have a high risk for paradoxical embolism, might improve after PFO closer.

  15. Use of computer modeling to investigate a dynamic interaction problem in the Skylab TACS quad-valve package

    NASA Technical Reports Server (NTRS)

    Hesser, R. J.; Gershman, R.

    1975-01-01

    A valve opening-response problem encountered during development of a control valve for the Skylab thruster attitude control system (TACS) is described. The problem involved effects of dynamic interaction among valves in the quad-redundant valve package. Also described is a detailed computer simulation of the quad-valve package which was helpful in resolving the problem.

  16. 2005 Defense Base Closure and Realignment Commission Report. Volume 1

    DTIC Science & Technology

    2005-01-01

    and Beale, and 15 A-10 aircraft realigned by the recommended closures of W.K. Kellogg Airport Air Guard Station, MI, and NAS Willow Grove, PA...functions of the Missile Defense Agency, except the Command and Control Battle Management and Communications Directorate, to Redstone Arsenal, AL... of other ships in the battle group. Systems are functionally integrated and not 287 separable as independent components. Furthermore, based on BRAC

  17. Defense Base Realignment and Closure Budget Data for MCGuire Air Force Base, New Jersey

    DTIC Science & Technology

    1995-08-04

    The overall audit objective was to determine the accuracy of Defense base realignment and closure military construction budget data. This report provides the results of the audit of two projects, valued at $22.4 miilion, for the realignment of McGuire Air Force Base, New Jersey. The audit also assessed the adequacy of the management control program as it applied to the overall audit objective.

  18. The effect of packaging methods (paper, active paper, and edible coating) on the characteristic of papaya MJ9 in ambient temperature storage

    NASA Astrophysics Data System (ADS)

    Suwanti, D.; Utami, R.; Kawiji; Praseptiangga, D.; Khasanah, L. U.

    2018-01-01

    Papaya is one of the export commodities that contain high vitamin C but having short shelf-life. One method that use to extend the shelf-life and maintain the quality of papaya is packaging. The aim of this study was to investigate the effect of the packaging methods (paper, active paper and edible coating) on the characteristics of papaya MJ9 (weight loss, firmness, total soluble solid (TSS), Total Titratable Acid (TTA), pH, vitamin C and total mold and yeast). The packaging methods were control (F1), wrapping paper (F2), wrapping active paper (F3), combination of edible coating and wrapping paper (F4), and combination of edible coating and wrapping active paper (F5). The result showed that paper packaging, edible coating and active paper packaging significantly affected the weight loss, firmness, total soluble solid, total titratable acids, pH, vitamin C, and total mold and yeast of papaya. The weight loss, total soluble solid and pH of packaged papaya was lower than that of control sample, however, the value of firmness and total titratable acid was higher than that of the control sample. Packaging can inhibit the increase of weight loss, total soluble solids and pH, and the decrease of firmness, total titratable acid, vitamin C and total mold and yeast. Based on the papaya characteristics, the selected packaging method was the combination of edible coating and wrapping active paper.

  19. Efficacy of elastic memory chains versus nickel-titanium coil springs in canine retraction: A two-center split-mouth randomized clinical trial.

    PubMed

    Khanemasjedi, Mashallah; Moradinejad, Mehrnaz; Javidi, Pedram; Niknam, Ozra; Jahromi, Nima Haghighat; Rakhshan, Vahid

    2017-12-01

    The use of newly-introduced elastic memory chains (EMCs) in space closure is increasingly gaining popularity. However, no clinical studies have evaluated their efficacy. Therefore, this study was conducted. In this two-center split-mouth single-blind randomized controlled trial, 21 jaws were divided into 42 quadrants. The two treatments [canine retraction using EMCs versus nickel-titanium (NiTi) coil springs (as control)] were randomly assigned to two quadrants of each jaw. The premolar space was measured at the baseline, and in the 1st, 2nd, and 3rd months of canine retraction, by a blinded orthodontist. Space closure rates were compared using a paired t-test. The rates of space closure using NiTi springs were 1.93±0.62, 1.71±0.75, and 1.36±0.51mm/month, during the 1st, 2nd, and 3rd months of treatment, respectively. The 3-month average rates of space closure were 1.67±0.39 and 1.89±0.36mm/month in the NiTi and elastic groups, respectively (faster in the elastic group, P=0.022). The application of elastic memory chains is as effective as NiTi springs. Copyright © 2017. Published by Elsevier Masson SAS.

  20. Achieving a Successful Closure of an Anterior Tympanic Membrane Perforation: Evidence-Based Systematic Review.

    PubMed

    Visvanathan, Vikranth; Vallamkondu, Vamsidhar; Bhimrao, Sanjiv K

    2018-06-01

    Objectives Surgical repair of a tympanic membrane perforation is a common otologic procedure. However, achieving a successful closure can be challenging, especially if the anterior margin of the tympanic membrane is involved. The aim of this study was to systematically review the literature on evidence published in closure of anterior tympanic membrane perforations. Data Sources The following data sources were searched: Cochrane Central Register of Controlled Trials (1997 to August, 3 2017), MEDLINE (February 1948 to August 3, 2017), and Embase (1975 to August 3, 2017). Data Extraction Two authors independently reviewed titles and abstracts. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines were followed. For the purpose of this study, the inclusion criteria were as follows; (1) studies reporting surgical technique for closure of anterior tympanic membrane perforations, (2) primary cases only, (3) articles published in the English language, (4) minimum 6-month follow-up, and (5) recorded pre- and postoperative audiometry. The exclusion criteria were non-English language articles, revision surgery, and no audiometric outcomes. Results On initial search, a total of 181 articles were identified (PubMed, n = 136; Cochrane, n = 28; Embase, n = 17). Based on the criteria, 136 articles were excluded. Full text of 45 articles was reviewed, and a further 24 articles were excluded. A total of 21 articles fulfilled the criteria for study inclusion. Conclusions All published evidence is level 4. High-quality controlled studies are required to determine the most effective method for closure of anterior tympanic membrane perforation.

  1. Planned secondary wound closure at the circular stapler insertion site after laparoscopic gastric bypass reduces postoperative morbidity, costs, and hospital stay.

    PubMed

    Vetter, Diana; Raptis, Dimitri Aristotle; Giama, Mira; Hosa, Hanna; Muller, Markus K; Nocito, Antonio; Schiesser, Marc; Moos, Rudolf; Bueter, Marco

    2017-12-01

    The aims of the present study were to assess whether planned secondary wound closure at the insertion site of the circular stapler reduces wound infection rate and postoperative morbidity after laparoscopic Roux-en-Y gastric bypass (RYGB) and to identify independent predictive factors increasing the risk for wound infections after RYGB. This paper is a retrospective single-center analysis of a prospectively collected database of 1400 patients undergoing RYGB surgery in circular technique between June 2000 and June 2016. Planned secondary wound closure at the circular stapler introduction site was performed at postoperative day 3 in 291 (20.8%) consecutive patients and compared to a historical control of 1109 (79.2%) consecutive patients with primary wound closure. Independent predictive factors for wound infection were assessed by multivariable analysis. Secondary wound closure significantly decreased wound infection rate from 9.3% (103/1109) to 1% (3/291) (p < 0.001) leading to a shorter hospital stay (mean 9 (SD8) vs. 7 days (SD2), p < 0.001), lower costs (p = 0.039), and reduced postoperative morbidity (mean 90-day Comprehensive Complication Index (CCI) 7.4 (SD14.0) vs. 5.1 (SD11.1) p = 0.008) when compared to primary wound closure. Primary wound closure, dyslipidemia, and preoperative gastritis were independent predictive risk factors for developing wound infections both in the univariate (p < 0.001; p = 0.048; p = 0.003) and multivariable analysis (p < 0.001; p = 0.040; p = 0.012). Further, on multivariable analysis, the female gender was a predictive factor (p = 0.034) for wound infection development. Secondary wound closure at the circular stapler introduction site in laparoscopic RYGB significantly reduces the overall wound infection rate as well as postoperative morbidity, costs, and hospital stay when compared to primary wound closure.

  2. Control of extended-spectrum β-lactamase-producing Enterobacteriaceae nosocomial acquisition in an intensive care unit: A time series regression analysis.

    PubMed

    Boyer, Alexandre; Couallier, Vincent; Clouzeau, Benjamin; Lasheras, Agnes; M'zali, Fatima; Kann, Michael; Rogues, Anne-Marie; Gruson, Didier

    2015-12-01

    This study was undertaken to determine the temporal relationship between implementation of different interventions in an intensive care unit (ICU) and control of endemic nosocomial acquisition of extended-spectrum β-lactamase Enterobacteriaceae (ESBLE). This was a prospective observational study with time-series analysis of the monthly incidence of ESBLE and its predictors. In November 2007, after a 14-month baseline period, an intervention consisting of restriction of third-generation cephalosporins (3 GC) and increased use of alcohol-based hand rubs was implemented. In January 2008, an increased health care worker (HCW):patient ratio was also implemented. In March 2010, the ICU was closed, and patients were moved to a clean ICU. The first intervention resulted in global reduction in 3 GC and increased use of alcohol-based hand rub. A significant change in ESBLE incidence was observed in a full segmented univariate regression analysis (mean change in level, -0.91 ± 0.19; P < .0001). After ICU closure, there was a dramatic reduction in ESBLE acquisition. According to the multivariate model, the ICU closure was the main protective factor. Before ICU closure, an increase in the HCW:patient ratio of 0.1 point tended to be associated with a decreased risk of ESBLE acquisition (relative risk, 0.28; 95% confidence interval, 0.06-1.25; P = .09). This study shows that ICU closure was associated with, but not necessarily the reason for, control of ESBLE cross-transmission in a nonoutbreak setting. Environmental ESBE sources may play a role in cross-transmission. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  3. Results of coil closure of patent ductus arteriosus using a tapered tip catheter for enhanced control.

    PubMed

    Devanagondi, Rajiv; Latson, Larry; Bradley-Skelton, Sharon; Prieto, Lourdes

    2016-08-01

    This article describes the efficacy and embolization rates of coil delivery via modified vertebral catheter (MVC) for patent ductus arteriosus (PDA) closure. Various techniques have been devised to enhance coil control and prevent embolization during PDA closure. Since 1995, they have delivered coils via tapered vertebral catheters for improved coil control. Catheterization reports, angiograms, and echocardiograms were reviewed for patients with PDA occlusion via MVC from 2001 to 2014. Residual shunting was determined by angiography and echocardiogram within 24 hr post-procedure. Procedural success was defined as ≤ trivial angiographic and echocardiographic shunt, and no aortic nor LPA obstruction, after final coil delivery. About 125 coil occlusions were attempted in 103 patients. Minimal PDA diameter was 2 (0.6-6) mm. Four coils were removed with a snare/bioptome due to aortic/LPA obstruction following release. Seven were malpositioned while still held by the MVC of which three embolized while attempting withdrawal. Five embolized after full release from the MVC. The embolization rate was 6.4%. Embolizations were more likely in PDAs ≥ 2.5 mm (P < 0.05). Ultimately, 98/103 PDAs were occluded using the MVC. No patient had greater trivial residual shunt or aortic/LPA obstruction for an overall success rate of 95%. For PDAs < 2.5 mm the success rate was 97%. Coil delivery via MVC was safe and effective for small PDAs. While fully controlled release and retrieval devices are now available for PDA closure with lower embolization rates, coil occlusion by MVC should still be considered for small PDAs, especially in resource limited regions. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  4. Effect of the dietary supplementation with Vitamin E on colour stability of packaged, sliced pasteurized ham.

    PubMed

    Houben, J H; Gerris, C V

    1998-12-01

    The effect of dietary supplementation with vitamin E (200IU kg(-1) feed) on the colour stability of pasteurized ham was studied. Pigs were fed on control and enriched diets for the last 12 weeks before slaughter. Pasteurized ham was manufactured from the hams from 6 barrows and 6 gilts per dietary group. Half of the samples of sliced ham from control and supplemented pigs were packaged under vacuum (VAC) and half in low-oxygen modified atmosphere packs (FOG, gas mixture: CO(2)/N(2)=60/40). Half the packages were kept under constant illumination and the other half in the dark, both for 22 days at 7°C. The redness component of the VAC-packaged ham prepared from vitamin E-supplemented pigs was slightly more stable than that of comparably packaged ham prepared from control pigs. The opposite was observed for the FOG-packaged products. Overall, colour changes were greater in the ham in FOG-packs than in the ham in VAC-packs. In addition, the colour of the FOG-packaged ham was clearly affected by illumination, whereas the colour of the VAC-packaged ham appeared more stable. It is concluded that dietary supplementation of pigs with vitamin E does not appear to offer significant advantages over currently used feeding regimens with regard to the quality of the ham produced.

  5. 75 FR 59179 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... (RACT) for sources covered by EPA's Control Techniques Guidelines (CTG) for flexible packaging printing... Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control Techniques Guidelines for Flexible Packaging Printing AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY...

  6. Water-tight knee arthrotomy closure: comparison of a novel single bidirectional barbed self-retaining running suture versus conventional interrupted sutures.

    PubMed

    Nett, Michael; Avelar, Rui; Sheehan, Michael; Cushner, Fred

    2011-03-01

    Standard medial parapatellar arthrotomies of 10 cadaveric knees were closed with either conventional interrupted absorbable sutures (control group, mean of 19.4 sutures) or a single running knotless bidirectional barbed absorbable suture (experimental group). Water-tightness of the arthrotomy closure was compared by simulating a tense hemarthrosis and measuring arthrotomy leakage over 3 minutes. Mean total leakage was 356 mL and 89 mL in the control and experimental groups, respectively (p = 0.027). Using 8 of the 10 knees (4 closed with control sutures, 4 closed with an experimental suture), a tense hemarthrosis was again created, and iatrogenic suture rupture was performed: a proximal suture was cut at 1 minute; a distal suture was cut at 2 minutes. The impact of suture rupture was compared by measuring total arthrotomy leakage over 3 minutes. Mean total leakage was 601 mL and 174 mL in the control and experimental groups, respectively (p = 0.3). In summary, using a cadaveric model, arthrotomies closed with a single bidirectional barbed running suture were statistically significantly more water-tight than those closed using a standard interrupted technique. The sample size was insufficient to determine whether the two closure techniques differed in leakage volume after suture rupture.

  7. Modelling the impact of local reactive school closures on critical care provision during an influenza pandemic

    PubMed Central

    House, Thomas; Baguelin, Marc; Van Hoek, Albert Jan; White, Peter J.; Sadique, Zia; Eames, Ken; Read, Jonathan M.; Hens, Niel; Melegaro, Alessia; Edmunds, W. John; Keeling, Matt J.

    2011-01-01

    Despite the fact that the 2009 H1N1 pandemic influenza strain was less severe than had been feared, both seasonal epidemics of influenza-like-illness and future influenza pandemics have the potential to place a serious burden on health services. The closure of schools has been postulated as a means of reducing transmission between children and hence reducing the number of cases at the peak of an epidemic; this is supported by the marked reduction in cases during school holidays observed across the world during the 2009 pandemic. However, a national policy of long-duration school closures could have severe economic costs. Reactive short-duration closure of schools in regions where health services are close to capacity offers a potential compromise, but it is unclear over what spatial scale and time frame closures would need to be made to be effective. Here, using detailed geographical information for England, we assess how localized school closures could alleviate the burden on hospital intensive care units (ICUs) that are reaching capacity. We show that, for a range of epidemiologically plausible assumptions, considerable local coordination of school closures is needed to achieve a substantial reduction in the number of hospitals where capacity is exceeded at the peak of the epidemic. The heterogeneity in demand per hospital ICU bed means that even widespread school closures are unlikely to have an impact on whether demand will exceed capacity for many hospitals. These results support the UK decision not to use localized school closures as a control mechanism, but have far wider international public-health implications. The spatial heterogeneities in both population density and hospital capacity that give rise to our results exist in many developed countries, while our model assumptions are sufficiently general to cover a wide range of pathogens. This leads us to believe that when a pandemic has severe implications for ICU capacity, only widespread school closures (with their associated costs and organizational challenges) are sufficient to mitigate the burden on the worst-affected hospitals. PMID:21288945

  8. A homeopathic remedy from arnica, marigold, St. John's wort and comfrey accelerates in vitro wound scratch closure of NIH 3T3 fibroblasts.

    PubMed

    Hostanska, Katarina; Rostock, Matthias; Melzer, Joerg; Baumgartner, Stephan; Saller, Reinhard

    2012-07-18

    Drugs of plant origin such as Arnica montana, Calendula officinalis or Hypericum perforatum have been frequently used to promote wound healing. While their effect on wound healing using preparations at pharmacological concentrations was supported by several in vitro and clinical studies, investigations of herbal homeopathic remedies on wound healing process are rare. The objective of this study was to investigate the effect of a commercial low potency homeopathic remedy Similasan® Arnica plus Spray on wound closure in a controlled, blind trial in vitro. We investigated the effect of an ethanolic preparation composed of equal parts of Arnica montana 4x, Calendula officinalis 4x, Hypericum perforatum 4x and Symphytum officinale 6x (0712-2), its succussed hydroalcoholic solvent (0712-1) and unsuccussed solvent (0712-3) on NIH 3T3 fibroblasts. Cell viability was determined by WST-1 assay, cell growth using BrdU uptake, cell migration by chemotaxis assay and wound closure by CytoSelect ™Wound Healing Assay Kit which generated a defined "wound field". All assays were performed in three independent controlled experiments. None of the three substances affected cell viability and none showed a stimulating effect on cell proliferation. Preparation (0712-2) exerted a stimulating effect on fibroblast migration (31.9%) vs 14.7% with succussed solvent (0712-1) at 1:100 dilutions (p < 0.001). Unsuccussed solvent (0712-3) had no influence on cell migration (6.3%; p > 0.05). Preparation (0712-2) at a dilution of 1:100 promoted in vitro wound closure by 59.5% and differed significantly (p < 0.001) from succussed solvent (0712-1), which caused 22.1% wound closure. Results of this study showed that the low potency homeopathic remedy (0712-2) exerted in vitro wound closure potential in NIH 3T3 fibroblasts. This effect resulted from stimulation of fibroblasts motility rather than of their mitosis.

  9. Cost savings associated with prevention of recurrent lumbar disc herniation with a novel annular closure device: a multicenter prospective cohort study.

    PubMed

    Parker, Scott L; Grahovac, Gordan; Vukas, Duje; Ledic, Darko; Vilendecic, Milorad; McGirt, Matthew J

    2013-09-01

    Same-level recurrent disc herniation is a well-defined complication following lumbar discectomy. Reherniation results in increased morbidity and health care costs. Techniques to reduce these consequences may improve outcomes and reduce cost after lumbar discectomy. In a prospective cohort study, we set out to evaluate the cost associated with surgical management of recurrent, same-level lumbar disc herniation following primary discectomy. Forty-six consecutive European patients undergoing lumbar discectomy for a single-level herniated disc at two institutions were prospectively followed with clinical and radiographic evaluations. A second consecutive cohort of 30 patients undergoing 31 lumbar discectomies with implantation of an annular closure device was followed at the same hospitals and same follow-up intervals. Cost estimates for reherniation were modeled on Medicare national allowable payment amounts (direct cost) and patient work-day losses (indirect cost). Annular closure and control cohorts were matched at baseline. By 2 years follow-up, symptomatic recurrent same-level disc herniation occurred in three (6.5%) patients in the control cohort versus zero (0%) patients in the annular closure cohort. For patients experiencing recurrent disc herniation, mean estimated direct and indirect cost of management of recurrent disc herniation was $34,242 and $3,778, respectively. Use of an annular closure device potentially results in a cost savings of $222,573 per 100 primary discectomy procedures performed (or $2,226 per discectomy), based solely on the reduction of reoperated reherniations when modeled on U.S. Medicare costs. Recurrent disc herniation did not occur in any patients after annular closure within the 12-month follow-up. The reduction in the incidence of reherniation was associated with potentially significant cost savings. Development of novel techniques to prevent recurrent lumbar disc herniation is warranted to decrease the associated morbidity and health care costs associated with this complication. Georg Thieme Verlag KG Stuttgart · New York.

  10. Management of complex abdominal wall defects associated with penetrating abdominal trauma.

    PubMed

    Arul, G Suren; Sonka, B J; Lundy, J B; Rickard, R F; Jeffery, S L A

    2015-03-01

    The paradigm of Damage Control Surgery (DCS) has radically improved the management of abdominal trauma, but less well described are the options for managing the abdominal wall itself in an austere environment. This article describes a series of patients with complex abdominal wall problems managed at the UK-led Role 3 Medical Treatment Facility (MTF) in Camp Bastion, Afghanistan. Contemporaneous review of a series of patients with complex abdominal wall injuries who presented to the Role 3 MTF between July and November 2012. Five patients with penetrating abdominal trauma associated with significant damage to the abdominal wall were included. All patients were managed using DCS principles, leaving the abdominal wall open at the end of the first procedure. Subsequent management of the abdominal wall was determined by a multidisciplinary team of general and plastic surgeons, intensivists and specialist nurses. The principles of management identified included minimising tissue loss on initial laparotomy by joining adjacent wounds and marginal debridement of dead tissue; contraction of the abdominal wall was minimised by using topical negative pressure dressing and dermal-holding sutures. Definitive closure was timed to allow oedema to settle and sepsis to be controlled. Closure techniques include delayed primary closure with traction sutures, components separation, and mesh closure with skin grafting. A daily multidisciplinary team discussion was invaluable for optimal decision making regarding the most appropriate means of abdominal closure. Dermal-holding sutures were particularly useful in preventing myostatic contraction of the abdominal wall. A simple flow chart was developed to aid decision making in these patients. This flow chart may prove especially useful in a resource-limited environment in which returning months or years later for closure of a large ventral hernia may not be possible. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  11. Influence of glottal closure on the phonatory process in ex vivo porcine larynges.

    PubMed

    Birk, Veronika; Kniesburges, Stefan; Semmler, Marion; Berry, David A; Bohr, Christopher; Döllinger, Michael; Schützenberger, Anne

    2017-10-01

    Many cases of disturbed voice signals can be attributed to incomplete glottal closure, vocal fold oscillation asymmetries, and aperiodicity. Often these phenomena occur simultaneously and interact with each other, making a systematic, isolated investigation challenging. Therefore, ex vivo porcine experiments were performed which enable direct control of glottal configurations. Different pre-phonatory glottal gap sizes, adduction levels, and flow rates were adjusted. The resulting glottal closure types were identified in a post-processing step. Finally, the acoustic quality, aerodynamic parameters, and the characteristics of vocal fold oscillation were analyzed in reference to the glottal closure types. Results show that complete glottal closure stabilizes the phonation process indicated through a reduced left-right phase asymmetry, increased amplitude and time periodicity, and an increase in the acoustic quality. Although asymmetry and periodicity parameter variation covers only a small range of absolute values, these small variations have a remarkable influence on the acoustic quality. Due to the fact that these parameters cannot be influenced directly, the authors suggest that the (surgical) reduction of the glottal gap seems to be a promising method to stabilize the phonatory process, which has to be confirmed in future studies.

  12. A field evaluation of the Eye-Closure Interview with witnesses of serious crimes.

    PubMed

    Vredeveldt, Annelies; Tredoux, Colin G; Nortje, Alicia; Kempen, Kate; Puljević, Cheneal; Labuschagne, Gérard N

    2015-04-01

    Laboratory research shows that eye-closure during memory retrieval improves both the amount and the factual accuracy of memory reports about witnessed events. Based on these findings, we developed the Eye-Closure Interview, and examined its feasibility (in terms of compliance with the instructions) and effectiveness (in terms of the quantity and quality of reported information) in eyewitness interviews conducted by the South African Police Service. Police interviewers from the Facial Identification Unit were randomly assigned to receive Eye-Closure Interview training or no training. We analyzed 95 interviews with witnesses of serious crimes (including robbery, rape, and murder), some of whom were instructed to close their eyes during salient parts of the interview. Witnesses in the control condition rarely spontaneously closed their eyes, but witnesses in the Eye-Closure Interview condition kept their eyes closed during 97% of their descriptions, suggesting that the Eye-Closure Interview would be easy to implement in a field setting. Although witnesses who closed their eyes did not remember more information overall, the information they provided was considered to be of significantly greater forensic relevance (as reflected in 2 independent blind assessments, 1 by a senior police expert and 1 by a senior researcher). Thus, based on the findings from this field study and from previous laboratory research, we conclude that implementation of the Eye-Closure Interview in witness interviews would help police interviewers to elicit more valuable information from witnesses, which could be relevant to the police investigation and/or in court. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  13. A simple model for closure temperature of a trace element in cooling bi-mineralic systems

    NASA Astrophysics Data System (ADS)

    Liang, Yan

    2015-09-01

    Closure temperature is defined as the lower temperature limit at which the element of interest effectively ceases diffusive exchange with its surrounding medium during cooling. Here we generalize the classic equation of Dodson (1973) for cooling mono-mineralic systems to cooling bi-mineralic aggregates by considering diffusive exchange of a trace element between the two minerals in a closed system. We present a simple analytical model that includes key parameters affecting the closure temperature of a trace element in cooling bi-mineralic systems: cooling rate, temperature-dependent diffusion coefficients for the trace element in the two minerals, temperature-dependent partition coefficient of the trace element between the two minerals, effective grain sizes of the two minerals, and volume proportions of the minerals in the system. We show that closure temperatures of a trace element in cooling bi-mineralic systems are bounded by the closure temperatures of the trace element in the two mono-mineralic systems and that our generalized model reduces to Dodson's equation when one of the mineral serves as "an effective infinite" reservoir to the other mineral. Application to closure temperatures of REE in orthopyroxene and clinopyroxene bi-mineralic systems highlights the importance of REE diffusion and partitioning in the pyroxenes as well as clinopyroxene modal abundance and grain size in the systems. Closure temperatures for REE in two-pyroxene bearing equigranular rocks are controlled primarily by diffusion in orthopyroxene unless the modal abundance of clinopyroxene is very small. This has important bearings on the interpretation of temperatures derived from the REE-in-two-pyroxene thermometer.

  14. Plain packaging of cigarettes and smoking behavior: study protocol for a randomized controlled study.

    PubMed

    Maynard, Olivia M; Leonards, Ute; Attwood, Angela S; Bauld, Linda; Hogarth, Lee; Munafò, Marcus R

    2014-06-25

    Previous research on the effects of plain packaging has largely relied on self-report measures. Here we describe the protocol of a randomized controlled trial investigating the effect of the plain packaging of cigarettes on smoking behavior in a real-world setting. In a parallel group randomization design, 128 daily cigarette smokers (50% male, 50% female) will attend an initial screening session and be assigned plain or branded packs of cigarettes to smoke for a full day. Plain packs will be those currently used in Australia where plain packaging has been introduced, while branded packs will be those currently used in the United Kingdom. Our primary study outcomes will be smoking behavior (self-reported number of cigarettes smoked and volume of smoke inhaled per cigarette as measured using a smoking topography device). Secondary outcomes measured pre- and post-intervention will be smoking urges, motivation to quit smoking, and perceived taste of the cigarettes. Secondary outcomes measured post-intervention only will be experience of smoking from the cigarette pack, overall experience of smoking, attributes of the cigarette pack, perceptions of the on-packet health warnings, behavior changes, views on plain packaging, and the rewarding value of smoking. Sex differences will be explored for all analyses. This study is novel in its approach to assessing the impact of plain packaging on actual smoking behavior. This research will help inform policymakers about the effectiveness of plain packaging as a tobacco control measure. Current Controlled Trials ISRCTN52982308 (registered 27 June 2013).

  15. Wafer-level vacuum/hermetic packaging technologies for MEMS

    NASA Astrophysics Data System (ADS)

    Lee, Sang-Hyun; Mitchell, Jay; Welch, Warren; Lee, Sangwoo; Najafi, Khalil

    2010-02-01

    An overview of wafer-level packaging technologies developed at the University of Michigan is presented. Two sets of packaging technologies are discussed: (i) a low temperature wafer-level packaging processes for vacuum/hermeticity sealing, and (ii) an environmentally resistant packaging (ERP) technology for thermal and mechanical control as well as vacuum packaging. The low temperature wafer-level encapsulation processes are implemented using solder bond rings which are first patterned on a cap wafer and then mated with a device wafer in order to encircle and encapsulate the device at temperatures ranging from 200 to 390 °C. Vacuum levels below 10 mTorr were achieved with yields in an optimized process of better than 90%. Pressures were monitored for more than 4 years yielding important information on reliability and process control. The ERP adopts an environment isolation platform in the packaging substrate. The isolation platform is designed to provide low power oven-control, vibration isolation and shock protection. It involves batch flip-chip assembly of a MEMS device onto the isolation platform wafer. The MEMS device and isolation structure are encapsulated at the wafer-level by another substrate with vertical feedthroughs for vacuum/hermetic sealing and electrical signal connections. This technology was developed for high performance gyroscopes, but can be applied to any type of MEMS device.

  16. Use of activated carbon inside modified atmosphere packages to maintain tomato fruit quality during cold storage.

    PubMed

    Bailén, Gloria; Guillén, Fabián; Castillo, Salvador; Serrano, María; Valero, Daniel; Martínez-Romero, Domingo

    2006-03-22

    Ethylene triggers the ripening process of tomato affecting the storage durability and shelf life (loss of quality) and inducing fruit decay. In this paper, an active packaging has been developed on the basis of the combination of modified atmosphere packaging (MAP) and the addition of granular-activated carbon (GAC) alone or impregnated with palladium as a catalyst (GAC-Pd). A steady-state atmosphere was 4 and 10 kPa for O2 and CO2 in control packages, while it was 8 and 7 kPa for O2 and CO2 in treated ones. The addition of GAC-Pd led to the lower ethylene accumulation inside packages, while the higher was obtained in controls. The parameters related to ripening showed that treated tomatoes exhibited a reduction in color evolution, softening, and weight loss, especially for GAC-Pd treatment. Moreover, these treatments were also effective in delaying tomato decay. After sensorial panel, tomatoes treated with GAC-Pd received the higher scores in terms of sweetness, firmness, juiciness, color, odor, and flavor. Results from the GC-MS analysis of the MAP headspace showed that 23 volatile compounds were identified in control packages, with these volatiles being significantly reduced in MAP-treated packages, which was correlated to the odor intensity detected by panelists after bag opening.

  17. Approximations for Quantitative Feedback Theory Designs

    NASA Technical Reports Server (NTRS)

    Henderson, D. K.; Hess, R. A.

    1997-01-01

    The computational requirements for obtaining the results summarized in the preceding section were very modest and were easily accomplished using computer-aided control system design software. Of special significance is the ability of the PDT to indicate a loop closure sequence for MIMO QFT designs that employ sequential loop closure. Although discussed as part of a 2 x 2 design, the PDT is obviously applicable to designs with a greater number of inputs and system responses.

  18. Calibration of TWSTFT Links Through the Triangle Closure Condition

    DTIC Science & Technology

    2008-12-01

    40th Annual Precise Time and Time Interval (PTTI) Meeting 467 CALIBRATION OF TWSTFT LINKS THROUGH THE TRIANGLE CLOSURE CONDITION Z... TWSTFT (Two-Way Satellite Time and Frequency Transfer, TW for short) is, together with GPS time transfer, the primary technique used for UTC generation...valid OMB control number. 1. REPORT DATE 01 DEC 2008 2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE Calibration Of Twstft Links

  19. A Self-Control Classroom for Hyperactive Children.

    ERIC Educational Resources Information Center

    Barkley, Russell A.; And Others

    1980-01-01

    The effectiveness of a package of self-control procedures in a classroom with six hyperactive boys ages 7 to 10 was investigated. Results indicated that the self-control package was effective in improving misbehavior and attention to tasks during the individual seat work but not during group instruction. (Author)

  20. Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial.

    PubMed

    Wilkinson, Kate M; Krige, Anton; Brearley, Sarah G; Lane, Steven; Scott, Michael; Gordon, Anthony C; Carlson, Gordon L

    2014-10-21

    Thoracic epidural analgesia (TEA) is recommended for post-operative pain relief in patients undergoing major abdominal surgery via a midline incision. However, the effectiveness of TEA is variable with high failure rates reported post-operatively. Common side effects such as low blood pressure and motor block can reduce mobility and hinder recovery, and a number of rare but serious complications can also occur following their use.Rectus sheath catheters (RSC) may provide a novel alternative approach to somatic analgesia without the associated adverse effects of TEA. The aim of this study is to compare the efficacy of both techniques in terms of pain relief, patient experience, post-operative functional recovery, safety and cost-effectiveness. This is a single-centre randomised controlled non-blinded trial, which also includes a nested qualitative study. Over a two-year period, 132 patients undergoing major abdominal surgery via a midline incision will be randomised to receive either TEA or RSC for post-operative analgesia. The primary outcome measures pain scores on moving from a supine to a sitting position at 24 hours post wound closure, and the patient experience between groups evaluated through in-depth interviews. Secondary outcomes include pain scores at rest and on movement at other time points, opiate consumption, functional recovery, morbidity and cost-effectiveness. This will be the first randomised controlled trial comparing thoracic epidurals to ultrasound-guided rectus sheath catheters in adults undergoing elective midline laparotomy. The standardised care provided by an Enhanced Recovery Programme makes this a comparison between two complex pain packages and not simply two analgesic techniques, in order to ascertain if RSC is a viable alternative to TEA. Current Controlled Trials ISRCTN81223298 (16 January 2014).

  1. Ferroelectric Fluid Flow Control Valve

    NASA Technical Reports Server (NTRS)

    Jalink, Antony, Jr. (Inventor); Hellbaum, Richard F. (Inventor); Rohrbach, Wayne W. (Inventor)

    1999-01-01

    An active valve is controlled and driven by external electrical actuation of a ferroelectric actuator to provide for improved passage of the fluid during certain time periods and to provide positive closure of the valve during other time periods. The valve provides improved passage in the direction of flow and positive closure in the direction against the flow. The actuator is a dome shaped internally prestressed ferroelectric actuator having a curvature, said dome shaped actuator having a rim and an apex. and a dome height measured from a plane through said rim said apex that varies with an electric voltage applied between an inside and an outside surface of said dome shaped actuator.

  2. Long-term effects of a factory closure: unemployment and disability during ten years' follow-up.

    PubMed

    Westin, S; Schlesselman, J J; Korper, M

    1989-01-01

    The consequences of a factory closure on future employment, disability and death were investigated in a 10-year prospective follow-up study in a general practice setting. The study population consisted of 85 persons who lost their jobs when a brisling sardine factory close to Bergen in Norway was shut down in 1975. The employees of a nearby "sister factory" within the same company were chosen as a control population, consisting of 87 persons. After the factory closure, the annual employment rate of the study group showed a steady rise to a maximum level of 44% within 6 years, but even after 10 years never matched the employment rate of the controls. The cumulative rates of disability pension, granted for medical conditions only, was more than three times higher in the study group than among controls from the second through the fourth year of follow-up. This excess of disabilities then stayed relatively constant at approximately 17 per 100 persons from 5 to 10 years after the shut-down. Given present days' unemployment, the results of this investigation point to the importance of acknowledging a long-term effect of job-loss on health and social readjustment.

  3. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  4. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  5. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  6. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  7. Accidental poisoning in childhood: a multicentre survey. 2. The role of packaging in accidents involving medications.

    PubMed

    Wiseman, H M; Guest, K; Murray, V S; Volans, G N

    1987-07-01

    To assess the effectiveness of child-resistant closures (CRCs) and unit dose packaging in preventing childhood poisoning with medications, a survey by 14 hospitals of accidental suspected poisoning in children under 5-years-old, was compared with a survey of a representative sample of households with children under 5 living in the catchment areas of the hospitals. Nine hundred and thirty-eight medications thought to have been ingested by 877 children were compared with 5827 medications found in households with children. The relationship between availability of packs or medications in the home and their involvement in accidents was quantified by means of an Accident Association Index (AAI). A low AAI indicated that the involvement of a pack or medication was less than expected from availability and therefore safe. A high AAI indicated that involvement was greater than expected and therefore unsafe. Medications involved in suspected poisoning were most frequently packed in containers without CRCs (63%) or transparent blisters (20%); both had high AAIs. CRCs, strips, sachets and opaque blisters had low AAIs. Analgesics, expectorants and gastrointestinal medications, had low AAIs, while oral contraceptives, hypnotics, sedative/tranquillizers, antidepressants, anticonvulsants, anti-emetics, and anti-infectives had high AAIs. Prescription medications were more frequently involved in accidents than over-the-counter (OTC) medications and had a higher AAI. Comparison of the AAIs of different kinds of medication in each of their various pack types showed that safe packaging reduced the risk from medications which had a high average AAI. Only 40% of medications were in their normal storage place at the time of the accident. Medicine and bathroom cabinets, and kitchen cupboards and drawers were the safest places to store medications. Handbags, fridges, and shelves or ledges in the bathroom were the most unsafe places. No pack had a low AAI when stored on open shelves indicating that safe packaging cannot compensate for unsafe storage. Other factors which influenced the involvement of medications in accidents were the intended user and the duration of storage. The results of the study have important implications for design of packaging for medications and for education of the public.

  8. Transabdominal preperitoneal herniorrhaphy using laser-assisted tissue soldering in a porcine model.

    PubMed

    Lanzafame, Raymond J; Soltz, Barbara A; Stadler, Istvan; Soltz, Robert

    2009-01-01

    Collagen solder is capable of fixation of surgical meshes during laparoscopic herniorrhaphy without compromising tissue integration, increasing adhesions or inflammation. This pilot study describes development of instrumentation and techniques for transabdominal preperitoneal (TAPP) herniorrhaphy using laser-assisted soldering technology. Anesthetized 20-kg to 25-kg female Yorkshire pigs underwent laparoscopy performed using a 3-trocar technique. Peritoneal incisions were made and pockets created in the preperitoneal space for mesh placement. Parietex TEC mesh segments embedded in 60% collagen-solder were soldered to the muscle surface by using a prototype laser (1.45micro, 4.5W CW, 5mm spot, and 55 degrees C set temperature) and custom laparoscopic handpiece. Parietex TEC mesh segments (Control) were affixed to the muscle with fibrin sealant (Tisseel). Peritoneal closure was with staples (Control) or by soldering collagen embedded Vicryl mesh segments over the peritoneal incision (Mesh/TAPP). Segments were inserted using a specially designed introducer. Animals were recovered and underwent second-look laparoscopy at 6 weeks postimplantation. Mesh sites were harvested after animals were euthanized. The mesh-solder constructs were easily inserted and affixed in the TAPP approach. Tisseel tended to drip during application, particularly in vertical and ventral locations. Postoperative healing was similar to Control segments in all cases. Mesh/TAPP closures healed without scarring or adhesion formation. Collagen-based tissue soldering permits normal wound healing and may mitigate or reduce use of staples for laparoscopic mesh fixation and peritoneal closure. Laser-assisted mesh fixation and peritoneal closure is a promising alternative for laparoscopic herniorrhaphy. Further development of this strategy is warranted.

  9. Pericardium closure after heart operations: a safety option?

    PubMed

    Dantas, Carlos Eduardo Pereira; Sá, Mauro Paes Leme de; Bastos, Eduardo Sergio; Magnanini, Monica M F

    2010-01-01

    Primary pericardium closure may reduce the risk of cardiac injury during chest re opening, especially the right ventricle, aorta and coronary bypass grafts. Nevertheless, concern about adverse hemodynamic effects prevents most heart surgeons of closuring the pericardium. We evaluated 48 patients undergoing open heart surgery consecutively which the pericardium was closed in 30 patients (group A) and 18 patients, as a control group (group B) in which the pericardium was left open. All patients underwent posteroanterior and lateral chest roentgenograms before surgery and one week postoperatively. Postoperative evaluation also included echocardiograms, ECG and postoperative enzyme analysis. There were no deaths or any complications in both groups (acute myocardial infarction, stroke, bleeding or cardiac tamponate). It was observed statistically differences between both groups especially in echocardiogram parameters and cardiothoracic ratio without clinical impact. Pericardium closure is a simple method to facilitate resternotomy during subsequent re operative procedures. However, cardiac surgeons should be aware of the transient deterioration in hemodynamics associated with it, even thought there was no clinical significance in this study.

  10. Comparison of Outcomes with Hand-sewn Versus Stapler Closure of Pancreatic Stump in Distal Pancreatectomy.

    PubMed

    Futagawa, Yasuro; Takano, Yuki; Furukawa, Kenei; Kanehira, Masaru; Onda, Shinji; Sakamoto, Taro; Gocho, Takeshi; Shiba, Hiroaki; Yanaga, Katsuhiko

    2017-05-01

    The optimal method for pancreatic stump closure to prevent postoperative pancreatic fistula (POPF) after distal pancreatectomy (DP), remains controversial though DP is still the only curative treatment for pancreatic cancer and other malignancies located on pancreatic body or tail. A total of 44 patients who consecutively underwent open DP were retrospectively analyzed, dividing them into two groups: group H (hand-sewn; n=24) and group S (stapler closure; n=20). POPFs were encountered in 5 (21%) and 11 (55%) patients in groups H and S, respectively (p=0.02). POPFs of Clavien-Dindo grade IIIa or above were observed in two (8%) and seven (35%) patients in groups H and S, respectively (p=0.03). When indicating stapler closure, caution should be exercised for pancreatic consistency and thickness, device and cartridge type, and pancreatic duct ligation to more effectively control POPF rates. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  11. Active bio-based food-packaging: Diffusion and release of active substances through and from cellulose nanofiber coating toward food-packaging design.

    PubMed

    Lavoine, Nathalie; Guillard, Valérie; Desloges, Isabelle; Gontard, Nathalie; Bras, Julien

    2016-09-20

    Cellulose nanofibers (CNFs) were recently investigated for the elaboration of new functional food-packaging materials. Their nanoporous network was especially of interest for controlling the release of active species. Qualitative release studies were conducted, but quantification of the diffusion phenomenon observed when the active species are released from and through CNF coating has not yet been studied. Therefore, this work aims to model CNF-coated paper substrates as controlled release system for food-packaging using release data obtained for two model molecules, namely caffeine and chlorhexidine digluconate. The applied mathematical model - derived from Fickian diffusion - was validated for caffeine only. When the active species chemically interacts with the release device, another model is required as a non-predominantly diffusion-controlled release was observed. From caffeine modeling data, a theoretical active food-packaging material was designed. The use of CNFs as barrier coating was proved to be the ideal material configuration that best meets specifications. Copyright © 2016. Published by Elsevier Ltd.

  12. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Willoughby III, O.H.; Lukes, G.C.

    EnergySolutions, LLC operates its Mixed Waste Facility at Clive, Utah under the provisions of its State-issued Part B Permit. The facility accepts waste that contains both hazardous and radioactive contaminants. Utah is an EPA Agreement State and therefore the Utah Division of Solid and Hazardous Waste (DSHW) is authorized to regulate the hazardous waste operations at the facility. The radioactive portion of the waste is regulated by the Utah Division of Radiation Control. 40 CFR 264.142 outlines the facility requirements for Closure Costs. The owner or operator must have a detailed written estimate of the cost of closing the facilitymore » in accordance with the rules. For many years the State of Utah had relied on the facility's estimate of closure costs as the amount that needed to be funded. This amount is reviewed annually and adjusted for inflation and for changes at the facility. In 2004 the agency and the facility requested bids from independent contractors to provide their estimate for closure costs. Three engineering firms bid on the project. The facility funded the project and both the agency and the facility chose one of the firms to provide an independent estimate. The engineering firms met with both parties and toured the facility. They were also provided with the current closure cost line items. Each firm provided an estimated cost for closure of the facility at the point in the facility's active life that would make the closure most expensive. Included with the direct costs were indirect line items such as overhead, profit, mobilization, hazardous working conditions and regulatory oversight. The agency and the facility reviewed the independent estimates and negotiated a final Closure and Post-Closure Cost Estimate for the Mixed Waste Facility. There are several mechanisms allowed under the rules to fund the Closure and Post- Closure Care Funds. EnergySolutions has chosen to fund their costs through the use of an insurance policy. Changing mechanisms from an irrevocable trust to an insurance policy required extensive review by the DSHW and the Utah Attorney General's Office. The duration of the Post-Closure Care Period is generally designated as 30 years under the hazardous waste rules. The Legislature of the State of Utah commissioned a review of the need for Perpetual Care Funds for hazardous waste facilities. This fund would provide funds for maintenance and monitoring of facilities following termination of the Post-Closure Permit. The DSHW has recommended to the legislature that a perpetual care fund be created. The legislature will study the recommendation and take appropriate action. (authors)« less

  13. Scaling up malaria intervention "packages" in Senegal: using cost effectiveness data for improving allocative efficiency and programmatic decision-making.

    PubMed

    Faye, Sophie; Cico, Altea; Gueye, Alioune Badara; Baruwa, Elaine; Johns, Benjamin; Ndiop, Médoune; Alilio, Martin

    2018-04-10

    Senegal's National Malaria Control Programme (NMCP) implements control interventions in the form of targeted packages: (1) scale-up for impact (SUFI), which includes bed nets, intermittent preventive treatment in pregnancy, rapid diagnostic tests, and artemisinin combination therapy; (2) SUFI + reactive case investigation (focal test and treat); (3) SUFI + indoor residual spraying (IRS); (4) SUFI + seasonal malaria chemoprophylaxis (SMC); and, (5) SUFI + SMC + IRS. This study estimates the cost effectiveness of each of these packages to provide the NMCP with data for improving allocative efficiency and programmatic decision-making. This study is a retrospective analysis for the period 2013-2014 covering all 76 Senegal districts. The yearly implementation cost for each intervention was estimated and the information was aggregated into a package cost for all covered districts. The change in the burden of malaria associated with each package was estimated using the number of disability adjusted life-years (DALYs) averted. The cost effectiveness (cost per DALY averted) was then calculated for each package. The cost per DALY averted ranged from $76 to $1591 across packages. Using World Health Organization standards, 4 of the 5 packages were "very cost effective" (less than Senegal's GDP per capita). Relative to the 2 other packages implemented in malaria control districts, the SUFI + SMC package was the most cost-effective package at $76 per DALY averted. SMC seems to make IRS more cost effective: $582 per DALY averted for SUFI + IRS compared with $272 for the SUFI + IRS + SMC package. The SUFI + focal test and treat, implemented in malaria elimination districts, had a cost per DALY averted of $1591 and was only "cost-effective" (less than three times Senegal's per capita GDP). Senegal's choice of deploying malaria interventions by packages seems to be effectively targeting high burden areas with a wide range of interventions. However, not all districts showed the same level of performance, indicating that efficiency gains are still possible.

  14. Effects of packaging materials on storage quality of peanut kernels

    PubMed Central

    Fu, Xiaoji; Xing, Shengping; Xiong, Huiwei; Min, Hua; Zhu, Xuejing; He, Jialin; Mu, Honglei

    2018-01-01

    In order to obtain optimum packaging materials for peanut kernels, the effects of four types of packaging materials on peanut storage quality (coat color, acid value, germination rate, relative damage, and prevention of aflatoxin contamination) were examined. The results showed that packaging materials had a major influence on peanut storage quality indexes. The color of the peanut seed coat packaged in the polyester/aluminum/polyamide/polyethylene (PET/AL/PA/PE) composite film bag did not change significantly during the storage period. Color deterioration was slower with polyamide/polyethylene (PA/PE) packaging materials than with polyethylene (PE) film bags and was slower in PE bags than in the woven bags. The use of PET/AL/PA/PE and PA/PE bags maintained peanut quality and freshness for more than one year and both package types resulted in better germination rates. There were significant differences between the four types of packaging materials in terms of controlling insect pests. The peanuts packaged in the highly permeable woven bags suffered serious invasion from insect pests, while both PET/AL/PA/PE and PA/PE bags effectively prevented insect infection. Peanuts stored in PET/AL/PA/PE and PA/PE bags were also better at preventing and controlling aflatoxin contamination. PMID:29518085

  15. Recent developments in intelligent packaging for enhancing food quality and safety.

    PubMed

    Sohail, Muhammad; Sun, Da-Wen; Zhu, Zhiwei

    2018-03-07

    The role of packaging cannot be denied in the life cycle of any food product. Intelligent packaging is an emerging technology in the food packaging sector. Although it still needs its full emergence in the market, its importance has been proved for the maintenance of food quality and safety. The present review describes several aspects of intelligent packaging. It first highlights different tools used in intelligent packaging and elucidates the role of these packaging devices for maintaining the quality of different food items in terms of controlling microbial growth and gas concentration, and for providing convenience and easiness to its users in the form of time temperature indication. This review also discusses other intelligent packaging solutions in supply chain management of food products to control theft and counterfeiting conducts and broaden the image of the food companies in terms of branding and marketing. Overall, intelligent packaging can ensure food quality and safety in the food industry, however there are still some concerns over this emerging technology including high cost and legal aspects, and thus future work should be performed to overcome these problems for further promoting its applications in the food industry. Moreover, work should also be carried out to combine several single intelligent packaging devices into a single one, so that most of the benefits from this emerging technology can be achieved.

  16. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  17. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  18. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  19. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  20. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  1. 49 CFR 175.703 - Other special requirements for the acceptance and carriage of packages containing Class 7 materials.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... transport, by air— (1) Vented Type B(M) packages, packages which require external cooling by an ancillary cooling system or packages subject to operational controls during transport; or (2) Liquid pyrophoric... transport index in excess of the limits specified in § 173.441(a) of this subchapter may not be transported...

  2. Efficacy and safety of non-suture dural closure using a novel dural substitute consisting of polyglycolic acid felt and fibrin glue to prevent cerebrospinal fluid leakage-A non-controlled, open-label, multicenter clinical trial.

    PubMed

    Terasaka, Shunsuke; Taoka, Toshiaki; Kuroda, Satoshi; Mikuni, Nobutaka; Nishi, Toru; Nakase, Hiroyuki; Fujii, Yukihiko; Hayashi, Yasuhiko; Murata, Jun-Ichi; Kikuta, Ken-Ichiro; Kuroiwa, Toshihiko; Shimokawa, Sachie; Houkin, Kiyohiro

    2017-05-01

    The objective of this study is to evaluate the efficacy and safety of non-suture dural closure using a novel dural substitute (GM111) consisting of polyglycolic acid felt with a fibrin-glue-coated area commensurate in size with the dural defect. This was a non-controlled, open-label, multicenter clinical trial. The efficacy evaluation endpoints were (1) GM111's intra-operative capability to close dural defects and (2) prevention of cerebrospinal fluid (CSF) leakage and subcutaneous CSF retention throughout the postoperative period (evaluated by diagnostic imaging). Patients meeting the following three preoperative and two intra-operative selection criteria were enrolled: (1) between 12 and <75 years of age; (2) the dura is surmised to be defective and in need of reconstruction; (3) informed written consent was obtained from the patient; (4) the surgical wound is class 1; and (5) the size of duraplasty is ≥0.2 cm 2 to <100 cm 2 . Sixty patients were enrolled. The craniotomy site was supratentorial in 77.2%, infratentorial in 12.3% and sellar in 10.5%. The GM111 prosthesis size ranged from 0.24 to 42 cm 2 . To evaluate the efficacy, intra-operative closure was confirmed by Valsalva's maneuver, water infusion, etc., in all patients. CSF leakage and subcutaneous CSF retention throughout the postoperative period were found in four patients. Adverse events for which a causal relationship with GM111 could not be ruled out occurred in 8.8% of the patients. There were no instances of postoperative infection due to GM111. GM111 showed good closure capability and safety when used for non-suture dural closure.

  3. A banana NAC transcription factor (MusaSNAC1) impart drought tolerance by modulating stomatal closure and H2O2 content.

    PubMed

    Negi, Sanjana; Tak, Himanshu; Ganapathi, T R

    2018-03-01

    MusaSNAC1 function in H 2 O 2 mediated stomatal closure and promote drought tolerance by directly binding to CGT[A/G] motif in regulatory region of multiple stress-related genes. Drought is a abiotic stress-condition, causing reduced plant growth and diminished crop yield. Guard cells of the stomata control photosynthesis and transpiration by regulating CO 2 exchange and water loss, thus affecting growth and crop yield. Roles of NAC (NAM, ATAF1/2 and CUC2) protein in regulation of stress-conditions has been well documented however, their control over stomatal aperture is largely unknown. In this study we report a banana NAC protein, MusaSNAC1 which induced stomatal closure by elevating H 2 O 2 content in guard cells during drought stress. Overexpression of MusaSNAC1 in banana resulted in higher number of stomata closure causing reduced water loss and thus elevated drought-tolerance. During drought, expression of GUS (β-glucuronidase) under P MusaSNAC1 was remarkably elevated in guard cells of stomata which correlated with its function as a transcription factor regulating stomatal aperture closing. MusaSNAC1 is a transcriptional activator belonging to SNAC subgroup and its 5'-upstream region contain multiple Dof1 elements as well as stress-associated cis-elements. Moreover, MusaSNAC1 also regulate multiple stress-related genes by binding to core site of NAC-proteins CGT[A/G] in their 5'-upstream region. Results indicated an interesting mechanism of drought tolerance through stomatal closure by H 2 O 2 generation in guard cells, regulated by a NAC-protein in banana.

  4. Body mass index affects time to definitive closure after damage control surgery.

    PubMed

    Haricharan, Ramanath N; Dooley, Adam C; Weinberg, Jordan A; McGwin, Gerald; MacLennan, Paul A; Griffin, Russell L; Rue, Loring W; Reiff, Donald A

    2009-06-01

    A growing body of literature demonstrates that irrespective of the mechanism of injury, obesity is associated with significantly worse morbidity and mortality after trauma. Among patients requiring damage control laparotomy (DCL), clinical experience suggests that obesity affects time to definitive closure though this association has never been demonstrated quantitatively. All patients at an academic Level I trauma center requiring a DCL between January 2002 and December 2006 (N = 148) were included. Information pertaining to demographic, injury, and clinical characteristics was abstracted from patient medical records. The risk of specific complications including pneumonia, renal failure, and sepsis was compared between normal and overweight/obese patients, as measured by body mass index (BMI). The lengths of intensive care unit (ICU) stay and mechanical ventilation as well as time to abdominal closure were also compared. The risk of pneumonia, sepsis, and renal failure was 2.05-times, 1.77-times, and 2.84-times higher among overweight patients compared with patients with a normal BMI. The risk of pneumonia, sepsis, and renal failure was 2.01-times, 4.24-times, and 1.85-times higher among obese patients compared with those with a normal BMI. Obese patients also had a significantly longer ICU length of stay (28.7 days vs. 15.1 days; p < 0.0001), longer hospitalization (39.3 days vs. 27.0 days; p = 0.008), and time to definitive closure (8.4 days vs. 3.9 days; p = 0.03) compared with patients with a normal BMI. Among patients requiring DCL, those who are overweight or obese have a prolonged time to definitive closure. These patients also experience a significantly longer ICU course and a higher risk of pneumonia.

  5. The Synthesis of Force Closure Grasps in the Plane.

    DTIC Science & Technology

    1985-09-01

    TASK U Artificial Inteligence Laboratory AREA A WORK UN IT "NMUIERS ~( 545 Technology Square Cambridge, MA 02139 SI. CONTROLLING OFICE NAME ANO... ARTIFICIAL INThLLIX’ ENCE LABORATORY A. 1. Memo 861 September, 1985 The Synthesis of Force-Closure Grasps In the Plane DTIC ’VeL% ,#ECTE 1 VnDcNguyenU Abstract... Artificial In- telligenmcc Liabomatory of thle Massachuset Is hInsttute of Teclhnolog3 . Support for the Lahoratot * s Artificial Intelligence research is

  6. Regulation of Stomatal Immunity by Interdependent Functions of a Pathogen-Responsive MPK3/MPK6 Cascade and Abscisic Acid

    PubMed Central

    Zhang, Lawrence; Sun, Tiefeng

    2017-01-01

    Activation of mitogen-activated protein kinases (MAPKs) is one of the earliest responses after plants sense an invading pathogen. Here, we show that MPK3 and MPK6, two Arabidopsis thaliana pathogen-responsive MAPKs, and their upstream MAPK kinases, MKK4 and MKK5, are essential to both stomatal and apoplastic immunity. Loss of function of MPK3 and MPK6, or their upstream MKK4 and MKK5, abolishes pathogen/microbe-associated molecular pattern- and pathogen-induced stomatal closure. Gain-of-function activation of MPK3/MPK6 induces stomatal closure independently of abscisic acid (ABA) biosynthesis and signaling. In contrast, exogenously applied organic acids such as malate or citrate are able to reverse the stomatal closure induced by MPK3/MPK6 activation. Gene expression analysis and in situ enzyme activity staining revealed that malate metabolism increases in guard cells after activation of MPK3/MPK6 or inoculation of pathogen. In addition, pathogen-induced malate metabolism requires functional MKK4/MKK5 and MPK3/MPK6. We propose that the pathogen-responsive MPK3/MPK6 cascade and ABA are two essential signaling pathways that control, respectively, the organic acid metabolism and ion channels, two main branches of osmotic regulation in guard cells that function interdependently to control stomatal opening/closure. PMID:28254778

  7. Effectiveness of Recombinant Human Growth Hormone for Pharyngocutaneous Fistula Closure.

    PubMed

    Kucuk, Nurten; Sari, Murat; Midi, Ahmet; Yumusakhuylu, Ali Cemal; Findik, Ozan; Binnetoglu, Adem

    2015-12-01

    In laryngeal cancer, which comprises 25% of head and neck cancer, chemotherapy has come into prominence with the increase in organ-protective treatments. With such treatment, salvage surgery has increased following recurrence; the incidence of pharyngocutaneous fistula has also increased in both respiratory and digestive system surgery. We investigated the effects of recombinant human growth hormone on pharyngocutaneous fistula closure in Sprague-Dawley rats, based on an increase in amino acid uptake and protein synthesis for wound healing, an increase in mitogenesis, and enhancement of collagen formation by recombinant human growth hormone. This study was experimental animal study. Forty Sprague-Dawley rats were separated into two groups, and pharyngoesophagotomy was performed. The pharyngoesophagotomy was sutured with vicryl in both groups. Rats in group 1 (control group) received no treatment, while those in group 2 were administered a subcutaneous injection of recombinant human growth hormone daily. On day 14, the pharynx, larynx, and upper oesophagus were excised and examined microscopically. Pharyngocutaneous fistula exhibited better closure macroscopically in the recombinant human growth hormone group. There was a significant difference in collagen formation and epithelisation in the recombinant human growth hormone group compared to the control group. This study is believed to be the first in which the effect of recombinant human growth hormone on pharyngocutaneous fistula closure was evaluated, and the findings suggest the potential of use of growth hormone for treatment of pharyngocutaneous fistula.

  8. Initial Radionuclide Inventories

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Miller, H

    The purpose of this analysis is to provide an initial radionuclide inventory (in grams per waste package) and associated uncertainty distributions for use in the Total System Performance Assessment for the License Application (TSPA-LA) in support of the license application for the repository at Yucca Mountain, Nevada. This document is intended for use in postclosure analysis only. Bounding waste stream information and data were collected that capture probable limits. For commercially generated waste, this analysis considers alternative waste stream projections to bound the characteristics of wastes likely to be encountered using arrival scenarios that potentially impact the commercial spent nuclearmore » fuel (CSNF) waste stream. For TSPA-LA, this radionuclide inventory analysis considers U.S. Department of Energy (DOE) high-level radioactive waste (DHLW) glass and two types of spent nuclear fuel (SNF): CSNF and DOE-owned (DSNF). These wastes are placed in two groups of waste packages: the CSNF waste package and the codisposal waste package (CDSP), which are designated to contain DHLW glass and DSNF, or DHLW glass only. The radionuclide inventory for naval SNF is provided separately in the classified ''Naval Nuclear Propulsion Program Technical Support Document'' for the License Application. As noted previously, the radionuclide inventory data presented here is intended only for TSPA-LA postclosure calculations. It is not applicable to preclosure safety calculations. Safe storage, transportation, and ultimate disposal of these wastes require safety analyses to support the design and licensing of repository equipment and facilities. These analyses will require radionuclide inventories to represent the radioactive source term that must be accommodated during handling, storage and disposition of these wastes. This analysis uses the best available information to identify the radionuclide inventory that is expected at the last year of last emplacement, currently identified as 2030 and 2033, depending on the type of waste. TSPA-LA uses the results of this analysis to decay the inventory to the year of repository closure projected for the year of 2060.« less

  9. 49 CFR 173.403 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    .... Consignment means a package or group of packages or load of radioactive material offered by a person for... removed from a surface during normal conditions of transport. (2) Non-fixed radioactive contamination... provide control over the accumulation of packages, overpacks or freight containers containing fissile...

  10. 49 CFR 173.403 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    .... Consignment means a package or group of packages or load of radioactive material offered by a person for... removed from a surface during normal conditions of transport. (2) Non-fixed radioactive contamination... provide control over the accumulation of packages, overpacks or freight containers containing fissile...

  11. 49 CFR 173.403 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    .... Consignment means a package or group of packages or load of radioactive material offered by a person for... removed from a surface during normal conditions of transport. (2) Non-fixed radioactive contamination... provide control over the accumulation of packages, overpacks or freight containers containing fissile...

  12. 49 CFR 173.403 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    .... Consignment means a package or group of packages or load of radioactive material offered by a person for... removed from a surface during normal conditions of transport. (2) Non-fixed radioactive contamination... provide control over the accumulation of packages, overpacks or freight containers containing fissile...

  13. 49 CFR 236.342 - Switch circuit controller.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Switch circuit controller. 236.342 Section 236.342... Instructions § 236.342 Switch circuit controller. Switch circuit controller connected at the point to switch... corresponding to switch point closure when switch point is open one-fourth inch or more. Inspection and Tests ...

  14. 49 CFR 236.342 - Switch circuit controller.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false Switch circuit controller. 236.342 Section 236.342... Instructions § 236.342 Switch circuit controller. Switch circuit controller connected at the point to switch... corresponding to switch point closure when switch point is open one-fourth inch or more. Inspection and Tests ...

  15. 49 CFR 236.342 - Switch circuit controller.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Switch circuit controller. 236.342 Section 236.342... Instructions § 236.342 Switch circuit controller. Switch circuit controller connected at the point to switch... corresponding to switch point closure when switch point is open one-fourth inch or more. Inspection and Tests ...

  16. 49 CFR 236.342 - Switch circuit controller.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Switch circuit controller. 236.342 Section 236.342... Instructions § 236.342 Switch circuit controller. Switch circuit controller connected at the point to switch... corresponding to switch point closure when switch point is open one-fourth inch or more. Inspection and Tests ...

  17. 49 CFR 236.342 - Switch circuit controller.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Switch circuit controller. 236.342 Section 236.342... Instructions § 236.342 Switch circuit controller. Switch circuit controller connected at the point to switch... corresponding to switch point closure when switch point is open one-fourth inch or more. Inspection and Tests ...

  18. Patent foramen ovale closure versus medical therapy after cryptogenic stroke: An updated meta-analysis of all randomized clinical trials.

    PubMed

    Kheiri, Babikir; Abdalla, Ahmed; Osman, Mohammed; Ahmed, Sahar; Hassan, Mustafa; Bachuwa, Ghassan

    2018-03-07

    Cryptogenic strokes can be attributed to paradoxical emboli through patent foramen ovale (PFO). However, the effectiveness of PFO closure in preventing recurrent stroke is uncertain and the results of previous randomized clinical trials (RCTs) have been inconclusive. Hence, this study provides an updated meta-analysis of all RCTs comparing PFO closure with medical therapy for secondary prevention of cryptogenic stroke. All RCTs were identified by a comprehensive literature search of PubMed, Embase, the Cochrane Collaboration Central Register of Controlled Trials, Scopus, and Clinicaltrials.gov. The primary outcome was recurrent ischemic stroke and secondary outcomes were transient ischemic attack (TIA), all-cause mortality, new-onset atrial fibrillation (AF), serious adverse events, and major bleeding. 5 RCTs with 3440 participants were included in the present study (1829 patients underwent PFO closure and 1611 were treated medically). Pooled analysis showed a statistically significant reduction in the rate of recurrent stroke with PFO closure in comparison to medical therapy (OR 0.41; 95% CI 0.19-0.90; p = 0.03). However, there were no statistically significant reductions of recurrent TIAs (OR 0.77; 95% CI 0.51-1.14; p = 0.19) or all-cause mortality (OR 0.76; 95% CI 0.35-1.65; p = 0.48). The risk of developing new-onset AF was increased significantly with PFO closure (OR 4.74; 95% CI 2.33-9.61; p < 0.0001), but no significant differences in terms of serious adverse events or major bleeding between both groups. Patent foramen ovale closure in adults with recent cryptogenic stroke was associated with a lower rate of recurrent strokes in comparison with medical therapy alone.

  19. The receptor tyrosine kinase Pvr promotes tissue closure by coordinating corpse removal and epidermal zippering

    PubMed Central

    Garlena, Rebecca A.; Lennox, Ashley L.; Baker, Lewis R.; Parsons, Trish E.; Weinberg, Seth M.; Stronach, Beth E.

    2015-01-01

    A leading cause of human birth defects is the incomplete fusion of tissues, often manifested in the palate, heart or neural tube. To investigate the molecular control of tissue fusion, embryonic dorsal closure and pupal thorax closure in Drosophila are useful experimental models. We find that Pvr mutants have defects in dorsal midline closure with incomplete amnioserosa internalization and epidermal zippering, as well as cardia bifida. These defects are relatively mild in comparison to those seen with other signaling mutants, such as in the JNK pathway, and we demonstrate that JNK signaling is not perturbed by altering Pvr receptor tyrosine kinase activity. Rather, modulation of Pvr levels in the ectoderm has an impact on PIP3 membrane accumulation, consistent with a link to PI3K signal transduction. Polarized PI3K activity influences protrusive activity from the epidermal leading edge and the protrusion area changes in accord with Pvr signaling intensity, providing a possible mechanism to explain Pvr mutant phenotypes. Tissue-specific rescue experiments indicate a partial requirement in epithelial tissue, but confirm the essential role of Pvr in hemocytes for embryonic survival. Taken together, we argue that inefficient removal of the internalizing amnioserosa tissue by mutant hemocytes coupled with impaired midline zippering of mutant epithelium creates a situation in some embryos whereby dorsal midline closure is incomplete. Based on these observations, we suggest that efferocytosis (corpse clearance) could contribute to proper tissue closure and thus might underlie some congenital birth defects. PMID:26293306

  20. The association between pharmacy closures and prescription drug use: a retrospective analysis of Medicaid prescription claims in Iowa.

    PubMed

    Xiao, H; Sorofman, B; Manasse, H R

    2000-03-01

    The objectives of this study were 2-fold: (1) to examine the association of pharmacy closures with prescription drug use by Medicaid recipients in Iowa; and (2) to evaluate how drug utilization patterns differ between patients whose pharmacies closed and patients whose pharmacies remained open. A 2-group pretest-posttest study of Medicaid enrollees who may have been affected by pharmacy closures. Prescription medication use during the periods preceding and after pharmacy closures was compared. A comparison group was used to account for extraneous factors. Sixteen community pharmacies were selected from a pool of pharmacies that closed during 1994; 1092 patients were identified as the main users of these pharmacies, and a comparison group of 3491 patients whose main pharmacies had not closed also was identified. The average number of each patient's prescription claims for the 6 months preceding closing and the 6 months after closing was computed. Multiple regression analysis was conducted to determine whether any association existed between pharmacy closures and the use of prescription drugs. Patients whose pharmacies closed during 1994 had fewer prescription claims after the closings than before the closings. In contrast, patients whose pharmacies remained open had more prescription claims. This difference remains statistically significant after controlling for other factors, such as patient demographics and health status. A decrease in prescription drug use was associated with pharmacy closures. Attention should be directed to patient access to prescription medications in rural areas, as relatively more pharmacies close in rural areas.

  1. Co-activated yet disconnected-Neural correlates of eye closures when trying to stay awake.

    PubMed

    Ong, Ju Lynn; Kong, Danyang; Chia, Tiffany T Y; Tandi, Jesisca; Thomas Yeo, B T; Chee, Michael W L

    2015-09-01

    Spontaneous eye-closures that herald sleep onset become more frequent when we are sleep deprived. Although these are typically associated with decreased responsiveness to external stimuli, it is less clear what occurs in the brain at these transitions to drowsiness and light sleep. To investigate this, task-free fMRI of sleep-deprived participants was acquired. BOLD activity associated with periods of spontaneously occurring eye closures were marked and analyzed. We observed concurrent and extensive hypnagogic co-activation of the extrastriate visual, auditory, and somatosensory cortices as well as the default mode network, consistent with internal sensory activity without external stimulation. Co-activation of fronto-parietal areas known to mediate attentional control could correspond with participants resisting sleep or additional engagement of mental imagery. This constellation of signal changes differed from those elicited by cued eye closures of similar duration and distribution in the same, rested participants. They also differ from signal changes associated with mind-wandering and consolidated light sleep. Concurrent with the observed event-related changes, eye closures elicited additional reduction in functional connectivity within nodes of the DMN and DAN, superposed on already reduced connectivity associated with sleep deprivation. There was concurrent deactivation of the thalamus during eye-closure during the sleep-deprived state but almost similar changes occurred in the well-rested state that may also be relevant. These findings highlight the dynamic shifts in brain activity and connectivity at border between wakefulness and sleep. Copyright © 2015. Published by Elsevier Inc.

  2. Cost-effectiveness of Ward Closure to Control Outbreaks of Norovirus Infection in United Kingdom National Health Service Hospitals.

    PubMed

    Sadique, Zia; Lopman, Ben; Cooper, Ben S; Edmunds, W John

    2016-02-01

    Norovirus is the most common cause of outbreaks of acute gastroenteritis in National Health Service hospitals in the United Kingdom. Wards (units) are often closed to new admissions to stop the spread of the virus, but there is limited evidence describing the cost-effectiveness of ward closure. An economic analysis based on the results from a large, prospective, active-surveillance study of gastroenteritis outbreaks in hospitals and from an epidemic simulation study compared alternative ward closure options evaluated at different time points since first infection, assuming different efficacies of ward closure. A total of 232 gastroenteritis outbreaks occurring in 14 hospitals over a 1-year period were analyzed. The risk of a new outbreak in a hospital is significantly associated with the number of admission, general medical, and long-stay wards that are concurrently affected but is less affected by the level of community transmission. Ward closure leads to higher costs but reduces the number of new outbreaks by 6%-56% and the number of clinical cases by 1%-55%, depending on the efficacy of the intervention. The incremental cost per outbreak averted varies from £10 000 ($14 000) to £306 000 ($428 000), and the cost per case averted varies from £500 ($700) to £61 000 ($85 000). The cost-effectiveness of ward closure decreases as the efficacy of the intervention increases, and the cost-effectiveness increases with the timing of the intervention. The efficacy of ward closure is critical from a cost-effectiveness perspective. Ward closure may be cost-effective, particularly if targeted to high-throughput units. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  3. POLLUTANT CONTROL TECHNIQUES FOR PACKAGE BOILERS: HARDWARE MODIFICATIONS AND ALTERNATE FUELS

    EPA Science Inventory

    The report gives results of investigations of four ways to control nitrogen oxide (NOx) emissions from package boilers (both field operating boilers and boiler simulators): (1) variations in combustor operating procedure; (2) combustion modification (flue gas recirculation and st...

  4. 10 CFR 960.5-2-2 - Site ownership and control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and control. (a) Qualifying condition. The site shall be located on land for which the DOE can obtain... operation and closure will not be likely to lead to radionuclide releases to an unrestricted area greater...

  5. Summary Report on the Audit of Defense Base Realignment and Closure Budget Data

    DTIC Science & Technology

    1996-04-03

    management control program as it applied to the audit objectives. This report summarizes the results of the specific objectives in Finding A and discusses the management control objective in Finding B.

  6. Development of recommendations for arterial lane closures to optimize traffic operations.

    DOT National Transportation Integrated Search

    2013-01-01

    The 2010 FDOT Design Standards provide information regarding traffic control through work zones at multilane arterials. : However, there are currently no quantitative guidelines for optimizing signal control around work zones. The objective of this :...

  7. Authority defied: need for cognitive closure influences regulatory control when resisting authority.

    PubMed

    Damen, Tom G E; van Leeuwen, Matthijs L; Dijksterhuis, Ap; van Baaren, Rick B

    2014-08-01

    The present studies examined whether differences in need for cognitive closure (NCC) were related to differences in regulatory control when confronted with authority. In two studies, levels of regulatory control were measured when participants resisted (Study 1; N = 46) or prepared to resist the influence attempt of an authority figure (Study 2; N = 50). Results showed that resisting the influence attempt from a high-authority figure was more depleting for participants higher in NCC compared to individuals lower in NCC. However, when they were given instructions and time to prepare the act of resistance, individuals high in NCC actually showed an increase in regulatory control. Authority is usually viewed as a general principle of influence; however, the present studies suggest that there are individual differences that influence how people may experience interactions with authorities. © 2013 Wiley Periodicals, Inc.

  8. Effect of closure of live poultry markets on poultry-to-person transmission of avian influenza A H7N9 virus: an ecological study.

    PubMed

    Yu, Hongjie; Wu, Joseph T; Cowling, Benjamin J; Liao, Qiaohong; Fang, Vicky J; Zhou, Sheng; Wu, Peng; Zhou, Hang; Lau, Eric H Y; Guo, Danhuai; Ni, Michael Y; Peng, Zhibin; Feng, Luzhao; Jiang, Hui; Luo, Huiming; Li, Qun; Feng, Zijian; Wang, Yu; Yang, Weizhong; Leung, Gabriel M

    2014-02-08

    Transmission of the novel avian influenza A H7N9 virus seems to be predominantly between poultry and people. In the major Chinese cities of Shanghai, Hangzhou, Huzhou, and Nanjing--where most human cases of infection have occurred--live poultry markets (LPMs) were closed in April, 2013, soon after the initial outbreak, as a precautionary public health measure. Our objective was to quantify the effect of LPM closure in these cities on poultry-to-person transmission of avian influenza A H7N9 virus. We obtained information about every laboratory-confirmed human case of avian influenza A H7N9 virus infection reported in the four cities by June 7, 2013, from a database built by the Chinese Center for Disease Control and Prevention. We used data for age, sex, location, residence type (rural or urban area), and dates of illness onset. We obtained information about LPMs from official sources. We constructed a statistical model to explain the patterns in incidence of cases reported in each city on the basis of the assumption of a constant force of infection before LPM closure, and a different constant force of infection after closure. We fitted the model with Markov chain Monte Carlo methods. 85 human cases of avian influenza A H7N9 virus infection were reported in Shanghai, Hangzhou, Huzhou, and Nanjing by June 7, 2013, of which 60 were included in our main analysis. Closure of LPMs reduced the mean daily number of infections by 99% (95% credibility interval 93-100%) in Shanghai, by 99% (92-100%) in Hangzhou, by 97% (68-100%) in Huzhou, and by 97% (81-100%) in Nanjing. Because LPMs were the predominant source of exposure to avian influenza A H7N9 virus for confirmed cases in these cities, we estimated that the mean incubation period was 3·3 days (1·4-5·7). LPM closures were effective in the control of human risk of avian influenza A H7N9 virus infection in the spring of 2013. In the short term, LPM closure should be rapidly implemented in areas where the virus is identified in live poultry or people. In the long term, evidence-based discussions and deliberations about the role of market rest days and central slaughtering of all live poultry should be renewed. Ministry of Science and Technology, China; Research Fund for the Control of Infectious Disease; Hong Kong University Grants Committee; China-US Collaborative Program on Emerging and Re-emerging Infectious Diseases; Harvard Center for Communicable Disease Dynamics; and the US National Institutes of Health. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Catheter closure of patent foramen ovale in patients with cryptogenic cerebrovascular accidents: initial experiences in Japan.

    PubMed

    Kijima, Yasufumi; Akagi, Teiji; Nakagawa, Koji; Taniguchi, Manabu; Ueoka, Akira; Deguchi, Kentaro; Toh, Norihisa; Oe, Hiroki; Kusano, Kengo; Sano, Shunji; Ito, Hiroshi

    2014-01-01

    Although numerous studies have shown an association between a patent foramen ovale (PFO) and cryptogenic cerebrovascular accidents (CVA), there has been no definitive control study that demonstrated the benefit of percutaneous device closure of a PFO compared to medical therapy in patients with CVA. Additionally, few clinical data exist for Japanese patients in this field. We demonstrate the initial experiences in catheter closure of a PFO as secondary prevention of CVA in Japan. Catheter closure of a PFO was attempted in 7 patients who were diagnosed with cryptogenic CVA. Mean age at the procedure was 54 ± 19 years. The presence of spontaneous interatrial right-to-left shunts was demonstrated by transesophageal contrast echocardiography without Valsalva maneuver in all of the patients. Amplatzer Cribriform device (n = 4) or Amplatzer PFO Occluder (n = 3) was used for the procedure and was successfully deployed. Device-related complications were not observed at the time of the procedure or during the follow-up period (mean period of 16 ± 9 months). Catheter closure of a PFO could be safely performed with Amplatzer Cribriform or Amplatzer PFO Occluder. This procedure may contribute to prevention of recurrent cryptogenic CVA in Japanese patients.

  10. RCRA, superfund and EPCRA hotline training module. Introduction to: Closure/post-closure (40 cfr parts 264/265, subpart g) updated July 1996

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    1996-07-01

    The module explains the difference between closure and post-closure. It lists the types of facilities that are subject to closure/post-closures and defines the difference between partial and final closure. It specifies who submits a closure plan and when a closure plan must be submitted, lists the steps in the process, and states the time frame for submittal. It identifies when and how a closure must be amended. It explains the time frame for notification of closure and the deadlines for beginning and completing closure. It specifies which facilities need contingent post-closure plans and lists and the elements of post-closure andmore » cites the requirements. It specifies the conditions and timing for amending a post-closure plan and states who must certify closure/post-closure.« less

  11. ENGINEERED NEAR SURFACE DISPOSAL FACILITY OF THE INDUSTRIAL COMPLEX FOR SOLID RADWASTE MANAGEMENT AT CHERNOBYL NUCLEAR POWER PLANT

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ziehm, Ronny; Pichurin, Sergey Grigorevich

    2003-02-27

    As a part of the turnkey project ''Industrial Complex for Solid Radwaste Management (ICSRM) at the Chernobyl Nuclear Power Plant (ChNPP)'' an Engineered Near Surface Disposal Facility (ENSDF, LOT 3) will be built on the VEKTOR site within the 30 km Exclusion Zone of the ChNPP. This will be performed by RWE NUKEM GmbH, Germany, and it governs the design, licensing support, fabrication, assembly, testing, inspection, delivery, erection, installation and commissioning of the ENSDF. The ENSDF will receive low to intermediate level, short lived, processed/conditioned wastes from the ICSRM Solid Waste Processing Facility (SWPF, LOT 2), the ChNPP Liquid Radwastemore » Treatment Plant (LRTP) and the ChNPP Interim Storage Facility for RBMK Fuel Assemblies (ISF). The ENSDF has a capacity of 55,000 m{sup 3}. The primary functions of the ENSDF are: to receive, monitor and record waste packages, to load the waste packages into concrete disposal units, to enable capping and closure of the disposal unit s, to allow monitoring following closure. The ENSDF comprises the turnkey installation of a near surface repository in the form of an engineered facility for the final disposal of LILW-SL conditioned in the ICSRM SWPF and other sources of Chernobyl waste. The project has to deal with the challenges of the Chernobyl environment, the fulfillment of both Western and Ukrainian standards, and the installation and coordination of an international project team. It will be shown that proven technologies and processes can be assembled into a unique Management Concept dealing with all the necessary demands and requirements of a turnkey project. The paper emphasizes the proposed concepts for the ENSDF and their integration into existing infrastructure and installations of the VEKTOR site. Further, the paper will consider the integration of Western and Ukrainian Organizations into a cohesive project team and the requirement to guarantee the fulfillment of both Western standards and Ukrainian regulations and licensing requirements. The paper provides information on the output of the Detail Design and will reflect the progress of the design work.« less

  12. Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: a risk-based perspective.

    PubMed

    Markovic, Ingrid

    2007-09-01

    Leachables are chemical entities that migrate spontaneously from the final container closure system, packaging components and/or processing equipment under recommended conditions of product use and storage. Unlike leachables, extractables are generated under exaggerated temperature and time conditions in the presence of an appropriate solvent. Increasing evidence suggests that leachables may pose a safety risk by causing toxicity, carcinogenicity, immunogenicity and/or endocrine dysregulation. These substances may also alter product physico-chemical properties via interaction with the active pharmaceutical ingredient or the excipients in product vehicle, thereby adversely affecting the final product quality. The evaluation of leachable compounds begins with a thorough identification of extractable compounds released from the production and packaging components under exaggerated conditions. The set of observed extractables helps to identify possible targets to be monitored in a subsequent leachables study over extended time periods. Although extractables and leachables also present a challenge for the safe use of device components (e.g., metered dose inhalers, dry powder inhalers, nasal spray devices or various implants), this review focusses on a safety risk assessment for specified therapeutic biological protein products. Regulatory, safety and scientific considerations in evaluating extractables and leachables are discussed, along with strategies for the analytical identification, quantification and monitoring.

  13. Pressure disequilibria induced by rapid valve closure in noble gas extraction lines

    USGS Publications Warehouse

    Morgan, Leah; Davidheiser-Kroll, Brett

    2015-01-01

    Pressure disequilibria during rapid valve closures can affect calculated molar quantities for a range of gas abundance measurements (e.g., K-Ar geochronology, (U-Th)/He geochronology, noble gas cosmogenic chronology). Modeling indicates this effect in a system with a 10 L reservoir reaches a bias of 1% before 1000 pipette aliquants have been removed from the system, and a bias of 10% before 10,000 aliquants. Herein we explore the causes and effects of this problem, which is the result of volume changes during valve closure. We also present a solution in the form of an electropneumatic pressure regulator that can precisely control valve motion. This solution reduces the effect to ∼0.3% even after 10,000 aliquants have been removed from a 10 L reservoir.

  14. Pressure disequilibria induced by rapid valve closure in noble gas extraction lines

    NASA Astrophysics Data System (ADS)

    Morgan, Leah E.; Davidheiser-Kroll, Brett

    2015-06-01

    Pressure disequilibria during rapid valve closures can affect calculated molar quantities for a range of gas abundance measurements (e.g., K-Ar geochronology, (U-Th)/He geochronology, noble gas cosmogenic chronology). Modeling indicates this effect in a system with a 10 L reservoir reaches a bias of 1% before 1000 pipette aliquants have been removed from the system, and a bias of 10% before 10,000 aliquants. Herein we explore the causes and effects of this problem, which is the result of volume changes during valve closure. We also present a solution in the form of an electropneumatic pressure regulator that can precisely control valve motion. This solution reduces the effect to ˜0.3% even after 10,000 aliquants have been removed from a 10 L reservoir.

  15. Enlargement of the supraglottal cavity and its relation to stop consonant voicing.

    PubMed

    Westbury, J R

    1983-04-01

    Measurements were made of saggital plane movements of the larynx, soft palate, and portions of the tongue, from a high-speed cinefluorographic film of utterances produced by one adult male speaker of American English. These measures were then used to approximate the temporal variations in supraglottal cavity volume during the closures of voiced and voiceless stop consonants. All data were subsequently related to a synchronous acoustic recording of the utterances. Instances of /p,t,k/ were always accompanied by silent closures, and sometimes accompanied by decreases in supraglottal volume. In contrast, instances of /b,d,g/ were always accompanied both by significant intervals of vocal fold vibration during closure, and relatively large increases in supraglottal volume. However, the magnitudes of volume increments during the voiced stops, and the means by which those increments were achieved, differed considerably across place of articulation and phonetic environment. These results are discussed in the context of a well-known model of the breath-stream control mechanism, and their relevance for a general theory of speech motor control is considered.

  16. Growth of Small Cracks in Aeroengine Disc Materials.

    DTIC Science & Technology

    1988-06-01

    parameters is given in Figure 4-12. Al though the load required to open the crack (Pop) is the basic measurement in any crack closure study, this measurement...See Section 6.3). The latter observation supports the previous hypothesis of Hicks et al [4.11] that crack closure in these alloys is controlled by...cyclic stress relaxation on the local mean stress can be estimated from the measurements of Lindholm et al [5.21, obtained on the superalloy B1900+Hf

  17. Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes.

    PubMed

    Lu, Xujin; Lloyd, David K; Klohr, Steven E

    2016-01-01

    A feasibility study was conducted for a sensitive and robust dye immersion method for the measurement of container closure integrity of unopened prefilled syringes using fluorescence spectrophotometry as the detection method. A Varian Cary Eclipse spectrofluorometer was used with a custom-made sample holder to position the intact syringe in the sample compartment for fluorescence measurements. Methylene blue solution was initially evaluated as the fluorophore in a syringe with excitation at 607 nm and emission at 682 nm, which generated a limit of detection of 0.05 μg/mL. Further studies were conducted using rhodamine 123, a dye with stronger fluorescence. Using 480 nm excitation and 525 nm emission, the dye in the syringe could be easily detected at levels as low as 0.001 μg/mL. The relative standard deviation for 10 measurements of a sample of 0.005 μg/mL (with repositioning of the syringe after each measurement) was less than 1.1%. A number of operational parameters were optimized, including the photomultiplier tube voltage, excitation, and emission slit widths. The specificity of the testing was challenged by using marketed drug products and a protein sample, which showed no interference to the rhodamine detection. Results obtained from this study demonstrated that using rhodamine 123 for container closure integrity testing with in-situ (in-syringe) fluorescence measurements significantly enhanced the sensitivity and robustness of the testing and effectively overcame limitations of the traditional methylene blue method with visual or UV-visible absorption detection. Ensuring container closure integrity of injectable pharmaceutical products is necessary to maintain quality throughout the shelf life of a sterile drug product. Container closure integrity testing has routinely been used to evaluate closure integrity during product development and production line qualification of prefilled syringes, vials, and devices. However, container closure integrity testing has recently gained industry attention due to increased regulatory agency scrutiny regarding the analytical rigor of container closure integrity testing methods and expectations to use container closure integrity testing in lieu of sterility tests in stability programs. Methylene blue dye is often used for dye ingress testing of container closure integrity, but we found it unsuitable for reliable detection of small breaches in prefilled syringes of drug product. This work describes the suitability and advantages of using a fluorescent dye and spectroscopic detection for a robust, sensitive, and quality control-friendly container closure integrity testing method for prefilled syringes. © PDA, Inc. 2016.

  18. Can counter-advertising reduce pre-adolescent children's susceptibility to front-of-package promotions on unhealthy foods? Experimental research.

    PubMed

    Dixon, Helen; Scully, Maree; Kelly, Bridget; Chapman, Kathy; Wakefield, Melanie

    2014-09-01

    This study aimed to test whether counter-advertisements (i.e. messages contesting industry marketing) make pre-adolescent children less susceptible to the influence of food promotions. Since children have lower media literacy levels due to their immature cognitive abilities, specific research questions explored were: (1) whether the effectiveness of counter-ads is contingent on children having understood them; and (2) whether counter-ads may be detrimental when they are misinterpreted. A between-subjects experimental design using a web-based methodology was employed. 1351 grade 5-6 students (mean age 11 years) from schools located in metropolitan Melbourne, Australia participated. Participants were randomly shown an animated web banner advertisement (counter-ad challenging front-of-package promotion or control ad) and a pair of food packages from the same product category comprising an unhealthy product featuring a front-of-package promotion (nutrient content claim or sports celebrity endorsement) and a healthier control pack without a front-of-package promotion. Responses to the assigned advertisement, choice of product (healthy versus unhealthy) and ratings of the unhealthy product and front-of-package promotion on various nutritional and image-related attributes were recorded for each child. Sixty-six percent of children who viewed a counter-ad understood its main message. These children rated the front-of-package promotion as less believable and rated the unhealthy product bearing the front-of-package promotion as less healthy compared to the control group. However, children who misunderstood the counter-ad rated the unhealthy product bearing a front-of-package promotion as more healthy and rated the front-of-package promotion more favourably than those who correctly understood the counter-ad. Counter-advertising may have unintended consequences when misunderstood. If public health organizations or government pursue counter-advertising as a strategy to reduce the negative influence of unhealthy food marketing among children, caution is needed in designing counter-ads to guard against possible contradictory effects. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. [Effect of grain-bean package, grain-bean package dietary fiber and single whole grain dietary fiber on dyslipidemia rats].

    PubMed

    Liu, Yang; Zhai, Chengkai; Sun, Guiju; Zhang, Hong; Jiang, Mingxia; Zhang, Haifeng; Guo, Junling; Lan, Xi

    2014-05-01

    To observe and compare the effects of grain-bean package, dietary fiber (DF) extracted from grain-bean package, and DF from grain corn on the blood lipids and fatty acid synthase (FAS) activity in high-fat, high-cholesterol feeding induced dyslipidemia rats, and observe its effects on regulation of sterol regulatory element protein-1c (SREBP-1c) mRNA expression in rat liver. Consolidation 50 SD rats of clean grade feeding adaptation for one week, randomly assigned into normal control group, hyperlipidemia model group, grain-bean package group, grain-bean package DF group and grain corn group. Feed with corresponding diets for 8 weeks, and measure the total cholesterol (TC), triglyceridaemia (TG), high density lipoprotein cholesterol (HDL-C), fasting blood glucose (FBG), FAS, SREBP-1c mRNA of all groups. Compared with control group, TC, TG, FBG levels of hyperlipidemia model group were significantly increased (P < 0.05). Compared with model group, TC, TG, FBG levels of grain-bean package group, grain-bean package DF group were significantly decreased, HDL-C levels significantly increased, and activity of FAS, regulation of SREBP-1c were significantly decreased (P < 0.05). The Grain-bean package dietary fiber can improve blood lipids levels of dyslipidemia rats, and decrease FAS activity and SREBP-1c mRNA expression.

  20. Nickel elution properties of contemporary interatrial shunt closure devices.

    PubMed

    Verma, Divya Ratan; Khan, Muhammad F; Tandar, Anwar; Rajasekaran, Namakkal S; Neuharth, Renée; Patel, Amit N; Muhlestein, Joseph B; Badger, Rodney S

    2015-02-01

    We sought to compare nickel elution properties of contemporary interatrial shunt closure devices in vitro. There are two United States Food and Drug Administration (FDA)-approved devices for percutaneous closure of secundum atrial septal defect: the Amplatzer septal occluder (ASO; St Jude Medical Corporation) and Gore Helex septal occluder (HSO; W.L. Gore & Associates). The new Gore septal occluder (GSO) device is in clinical trials. These are also used off-label for patent foramen ovale closure in highly selected patients. These devices have high nickel content. Nickel allergy is the most common reason for surgical device explantation. Nickel elution properties of contemporary devices remain unknown. We compared nickel elution properties of 4 devices - ASO, GSO, HSO, and sternal wire (SW) - while Dulbecco's phosphate-buffered saline (DPBS) served as control. Three samples of each device were submerged in DPBS. Nickel content was measured at 14 intervals over 90 days. Nickel elution at 24 hours, compared to control (0.005 ± 0.0 mg/L), was significantly higher for ASO (2.98 ± 1.65 mg/L; P=.04) and SW (0.03 ± 0.014 mg/L; P=.03). Nickel levels at 90 days, compared to control (0.005 ± 0.0 mg/L) and adjusting for multiple comparisons, were significantly higher for ASO (19.80 ± 2.30 mg/L; P=.01) and similar for HSO (P=.34), GSO (P=.34), and SW (P=.34). ASO had significantly higher nickel elution compared to HSO, GSO, and SW (P=.01). There is substantial variability in nickel elution; devices with less exposed nickel (HSO and GSO) have minimal elution. The safety of low nickel elution devices in patients with nickel allergy needs to be evaluated in prospective trials.

  1. Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement.

    PubMed

    2016-09-01

    Hernia formation occurs at closed stoma sites in up to 30% of patients. The Reinforcement of Closure of Stoma Site (ROCSS) randomized controlled trial is evaluating whether placement of biological mesh during stoma closure safely reduces hernia rates compared with closure without mesh, without increasing surgical or wound complications. This paper aims to report recruitment, deliverability and safety from the internal feasibility study. A multicentre, patient and assessor blinded, randomized controlled trial, delivered through surgical trainee research networks. A 90-patient internal feasibility study assessed recruitment, randomization, deliverability and early (30 day) safety of the novel surgical technique (ClinicalTrials.gov registration number NCT02238964). The feasibility study recruited 90 patients from the 104 considered for entry (45 to mesh, 45 to no mesh). Seven of eight participating centres randomized patients within 30 days of opening. Overall, 41% of stomas were created for malignant disease and 73% were ileostomies. No mesh-specific complications occurred. Thirty-one postoperative adverse events were experienced by 31 patients, including surgical site infection (9%) and postoperative ileus (6%). One mesh was removed for re-access to the abdominal cavity, for reasons unrelated to the mesh. Independent review by the Data Monitoring and Ethics Committee of adverse event data by treatment allocation found no safety concerns. Multicentre randomization to this trial of biological mesh is feasible, with no early safety concerns. Progression to the full Phase III trial has continued. ROCSS shows that trainee research networks can efficiently develop and deliver complex interventional surgical trials. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

  2. Transabdominal Preperitoneal Herniorrhaphy using Laser-Assisted Tissue Soldering in a Porcine Model

    PubMed Central

    Soltz, Barbara A.; Stadler, Istvan; Soltz, Robert

    2009-01-01

    Background and Objectives: Collagen solder is capable of fixation of surgical meshes during laparoscopic herniorrhaphy without compromising tissue integration, increasing adhesions or inflammation. This pilot study describes development of instrumentation and techniques for transabdominal preperitoneal (TAPP) herniorrhaphy using laser-assisted soldering technology. Methods: Anesthetized 20-kg to 25-kg female Yorkshire pigs underwent laparoscopy performed using a 3-trocar technique. Peritoneal incisions were made and pockets created in the preperitoneal space for mesh placement. Parietex TEC mesh segments embedded in 60% collagen-solder were soldered to the muscle surface by using a prototype laser (1.45µ, 4.5W CW, 5mm spot, and 55°C set temperature) and custom laparoscopic handpiece. Parietex TEC mesh segments (Control) were affixed to the muscle with fibrin sealant (Tisseel). Peritoneal closure was with staples (Control) or by soldering collagen embedded Vicryl mesh segments over the peritoneal incision (Mesh/TAPP). Segments were inserted using a specially designed introducer. Animals were recovered and underwent second-look laparoscopy at 6 weeks postimplantation. Mesh sites were harvested after animals were euthanized. Results: The mesh-solder constructs were easily inserted and affixed in the TAPP approach. Tisseel tended to drip during application, particularly in vertical and ventral locations. Postoperative healing was similar to Control segments in all cases. Mesh/TAPP closures healed without scarring or adhesion formation. Discussion and Conclusion: Collagen-based tissue soldering permits normal wound healing and may mitigate or reduce use of staples for laparoscopic mesh fixation and peritoneal closure. Laser-assisted mesh fixation and peritoneal closure is a promising alternative for laparoscopic herniorrhaphy. Further development of this strategy is warranted. PMID:19660214

  3. T-tube drainage versus primary closure after open common bile duct exploration.

    PubMed

    Gurusamy, Kurinchi Selvan; Koti, Rahul; Davidson, Brian R

    2013-06-21

    Between 5% and 11% of people undergoing cholecystectomy have common bile duct stones. Stones may be removed at the time of cholecystectomy by opening and clearing the common bile duct. The optimal technique is unclear. The aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after open common bile duct exploration for common bile duct stones. We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until April 2013. We included all randomised clinical trials comparing T-tube drainage versus primary closure after open common bile duct exploration. Two of four authors independently identified the studies for inclusion and extracted data. We analysed the data with both the fixed-effect and the random-effects model using Review Manager (RevMan) analyses. For each outcome we calculated the risk ratio (RR), rate ratio (RaR), or mean difference (MD) with 95% confidence interval (CI) based on intention-to-treat analysis. We included six trials randomising 359 participants, 178 to T-tube drainage and 181 to primary closure. All trials were at high risk of bias. There was no significant difference in mortality between the two groups (4/178 (weighted percentage 1.2%) in the T-tube group versus 1/181 (0.6%) in the primary closure group; RR 2.25; 95% CI 0.55 to 9.25; six trials). There was no significant difference in the serious morbidity rate between the two groups (24/136 (weighted serious morbidity rate, 145 events per 1000 patients) in the T-tube group versus 9/136 (weighted serious morbidity rate, 66 events per 1000 patients) in the primary closure group; RaR 2.19; 95% CI 0.98 to 4.91; four trials). Quality of life and return to work were not reported in any of the trials. The operating time was significantly longer in the T-tube drainage group compared with the primary closure group (MD 28.90 minutes; 95% CI 17.18 to 40.62 minutes; one trial). The hospital stay was significantly longer in the T-tube drainage group compared with the primary closure group (MD 4.72 days; 95% CI 0.83 days to 8.60 days; five trials). T-tube drainage appeared to result in significantly longer operating time and hospital stay compared with primary closure without any apparent evidence of benefit on clinically important outcomes after open common bile duct exploration. Based on the currently available evidence, there is no justification for the routine use of T-tube drainage after open common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well designed randomised clinical trials. More randomised trials comparing the effects of T-tube drainage versus primary closure after open common bile duct exploration may be needed. Such trials should be conducted with low risk of bias and assessing the long-term beneficial and harmful effects of T-tube drainage, including long-term complications such as bile stricture and recurrence of common bile duct stones.

  4. Usefulness of a New Gelatin Glue Sealant System for Dural Closure in a Rat Durotomy Model

    PubMed Central

    KAWAI, Hisashi; NAKAGAWA, Ichiro; NISHIMURA, Fumihiko; MOTOYAMA, Yasushi; PARK, Young-Su; NAKAMURA, Mitsutoshi; NAKASE, Hiroyuki; SUZUKI, Shuko; IKADA, Yoshito

    2014-01-01

    Watertight dural closure is imperative after neurosurgical procedures, because inadequately treated leakage of cerebrospinal fluid (CSF) can have serious consequences. We used a rat durotomy model to test the usefulness of a new gelatin glue as a dural sealant in a rat model of transdural CSF leakage. All rats were randomly divided into one of the following three treatment groups: no application (control group: N = 18), application of fibrin glue (fibrin glue group: N = 18), and application of the new gelatin glue (new gelatin glue group: N = 18). The craniotomy side was re-opened, and CSF leakage was checked and recorded at 1, 7, and 28 days postoperatively. The new gelatin glue was adequate for stopping CSF leakage; no leakage was observed at postoperative days 1 or 7, and leakage was observed in only one rat at postoperative day 28. This result was statistically significant when compared to the control group (P = 0.002, P = 0.015, P = 0.015, respectively). The pathologic score of the new gelatin group was not different from that of the control or fibrin glue groups. We conclude that our new gelatin glue provides effective watertight closure 1, 7, and 28 days after operation in the rat durotomy model. PMID:25070015

  5. Packaging films for electronic and space-related hardware

    NASA Astrophysics Data System (ADS)

    Shon, E. M.; Hamberg, O.

    1985-08-01

    Flexible packaging films are used to bag and/or wrap precision cleaned electronic or space hardware to protect them from environmental degradation during shipping and storage. Selection of packaging films depends on a knowledge of product requirements and packaging film characteristics. The literature presently available on protective packaging films has been updated to include new materials and to amplify space-related applications. Presently available packaging film materials are compared for their various characteristics: electrostatic discharge (ESD) control, flame retardancy, water vapor transmission rate, particulate shedding, molecular contamination, and transparency. The tradeoff between product requirements and the characteristics of the packaging films available are discussed. Selection considerations are given for the application of specific materials of space hardware-related applications. Applications for intimate, environmental, and electrostatic protective packaging are discussed.

  6. 40 CFR 265.310 - Closure and post-closure care.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 27 2013-07-01 2013-07-01 false Closure and post-closure care. 265.310... DISPOSAL FACILITIES Landfills § 265.310 Closure and post-closure care. (a) At final closure of the landfill... subsoils present. (b) After final closure, the owner or operator must comply with all post-closure...

  7. 40 CFR 265.310 - Closure and post-closure care.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 27 2012-07-01 2012-07-01 false Closure and post-closure care. 265.310... DISPOSAL FACILITIES Landfills § 265.310 Closure and post-closure care. (a) At final closure of the landfill... subsoils present. (b) After final closure, the owner or operator must comply with all post-closure...

  8. 40 CFR 265.310 - Closure and post-closure care.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 26 2014-07-01 2014-07-01 false Closure and post-closure care. 265.310... DISPOSAL FACILITIES Landfills § 265.310 Closure and post-closure care. (a) At final closure of the landfill... subsoils present. (b) After final closure, the owner or operator must comply with all post-closure...

  9. Solar Water-Heater Design Package

    NASA Technical Reports Server (NTRS)

    1982-01-01

    Information on a solar domestic-hot water heater is contained in 146 page design package. System consists of solar collector, storage tanks, automatic control circuitry and auxiliary heater. Data-acquisition equipment at sites monitors day-by-day performance. Includes performance specifications, schematics, solar-collector drawings and drawings of control parts.

  10. 21 CFR 110.37 - Sanitary facilities and controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... food-packaging materials, or for employee sanitary facilities. (b) Plumbing. Plumbing shall be of... understandable signs directing employees handling unproteced food, unprotected food-packaging materials, of food... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Sanitary facilities and controls. 110.37 Section...

  11. Data Qualification Report For: Thermodynamic Data File, DATA0.YMP.R0 For Geochemical Code, EQ3/6 

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    P.L. Cloke

    The objective of this work is to evaluate the adequacy of chemical thermodynamic data provided by Lawrence Livermore National Laboratory (LLNL) as DataO.ymp.ROA in response to an input request submitted under AP-3.14Q. This request specified that chemical thermodynamic data available in the file, Data0.com.R2, be updated, improved, and augmented for use in geochemical modeling used in Process Model Reports (PMRs) for Engineered Barrier Systems, Waste Form, Waste Package, Unsaturated Zone, and Near Field Environment, as well as for Performance Assessment. The data are qualified in the temperature range 0 to 100 C. Several Data Tracking Numbers (DTNs) associated with Analysis/Modelmore » Reports (AMR) addressing various aspects of the post-closure chemical behavior of the waste package and the Engineered Barrier System that rely on EQ316 outputs to which these data are used as input, are Principal Factor affecting. This qualification activity was accomplished in accordance with the AP-SIII.2Q using the Technical Assessment method. A development plan, TDP-EBS-MD-000044, was prepared in accordance with AP-2.13Q and approved by the Responsible Manager. In addition, a Process Control Evaluation was performed in accordance with AP-SV.1Q. The qualification method, selected in accordance with AP-SIII.2Q, was Technical Assessment. The rationale for this approach is that the data in File Data0.com.R2 are considered Handbook data and therefore do not themselves require qualification. Only changes to Data0.com.R2 required qualification. A new file has been produced which contains the database Data0.ymp.R0, which is recommended for qualification as a result of this action. Data0.ymp.R0 will supersede Data0.com.R2 for all Yucca Mountain Project (YMP) activities.« less

  12. Packaging Technology for SiC High Temperature Circuits Operable up to 500 Degrees Centigrade

    NASA Technical Reports Server (NTRS)

    Chen, Lian-Yu

    2002-01-01

    New high temperature low power 8-pin packages have been fabricated using commercial fabrication service. These packages are made of aluminum nitride and 96 percent alumina with Au metallization. The new design of these packages provides the chips inside with EM shielding. Wirebond geometry control has been achieved for precise mechanical tests. Au wirebond samples with 45 degree heel-angle have been tested using wireloop test module. The geometry control improves the consistency of measurement of the wireloop breaking point.Also reported on is a parametric study of the thermomechanical reliability of a Au thick-film based SiC die-attach assembly using nonlinear finite element analysis (FEA) was conducted to optimize the die-attach thermo-mechanical performance for operation at temperatures from room temperature to 500 degrees Centigrade. This parametric study centered on material selection, structure design and process control.

  13. 76 FR 36627 - Required Warnings for Cigarette Packages and Advertisements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ...The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.

  14. Required warnings for cigarette packages and advertisements. Final rule.

    PubMed

    2011-06-22

    The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.

  15. Impact of Nisin-Activated Packaging on Microbiota of Beef Burgers during Storage

    PubMed Central

    Ferrocino, Ilario; Greppi, Anna; La Storia, Antonietta; Rantsiou, Kalliopi; Ercolini, Danilo

    2015-01-01

    Beef burgers were stored at 4°C in a vacuum in nisin-activated antimicrobial packaging. Microbial ecology analyses were performed on samples collected between days 0 and 21 of storage to discover the population diversity. Two batches were analyzed using RNA-based denaturing gradient gel electrophoresis (DGGE) and pyrosequencing. The active packaging retarded the growth of the total viable bacteria and lactic acid bacteria. Culture-independent analysis by pyrosequencing of RNA extracted directly from meat showed that Photobacterium phosphoreum, Lactococcus piscium, Lactobacillus sakei, and Leuconostoc carnosum were the major operational taxonomic units (OTUs) shared between control and treated samples. Beta diversity analysis of the 16S rRNA sequence data and RNA-DGGE showed a clear separation between two batches based on the microbiota. Control samples from batch B showed a significant high abundance of some taxa sensitive to nisin, such as Kocuria rhizophila, Staphylococcus xylosus, Leuconostoc carnosum, and Carnobacterium divergens, compared to control samples from batch A. However, only from batch B was it possible to find a significant difference between controls and treated samples during storage due to the active packaging. Predicted metagenomes confirmed differences between the two batches and indicated that the use of nisin-based antimicrobial packaging can determine a reduction in the abundance of specific metabolic pathways related to spoilage. The present study aimed to assess the viable bacterial communities in beef burgers stored in nisin-based antimicrobial packaging, and it highlights the efficacy of this strategy to prolong beef burger shelf life. PMID:26546424

  16. Remote control of astronomical instruments via the Internet

    NASA Astrophysics Data System (ADS)

    Ashley, M. C. B.; Brooks, P. W.; Lloyd, J. P.

    1996-01-01

    A software package called ERIC is described that provides a framework for allowing scientific instruments to be remotely controlled via the Internet. The package has been used to control four diverse astronomical instruments, and is now being made freely available to the community. For a description of ERIC's capabilities, and how to obtain a copy, see the conclusion to this paper.

  17. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  18. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  19. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  20. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

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