49 CFR 38.173 - Automated guideway transit vehicles and systems.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false Automated guideway transit vehicles and systems... DISABILITIES ACT (ADA) ACCESSIBILITY SPECIFICATIONS FOR TRANSPORTATION VEHICLES Other Vehicles and Systems § 38.173 Automated guideway transit vehicles and systems. (a) Automated Guideway Transit (AGT) vehicles and...

49 CFR 38.173 - Automated guideway transit vehicles and systems.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false Automated guideway transit vehicles and systems... DISABILITIES ACT (ADA) ACCESSIBILITY SPECIFICATIONS FOR TRANSPORTATION VEHICLES Other Vehicles and Systems § 38.173 Automated guideway transit vehicles and systems. (a) Automated Guideway Transit (AGT) vehicles and...

49 CFR 38.173 - Automated guideway transit vehicles and systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false Automated guideway transit vehicles and systems... DISABILITIES ACT (ADA) ACCESSIBILITY SPECIFICATIONS FOR TRANSPORTATION VEHICLES Other Vehicles and Systems § 38.173 Automated guideway transit vehicles and systems. (a) Automated Guideway Transit (AGT) vehicles and...

36 CFR 1192.173 - Automated guideway transit vehicles and systems.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TRANSPORTATION VEHICLES Other Vehicles and Systems § 1192.173 Automated guideway transit vehicles and systems. (a) Automated Guideway Transit (AGT) vehicles and systems, sometimes called “people movers”, operated in... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Automated guideway transit...

36 CFR 1192.173 - Automated guideway transit vehicles and systems.

Code of Federal Regulations, 2012 CFR

2012-07-01

... TRANSPORTATION VEHICLES Other Vehicles and Systems § 1192.173 Automated guideway transit vehicles and systems. (a) Automated Guideway Transit (AGT) vehicles and systems, sometimes called “people movers”, operated in... 36 Parks, Forests, and Public Property 3 2012-07-01 2012-07-01 false Automated guideway transit...

36 CFR 1192.173 - Automated guideway transit vehicles and systems.

Code of Federal Regulations, 2011 CFR

2011-07-01

... TRANSPORTATION VEHICLES Other Vehicles and Systems § 1192.173 Automated guideway transit vehicles and systems. (a) Automated Guideway Transit (AGT) vehicles and systems, sometimes called “people movers”, operated in... 36 Parks, Forests, and Public Property 3 2011-07-01 2011-07-01 false Automated guideway transit...

36 CFR 1192.173 - Automated guideway transit vehicles and systems.

Code of Federal Regulations, 2014 CFR

2014-07-01

... TRANSPORTATION VEHICLES Other Vehicles and Systems § 1192.173 Automated guideway transit vehicles and systems. (a) Automated Guideway Transit (AGT) vehicles and systems, sometimes called “people movers”, operated in... 36 Parks, Forests, and Public Property 3 2014-07-01 2014-07-01 false Automated guideway transit...

Assessment of Operational Automated Guideway Systems - Airtrans (Phase I)

DOT National Transportation Integrated Search

1976-09-01

This report presents the results of an evaluation study of AIRTRANS, a unique, automated guideway system located at the Dallas/Fort Worth Airport. AIRTRANS was designed to move passengers, employees, baggage, mail, trash and supplies. The newest and ...

Static characteristics design of hydrostatic guide-ways based on fluid-structure interactions

NASA Astrophysics Data System (ADS)

Lin, Shuo; Yin, YueHong

2016-10-01

With the raising requirements in micro optical systems, the available machines become hard to achieve the process dynamic and accuracy in all aspects. This makes compact design based on fluid/structure interactions (FSI) important. However, there is a difficulty in studying FSI with oil film as fluid domain. This paper aims at static characteristic design of a hydrostatic guide-way with capillary restrictors based on FSI. The pressure distribution of the oil film land is calculated by solving the Reynolds-equation with Galerkin technique. The deformation of structure is calculated by commercial FEM software, MSC. Nastran. A matlab program is designed to realize the coupling progress by modifying the load boundary in the submitting file and reading the deformation result. It's obvious that the stiffness of the hydrostatic bearing decreases with the weakening of the bearing structure. This program is proposed to make more precise prediction of bearing stiffness.

36 CFR § 1192.173 - Automated guideway transit vehicles and systems.

Code of Federal Regulations, 2013 CFR

2013-07-01

... TRANSPORTATION VEHICLES Other Vehicles and Systems § 1192.173 Automated guideway transit vehicles and systems. (a) Automated Guideway Transit (AGT) vehicles and systems, sometimes called “people movers”, operated in... 36 Parks, Forests, and Public Property 3 2013-07-01 2012-07-01 true Automated guideway transit...

Assessment of Operational Automated Guideway Systems - Airtrans (Phase II)

DOT National Transportation Integrated Search

1980-01-01

This study, Phase II, completes the assessment of AIRTRANS, the automated guideway system located at the Dallas-Fort Worth Airport. The Phase I assessment report: "Assessment of Operational Automated Guideway Systems--AIRTRANS (Phase I)" (PB-261 339)...

Experiments and Identification of the Unbalance of Aerostatic Guideways on the Micro-Scale

PubMed Central

Chen, Dongju; Bian, Yanhua; Fan, Jinwei

2014-01-01

In order to diagnose the unbalance of aerostatic guideways, displacement and acceleration sensors were used to measure the vibration signals of the unbalance of the aerostatic guideways caused by the gas fluctuation. The frequency characteristics for the unbalance of aerostatic guideways caused by gas fluctuation has been extracted from the measured signals by power spectral density, and the basic frequencies of the guideway system have been diagnosed according to spectral characteristics, in agreement with the results calculated by the corresponding motion equations and the finite element method. PMID:24603638

Magnetic superelevation design of Halbach permanent magnet guideway for high-temperature superconducting maglev

NASA Astrophysics Data System (ADS)

Lei, Wuyang; Qian, Nan; Zheng, Jun; Huang, Huan; Zhang, Ya; Deng, Zigang

2017-07-01

To improve the curve negotiating ability of high-temperature superconducting (HTS) maglev system, a special structure of magnetic superelevation for double-pole Halbach permanent magnet guideway (PMG) was designed. The most significant feature of this design is the asymmetrical PMG that forms a slanting magnetic field without affecting the smoothness of the PMG surface. When HTS maglev vehicle runs through curves with magnetic superelevation, the vehicle will slant due to asymmetry in magnetic field and the flux-pinning effect of onboard HTS bulks. At the same time, one component of the levitation force provides a part of the centripetal force that reduces lateral acceleration of the vehicle and thus enhances its curve negotiating ability. Furthermore, the slant angle of magnetic superelevation can be adjusted by changing the materials and the thickness of the added permanent magnets. This magnetic superelevation method, together with orographic uplift, can be applied to different requirements of PMG designs. Besides, the applicability of this method would benefit future development of high-speed HTS maglev system.

Automated Guideway Network Traffic Modeling

DOT National Transportation Integrated Search

1972-02-01

In the literature concerning automated guideway transportation systems, such as dual mode, a great deal of effort has been expended on the use of deterministic reservation schemes and the problem of merging streams of vehicles. However, little attent...

Automated Guideway Ground Transportation Network Simulation

DOT National Transportation Integrated Search

1975-08-01

The report discusses some automated guideway management problems relating to ground transportation systems and provides an outline of the types of models and algorithms that could be used to develop simulation tools for evaluating system performance....

Systems Operations Studies for Automated Guideway Transit Systems : System Availability Model Programmer's Manual

DOT National Transportation Integrated Search

1981-07-01

In order to examine specific automated guideway transit (AGT) developments and concepts, UMTA undertook a program of studies and technology investigations called Automated Guideway Transit Technology (AGTT) Program. The objectives of one segment of t...

System Operations Studies for Automated Guideway Transit Systems : Discrete Event Simulation Model Programmer's Manual

DOT National Transportation Integrated Search

1982-07-01

In order to examine specific automated guideway transit (AGT) developments and concepts, UMTA undertook a program of studies and technology investigations called Automated Guideway Transit Technology (AGTT) Program. The objectives of one segment of t...

Systems Operations Studies for Automated Guideway Transit Systems : Quantitative Analysis of Alternative AGT Operational Control Strategies

DOT National Transportation Integrated Search

1981-10-01

The objectives of the Systems Operation Studies (SOS) for automated guideway transit (AGT) systems are to develop models for the analysis of system operations, to evaluate performance and cost, and to establish guidelines for the design and operation...

Predicting automated guideway transit system station security requirements

DOT National Transportation Integrated Search

1980-03-01

This study addresses the issues of personal security on Automated Guideway Transit (AGT) Systems, as they might be deployed in typical urban residential and non-residential settings. Based upon a literature review, it outlines basic characteristics o...

Rail fixed guideway systems : state safety oversight : final rule

DOT National Transportation Integrated Search

1995-12-27

As required by the Intermodal Surface Transportation Efficiency Act of 1991, the Federal Transit Administration (FTA) issues a rule requiring states to oversee the safety of rail fixed guideway systems not regulated by the Federal Railroad Administra...

Extended System Operations Studies for Automated Guideway Transit Systems

DOT National Transportation Integrated Search

1982-02-01

The objectives of the System Operations Studies (SOS) of the Automated Guideway Transit Technology (AGTT) program was to develop models for the analysis of system operations, to evaluate AGT system performance and cost, and to establish guidelines fo...

Cost Experience of Automated Guideway Transit Systems (Supplement IV)

DOT National Transportation Integrated Search

1982-12-01

By the end of 1982, automated guideway transit (AGT) systems will have carried over 500 million passengers since their first commercial operation of the Tampa International Airport in 1971. To keep abreast of the domestic use of AGT systems in the U....

Systems Operation Studies for Automated Guideway Transit Systems : Summary Report

DOT National Transportation Integrated Search

1980-02-01

In order to examine specific Automated Guideway Transit (AGT) developments and concepts and to build a better knowledge base for future decision-making, UMTA has undertaken a new program of studies and technology investigations called the Urban Mass ...

Dynamics and controls in maglev systems

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

Cai, Y.; Chen, S.S.; Rote, D.M.

1992-09-01

The dynamic response of magnetically levitated (maglev) ground transportation systems has important consequences for safety and ride quality, guideway design, and system costs. Ride quality is determined by vehicle response and by environmental factors such as humidity and noise. The dynamic response of the vehicles is the key element in determining ride quality, and vehicle stability is an important safety-related element. To design a proper guideway that provides acceptable ride quality in the stable region, vehicle dynamics must be understood. Furthermore the trade-off between guideway smoothness and the levitation and control systems must be considered if maglev systems are tomore » be economically feasible. The link between the guideway and the other maglev components is vehicle dynamics. For a commercial maglev system, vehicle dynamics must be analyzed and tested in detail. In this study, the role of dynamics and controls in maglev vehicle/guideway interactions is discussed, and the literature on modeling the dynamic interactions of vehicle/guideway and suspension controls for ground vehicles is reviewed. Particular emphasis is placed on modeling vehicle/guideway interactions and response characteristics of maglev systems for a multicar, multiload vehicle traveling on a single- or doublespan flexible guideway, including coupling effects of vehicle/guideway, comparison of concentrated and distributed loads, and ride comfort. Different control-law designs are introduced into vehicle suspensions when a simple two-degree-of-freedom vehicle model is applied. Active and semiactive control designs for primary and secondary suspensions do improve the response of vehicle and provide acceptable ride comfort. Finally, future research associated with dynamics and controls of vehicle/guideway systems is identified.« less

Aerodynamic vibrations of a maglev vehicle running on flexible guideways under oncoming wind actions

NASA Astrophysics Data System (ADS)

Yau, J. D.

2010-05-01

This paper intends to present a computational framework of aerodynamic analysis for a maglev (magnetically levitated) vehicle traveling over flexible guideways under oncoming wind loads. The guideway unit is simulated as a series of simple beams with identical span and the maglev vehicle as a rigid car body supported by levitation forces. To carry out the interaction dynamics of maglev vehicle/guideway system, this study adopts an onboard PID (proportional-integral-derivative) controller based on Ziegler-Nicholas (Z-N) method to control the levitation forces. Interaction of wind with high-speed train is a complicated situation arising from unsteady airflow around the train. In this study, the oncoming wind loads acting on the running maglev vehicle are generated in temporal/spatial domain using digital simulation techniques that can account for the moving effect of vehicle's speed and the spatial correlation of stochastic airflow velocity field. Considering the motion-dependent nature of levitation forces and the non-conservative characteristics of turbulent airflows, an iterative approach is used to compute the interaction response of the maglev vehicle/guideway coupling system under wind actions. For the purpose of numerical simulation, this paper employs Galerkin's method to convert the governing equations containing a maglev vehicle into a set of differential equations in generalized systems, and then solve the two sets of differential equations using an iterative approach with the Newmark method. From the present investigation, the aerodynamic forces may result in a significant amplification on acceleration amplitude of the running maglev vehicle at higher speeds. For this problem, a PID+LQR (linear quadratic regulator) controller is proposed to reduce the vehicle's acceleration response for the ride comfort of passengers.

Simulation Models for the Electric Power Requirements in a Guideway Transit System

DOT National Transportation Integrated Search

1980-04-01

This report describes a computer simulation model developed at the Transportation Systems Center to study the electrical power distribution characteristics of Automated Guideway Transit (AGT) systems. The objective of this simulation effort is to pro...

A Concept for the Use and Integration of Super-Conducting Magnets in Structural Systems in General and Maglev Guideway Mega-Structures in Particular

NASA Technical Reports Server (NTRS)

Ussery, Wilfred T.; MacCalla, Eric; MacCalla, Johnetta; Elnimeiri, Mahjoub; Goldsmith, Myron; Polk, Sharon Madison; Jenkins, Mozella; Bragg, Robert H.

1996-01-01

Recent breakthroughs in several different fields now make it possible to incorporate the use of superconducting magnets in structures in ways which enhance the performance of structural members or components of structural systems in general and Maglev guideway mega-structures in particular. The building of structural systems which connect appropriately scaled superconducting magnets with the post-tensioned tensile components of beams, girders, or columns would, if coupled with 'state of the art' structure monitoring, feedback and control systems, and advanced computer software, constitute a distinct new generation of structures that would possess the unique characteristic of being heuristic and demand or live-load responsive. The holistic integration of powerful superconducting magnets in structures so that they do actual structural work, creates a class of 'technologically endowed' structures that, in part - literally substitute superconductive electric power and magnetism for concrete and steel. The research and development engineering, and architectural design issues associated with such 'technologically endowed' structural system can now be conceptualized, designed, computer simulates built and tested. The Maglev guideway mega-structure delineated herein incorporates these concepts, and is designed for operation in the median strip of U.S. Interstate Highway 5 from San Diego to Seattle an Vancouver, and possibly on to Fairbanks, Alaska. This system also fits in the median strip of U.S. Interstate Highway 55 and 95 North-South, and 80 and 10, East-West. As a Western Region 'Peace Dividend' project, it could become a National or Bi-National research, design and build, super turnkey project that would create thousands of jobs by applying superconducting, material science, electronic aerospace and other defense industry technologies to a multi-vehicle, multi-use Maglev guideway megastructure that integrates urban mass transit Lower Speed (0-100 mph), High Speed

Systems Operation Studies for Automated Guideway Transit Systems : Representative Application Areas for AGT

DOT National Transportation Integrated Search

1980-11-01

The purpose of the Application Area Definition task is to define the travel demands and guideway networks for a set of representative AGT system deployments. These demands and networks, when combined with detailed descriptions of the systems and thei...

Dynamics, stability, and control of maglev systems

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

Cai, Y.; Chen, S.S.; Rote, D.M.

1993-06-01

The dynamic response of maglev systems is important in several respects: Safety and ride quality, guideway design, and system costs. The dynamic response of vehicles is the key element in the determination of ride quality, and vehicle stability is one of the important elements relative to safety. To design a proper guideway that provides acceptable ride quality in the stable region, the vehicle dynamics must be understood. The trade-off between guideway smoothness and the levitation and control systems must be considered if maglev systems are to be economically feasible. This paper is a summary of our previous work on dynamics,more » stability and control of maglev systems. First of all, the importance of dynamics of vehicle/guideway of maglev systems is discussed. Emphasis is placed on the modeling vehicle/guideway interactions of maglev systems with a multicar, or multiload vehicle traversing on a single or double-span flexible guideway. Coupled effects of vehicle/guideway interactions in wide range of vehicle speeds with various vehicle and guideway parameters for maglev systems are investigated. Secondly, the alternative control designs of maglev vehicle suspension systems are investigated in this study to achieve safe, stable operation and acceptable ride comfort requires some form of vehicle motion control. Active and semi-active control law designs are introduced into primary and secondary suspensions of maglev vehicles. Finally, this paper discusses the stability of maglev systems based on experimental data, scoping calculations, and simple mathematical models. Divergence and flutter are obtained for coupled vibration of a three-degree-of-freedom maglev vehicle on a guideway consisting of double L-shaped aluminum segments. The theory and analysis developed in this study provides basic stability characteristics and identifies future research needs for maglev systems.« less

Dynamics, stability, and control of maglev systems

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

Cai, Y.; Chen, S.S.; Rote, D.M.

1993-01-01

The dynamic response of maglev systems is important in several respects: Safety and ride quality, guideway design, and system costs. The dynamic response of vehicles is the key element in the determination of ride quality, and vehicle stability is one of the important elements relative to safety. To design a proper guideway that provides acceptable ride quality in the stable region, the vehicle dynamics must be understood. The trade-off between guideway smoothness and the levitation and control systems must be considered if maglev systems are to be economically feasible. This paper is a summary of our previous work on dynamics,more » stability and control of maglev systems. First of all, the importance of dynamics of vehicle/guideway of maglev systems is discussed. Emphasis is placed on the modeling vehicle/guideway interactions of maglev systems with a multicar, or multiload vehicle traversing on a single or double-span flexible guideway. Coupled effects of vehicle/guideway interactions in wide range of vehicle speeds with various vehicle and guideway parameters for maglev systems are investigated. Secondly, the alternative control designs of maglev vehicle suspension systems are investigated in this study to achieve safe, stable operation and acceptable ride comfort requires some form of vehicle motion control. Active and semi-active control law designs are introduced into primary and secondary suspensions of maglev vehicles. Finally, this paper discusses the stability of maglev systems based on experimental data, scoping calculations, and simple mathematical models. Divergence and flutter are obtained for coupled vibration of a three-degree-of-freedom maglev vehicle on a guideway consisting of double L-shaped aluminum segments. The theory and analysis developed in this study provides basic stability characteristics and identifies future research needs for maglev systems.« less

Systems Operations Studies for Automated Guideway Transit Systems : Discrete Event Simulation Model User's Manual.

DOT National Transportation Integrated Search

1982-06-01

In order to examine specific Automated Guideway Transit (AGT) developments and concepts, and to build a better knowledge base for future decision-making, the Urban Mass Transportation Administration (UMTA) undertook a new program of studies and techn...

Design criteria for maglev structures

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

Sandberg, H.R.; Williams, J.R.

1997-05-01

Maglev systems represent an entirely new concept in transportation. They will not operate on nor share the right-of-way with any other system. It is important, therefore, that the guideways be designed and constructed so as to be economical, constructable, durable, adaptable, reliable, and readily maintained. Comparisons should be made with the current transportation systems, especially highways and railroads. Since most of the guideway will be elevated, the comparison should be with the bridges. The object of the comparisons should be to avoid the shortcomings of the other systems while building on their strengths. This paper develops in some detail designmore » and construction criteria that will ensure a good, long-lived performance of the maglev guideway. The importance of beauty should have a low priority in comparison to the other design criteria. Clean, simple details meeting other criteria will ensure an acceptable appearance. These criteria were used in evaluating the four maglev concepts developed for the National Maglev Initiative.« less

The influence of inhomogeneous magnetic field over a NdFeB guideway on levitation force of the HTS bulk maglev system

NASA Astrophysics Data System (ADS)

Zhao, Lifeng; Deng, Jiangtao; Li, Linbo; Feng, Ning; Wei, Pu; Lei, Wei; Jiang, Jing; Wang, Xiqin; Zhang, Yong; Zhao, Yong

2018-04-01

Dynamic responses of high temperature superconducting bulk to inhomogeneous magnetic field distribution of permanent magnet guideway, as well as enlarged amplitude of magnetic field obtained by partially covering the permanent magnet guideway (PMG) with iron sheets in different thickness, are investigated. Experiments show that the instantaneous levitation force increases with the increase of the variation rate of magnetic field (dB/dt). Meanwhile, inhomogeneous magnetic field from PMG causes the decay of levitation force. The decay of levitation force almost increases linearly with the increase of alternating magnetic field amplitude. It should be very important for the application of high-speed maglev system.

Safety of High Speed Magnetic Levitation Transportation Systems : Thermal Effects and Related Safety Issues of Typical Maglev Steel Guideways

DOT National Transportation Integrated Search

1994-09-01

This report presents a theoretical analysis predicting the temperature distribution, thermal deflections, and thermal stresses that may occur in typical steel Maglev guideways under the proposed Orlando FL thermal environment. Transient, finite eleme...

Preliminary design for a maglev development facility

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

Coffey, H.T.; He, J.L.; Chang, S.L.

1992-04-01

A preliminary design was made of a national user facility for evaluating magnetic-levitation (maglev) technologies in sizes intermediate between laboratory experiments and full-scale systems. A technical advisory committee was established and a conference was held to obtain advice on the potential requirements of operational systems and how the facility might best be configured to test these requirements. The effort included studies of multiple concepts for levitating, guiding, and propelling maglev vehicles, as well as the controls, communications, and data-acquisition and -reduction equipment that would be required in operating the facility. Preliminary designs for versatile, dual 2-MVA power supplies capable ofmore » powering attractive or repulsive systems were developed. Facility site requirements were identified. Test vehicles would be about 7.4 m (25 ft) long, would weigh form 3 to 7 metric tons, and would operate at speeds up to 67 m/s (150 mph) on a 3.3-km (2.05-mi) elevated guideway. The facility would utilize modular vehicles and guideways, permitting the substitution of levitation, propulsion, and guideway components of different designs and materials for evaluation. The vehicle would provide a test cell in which individual suspension or propulsion components or subsystems could be tested under realistic conditions. The system would allow economical evaluation of integrated systems under varying weather conditions and in realistic geometries.« less

Vibrational Properties of High- Superconductors Levitated Above a Bipolar Permanent Magnetic Guideway

NASA Astrophysics Data System (ADS)

Liu, Lu; Wang, Jiasu

2014-05-01

A bipolar permanent magnetic guideway (PMG) has a unique magnetic field distribution profile which may introduce a better levitation performance and stability to the high- superconducting (HTS) maglev system. The dynamic vibration properties of multiple YBCO bulks arranged into different arrays positioned above a bipolar PMG and free to levitate were investigated. The acceleration and resonance frequencies were experimentally measured, and the stiffness and damping coefficients were evaluated for dynamic stability. Results indicate that the levitation stiffness is closely related to the field-cooling-height and sample positioning. The damping ratio was found to be low and nonlinear for the Halbach bipolar HTS-PMG system.

Dynamic response characteristics of high temperature superconducting maglev systems: Comparison between Halbach-type and normal permanent magnet guideways

NASA Astrophysics Data System (ADS)

Wang, B.; Zheng, J.; Che, T.; Zheng, B. T.; Si, S. S.; Deng, Z. G.

2015-12-01

The permanent magnet guideway (PMG) is very important for the performance of the high temperature superconducting (HTS) system in terms of electromagnetic force and operational stability. The dynamic response characteristics of a HTS maglev model levitating on two types of PMG, which are the normal PMG with iron flux concentration and Halbach-type PMG, were investigated by experiments. The dynamic signals for different field-cooling heights (FCHs) and loading/unloading processes were acquired and analyzed by a vibration analyzer and laser displacement sensors. The resonant frequency, stiffness and levitation height of the model were discussed. It was found that the maglev model on the Halbach-type PMG has higher resonant frequency and higher vertical stiffness compared with the normal PMG. However, the low lateral stiffness of the model on the Halbach-type PMG indicates poor lateral stability. Besides, the Halbach-type PMG has better loading capacity than the normal PMG. These results are helpful to design a suitable PMG for the HTS system in practical applications.

High speed maglev design

DOEpatents

Rote, Donald M.; He, Jianliang; Coffey, Howard

1993-01-01

A propulsion and stabilization system for an inductive repulsion type magnetically levitated vehicle which is propelled and suspended by a system which includes dividing the superconducting magnets into two types: a strong field magnet which is located vertically below the vehicle for propulsion and guidance and a weak field superconducting magnet located at the ends of the vehicle for levitation and added guidance. Several proposed embodiments exist for the placement of the magnetic field shielding: locating the shielding on the vehicle, locating the shielding on the guideway, and locating the shielding on the guideway and adding shielding to the vertical undercarriage. In addition, the separation between the vehicle and the guideway can be controlled to reduce the exposure of the passenger cabin to magnetic fields.

High speed maglev design

DOEpatents

Rote, D.M.; Jianliang He; Coffey, H.

1993-10-19

A propulsion and stabilization system for an inductive repulsion type magnetically levitated vehicle which is propelled and suspended by a system which includes dividing the superconducting magnets into two types: a strong field magnet which is located vertically below the vehicle for propulsion and guidance and a weak field superconducting magnet located at the ends of the vehicle for levitation and added guidance. Several proposed embodiments exist for the placement of the magnetic field shielding: locating the shielding on the vehicle, locating the shielding on the guideway, and locating the shielding on the guideway and adding shielding to the vertical undercarriage. In addition, the separation between the vehicle and the guideway can be controlled to reduce the exposure of the passenger cabin to magnetic fields. 4 figures.

Automated guideway transit : an assessment of PRT and other new systems, including supporting panel reports : prepared at the request of the Senate Committee on Appropriations, Transportation Subcommittee

DOT National Transportation Integrated Search

1975-06-01

This assessment of Personal Rapid Transit and other forms of Automated Guideway : Transportation has been prepared in response to a request from Congress. The : scope of this assessment complements two other studies conducted by the Office : of Techn...

United States-Federal Republic of Germany cooperative study of planned magnetically levitated vehicle ride quality

DOT National Transportation Integrated Search

1979-10-01

The major goal of the second phase was to estimate the absolute comfort levels which would be associated with actual travel on highspeed, interurban, fixed-guideway, transportation systems. To accomplish this goal, the study design incorporated many ...

Improved high speed maglev design

DOEpatents

Rote, D.M.; He, Jianliang; Coffey, H.T.

1992-01-01

This report discusses a propulsion and stabilization system for an inductive repulsion type magnetically levitated vehicle which is propelled and suspended by a system which includes dividing the superconducting magnets into two types: a strong field magnet which is located vertically below the vehicle for propulsion and guidance and a weak field superconducting magnet located at the ends of the vehicle for levitation and added guidance. Several proposed embodiments exist for the placement of the magnetic field shielding: locating the shielding on the vehicle, locating the shielding on the guideway, and locating the shielding on the guideway and adding shielding to the vertical undercarriage. In addition, the separation between the be vehicle and the guideway can be controlled to reduce the exposure of the passenger cabin to magnetic fields.

Maglev guideway route alignment and right-of-way requirements

NASA Astrophysics Data System (ADS)

Carlton, S.; Andriola, T.

1992-12-01

The use of existing rights-of-way (ROW) is assessed for maglev systems by estimating trip times and land acquisition requirements for potential maglev corridors while meeting passenger comfort limits. Right-of-way excursions improve trip time but incur a cost for purchasing land. The final report documents findings of the eight tasks in establishing right-of-way feasibility by examining three city-pair corridors in detail and developing an approximation method for estimating route length and travel times in 20 additional city-pair corridor portions and 21 new corridors. The use of routes independent of existing railroad or highway right-of-way have trip time advantages and significantly reduce the need for aggressive guideway geometries on intercity corridors. Selection of the appropriate alignment is determined by many corridor specific issues. Use of existing intercity rights-of-way may be appropriate for parts of routes on a corridor-specific basis and for urban penetration where vehicle speeds are likely to be reduced by policy due to noise and safety considerations, and where land acquisition costs are high. Detailed aspects of available rights-of-way, land acquisition costs, geotechnical issues, land use, and population centers must be examined in more detail on a specific corridor basis before the proper or best maglev alignment can be chosen.

Dynamic analysis of the American Maglev system. Final report

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

Seda-Sanabria, Y.; Ray, J.C.

1996-06-01

Understanding the dynamic interaction between a magnetic levitated (Maglev) vehicle and its supporting guideway is essential in the evaluation of the performance of such a system. This interacting coupling, known as vehicle/guideway interaction (VGI), has a significant effect on system parameters such as the required magnetic suspension forces and gaps, vehicular ride quality, and guideway deflections and stresses. This report presents the VGI analyses conducted on an actual Maglev system concept definition (SCD), the American Maglev SCD, using a linear-elastic finite-element (FE) model. Particular interest was focused on the comparison of the ride quality of the vehicle, using two differentmore » suspension systems, and their effect on the guideway structure. The procedure and necessary assumptions in the modeling are discussed.« less

Maglev performance of a double-layer bulk high temperature superconductor above a permanent magnet guideway

NASA Astrophysics Data System (ADS)

Deng, Z.; Wang, J.; Zheng, J.; Lin, Q.; Zhang, Y.; Wang, S.

2009-05-01

In order to improve the performance of the present high temperature superconducting (HTS) maglev vehicle system, the maglev performance of single- and double-layer bulk high temperature superconductors (HTSC) was investigated above a permanent magnet guideway (PMG). It is found that the maglev performance of a double-layer bulk HTSC is not a simple addition of each layer's levitation and guidance force. Moreover, the applied magnetic field at the position of the upper layer bulk HTSC is not completely shielded by the lower layer bulk HTSC either. 53.5% of the levitation force and 27.5% of the guidance force of the upper layer bulk HTSC are excited in the double-layer bulk HTSC arrangement in the applied field-cooling condition and working gap, bringing a corresponding improvement of 16.9% and 8.8% to the conventional single-layer bulk HTSC. The present research implies that the cost performance of upper layer bulk HTSC is a little low for the whole HTS maglev system.

Study to Establish Ride Comfort Criteria for High Speed Magnetically Levitated Transportation Systems

DOT National Transportation Integrated Search

1994-06-01

Advanced high speed fixed guideway transportation systems such as magnetic levitation systems have speed, acceleration, : and banking capabilities which present new guideway design issues. This increased performance results in new concerns : for pass...

Design of an ultraprecision computerized numerical control chemical mechanical polishing machine and its implementation

NASA Astrophysics Data System (ADS)

Zhang, Chupeng; Zhao, Huiying; Zhu, Xueliang; Zhao, Shijie; Jiang, Chunye

2018-01-01

The chemical mechanical polishing (CMP) is a key process during the machining route of plane optics. To improve the polishing efficiency and accuracy, a CMP model and machine tool were developed. Based on the Preston equation and the axial run-out error measurement results of the m circles on the tin plate, a CMP model that could simulate the material removal at any point on the workpiece was presented. An analysis of the model indicated that lower axial run-out error led to lower material removal but better polishing efficiency and accuracy. Based on this conclusion, the CMP machine was designed, and the ultraprecision gas hydrostatic guideway and rotary table as well as the Siemens 840Dsl numerical control system were incorporated in the CMP machine. To verify the design principles of machine, a series of detection and machining experiments were conducted. The LK-G5000 laser sensor was employed for detecting the straightness error of the gas hydrostatic guideway and the axial run-out error of the gas hydrostatic rotary table. A 300-mm-diameter optic was chosen for the surface profile machining experiments performed to determine the CMP efficiency and accuracy.

Comprehensive comparison of the levitation performance of bulk YBaCuO arrays above two different types of magnetic guideways

NASA Astrophysics Data System (ADS)

Deng, Zigang; Qian, Nan; Che, Tong; Jin, Liwei; Si, Shuaishuai; Zhang, Ya; Zheng, Jun

2016-12-01

The permanent magnet guideway (PMG) is an important part of high temperature superconducting (HTS) maglev systems. So far, two types of PMG, the normal PMG and Halbach-type PMG, are widely applied in present maglev transportation systems. In this paper, the levitation performance of high temperature superconductor bulks above the two PMGs was synthetically compared. Both static levitation performance and dynamic response characteristics were investigated. Benefiting from the reasonable magnetic field distribution, the Halbach-type PMG is able to gain larger levitation force, greater levitation force decay during the same relaxation time, bigger resonance frequency and dynamic stiffness for the bulk superconductor levitation unit compared with the normal PMG. Another finding is that the Halbach-type PMG is not sensitive to the levitation performance of the bulk levitation unit with different arrays. These results are helpful for the practical application of HTS maglev systems.

Handling Qualities Optimization for Rotorcraft Conceptual Design

NASA Technical Reports Server (NTRS)

Lawrence, Ben; Theodore, Colin R.; Berger, Tom

2016-01-01

Over the past decade, NASA, under a succession of rotary-wing programs has been moving towards coupling multiple discipline analyses in a rigorous consistent manner to evaluate rotorcraft conceptual designs. Handling qualities is one of the component analyses to be included in a future NASA Multidisciplinary Analysis and Optimization framework for conceptual design of VTOL aircraft. Similarly, the future vision for the capability of the Concept Design and Assessment Technology Area (CD&A-TA) of the U.S Army Aviation Development Directorate also includes a handling qualities component. SIMPLI-FLYD is a tool jointly developed by NASA and the U.S. Army to perform modeling and analysis for the assessment of flight dynamics and control aspects of the handling qualities of rotorcraft conceptual designs. An exploration of handling qualities analysis has been carried out using SIMPLI-FLYD in illustrative scenarios of a tiltrotor in forward flight and single-main rotor helicopter at hover. Using SIMPLI-FLYD and the conceptual design tool NDARC integrated into a single process, the effects of variations of design parameters such as tail or rotor size were evaluated in the form of margins to fixed- and rotary-wing handling qualities metrics as well as the vehicle empty weight. The handling qualities design margins are shown to vary across the flight envelope due to both changing flight dynamic and control characteristics and changing handling qualities specification requirements. The current SIMPLI-FLYD capability and future developments are discussed in the context of an overall rotorcraft conceptual design process.

Design optimization for cost and quality: The robust design approach

NASA Technical Reports Server (NTRS)

Unal, Resit

1990-01-01

Designing reliable, low cost, and operable space systems has become the key to future space operations. Designing high quality space systems at low cost is an economic and technological challenge to the designer. A systematic and efficient way to meet this challenge is a new method of design optimization for performance, quality, and cost, called Robust Design. Robust Design is an approach for design optimization. It consists of: making system performance insensitive to material and subsystem variation, thus allowing the use of less costly materials and components; making designs less sensitive to the variations in the operating environment, thus improving reliability and reducing operating costs; and using a new structured development process so that engineering time is used most productively. The objective in Robust Design is to select the best combination of controllable design parameters so that the system is most robust to uncontrollable noise factors. The robust design methodology uses a mathematical tool called an orthogonal array, from design of experiments theory, to study a large number of decision variables with a significantly small number of experiments. Robust design also uses a statistical measure of performance, called a signal-to-noise ratio, from electrical control theory, to evaluate the level of performance and the effect of noise factors. The purpose is to investigate the Robust Design methodology for improving quality and cost, demonstrate its application by the use of an example, and suggest its use as an integral part of space system design process.

Chip Design Process Optimization Based on Design Quality Assessment

NASA Astrophysics Data System (ADS)

Häusler, Stefan; Blaschke, Jana; Sebeke, Christian; Rosenstiel, Wolfgang; Hahn, Axel

2010-06-01

Nowadays, the managing of product development projects is increasingly challenging. Especially the IC design of ASICs with both analog and digital components (mixed-signal design) is becoming more and more complex, while the time-to-market window narrows at the same time. Still, high quality standards must be fulfilled. Projects and their status are becoming less transparent due to this complexity. This makes the planning and execution of projects rather difficult. Therefore, there is a need for efficient project control. A main challenge is the objective evaluation of the current development status. Are all requirements successfully verified? Are all intermediate goals achieved? Companies often develop special solutions that are not reusable in other projects. This makes the quality measurement process itself less efficient and produces too much overhead. The method proposed in this paper is a contribution to solve these issues. It is applied at a German design house for analog mixed-signal IC design. This paper presents the results of a case study and introduces an optimized project scheduling on the basis of quality assessment results.

Ares Project Overview - Quality in Design

NASA Technical Reports Server (NTRS)

Cianciola, Chris; Crane, Kenneth

2008-01-01

This presentation introduces the audience to the overall goals of the Ares Project, which include providing human access to low-Earth orbit, the Moon, and beyond. The presentation also provides an overview of with the vehicles that will execute those goals and progress made on the vehicles to date. The briefing will provide an introduction to Lean, Six Sigma, and Kaizen practices Ares will use to improve the overall effectiveness and quality of its efforts. Finally, the briefing includes a summary of Safety and Mission Assurance practices being implemented within[Ares to ensure safety and quality early in the design process. Integrating Safety and Mission Assurance in Design: This presentation describes how the Ares Projects are learning from the successes and failures of previous launch systems in order to maximize safety and reliability while maintaining fiscal responsibility. The Ares Projects are integrating Safer T and Mission Assurance into design activities and embracing independent assessments by Quality experts in thorough reviews of designs and processes. Incorporating Lean thinking into the design process, Ares is also streamlining existing processes and future manufacturing flows which will yield savings during production. Understanding the value of early involvement of Quality experts, the Ares Projects are leading launch vehicle development into the 21st century.

Course Design Using the House of Quality

ERIC Educational Resources Information Center

Peters, Michael H.; Kethley, R. Bryan; Bullington, Kimball

2005-01-01

This article reports on the use of the House of Quality to facilitate the design of a required operations management course in an MBA program. The House of Quality is a relatively new approach that is used in product or service design and total quality management. The faculty identified the decision issues it felt would be pertinent to the design…

Flux-canceling electrodynamic maglev suspension. Part 1: Test fixture design and modeling

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

Thompson, M.T.; Thornton, R.D.; Kondoleon, A.

1999-05-01

The design and analysis of a scale-model suspension test facility for magnetic levitation (maglev) is discussed. The authors describe techniques for the design, construction, and testing of a prototype electrodynamic suspension (EDS) levitation system. The viability of future high-temperature superconducting magnet designs for maglev has been investigated with regard to their application to active secondary suspensions. In order to test the viability of a new flux-canceling EDS suspension, a 1/5-scale suspension magnet and guideway was constructed. The suspension was tested by using a high-speed rotating test wheel facility with linear peripheral speed of up to 84 m/s (300 km/h). Amore » set of approximate design tools and scaling laws has been developed in order to evaluate forces and critical velocities in the suspension.« less

Incorporating Handling Qualities Analysis into Rotorcraft Conceptual Design

NASA Technical Reports Server (NTRS)

Lawrence, Ben

2014-01-01

This paper describes the initial development of a framework to incorporate handling qualities analyses into a rotorcraft conceptual design process. In particular, the paper describes how rotorcraft conceptual design level data can be used to generate flight dynamics models for handling qualities analyses. Also, methods are described that couple a basic stability augmentation system to the rotorcraft flight dynamics model to extend analysis to beyond that of the bare airframe. A methodology for calculating the handling qualities characteristics of the flight dynamics models and for comparing the results to ADS-33E criteria is described. Preliminary results from the application of the handling qualities analysis for variations in key rotorcraft design parameters of main rotor radius, blade chord, hub stiffness and flap moment of inertia are shown. Varying relationships, with counteracting trends for different handling qualities criteria and different flight speeds are exhibited, with the action of the control system playing a complex part in the outcomes. Overall, the paper demonstrates how a broad array of technical issues across flight dynamics stability and control, simulation and modeling, control law design and handling qualities testing and evaluation had to be confronted to implement even a moderately comprehensive handling qualities analysis of relatively low fidelity models. A key outstanding issue is to how to 'close the loop' with an overall design process, and options for the exploration of how to feedback handling qualities results to a conceptual design process are proposed for future work.

Morgantown People Mover Collision Avoidance System Design Summary

DOT National Transportation Integrated Search

1980-09-01

The Morgantown People Mover (MPM) is an automated two-mode (schedule and demand) transit system that consists of a fleet of electrically powered, rubber-tired, passenger-carrying vehicles operating on a dedicated guideway under computer control. The ...

Correlations Between Magnetic Flux and Levitation Force of HTS Bulk Above a Permanent Magnet Guideway

NASA Astrophysics Data System (ADS)

Huang, Huan; Zheng, Jun; Zheng, Botian; Qian, Nan; Li, Haitao; Li, Jipeng; Deng, Zigang

2017-10-01

In order to clarify the correlations between magnetic flux and levitation force of the high-temperature superconducting (HTS) bulk, we measured the magnetic flux density on bottom and top surfaces of a bulk superconductor while vertically moving above a permanent magnet guideway (PMG). The levitation force of the bulk superconductor was measured simultaneously. In this study, the HTS bulk was moved down and up for three times between field-cooling position and working position above the PMG, followed by a relaxation measurement of 300 s at the minimum height position. During the whole processes, the magnetic flux density and levitation force of the bulk superconductor were recorded and collected by a multipoint magnetic field measurement platform and a self-developed maglev measurement system, respectively. The magnetic flux density on the bottom surface reflected the induced field in the superconductor bulk, while on the top, it reveals the penetrated magnetic flux. The results show that the magnetic flux density and levitation force of the bulk superconductor are in direct correlation from the viewpoint of inner supercurrent. In general, this work is instructive for understanding the connection of the magnetic flux density, the inner current density and the levitation behavior of HTS bulk employed in a maglev system. Meanwhile, this magnetic flux density measurement method has enriched present experimental evaluation methods of maglev system.

Relationship of the Levitation Force Between Single and Multiple YBCO Bulks Above a Permanent Magnet Guideway Operating Dive-Lift Movement with Different Angles

NASA Astrophysics Data System (ADS)

Zeng, R.; Wang, S. Y.; Liao, X. L.; Deng, Z. G.; Wang, J. S.

2013-04-01

In practical applications, the acceleration and deceleration motions inevitably happen in the operation of high temperature superconducting (HTS) maglev trains. For further research of the maglev properties of YBaCuO bulk above a permanent magnet guideway (PMG), by moving a fixed vertical distance, this paper studies the relationship of the levitation force between single and multiple YBCO bulks above a PMG operating dive-lift movement with different angles. Experimental results show that the maximal levitation force increment of two bulks than one bulk is smaller than the maximal levitation force increment of three bulks than two bulks. With the degree decreasing, the maximal levitation force increment of three bulks is bigger than the maximal levitation force increment of two bulks and one bulk, and the hysteresis loop of the levitation force of the three-bulk arrangement is getting smaller.

Quality By Design: Concept To Applications.

PubMed

Swain, Suryakanta; Padhy, Rabinarayan; Jena, Bikash Ranjan; Babu, Sitty Manohar

2018-03-08

Quality by Design is associated to the modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also leads to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify desire and required product performance report such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality attributes (CQA). This review highlighted about the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected and consistently manufacture the required product. Risk assessment tools and design of experiments are its prime components. This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. This article provides a complete data as well as the road map for universal implementation and application of QbD for pharmaceutical products. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Computation of magnetic suspension of maglev systems using dynamic circuit theory

NASA Technical Reports Server (NTRS)

He, J. L.; Rote, D. M.; Coffey, H. T.

1992-01-01

Dynamic circuit theory is applied to several magnetic suspensions associated with maglev systems. These suspension systems are the loop-shaped coil guideway, the figure-eight-shaped null-flux coil guideway, and the continuous sheet guideway. Mathematical models, which can be used for the development of computer codes, are provided for each of these suspension systems. The differences and similarities of the models in using dynamic circuit theory are discussed in the paper. The paper emphasizes the transient and dynamic analysis and computer simulation of maglev systems. In general, the method discussed here can be applied to many electrodynamic suspension system design concepts. It is also suited for the computation of the performance of maglev propulsion systems. Numerical examples are presented in the paper.

Rotorcraft handling-qualities design criteria development

NASA Technical Reports Server (NTRS)

Aiken, Edwin W.; Lebacqz, J. Victor; Chen, Robert T. N.; Key, David L.

1988-01-01

Joint NASA/Army efforts at the Ames Research Center to develop rotorcraft handling-qualities design criteria began in earnest in 1975. Notable results were the UH-1H VSTOLAND variable stability helicopter, the VFA-2 camera-and-terrain-board simulator visual system, and the generic helicopter real-time mathematical model, ARMCOP. An initial series of handling-qualities studies was conducted to assess the effects of rotor design parameters, interaxis coupling, and various levels of stability and control augmentation. The ability to conduct in-flight handling-qualities research was enhanced by the development of the NASA/Army CH-47 variable-stability helicopter. Research programs conducted using this vehicle include vertical-response investigations, hover augmentation systems, and the effects of control-force characteristics. The handling-qualities data base was judged to be sufficient to allow an update of the military helicopter handling-qualities specification, MIL-H-8501. These efforts, including not only the in-house experimental work but also contracted research and collaborative programs performed under the auspices of various international agreements. The report concludes by reviewing the topics that are currently most in need of work, and the plans for addressing these topics.

The pitch-heave dynamics of transportation vehicles

NASA Technical Reports Server (NTRS)

Sweet, L. M.; Richardson, H. H.

1975-01-01

The analysis and design of suspensions for vehicles of finite length using pitch-heave models is presented. Dynamic models for the finite length vehicle include the spatial distribution of the guideway input disturbance over the vehicle length, as well as both pitch and heave degrees-of-freedom. Analytical results relate the vehicle front and rear accelerations to the pitch and heave natural frequencies, which are functions of vehicle suspension geometry and mass distribution. The effects of vehicle asymmetry and suspension contact area are evaluated. Design guidelines are presented for the modification of vehicle and suspension parameters to meet alternative ride quality criteria.

77 FR 30087 - Air Quality Designations for the 2008 Ozone National Ambient Air Quality Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

...This rule establishes initial air quality designations for most areas in the United States, including areas of Indian country, for the 2008 primary and secondary national ambient air quality standards (NAAQS) for ozone. The designations for several counties in Illinois, Indiana, and Wisconsin that the EPA is considering for inclusion in the Chicago nonattainment area will be designated in a subsequent action, no later than May 31, 2012. Areas designated as nonattainment are also being classified by operation of law according to the severity of their air quality problems. The classification categories are Marginal, Moderate, Serious, Severe, and Extreme. The EPA is establishing the air quality thresholds that define the classifications in a separate rule that the EPA is signing and publishing in the Federal Register on the same schedule as these designations. In accordance with that separate rule, six nonattainment areas in California are being reclassified to a higher classification.

Magnetic and levitation characteristics of bulk high-temperature superconducting magnets above a permanent magnet guideway

NASA Astrophysics Data System (ADS)

Zheng, Jun; Zheng, Botian; He, Dabo; Sun, Ruixue; Deng, Zigang; Xu, Xun; Dou, Shixue

2016-09-01

Due to the large levitation force or the large guidance force of bulk high-temperature superconducting magnets (BHTSMs) above a permanent magnet guideway (PMG), it is reasonable to employ pre-magnetized BHTSMs to replace applied-magnetic-field-cooled superconductors in a maglev system. There are two combination modes between the BHTSM and the PMG, distinguished by the different directions of the magnetization. One is the S-S pole mode, and the other is the S-N pole mode combined with a unimodal PMG segment. A multi-point magnetic field measurement platform was employed to acquire the magnetic field signals of the BHTSM surface in real time during the pre-magnetization process and the re-magnetization process. Subsequently, three experimental aspects of levitation, including the vertical movement due to the levitation force, the lateral movement due to the guidance force, and the force relaxation with time, were explored above the PMG segment. Moreover, finite element modeling by COMSOL Multiphysics has been performed to simulate the different induced currents and the potentially different temperature rises with different modes inside the BHTSM. It was found that the S-S pole mode produced higher induced current density and a higher temperature rise inside the BHTSM, which might escalate its lateral instability above the PMG. The S-N pole mode exhibits the opposite characteristics. In general, this work is instructive for understanding and connecting the magnetic flux, the inner current density, the levitation behavior, and the temperature rise of BHTSMs employed in a maglev system.

United States-Federal Republic of Germany cooperative study of advanced ground vehicle ride quality

DOT National Transportation Integrated Search

1979-11-01

In the first phase of this study, the relative comfort : assoiciated with various speed-guideway configurations for a proposed : magnetically levitated vehicle (Figure 1) and for a currently : operating Bundesbahn rail-coach were determined. The ride...

Design Quality in the Context of Healthcare Environments: A Scoping Review

PubMed Central

Anåker, Anna; Heylighen, Ann; Nordin, Susanna; Elf, Marie

2016-01-01

Objective: We explored the concept of design quality in relation to healthcare environments. In addition, we present a taxonomy that illustrates the wide range of terms used in connection with design quality in healthcare. Background: High-quality physical environments can promote health and well-being. Developments in healthcare technology and methodology put high demands on the design quality of care environments, coupled with increasing expectations and demands from patients and staff that care environments be person centered, welcoming, and accessible while also supporting privacy and security. In addition, there are demands that decisions about the design of healthcare architecture be based on the best available information from credible research and the evaluation of existing building projects. Method: The basic principles of Arksey and O’Malley’s model of scoping review design were used. Data were derived from literature searches in scientific databases. A total of 18 articles and books were found that referred to design quality in a healthcare context. Results: Design quality of physical healthcare environments involves three different themes: (i) environmental sustainability and ecological values, (ii) social and cultural interactions and values, and (iii) resilience of the engineering and building construction. Design quality was clarified herein with a definition. Conclusions: Awareness of what is considered design quality in relation to healthcare architecture could help to design healthcare environments based on evidence. To operationalize the concept, its definition must be clear and explicit and able to meet the complex needs of the stakeholders in a healthcare context, including patients, staff, and significant others. PMID:28643560

Design Quality in the Context of Healthcare Environments: A Scoping Review.

PubMed

Anåker, Anna; Heylighen, Ann; Nordin, Susanna; Elf, Marie

2017-07-01

We explored the concept of design quality in relation to healthcare environments. In addition, we present a taxonomy that illustrates the wide range of terms used in connection with design quality in healthcare. High-quality physical environments can promote health and well-being. Developments in healthcare technology and methodology put high demands on the design quality of care environments, coupled with increasing expectations and demands from patients and staff that care environments be person centered, welcoming, and accessible while also supporting privacy and security. In addition, there are demands that decisions about the design of healthcare architecture be based on the best available information from credible research and the evaluation of existing building projects. The basic principles of Arksey and O'Malley's model of scoping review design were used. Data were derived from literature searches in scientific databases. A total of 18 articles and books were found that referred to design quality in a healthcare context. Design quality of physical healthcare environments involves three different themes: (i) environmental sustainability and ecological values, (ii) social and cultural interactions and values, and (iii) resilience of the engineering and building construction. Design quality was clarified herein with a definition. Awareness of what is considered design quality in relation to healthcare architecture could help to design healthcare environments based on evidence. To operationalize the concept, its definition must be clear and explicit and able to meet the complex needs of the stakeholders in a healthcare context, including patients, staff, and significant others.

Spectrum analysis on quality requirements consideration in software design documents.

PubMed

Kaiya, Haruhiko; Umemura, Masahiro; Ogata, Shinpei; Kaijiri, Kenji

2013-12-01

Software quality requirements defined in the requirements analysis stage should be implemented in the final products, such as source codes and system deployment. To guarantee this meta-requirement, quality requirements should be considered in the intermediate stages, such as the design stage or the architectural definition stage. We propose a novel method for checking whether quality requirements are considered in the design stage. In this method, a technique called "spectrum analysis for quality requirements" is applied not only to requirements specifications but also to design documents. The technique enables us to derive the spectrum of a document, and quality requirements considerations in the document are numerically represented in the spectrum. We can thus objectively identify whether the considerations of quality requirements in a requirements document are adapted to its design document. To validate the method, we applied it to commercial software systems with the help of a supporting tool, and we confirmed that the method worked well.

Soft qualities in healthcare. Method and tools for soft qualities design in hospitals' built environments.

PubMed

Capolongo, S; Bellini, E; Nachiero, D; Rebecchi, A; Buffoli, M

2014-01-01

The design of hospital environments is determined by functional requirements and technical regulations, as well as numerous protocols, which define the structure and system characteristics that such environments need to achieve. In order to improve people's well-being and the quality of their experience within public hospitals, design elements (soft qualities) are added to those 'necessary' features. The aim of this research has been to experiment a new design process and also to create health care spaces with high environmental quality and capable to meet users' emotional and perceptual needs. Such needs were investigated with the help of qualitative research tools and the design criteria for one of these soft qualities - colour - were subsequently defined on the basis of the findings. The colour scheme design for the new San Paolo Hospital Emergency Department in Milan was used as case study. Focus groups were fundamental in defining the project's goals and criteria. The issues raised have led to believe that the proper procedure is not the mere consultation of the users in order to define the goals: users should rather be involved in the whole design process and become co-agents of the choices that determine the environment characteristics, so as to meet the quality requirements identified by the users themselves. The case study has shown the possibility of developing a designing methodology made by three steps (or operational tools) in which users' groups are involved in the choices, loading to plan the environments where compliance with expectations is already implied and verified by means of the process itself. Thus, the method leads to the creation of soft qualities in Healthcare.

Instructional Design and Online Learning: A Quality Assurance Study

ERIC Educational Resources Information Center

Monroe, Rose M.

2011-01-01

The purpose of this study was to investigate the difference in the evaluations of online course quality using the Quality Matters model among four groups of reviewers: instructional designers, faculty with subject-matter expertise, peer faculty with no subject-matter expertise, and administrators. A causal-comparative design was utilized to…

The Impact of Culture on Instructional Design and Quality

ERIC Educational Resources Information Center

Sharif, Afsaneh; Gisbert, Merce

2015-01-01

The purpose of this study was to investigate the effect of cultural differences, i.e. different contexts and backgrounds, on instructional designers' perspectives of quality in online environments. Using a questionnaire developed based on the Quality Matters rubric, we found designers in Canada focus slightly more on Learner Support strategies…

Design and Establishment of Quality Model of Fundamental Geographic Information Database

NASA Astrophysics Data System (ADS)

Ma, W.; Zhang, J.; Zhao, Y.; Zhang, P.; Dang, Y.; Zhao, T.

2018-04-01

In order to make the quality evaluation for the Fundamental Geographic Information Databases(FGIDB) more comprehensive, objective and accurate, this paper studies and establishes a quality model of FGIDB, which formed by the standardization of database construction and quality control, the conformity of data set quality and the functionality of database management system, and also designs the overall principles, contents and methods of the quality evaluation for FGIDB, providing the basis and reference for carry out quality control and quality evaluation for FGIDB. This paper designs the quality elements, evaluation items and properties of the Fundamental Geographic Information Database gradually based on the quality model framework. Connected organically, these quality elements and evaluation items constitute the quality model of the Fundamental Geographic Information Database. This model is the foundation for the quality demand stipulation and quality evaluation of the Fundamental Geographic Information Database, and is of great significance on the quality assurance in the design and development stage, the demand formulation in the testing evaluation stage, and the standard system construction for quality evaluation technology of the Fundamental Geographic Information Database.

Pharmaceutical product development: A quality by design approach

PubMed Central

Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

Pharmaceutical product development: A quality by design approach.

PubMed

Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

Tailoring recombinant protein quality by rational media design.

PubMed

Brühlmann, David; Jordan, Martin; Hemberger, Jürgen; Sauer, Markus; Stettler, Matthieu; Broly, Hervé

2015-01-01

Clinical efficacy and safety of recombinant proteins are closely associated with their structural characteristics. The major quality attributes comprise glycosylation, charge variants (oxidation, deamidation, and C- & N-terminal modifications), aggregates, low-molecular-weight species (LMW), and misincorporation of amino acids in the protein backbone. Cell culture media design has a great potential to modulate these quality attributes due to the vital role of medium in mammalian cell culture. The purpose of this review is to provide an overview of the way both classical cell culture medium components and novel supplements affect the quality attributes of recombinant therapeutic proteins expressed in mammalian hosts, allowing rational and high-throughput optimization of mammalian cell culture media. A selection of specific and/or potent inhibitors and activators of oligosaccharide processing as well as components affecting multiple quality attributes are presented. Extensive research efforts in this field show the feasibility of quality engineering through media design, allowing to significantly modulate the protein function. © 2015 American Institute of Chemical Engineers.

Design and analysis of an electromagnetic turnout for the superconducting Maglev system

NASA Astrophysics Data System (ADS)

Li, Y. J.; Dai, Q.; Zhang, Y.; Wang, H.; Chen, Z.; Sun, R. X.; Zheng, J.; Deng, C. Y.; Deng, Z. G.

2016-09-01

Turnout is a crucial track junction device of the ground rail transportation system. For high temperature superconducting (HTS) Maglev system, the permanent magnet guideway (PMG) makes the strong magnetic force existing between rail segments, which may cause moving difficulties and increase the operation cost when switching a PMG. In this paper, a non-mechanical 'Y' shaped Halbach-type electromagnetic turnout was proposed. By replacing the PMs with electromagnets, the turnout can guide the maglev vehicle running into another PMG by simply controlling the current direction of electromagnets. The material and structure parameters of the electromagnets were optimized by simulation. The results show that the optimized electromagnet can keep the magnetic field above it as strong as the PMs', meanwhile feasible for design and manufacture. This work provides valuable references for the future design in non-mechanical PMG turnout.

Taguchi Approach to Design Optimization for Quality and Cost: An Overview

NASA Technical Reports Server (NTRS)

Unal, Resit; Dean, Edwin B.

1990-01-01

Calibrations to existing cost of doing business in space indicate that to establish human presence on the Moon and Mars with the Space Exploration Initiative (SEI) will require resources, felt by many, to be more than the national budget can afford. In order for SEI to succeed, we must actually design and build space systems at lower cost this time, even with tremendous increases in quality and performance requirements, such as extremely high reliability. This implies that both government and industry must change the way they do business. Therefore, new philosophy and technology must be employed to design and produce reliable, high quality space systems at low cost. In recognizing the need to reduce cost and improve quality and productivity, Department of Defense (DoD) and National Aeronautics and Space Administration (NASA) have initiated Total Quality Management (TQM). TQM is a revolutionary management strategy in quality assurance and cost reduction. TQM requires complete management commitment, employee involvement, and use of statistical tools. The quality engineering methods of Dr. Taguchi, employing design of experiments (DOE), is one of the most important statistical tools of TQM for designing high quality systems at reduced cost. Taguchi methods provide an efficient and systematic way to optimize designs for performance, quality, and cost. Taguchi methods have been used successfully in Japan and the United States in designing reliable, high quality products at low cost in such areas as automobiles and consumer electronics. However, these methods are just beginning to see application in the aerospace industry. The purpose of this paper is to present an overview of the Taguchi methods for improving quality and reducing cost, describe the current state of applications and its role in identifying cost sensitive design parameters.

Discrete State Change Model of Manufacturing Quality to Aid Assembly Process Design

NASA Astrophysics Data System (ADS)

Koga, Tsuyoshi; Aoyama, Kazuhiro

This paper proposes a representation model of the quality state change in an assembly process that can be used in a computer-aided process design system. In order to formalize the state change of the manufacturing quality in the assembly process, the functions, operations, and quality changes in the assembly process are represented as a network model that can simulate discrete events. This paper also develops a design method for the assembly process. The design method calculates the space of quality state change and outputs a better assembly process (better operations and better sequences) that can be used to obtain the intended quality state of the final product. A computational redesigning algorithm of the assembly process that considers the manufacturing quality is developed. The proposed method can be used to design an improved manufacturing process by simulating the quality state change. A prototype system for planning an assembly process is implemented and applied to the design of an auto-breaker assembly process. The result of the design example indicates that the proposed assembly process planning method outputs a better manufacturing scenario based on the simulation of the quality state change.

Analytical quality by design: a tool for regulatory flexibility and robust analytics.

PubMed

Peraman, Ramalingam; Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

2015-01-01

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

PubMed Central

Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

2015-01-01

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT). PMID:25722723

Pharmaceutical quality by design: product and process development, understanding, and control.

PubMed

Yu, Lawrence X

2008-04-01

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

Quality-control design for surface-water sampling in the National Water-Quality Network

USGS Publications Warehouse

Riskin, Melissa L.; Reutter, David C.; Martin, Jeffrey D.; Mueller, David K.

2018-04-10

The data-quality objectives for samples collected at surface-water sites in the National Water-Quality Network include estimating the extent to which contamination, matrix effects, and measurement variability affect interpretation of environmental conditions. Quality-control samples provide insight into how well the samples collected at surface-water sites represent the true environmental conditions. Quality-control samples used in this program include field blanks, replicates, and field matrix spikes. This report describes the design for collection of these quality-control samples and the data management needed to properly identify these samples in the U.S. Geological Survey’s national database.

Quality cell therapy manufacturing by design.

PubMed

Lipsitz, Yonatan Y; Timmins, Nicholas E; Zandstra, Peter W

2016-04-01

Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.

The AMT maglev test sled -- EML weapons technology transition to transportation

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

Schaaf, J.C. Jr.; Zowarka, R.C. Jr.; Davey, K.

1997-01-01

Technology spinoffs from prior electromagnetic launcher work enhance a magnetic levitation transportation system test bed being developed by American Maglev Technology of Florida. This project uses a series wound linear DC motor and brushes to simplify the magnetic levitation propulsion system. It takes advantage of previous related work in electromagnetic launcher technology to achieve success with this innovative design. Technology and knowledge gained from developments for homopolar generators and proposed railgun arc control are key to successful performance. This contribution supports a cost effective design that is competitive with alternative concepts. Brushes transfer power from the guideway (rail) to themore » vehicle (armature) in a novel design that activates the guideway only under the vehicle, reducing power losses and guideway construction costs. The vehicle carries no power for propulsion and levitation, and acts only as a conduit for the power through the high speed brushes. Brush selection and performance is based on previous EML homopolar generator research. A counterpulse circuit, first introduced in an early EML conference, is used to suppress arcing on the trailing brush and to transfer inductive energy to the next propulsion coil. Isolated static lift and preliminary propulsion tests have been completed, and integrated propulsion and lift tests are scheduled in early 1996.« less

Performance Evaluation of an Air-Levitated, Air-Propelled, Passive Vehicle Personal Rapid Transit System

DOT National Transportation Integrated Search

1975-06-01

An eight-passenger Uniflo vehicle was tested to 30 ft/sec on enclosed guideway through curved straight and switch sections. The following parameters were measured: ride quality, as 3 axis acceleration; noise emission as perceived by passengers and in...

Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control.

PubMed

Westgard, James O; Westgard, Sten A

2017-03-01

Six sigma concepts provide a quality management system (QMS) with many useful tools for managing quality in medical laboratories. This Six Sigma QMS is driven by the quality required for the intended use of a test. The most useful form for this quality requirement is the allowable total error. Calculation of a sigma-metric provides the best predictor of risk for an analytical examination process, as well as a design parameter for selecting the statistical quality control (SQC) procedure necessary to detect medically important errors. Simple point estimates of sigma at medical decision concentrations are sufficient for laboratory applications. Copyright © 2016 Elsevier Inc. All rights reserved.

78 FR 47191 - Air Quality Designations for the 2010 Sulfur Dioxide (SO2) Primary National Ambient Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

... Air Quality Designations for the 2010 Sulfur Dioxide (SO[bdi2]) Primary National Ambient Air Quality... air quality designations for certain areas in the United States for the 2010 primary Sulfur Dioxide... of this document? III. What is sulfur dioxide? IV. What is the 2010 SO 2 NAAQS and what are the...

On Design Experiment Teaching in Engineering Quality Cultivation

ERIC Educational Resources Information Center

Chen, Xiao

2008-01-01

Design experiment refers to that designed and conducted by students independently and is surely an important method to cultivate students' comprehensive quality. According to the development and requirements of experimental teaching, this article carries out a study and analysis on the purpose, significance, denotation, connotation and…

Incorporating Servqual-QFD with Taguchi Design for optimizing service quality design

NASA Astrophysics Data System (ADS)

Arbi Hadiyat, M.

2018-03-01

Deploying good service design in service companies has been updated issue in improving customer satisfaction, especially based on the level of service quality measured by Parasuraman’s SERVQUAL. Many researchers have been proposing methods in designing the service, and some of them are based on engineering viewpoint, especially by implementing the QFD method or even using robust Taguchi method. The QFD method would found the qualitative solution by generating the “how’s”, while Taguchi method gives more quantitative calculation in optimizing best solution. However, incorporating both QFD and Taguchi has been done in this paper and yields better design process. The purposes of this research is to evaluate the incorporated methods by implemented it to a case study, then analyze the result and see the robustness of those methods to customer perception of service quality. Started by measuring service attributes using SERVQUAL and find the improvement with QFD, the deployment of QFD solution then generated by defining Taguchi factors levels and calculating the Signal-to-noise ratio in its orthogonal array, and optimized Taguchi response then found. A case study was given for designing service in local bank. Afterward, the service design obtained from previous analysis was then evaluated and shows that it was still meet the customer satisfaction. Incorporating QFD and Taguchi has performed well and can be adopted and developed for another research for evaluating the robustness of result.

Air quality considerations for stormwater green street design.

PubMed

Shaneyfelt, Kathryn M; Anderson, Andrew R; Kumar, Prashant; Hunt, William F

2017-12-01

Green streets are increasingly being used as a stormwater management strategy to mitigate stormwater runoff at its source while providing other environmental and societal benefits, including connecting pedestrians to the street. Simultaneously, human exposure to particulate matter from urban transportation is of major concern worldwide due to the proximity of pedestrians, drivers, and cyclists to the emission sources. Vegetation used for stormwater treatment can help designers limit the exposure of people to air pollutants. This goal can be achieved through the deliberate placement of green streets, along with strategic planting schemes that maximize pollutant dispersion. This communication presents general design considerations for green streets that combine stormwater management and air quality goals. There is currently limited guidance on designing green streets for air quality considerations; this is the first communication to offer suggestions and advice for the design of green stormwater streets in regards to their effects on air quality. Street characteristics including (1) the width to height ratio of the street to the buildings, (2) the type of trees and their location, and (3) any prevailing winds can have an impact on pollutant concentrations within the street and along sidewalks. Vegetation within stormwater control measures has the ability to reduce particulate matter concentrations; however, it must be carefully selected and placed within the green street to promote the dispersion of air flow. Copyright © 2017 Elsevier Ltd. All rights reserved.

Quality assurance program guidelines for application to and use by manufacturers of rail/guideway vehicles, buses, automatic train control systems, and their major subsystems

NASA Technical Reports Server (NTRS)

Witkin, S. A.

1976-01-01

Guidelines are presented for a quality assurance system to be implemented by the manufacturer in support of designing, developing, fabricating, assembling, inspecting, testing, handling, and delivery of equipment being procured for use in public urban mass transit systems. The guidelines apply to this equipment when being procured for: (1) use in revenue service; (2) demonstration of systems that will be revenue producing or used by the public; (3) use as a prototype for follow-on operational/revenue producing equipment procurements; and (4) qualification tests.

49 CFR 611.105 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... public transportation and other high occupancy vehicles, or uses a fixed catenary system and a right of... rail, commuter rail, automated guideway transit, people movers, ferry boat service, and fixed-guideway facilities for buses (such as bus rapid transit) and other high occupancy vehicles. A new fixed guideway...

49 CFR 611.105 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... public transportation and other high occupancy vehicles, or uses a fixed catenary system and a right of... rail, commuter rail, automated guideway transit, people movers, ferry boat service, and fixed-guideway facilities for buses (such as bus rapid transit) and other high occupancy vehicles. A new fixed guideway...

Taguchi experimental design to determine the taste quality characteristic of candied carrot

NASA Astrophysics Data System (ADS)

Ekawati, Y.; Hapsari, A. A.

2018-03-01

Robust parameter design is used to design product that is robust to noise factors so the product’s performance fits the target and delivers a better quality. In the process of designing and developing the innovative product of candied carrot, robust parameter design is carried out using Taguchi Method. The method is used to determine an optimal quality design. The optimal quality design is based on the process and the composition of product ingredients that are in accordance with consumer needs and requirements. According to the identification of consumer needs from the previous research, quality dimensions that need to be assessed are the taste and texture of the product. The quality dimension assessed in this research is limited to the taste dimension. Organoleptic testing is used for this assessment, specifically hedonic testing that makes assessment based on consumer preferences. The data processing uses mean and signal to noise ratio calculation and optimal level setting to determine the optimal process/composition of product ingredients. The optimal value is analyzed using confirmation experiments to prove that proposed product match consumer needs and requirements. The result of this research is identification of factors that affect the product taste and the optimal quality of product according to Taguchi Method.

[Quality by design approaches for pharmaceutical development and manufacturing of Chinese medicine].

PubMed

Xu, Bing; Shi, Xin-Yuan; Wu, Zhi-Sheng; Zhang, Yan-Ling; Wang, Yun; Qiao, Yan-Jiang

2017-03-01

The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory. The holistic design aims at constructing both the quality problem space from the patient requirement and the quality solution space from multidisciplinary knowledge. Holistic information analysis emphasizes understanding the quality pattern of Chinese medicine by integrating and mining multisource data and information at a relatively high level. The batch-to-batch quality consistence and manufacturing system reliability can be realized by comprehensive application of inspective quality control, statistical quality control, predictive quality control and intelligent quality control strategies. Holistic process optimization is to improve the product quality and process capability during the product lifecycle management. The implementation of QbD is useful to eliminate the ecosystem contradictions lying in the pharmaceutical development and manufacturing process of Chinese medicine product, and helps guarantee the cost effectiveness. Copyright© by the Chinese Pharmaceutical Association.

Design of agricultural product quality safety retrospective supervision system of Jiangsu province

NASA Astrophysics Data System (ADS)

Wang, Kun

2017-08-01

In store and supermarkets to consumers can trace back agricultural products through the electronic province card to query their origin, planting, processing, packaging, testing and other important information and found that the problems. Quality and safety issues can identify the responsibility of the problem. This paper designs a retroactive supervision system for the quality and safety of agricultural products in Jiangsu Province. Based on the analysis of agricultural production and business process, the goal of Jiangsu agricultural product quality safety traceability system construction is established, and the specific functional requirements and non-functioning requirements of the retroactive system are analyzed, and the target is specified for the specific construction of the retroactive system. The design of the quality and safety traceability system in Jiangsu province contains the design of the overall design, the trace code design and the system function module.

Co-designing for quality: Creating a user-driven tool to improve quality in youth mental health services.

PubMed

Hackett, Christina L; Mulvale, Gillian; Miatello, Ashleigh

2018-04-29

Although high quality mental health care for children and youth is a goal of many health systems, little is known about the dimensions of quality mental health care from users' perspectives. We engaged young people, caregivers and service providers to share experiences, which shed light on quality dimensions for youth mental health care. Using experience-based co-design, we collected qualitative data from young people aged 16-24 with a mental disorder (n = 19), identified caregivers (n = 12) and service providers (n = 14) about their experiences with respect to youth mental health services. Experience data were collected using multiple approaches including interviews, a suite of online and smartphone applications (n = 22), and a co-design event (n = 16) and analysed to extract touch points. These touch points were used to prioritize and co-design a user-driven prototype of a questionnaire to provide feedback to service providers. Young people, caregiver and service provider reports of service experiences were used to identify aspects of care quality at eight mental health service contact points: Access to mental health care; Transfer to/from hospital; Intake into hospital; Services provided; Assessment and treatment; Treatment environment; and Caregiver involvement in care. In some cases, low quality care was harmful to users and their caregivers. Young people co-designed a prototype of a user-driven feedback questionnaire to improve quality of service experiences that was supported by service providers and caregivers at the co-design event. By using EBCD to capture in-depth data regarding experiences of young people, their caregivers and service providers, study participants have begun to establish a baseline for acceptable quality of mental health care for young people. © 2018 The Authors. Health Expectations published by John Wiley & Sons Ltd.

Software archeology: a case study in software quality assurance and design

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

Macdonald, John M; Lloyd, Jane A; Turner, Cameron J

2009-01-01

Ideally, quality is designed into software, just as quality is designed into hardware. However, when dealing with legacy systems, demonstrating that the software meets required quality standards may be difficult to achieve. As the need to demonstrate the quality of existing software was recognized at Los Alamos National Laboratory (LANL), an effort was initiated to uncover and demonstrate that legacy software met the required quality standards. This effort led to the development of a reverse engineering approach referred to as software archaeology. This paper documents the software archaeology approaches used at LANL to document legacy software systems. A case studymore » for the Robotic Integrated Packaging System (RIPS) software is included.« less

Flying qualities - A costly lapse in flight-control design

NASA Technical Reports Server (NTRS)

Berry, D. T.

1982-01-01

Generic problems in advanced aircraft with advanced control systems which suffer from control sensitivity, sluggish response, and pilot-induced oscillation tendencies are examined, with a view to improving techniques for eliminating the problems in the design phase. Results of two NASA and NASA/AIAA workshops reached a consensus that flying qualities criteria do not match control system development, control system designers are not relying on past experience in their field, ground-based simulation is relied on too heavily, and communications between flying qualities and control systems engineers need improvement. A summation is offered in that hardware and software have outstripped the pilot's capacity to use the capabilities which new aircraft offer. The flying qualities data base is stressed to be dynamic, and continually redefining the man/machine relationships.

Academic Success Through Quality-Managed Course Design.

ERIC Educational Resources Information Center

Reese, Andy C.; Mobley, Mary F.

1996-01-01

Principles of quality management, focusing on defect prevention rather than correction, were applied to the design of a graduate biomedicine course in immunology. The principles require clearly stated course mission and objectives, numerous intermediate steps to achieving objectives, immediate feedback on student performance, and immediate…

Building quality into medical product software design.

PubMed

Mallory, S R

1993-01-01

The software engineering and quality assurance disciplines are a requisite to the design of safe and effective software-based medical devices. It is in the areas of software methodology and process that the most beneficial application of these disciplines to software development can be made. Software is a product of complex operations and methodologies and is not amenable to the traditional electromechanical quality assurance processes. Software quality must be built in by the developers, with the software verification and validation engineers acting as the independent instruments for ensuring compliance with performance objectives and with development and maintenance standards. The implementation of a software quality assurance program is a complex process involving management support, organizational changes, and new skill sets, but the benefits are profound. Its rewards provide safe, reliable, cost-effective, maintainable, and manageable software, which may significantly speed the regulatory review process and therefore potentially shorten the overall time to market. The use of a trial project can greatly facilitate the learning process associated with the first-time application of a software quality assurance program.

Product design enhancement using apparent usability and affective quality.

PubMed

Seva, Rosemary R; Gosiaco, Katherine Grace T; Santos, Ma Crea Eurice D; Pangilinan, Denise Mae L

2011-03-01

In this study, apparent usability and affective quality were integrated in a design framework called the Usability Perception and Emotion Enhancement Model (UPEEM). The UPEEM was validated using structural equation modeling (SEM). The methodology consists of four phases namely product selection, attribute identification, design alternative generation, and design alternative evaluation. The first stage involved the selection of a product that highly involves the consumer. In the attribute identification stage, design elements of the product were identified. The possible values of these elements were also determined for use in the experimentation process. Design of experiments was used to identify how the attributes will be varied in the design alternative stage and which of the attributes significantly contribute to affective quality, apparent usability, and desirability in the design evaluation stage. Results suggest that product attributes related to form are relevant in eliciting intense affect and perception of usability in mobile phones especially those directly related to functionality and aesthetics. This study considered only four product attributes among so many due to the constraints of the research design employed. Attributes related to aesthetic perception of a product enhance apparent usability such as those related to dimensional ratios. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design-A Worked-through Case Study.

PubMed

Paolantonacci, Philippe; Appourchaux, Philippe; Claudel, Béatrice; Ollivier, Monique; Dennett, Richard; Siret, Laurent

2018-01-01

Polyvalent human normal immunoglobulins for intravenous use (IVIg), indicated for rare and often severe diseases, are complex plasma-derived protein preparations. A quality by design approach has been used to develop the Laboratoire Français du Fractionnement et des Biotechnologies new-generation IVIg, targeting a high level of purity to generate an enhanced safety profile while maintaining a high level of efficacy. A modular approach of quality by design was implemented consisting of five consecutive steps to cover all the stages from the product design to the final product control strategy.A well-defined target product profile was translated into 27 product quality attributes that formed the basis of the process design. In parallel, a product risk analysis was conducted and identified 19 critical quality attributes among the product quality attributes. Process risk analysis was carried out to establish the links between process parameters and critical quality attributes. Twelve critical steps were identified, and for each of these steps a risk mitigation plan was established.Among the different process risk mitigation exercises, five process robustness studies were conducted at qualified small scale with a design of experiment approach. For each process step, critical process parameters were identified and, for each critical process parameter, proven acceptable ranges were established. The quality risk management and risk mitigation outputs, including verification of proven acceptable ranges, were used to design the process verification exercise at industrial scale.Finally, the control strategy was established using a mix, or hybrid, of the traditional approach plus elements of the quality by design enhanced approach, as illustrated, to more robustly assign material and process controls and in order to securely meet product specifications.The advantages of this quality by design approach were improved process knowledge for industrial design and process

75 FR 71033 - Air Quality Designations for the 2008 Lead (Pb) National Ambient Air Quality Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-22

.... These include damage to the central nervous system, cardiovascular function, kidneys, immune system, and... growth); (5) Meteorology (weather/transport patterns); (6) Geography/topography (mountain ranges or other... Air Quality Designations for the 2008 Lead (Pb) National Ambient Air Quality Standards AGENCY...

49 CFR 37.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., and work. (3) The phrase has a record of such an impairment means has a history of, or has been... guideway, or other advanced technology vehicles, designed to travel at speeds in excess of those possible...

Ethical challenges in designing and conducting medicine quality surveys.

PubMed

Tabernero, Patricia; Parker, Michael; Ravinetto, Raffaella; Phanouvong, Souly; Yeung, Shunmay; Kitutu, Freddy E; Cheah, Phaik Yeong; Mayxay, Mayfong; Guerin, Philippe J; Newton, Paul N

2016-06-01

In this paper we discuss the main ethical challenges related to the conduct of medicine quality surveys and make suggestions on how to address them. Most evidence-based information regarding medicine quality derives from surveys. However, existing research ethical guidelines do not provide specific guidance for medicine quality surveys. Hence, those conducting surveys are often left wondering how to judge what counts as best practice. A list of the main ethical challenges in the design and conduct of surveys is presented. It is vital that the design and conduct of medicine quality surveys uphold moral and ethical obligations and analyse the ethical implications and consequences of such work. These aspects include the impact on the local availability of and access to medicines; the confidentiality and privacy of the surveyors and the surveyed; questions as to whether outlet staff personnel should be told they are part of a survey; the need of ethical and regulatory approvals; and how the findings should be disseminated. Medicine quality surveys should ideally be conducted in partnership with the relevant national Medicine Regulatory Authorities. An international, but contextually sensitive, model of good ethical practice for such surveys is needed. © 2016 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

People’s Preferences of Urban Design Qualities for Walking on a Commercial Street

NASA Astrophysics Data System (ADS)

Ernawati, J.; Surjono; Sudarmo, B. S.

2018-03-01

This research aims to explore people’s preferences of urban design qualities for walking on a commercial street, with Kawi Street located in a commercial neighborhood in the town of Malang Indonesia as the case study. Based on a literature review, this study used eight urban design qualities, i.e., enclosure, legibility, human scale, transparency, complexity, coherence, linkage, and imageability. This study applied a survey research method using a self-administered paper-pencil questionnaire applying two measurement techniques: Likert scale was used to explore people’s evaluations of urban design qualities of the street, while multiple-rating scales were used to measure people’s preference for walking on the street. One hundred and ten people randomly selected as respondents. Regression analysis was employed to explore the influence of urban design qualities on people preference for walking. Results indicated four urban design qualities that affect people’s choice for walking on a commercial street, i.e., transparency, coherence, linkage, and imageability. Implications of the findings will be discussed in the paper.

Development/Deployment Investigation of Cabintaxi/Cabinlift Systems

DOT National Transportation Integrated Search

1977-12-01

This report presents the results of an investigation of the Cabintaxi/Cabinlift automated guideway transit (AGT) systems under development in the Federal Republic of Germany. These systems have not been conceived and designed for a particular transpo...

Innovative tools for quality assessment: integrated quality criteria for review of multiple study designs (ICROMS).

PubMed

Zingg, W; Castro-Sanchez, E; Secci, F V; Edwards, R; Drumright, L N; Sevdalis, N; Holmes, A H

2016-04-01

With the aim to facilitate a more comprehensive review process in public health including patient safety, we established a tool that we have termed ICROMS (Integrated quality Criteria for the Review Of Multiple Study designs), which unifies, integrates and refines current quality criteria for a large range of study designs including qualitative research. Review, pilot testing and expert consensus. The tool is the result of an iterative four phase process over two years: 1) gathering of established criteria for assessing controlled, non-controlled and qualitative study designs; 2) pilot testing of a first version in two systematic reviews on behavioural change in infection prevention and control and in antibiotic prescribing; 3) further refinement and adding of additional study designs in the context of the European Centre for Disease Prevention and Control funded project 'Systematic review and evidence-based guidance on organisation of hospital infection control programmes' (SIGHT); 4) scrutiny by the pan-European expert panel of the SIGHT project, which had the objective of ensuring robustness of the systematic review. ICROMS includes established quality criteria for randomised studies, controlled before-and-after studies and interrupted time series, and incorporates criteria for non-controlled before-and-after studies, cohort studies and qualitative studies. The tool consists of two parts: 1) a list of quality criteria specific for each study design, as well as criteria applicable across all study designs by using a scoring system; 2) a 'decision matrix', which specifies the robustness of the study by identifying minimum requirements according to the study type and the relevance of the study to the review question. The decision matrix directly determines inclusion or exclusion of a study in the review. ICROMS was applied to a series of systematic reviews to test its feasibility and usefulness in the appraisal of multiple study designs. The tool was applicable

Development Design Model of Academic Quality Assurance at Private Islamic University Jakarta Indonesia

ERIC Educational Resources Information Center

Suprihatin, Krebet; Bin Mohamad Yusof, Hj. Abdul Raheem

2015-01-01

This study aims to evaluate the practice of academic quality assurance in design model based on seven aspects of quality are: curriculum design, teaching and learning, student assessment, student selection, support services, learning resources, and continuous improvement. The design study was conducted in two stages. The first stage is to obtain…

Controlling Pollutants and Sources: Indoor Air Quality Design Tools for Schools

EPA Pesticide Factsheets

To protect indoor environmental quality the designer should understand indoor air quality problems and seek to eliminate potential sources of contamination that originate from outdoors as well as indoors.

The relationship between building design and residents' quality of life in extra care housing schemes.

PubMed

Orrell, Alison; McKee, Kevin; Torrington, Judith; Barnes, Sarah; Darton, Robin; Netten, Ann; Lewis, Alan

2013-05-01

Well-designed housing is recognised as being an important factor in promoting a good quality of life. Specialised housing models incorporating care services, such as extra care housing (ECH) schemes are seen as enabling older people to maintain a good quality of life despite increasing health problems that can accompany ageing. Despite the variation in ECH building design little is known about the impact of ECH building design on the quality of life of building users. The evaluation of older people's living environments (EVOLVE) study collected cross-sectional data on building design and quality of life in 23 ECH schemes in England, UK. Residents' quality of life was assessed using the schedule for the evaluation of individual quality of life-direct weighting (SEIQoL-DW) and on the four domains of control, autonomy, self-realisation and pleasure on the CASP-19. Building design was measured on 12 user-related domains by means of a new tool; the EVOLVE tool. Using multilevel linear regression, significant associations were found between several aspects of building design and quality of life. Furthermore, there was evidence that the relationship between building design and quality of life was partly mediated by the dependency of participants and scheme size (number of living units). Our findings suggest that good quality building design in ECH can support the quality of life of residents, but that designing features that support the needs of both relatively independent and frail users is problematic, with the needs of highly dependent users not currently supported as well as could be hoped by ECH schemes. Copyright © 2013 Elsevier Ltd. All rights reserved.

Off-Line Quality Control In Integrated Circuit Fabrication Using Experimental Design

NASA Astrophysics Data System (ADS)

Phadke, M. S.; Kackar, R. N.; Speeney, D. V.; Grieco, M. J.

1987-04-01

Off-line quality control is a systematic method of optimizing production processes and product designs. It is widely used in Japan to produce high quality products at low cost. The method was introduced to us by Professor Genichi Taguchi who is a Deming-award winner and a former Director of the Japanese Academy of Quality. In this paper we will i) describe the off-line quality control method, and ii) document our efforts to optimize the process for forming contact windows in 3.5 Aim CMOS circuits fabricated in the Murray Hill Integrated Circuit Design Capability Laboratory. In the fabrication of integrated circuits it is critically important to produce contact windows of size very near the target dimension. Windows which are too small or too large lead to loss of yield. The off-line quality control method has improved both the process quality and productivity. The variance of the window size has been reduced by a factor of four. Also, processing time for window photolithography has been substantially reduced. The key steps of off-line quality control are: i) Identify important manipulatable process factors and their potential working levels. ii) Perform fractional factorial experiments on the process using orthogonal array designs. iii) Analyze the resulting data to determine the optimum operating levels of the factors. Both the process mean and the process variance are considered in this analysis. iv) Conduct an additional experiment to verify that the new factor levels indeed give an improvement.

Lithography-induced limits to scaling of design quality

NASA Astrophysics Data System (ADS)

Kahng, Andrew B.

2014-03-01

Quality and value of an IC product are functions of power, performance, area, cost and reliability. The forthcoming 2013 ITRS roadmap observes that while manufacturers continue to enable potential Moore's Law scaling of layout densities, the "realizable" scaling in competitive products has for some years been significantly less. In this paper, we consider aspects of the question, "To what extent should this scaling gap be blamed on lithography?" Non-ideal scaling of layout densities has been attributed to (i) layout restrictions associated with multi-patterning technologies (SADP, LELE, LELELE), as well as (ii) various ground rule and layout style choices that stem from misalignment, reliability, variability, device architecture, and electrical performance vs. power constraints. Certain impacts seem obvious, e.g., loss of 2D flexibility and new line-end placement constraints with SADP, or algorithmically intractable layout stitching and mask coloring formulations with LELELE. However, these impacts may well be outweighed by weaknesses in design methodology and tooling. Arguably, the industry has entered a new era in which many new factors - (i) standard-cell library architecture, and layout guardbanding for automated place-and-route: (ii) performance model guardbanding and signoff analyses: (iii) physical design and manufacturing handoff algorithms spanning detailed placement and routing, stitching and RET; and (iv) reliability guardbanding - all contribute, hand in hand with lithography, to a newly-identified "design capability gap". How specific aspects of process and design enablements limit the scaling of design quality is a fundamental question whose answer must guide future RandD investment at the design-manufacturing interface. terface.

77 FR 9532 - Air Quality Designations for the 2010 Primary Nitrogen Dioxide (NO2

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-17

...This rule establishes air quality designations for all areas in the United States for the 2010 Primary Nitrogen Dioxide (NO2) National Ambient Air Quality Standards (NAAQS). Based on air quality monitoring data, the EPA is issuing this rule to designate all areas of the country as ``unclassifiable/attainment'' for the 2010 NO2 NAAQS. The EPA is designating areas as ``unclassifiable/attainment'' to mean that available information does not indicate that the air quality in these areas exceeds the 2010 NO2 NAAQS.

76 FR 76048 - Air Quality Designations for the 2008 Lead (Pb) National Ambient Air Quality Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-HQ-OAR-2009-0443; FRL-9492-3] RIN 2060-AR17 Air Quality Designations for the 2008 Lead (Pb) National Ambient Air Quality Standards Correction In rule document 2011-29460 appearing on pages 72097-72120 in the issues of Tuesday, November 22, 2011...

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics.

PubMed

Colombo, Stefano; Beck-Broichsitter, Moritz; Bøtker, Johan Peter; Malmsten, Martin; Rantanen, Jukka; Bohr, Adam

2018-04-05

Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field. Copyright © 2018 Elsevier B.V. All rights reserved.

30 CFR 27.20 - Quality of material, workmanship, and design.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality of material, workmanship, and design. 27.20 Section 27.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Construction and Design...

30 CFR 27.20 - Quality of material, workmanship, and design.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality of material, workmanship, and design. 27.20 Section 27.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Construction and Design...

Design and implementation air quality monitoring robot

NASA Astrophysics Data System (ADS)

Chen, Yuanhua; Li, Jie; Qi, Chunxue

2017-01-01

Robot applied in environmental protection can break through the limitations in working environment, scope and mode of the existing environmental monitoring and pollution abatement equipments, which undertake the innovation and improvement in the basin, atmosphere, emergency and pollution treatment facilities. Actually, the relevant technology is backward with limited research and investment. Though the device companies have achieved some results in the study on the water quality monitoring, pipeline monitoring and sewage disposal, this technological progress on the whole is still much slow, and the mature product has not been formed. As a result, the market urges a demand of a new type of device which is more suitable for environmental protection on the basis of robot successfully applied in other fields. This paper designs and realizes a tracked mobile robot of air quality monitoring, which can be used to monitor air quality for the pollution accident in industrial parks and regular management.

Buffer strip design for protecting water quality and fish habitat

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

Belt, G.H.; O'Laughlin, J.

1994-04-01

Buffer strips are protective areas adjacent to streams or lakes. Among other functions, they protect water quality and fish habitat. A typical buffer strip is found in western Oregon, where they are called Riparian Management Areas (RMAs). The authors use the term buffer strip to include functional descriptions such as filter, stabilization, or leave strips, and administrative designations such as Idaho's Stream Protection Zone (SPZ), Washington's Riparian Management Zone (RMZ), and the USDA Forest Service's Streamside Management Zone (SMZ). They address water quality and fishery protective functions of buffer strips on forestlands, pointing out improvements in buffer strip design possiblemore » through research or administrative changes. Buffer strip design requirements found in some western Forest Practices Act (FPA) regulations are also compared and related to findings in the scientific literature.« less

Extending cluster Lot Quality Assurance Sampling designs for surveillance programs

PubMed Central

Hund, Lauren; Pagano, Marcello

2014-01-01

Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance based on the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible non-parametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. PMID:24633656

Quality-by-design approach for the development of telmisartan potassium tablets.

PubMed

Oh, Ga-Hui; Park, Jin-Hyun; Shin, Hye-Won; Kim, Joo-Eun; Park, Young-Joon

2018-05-01

A quality-by-design approach was adopted to develop telmisartan potassium (TP) tablets, which were bioequivalent with the commercially available Micardis ® (telmisartan free base) tablets. The dissolution pattern and impurity profile of TP tablets differed from those of Micardis ® tablets because telmisartan free base is poorly soluble in water. After identifying the quality target product profile and critical quality attributes (CQAs), drug dissolution, and impurities were predicted to be risky CQAs. To determine the exact range and cause of risks, we used the risk assessment (RA) tools, preliminary hazard analysis and failure mode and effect analysis to determine the parameters affecting drug dissolution, impurities, and formulation. The range of the design space was optimized using the face-centered central composite design among the design of experiment (DOE) methods. The binder, disintegrant, and kneading time in the wet granulation were identified as X values affecting Y values (disintegration, hardness, friability, dissolution, and impurities). After determining the design space with the desired Y values, the TP tablets were formulated and their dissolution pattern was compared with that of the reference tablet. The selected TP tablet formulated using design space showed a similar dissolution to that of Micardis ® tablets at pH 7.5. The QbD approach TP tablet was bioequivalent to Micardis ® tablets in beagle dogs.

A Design Quality Learning Unit in Relational Data Modeling Based on Thriving Systems Properties

ERIC Educational Resources Information Center

Waguespack, Leslie J.

2013-01-01

This paper presents a learning unit that addresses quality design in relational data models. The focus on modeling allows the learning to span analysis, design, and implementation enriching pedagogy across the systems development life cycle. Thriving Systems Theory presents fifteen choice properties that convey design quality in models integrating…

Approach to design space from retrospective quality data.

PubMed

Puñal Peces, Daniel; García-Montoya, Encarna; Manich, Albert; Suñé-Negre, Josep Maria; Pérez-Lozano, Pilar; Miñarro, Montse; Ticó, Josep Ramon

2016-01-01

Nowadays, the entire manufacturing process is based on the current GMPs, which emphasize the reproducibility of the process, and companies have a lot of recorded data about their processes. The establishment of the design space (DS) from retrospective data for a wet compression process. A design of experiments (DoE) with historical data from 4 years of industrial production has been carried out using the experimental factors as the results of the previous risk analysis and eight key parameters (quality specifications) that encompassed process and quality control data. Software Statgraphics 5.0 was applied, and data were processed to obtain eight DS as well as their safe and working ranges. Experience shows that it is possible to determine DS retrospectively, being the greatest difficulty in handling and processing of high amounts of data; however, the practicality of this study is very interesting as it let have the DS with minimal investment in experiments since actual production batch data are processed statistically.

Applying Quality by Design Concepts to Pharmacy Compounding.

PubMed

Timko, Robert J

2015-01-01

Compounding of medications is an important part of the practice of the pharmacy profession. Because compounded medications do not have U.S. Food and Drug Administration approval, a pharmacist has the responsibility to ensure that compounded medications are of suitable quality, safety, and efficacy. The Federal Government and numerous states have updated their laws and regulations regarding pharmacy compounding as a result of recent quality issues. Compounding pharmacists are expected to follow good preparation prodecures in their compounding practices in much the same way pharmaceutical manufacturers are required to follow Current Good Manufacturing Procedures as detailed in the United States Code of Federal Regulations. Application of Quality by Design concepts to the preparation process for a compounded medication can help in understanding the potential pitfalls and the means to mitigate their impact. The goal is to build quality into the compounding process to ensure that the resultant compounded prescription meets the human or animal patients' requirements.

49 CFR 239.7 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... vehicles operating on rails or electromagnetic guideways which are expressly identified in a railroad's... or electromagnetic guideways, including— (i) Commuter or other short-haul rail passenger service in a...

49 CFR 239.7 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... vehicles operating on rails or electromagnetic guideways which are expressly identified in a railroad's... or electromagnetic guideways, including— (i) Commuter or other short-haul rail passenger service in a...

49 CFR 239.7 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... vehicles operating on rails or electromagnetic guideways which are expressly identified in a railroad's... or electromagnetic guideways, including— (i) Commuter or other short-haul rail passenger service in a...

49 CFR 239.7 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... vehicles operating on rails or electromagnetic guideways which are expressly identified in a railroad's... or electromagnetic guideways, including— (i) Commuter or other short-haul rail passenger service in a...

Flying qualities design criteria applicable to supersonic cruise aircraft

NASA Technical Reports Server (NTRS)

Chalk, C. R.

1980-01-01

A comprehensive set of flying qualities design criteria was prepared for use in the supersonic cruise research program. The framework for stating the design criteria is established and design criteria are included which address specific failures, approach to dangerous flight conditions, flight at high angle of attack, longitudinal and lateral directional stability and control, the primary flight control system, and secondary flight controls. Examples are given of lateral directional design criteria limiting lateral accelerations at the cockpit, time to roll through 30 deg of bank, and time delay in the pilot's command path. Flight test data from the Concorde certification program are used to substantiate a number of the proposed design criteria.

A quality by design approach to optimization of emulsions for electrospinning using factorial and D-optimal designs.

PubMed

Badawi, Mariam A; El-Khordagui, Labiba K

2014-07-16

Emulsion electrospinning is a multifactorial process used to generate nanofibers loaded with hydrophilic drugs or macromolecules for diverse biomedical applications. Emulsion electrospinnability is greatly impacted by the emulsion pharmaceutical attributes. The aim of this study was to apply a quality by design (QbD) approach based on design of experiments as a risk-based proactive approach to achieve predictable critical quality attributes (CQAs) in w/o emulsions for electrospinning. Polycaprolactone (PCL)-thickened w/o emulsions containing doxycycline HCl were formulated using a Span 60/sodium lauryl sulfate (SLS) emulsifier blend. The identified emulsion CQAs (stability, viscosity and conductivity) were linked with electrospinnability using a 3(3) factorial design to optimize emulsion composition for phase stability and a D-optimal design to optimize stable emulsions for viscosity and conductivity after shifting the design space. The three independent variables, emulsifier blend composition, organic:aqueous phase ratio and polymer concentration, had a significant effect (p<0.05) on emulsion CQAs, the emulsifier blend composition exerting prominent main and interaction effects. Scanning electron microscopy (SEM) of emulsion-electrospun NFs and desirability functions allowed modeling of emulsion CQAs to predict electrospinnable formulations. A QbD approach successfully built quality in electrospinnable emulsions, allowing development of hydrophilic drug-loaded nanofibers with desired morphological characteristics. Copyright © 2014 Elsevier B.V. All rights reserved.

A quality by design approach using artificial intelligence techniques to control the critical quality attributes of ramipril tablets manufactured by wet granulation.

PubMed

Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Özer, Özgen; Güneri, Tamer; York, Peter

2013-02-01

Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. This study was conducted in the framework of a QbD project involving ramipril tablets. Preliminary work included identification of the critical quality attributes (CQAs) and critical process parameters (CPPs) based on the quality target product profiles (QTPPs) using the historical data and risk assessment method failure mode and effect analysis (FMEA). Compendial and in-house specifications were selected as QTPPs for ramipril tablets. CPPs that affected the product and process were used to establish an experimental design. The results thus obtained can be used to facilitate definition of the design space using tools such as design of experiments (DoE), the response surface method (RSM) and artificial neural networks (ANNs). The project was aimed at discovering hidden knowledge associated with the manufacture of ramipril tablets using a range of artificial intelligence-based software, with the intention of establishing a multi-dimensional design space that ensures consistent product quality. At the end of the study, a design space was developed based on the study data and specifications, and a new formulation was optimized. On the basis of this formulation, a new laboratory batch formulation was prepared and tested. It was confirmed that the explored formulation was within the design space.

Better design quality of public toilets for visually impaired persons: an all-round concept in design for the promotion of health.

PubMed

Siu, Kin Wai Michael

2008-11-01

According to United Nations statistics, about one-thirtieth of the world's population is visually impaired. These visually impaired persons (VIPs) face a variety of difficulties in their daily lives. This is the case not only in countries with a shortage of resources or with relatively low living standards, but also in developed countries. Most of the time, such difficulties in daily life come from the misunderstanding of VIPs' wants and needs and in turn poor design quality. To enhance equal opportunities in society, promote public health and improve the design quality of the public environment and facilities, a project on how VIPs access public toilets has been under way since 2004. To maintain better design quality in public toilets, the FISH concept has been initiated. This design concept includes the design considerations of friendly, informative, safe, and hygienic. This paper reviews the wants and needs of VIPs that should be considered in using public toilets, and the help that they need to be given. Based on the findings of the project, this paper then discusses how better quality designs for public toilets to promote public health can be obtained by implementing FISH.

Nanosystem trends in drug delivery using quality-by-design concept.

PubMed

Li, Jing; Qiao, Yanjiang; Wu, Zhisheng

2017-06-28

Quality by design (QbD) has become an inevitable trend because of its benefits for product quality and process understanding. Trials have been conducted using QbD in nanosystems' optimization. This paper reviews the application of QbD for processing nanosystems and summarizes the application procedure. It provides prospective guidelines for future investigations that apply QbD to nanosystem manufacturing processes. Employing the QbD concept in this way is a novel area in nanosystem quality. Copyright © 2017 Elsevier B.V. All rights reserved.

Defining process design space for a hydrophobic interaction chromatography (HIC) purification step: application of quality by design (QbD) principles.

PubMed

Jiang, Canping; Flansburg, Lisa; Ghose, Sanchayita; Jorjorian, Paul; Shukla, Abhinav A

2010-12-15

The concept of design space has been taking root under the quality by design paradigm as a foundation of in-process control strategies for biopharmaceutical manufacturing processes. This paper outlines the development of a design space for a hydrophobic interaction chromatography (HIC) process step. The design space included the impact of raw material lot-to-lot variability and variations in the feed stream from cell culture. A failure modes and effects analysis was employed as the basis for the process characterization exercise. During mapping of the process design space, the multi-dimensional combination of operational variables were studied to quantify the impact on process performance in terms of yield and product quality. Variability in resin hydrophobicity was found to have a significant influence on step yield and high-molecular weight aggregate clearance through the HIC step. A robust operating window was identified for this process step that enabled a higher step yield while ensuring acceptable product quality. © 2010 Wiley Periodicals, Inc.

Quality by design case study 1: Design of 5-fluorouracil loaded lipid nanoparticles by the W/O/W double emulsion - Solvent evaporation method.

PubMed

Amasya, Gulin; Badilli, Ulya; Aksu, Buket; Tarimci, Nilufer

2016-03-10

With Quality by Design (QbD), a systematic approach involving design and development of all production processes to achieve the final product with a predetermined quality, you work within a design space that determines the critical formulation and process parameters. Verification of the quality of the final product is no longer necessary. In the current study, the QbD approach was used in the preparation of lipid nanoparticle formulations to improve skin penetration of 5-Fluorouracil, a widely-used compound for treating non-melanoma skin cancer. 5-Fluorouracil-loaded lipid nanoparticles were prepared by the W/O/W double emulsion - solvent evaporation method. Artificial neural network software was used to evaluate the data obtained from the lipid nanoparticle formulations, to establish the design space, and to optimize the formulations. Two different artificial neural network models were developed. The limit values of the design space of the inputs and outputs obtained by both models were found to be within the knowledge space. The optimal formulations recommended by the models were prepared and the critical quality attributes belonging to those formulations were assigned. The experimental results remained within the design space limit values. Consequently, optimal formulations with the critical quality attributes determined to achieve the Quality Target Product Profile were successfully obtained within the design space by following the QbD steps. Copyright © 2016 Elsevier B.V. All rights reserved.

Extending cluster lot quality assurance sampling designs for surveillance programs.

PubMed

Hund, Lauren; Pagano, Marcello

2014-07-20

Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance on the basis of the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible nonparametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. Copyright © 2014 John Wiley & Sons, Ltd.

Monitoring air quality in mountains: Designing an effective network

USGS Publications Warehouse

Peterson, D.L.

2000-01-01

A quantitatively robust yet parsimonious air-quality monitoring network in mountainous regions requires special attention to relevant spatial and temporal scales of measurement and inference. The design of monitoring networks should focus on the objectives required by public agencies, namely: 1) determine if some threshold has been exceeded (e.g., for regulatory purposes), and 2) identify spatial patterns and temporal trends (e.g., to protect natural resources). A short-term, multi-scale assessment to quantify spatial variability in air quality is a valuable asset in designing a network, in conjunction with an evaluation of existing data and simulation-model output. A recent assessment in Washington state (USA) quantified spatial variability in tropospheric ozone distribution ranging from a single watershed to the western third of the state. Spatial and temporal coherence in ozone exposure modified by predictable elevational relationships ( 1.3 ppbv ozone per 100 m elevation gain) extends from urban areas to the crest of the Cascade Range. This suggests that a sparse network of permanent analyzers is sufficient at all spatial scales, with the option of periodic intensive measurements to validate network design. It is imperative that agencies cooperate in the design of monitoring networks in mountainous regions to optimize data collection and financial efficiencies.

Application of quality by design for 3D printed bone prostheses and scaffolds

PubMed Central

Martinez-Marquez, Daniel; Mirnajafizadeh, Ali; Carty, Christopher P.

2018-01-01

3D printing is an emergent manufacturing technology recently being applied in the medical field for the development of custom bone prostheses and scaffolds. However, successful industry transformation to this new design and manufacturing approach requires technology integration, concurrent multi-disciplinary collaboration, and a robust quality management framework. This latter change enabler is the focus of this study. While a number of comprehensive quality frameworks have been developed in recent decades to ensure that the manufacturing of medical devices produces reliable products, they are centred on the traditional context of standardised manufacturing techniques. The advent of 3D printing technologies and the prospects for mass customisation provides significant market opportunities, but also presents a serious challenge to regulatory bodies tasked with managing and assuring product quality and safety. Before 3D printing bone prostheses and scaffolds can gain traction, industry stakeholders, such as regulators, clients, medical practitioners, insurers, lawyers, and manufacturers, would all require a high degree of confidence that customised manufacturing can achieve the same quality outcomes as standardised manufacturing. A Quality by Design (QbD) approach to custom 3D printed prostheses can help to ensure that products are designed and manufactured correctly from the beginning without errors. This paper reports on the adaptation of the QbD approach for the development process of 3D printed custom bone prosthesis and scaffolds. This was achieved through the identification of the Critical Quality Attributes of such products, and an extensive review of different design and fabrication methods for 3D printed bone prostheses. Research outcomes include the development of a comprehensive design and fabrication process flow diagram, and categorised risks associated with the design and fabrication processes of such products. An extensive systematic literature review

Application of quality by design for 3D printed bone prostheses and scaffolds.

PubMed

Martinez-Marquez, Daniel; Mirnajafizadeh, Ali; Carty, Christopher P; Stewart, Rodney A

2018-01-01

3D printing is an emergent manufacturing technology recently being applied in the medical field for the development of custom bone prostheses and scaffolds. However, successful industry transformation to this new design and manufacturing approach requires technology integration, concurrent multi-disciplinary collaboration, and a robust quality management framework. This latter change enabler is the focus of this study. While a number of comprehensive quality frameworks have been developed in recent decades to ensure that the manufacturing of medical devices produces reliable products, they are centred on the traditional context of standardised manufacturing techniques. The advent of 3D printing technologies and the prospects for mass customisation provides significant market opportunities, but also presents a serious challenge to regulatory bodies tasked with managing and assuring product quality and safety. Before 3D printing bone prostheses and scaffolds can gain traction, industry stakeholders, such as regulators, clients, medical practitioners, insurers, lawyers, and manufacturers, would all require a high degree of confidence that customised manufacturing can achieve the same quality outcomes as standardised manufacturing. A Quality by Design (QbD) approach to custom 3D printed prostheses can help to ensure that products are designed and manufactured correctly from the beginning without errors. This paper reports on the adaptation of the QbD approach for the development process of 3D printed custom bone prosthesis and scaffolds. This was achieved through the identification of the Critical Quality Attributes of such products, and an extensive review of different design and fabrication methods for 3D printed bone prostheses. Research outcomes include the development of a comprehensive design and fabrication process flow diagram, and categorised risks associated with the design and fabrication processes of such products. An extensive systematic literature review

General atomics low speed Maglev technology development program (Supplemental #3)

DOT National Transportation Integrated Search

2005-05-01

This report details accomplishments of the Low Speed Maglev Technology Development Program, Supplemental #3. The 4 major tasks included: guideway foundation construction, fabrication and installation of 7 guideway modules, system integration and test...

A quality by design study applied to an industrial pharmaceutical fluid bed granulation.

PubMed

Lourenço, Vera; Lochmann, Dirk; Reich, Gabriele; Menezes, José C; Herdling, Thorsten; Schewitz, Jens

2012-06-01

The pharmaceutical industry is encouraged within Quality by Design (QbD) to apply science-based manufacturing principles to assure quality not only of new but also of existing processes. This paper presents how QbD principles can be applied to an existing industrial pharmaceutical fluid bed granulation (FBG) process. A three-step approach is presented as follows: (1) implementation of Process Analytical Technology (PAT) monitoring tools at the industrial scale process, combined with multivariate data analysis (MVDA) of process and PAT data to increase the process knowledge; (2) execution of scaled-down designed experiments at a pilot scale, with adequate PAT monitoring tools, to investigate the process response to intended changes in Critical Process Parameters (CPPs); and finally (3) the definition of a process Design Space (DS) linking CPPs to Critical to Quality Attributes (CQAs), within which product quality is ensured by design, and after scale-up enabling its use at the industrial process scale. The proposed approach was developed for an existing industrial process. Through enhanced process knowledge established a significant reduction in product CQAs, variability already within quality specifications ranges was achieved by a better choice of CPPs values. The results of such step-wise development and implementation are described. Copyright © 2012 Elsevier B.V. All rights reserved.

Preliminary Quality Control System Design for the Pell Grant Program.

ERIC Educational Resources Information Center

Advanced Technology, Inc., Reston, VA.

A preliminary design for a quality control (QC) system for the Pell Grant Program is proposed, based on the needs of the Office of Student Financial Assistance (OSFA). The applicability of the general design for other student aid programs administered by OSFA is also considered. The following steps included in a strategic approach to QC system…

Detailed design of a Ride Quality Augmentation System for commuter aircraft

NASA Technical Reports Server (NTRS)

Suikat, Reiner; Donaldson, Kent E.; Downing, David R.

1989-01-01

The design of a Ride Quality Augmentation System (RQAS) for commuter aircraft is documented. The RQAS is designed for a Cessna 402B, an 8 passenger prop twin representative to this class of aircraft. The purpose of the RQAS is the reduction of vertical and lateral accelerations of the aircraft due to atmospheric turbulence by the application of active control. The detailed design of the hardware (the aircraft modifications, the Ride Quality Instrumentation System (RQIS), and the required computer software) is examined. The aircraft modifications, consisting of the dedicated control surfaces and the hydraulic actuation system, were designed at Cessna Aircraft by Kansas University-Flight Research Laboratory. The instrumentation system, which consist of the sensor package, the flight computer, a Data Acquisition System, and the pilot and test engineer control panels, was designed by NASA-Langley. The overall system design and the design of the software, both for flight control algorithms and ground system checkout are detailed. The system performance is predicted from linear simulation results and from power spectral densities of the aircraft response to a Dryden gust. The results indicate that both accelerations are possible.

Software Design Improvements. Part 2; Software Quality and the Design and Inspection Process

NASA Technical Reports Server (NTRS)

Lalli, Vincent R.; Packard, Michael H.; Ziemianski, Tom

1997-01-01

The application of assurance engineering techniques improves the duration of failure-free performance of software. The totality of features and characteristics of a software product are what determine its ability to satisfy customer needs. Software in safety-critical systems is very important to NASA. We follow the System Safety Working Groups definition for system safety software as: 'The optimization of system safety in the design, development, use and maintenance of software and its integration with safety-critical systems in an operational environment. 'If it is not safe, say so' has become our motto. This paper goes over methods that have been used by NASA to make software design improvements by focusing on software quality and the design and inspection process.

The quality estimation of exterior wall’s and window filling’s construction design

NASA Astrophysics Data System (ADS)

Saltykov, Ivan; Bovsunovskaya, Maria

2017-10-01

The article reveals the term of “artificial envelope” in dwelling building. Authors offer a complex multifactorial approach to the design quality estimation of external fencing structures, which is based on various parameters impact. These referred parameters are: functional, exploitation, cost, and also, the environmental index is among them. The quality design index Qк is inputting for the complex characteristic of observed above parameters. The mathematical relation of this index from these parameters is the target function for the quality design estimation. For instance, the article shows the search of optimal variant for wall and window designs in small, middle and large square dwelling premises of economic class buildings. The graphs of target function single parameters are expressed for the three types of residual chamber’s dimensions. As a result of the showing example, there is a choice of window opening’s dimensions, which make the wall’s and window’s constructions properly correspondent to the producible complex requirements. The authors reveal the comparison of recommended window filling’s square in accordance with the building standards, and the square, due to the finding of the optimal variant of the design quality index. The multifactorial approach for optimal design searching, which is mentioned in this article, can be used in consideration of various construction elements of dwelling buildings in accounting of suitable climate, social and economic construction area features.

Re-conceiving building design quality: A review of building users in their social context.

PubMed

Watson, Kelly J; Evans, James; Karvonen, Andrew; Whitley, Tim

2016-05-01

Considerable overlap exists between post-occupancy research evaluating building design quality and the concept of 'social value', popularised by its recent application to issues of the public realm. To outline this potential research agenda, the paper reviews design quality research on buildings in relation to users and their social context where the term 'social context' refers to building user group dynamics, a combination of organisational cultures, management strategies, and social norms and practices. The review is conducted across five key building types, namely housing, workplaces, healthcare, education, and the retail/service sector. Research commonalities and gaps are identified in order to build a more comprehensive picture of the design quality literature and its handling of users in their social context. The key findings concerning each building type are presented visually. It is concluded that the design quality field comprises a patchwork of relatively isolated studies of various building types, with significant potential for theoretical and empirical development through interdisciplinary collaboration. Users tend to be conceived as anonymous and autonomous individuals with little analysis of user identity or interaction. Further, the contextual impact of user group dynamics on the relationship between building design and building user is rarely addressed in the literature. Producing a more nuanced understanding of users in situ is proposed as an important area for future design quality research.

Re-conceiving building design quality: A review of building users in their social context

PubMed Central

Evans, James; Karvonen, Andrew; Whitley, Tim

2014-01-01

Considerable overlap exists between post-occupancy research evaluating building design quality and the concept of ‘social value’, popularised by its recent application to issues of the public realm. To outline this potential research agenda, the paper reviews design quality research on buildings in relation to users and their social context where the term ‘social context’ refers to building user group dynamics, a combination of organisational cultures, management strategies, and social norms and practices. The review is conducted across five key building types, namely housing, workplaces, healthcare, education, and the retail/service sector. Research commonalities and gaps are identified in order to build a more comprehensive picture of the design quality literature and its handling of users in their social context. The key findings concerning each building type are presented visually. It is concluded that the design quality field comprises a patchwork of relatively isolated studies of various building types, with significant potential for theoretical and empirical development through interdisciplinary collaboration. Users tend to be conceived as anonymous and autonomous individuals with little analysis of user identity or interaction. Further, the contextual impact of user group dynamics on the relationship between building design and building user is rarely addressed in the literature. Producing a more nuanced understanding of users in situ is proposed as an important area for future design quality research. PMID:27110217

Office of Student Financial Aid Quality Improvement Program: Design and Implementation Plan.

ERIC Educational Resources Information Center

Advanced Technology, Inc., Reston, VA.

The purpose and direction of the Office of Student Financial Aid (OSFA) quality improvement program are described. The background and context for the Pell Grant quality control (QC) design study and the meaning of QC are reviewed. The general approach to quality improvement consists of the following elements: a strategic approach that enables OSFA…

Impact of longitudinal flying qualities upon the design of a transport with active controls

NASA Technical Reports Server (NTRS)

Sliwa, S. M.

1980-01-01

Direct constrained parameter optimization was used to optimally size a medium range transport for minimum direct operating cost. Several stability and control constraints were varied to study the sensitivity of the configuration to specifying the unaugmented flying qualities of transports designed with relaxed static stability. Additionally, a number of handling quality related design constants were studied with respect to their impact to the design.

Evidence-Based Design Features Improve Sleep Quality Among Psychiatric Inpatients.

PubMed

Pyrke, Ryan J L; McKinnon, Margaret C; McNeely, Heather E; Ahern, Catherine; Langstaff, Karen L; Bieling, Peter J

2017-10-01

The primary aim of the present study was to compare sleep characteristics pre- and post-move into a state-of-the-art mental health facility, which offered private sleeping quarters. Significant evidence points toward sleep disruption among psychiatric inpatients. It is unclear, however, how environmental factors (e.g., dorm-style rooms) impact sleep quality in this population. To assess sleep quality, a novel objective technology, actigraphy, was used before and after a facility move. Subjective daily interviews were also administered, along with the Horne-Ostberg Morningness-Eveningness Questionnaire and the Pittsburgh Sleep Quality Index. Actigraphy revealed significant improvements in objective sleep quality following the facility move. Interestingly, subjective report of sleep quality did not correlate with the objective measures. Circadian sleep type appeared to play a role in influencing subjective attitudes toward sleep quality. Built environment has a significant effect on the sleep quality of psychiatric inpatients. Given well-documented disruptions in sleep quality present among psychiatric patients undergoing hospitalization, design elements like single patient bedrooms are highly desirable.

Quality by design approach of a pharmaceutical gel manufacturing process, part 1: determination of the design space.

PubMed

Rosas, Juan G; Blanco, Marcel; González, Josep M; Alcalá, Manel

2011-10-01

This work was conducted in the framework of a quality by design project involving the production of a pharmaceutical gel. Preliminary work included the identification of the quality target product profiles (QTPPs) from historical values for previously manufactured batches, as well as the critical quality attributes for the process (viscosity and pH), which were used to construct a D-optimal experimental design. The experimental design comprised 13 gel batches, three of which were replicates at the domain center intended to assess the reproducibility of the target process. The viscosity and pH models established exhibited very high linearity and negligible lack of fit (LOF). Thus, R(2) was 0.996 for viscosity and 0.975 for pH, and LOF was 0.53 for the former parameter and 0.84 for the latter. The process proved reproducible at the domain center. Water content and temperature were the most influential factors for viscosity, and water content and acid neutralized fraction were the most influential factors for pH. A desirability function was used to find the best compromise to optimize the QTPPs. The body of information was used to identify and define the design space for the process. A model capable of combining the two response variables into a single one was constructed to facilitate monitoring of the process. Copyright © 2011 Wiley-Liss, Inc.

The OA System of College - - Design of the Teaching Quality Monitoring Subsystem

NASA Astrophysics Data System (ADS)

Wu, Hongjuan; Ying, Hong; Jiang, Youyi; Yan, Pei

According to the drawbacks of traditional teaching quality monitoring subsystems and based on the achievements of practical research in the teaching quality monitoring administration in College, this paper provides a design of overall structure of teaching quality monitoring subsystem, that is more suitable for colleges' management. This new system is endowed with the same features as .NET application programes: easy to extend, easy to maintain, flexible, convenient, and it let enterprises, students' parents and excellent graduates participate in teaching quality monitoring administration, have significant effect to ensure the quality of talent training in colleges.

Morgantown People Mover Phase II : Impact Assessment

DOT National Transportation Integrated Search

1984-02-01

This report describes an assessment of the Morgantown People Mover (MPM) system, which is an automated guideway transit system extending over 5,300 meters (3.3 miles) of double lane guideway, connecting West Virginia University's downtown campus with...

Braking System Integration in Dual Mode Systems

DOT National Transportation Integrated Search

1974-05-01

An optimal braking system for Dual Mode is a complex product of vast number of multivariate, interdependent parameters that encompass on-guideway and off-guideway operation as well as normal and emergency braking. : Details of, and interralations amo...

Modal control theory and application to aircraft lateral handling qualities design

NASA Technical Reports Server (NTRS)

Srinathkumar, S.

1978-01-01

A multivariable synthesis procedure based on eigenvalue/eigenvector assignment is reviewed and is employed to develop a systematic design procedure to meet the lateral handling qualities design objectives of a fighter aircraft over a wide range of flight conditions. The closed loop modal characterization developed provides significant insight into the design process and plays a pivotal role in the synthesis of robust feedback systems. The simplicity of the synthesis algorithm yields an efficient computer aided interactive design tool for flight control system synthesis.

Implementation of Quality by Design for Formulation of Rebamipide Gastro-retentive Tablet.

PubMed

Ha, Jung-Myung; Seo, Jeong-Woong; Kim, Su-Hyeon; Kim, Ju-Young; Park, Chun-Woong; Rhee, Yun-Seok; Park, Eun-Seok

2017-11-01

The purpose of the present study was to develop a rebamipide (RBM) gastro-retentive (GR) tablet by implementing quality by design (QbD). RBM GR tablets were prepared using a sublimation method. Quality target product profile (QTPP) and critical quality attributes (CQAs) of the RBM GR tablets were defined according to the preliminary studies. Factors affecting the CQAs were prioritized using failure mode and effects analysis (FMEA). Design space and optimum formulation were established through a mixture design. The validity of the design space was confirmed using runs within the area. The QTPP of the RBM GR tablets was the orally administered GR tablet containing 300 mg of RBM taken once daily. Based on the QTPP, dissolution rate, tablet friability, and floating property were chosen as CQAs. According to the risk assessment, the amount of sustained-release agent, sublimating material, and diluent showed high-risk priority number (RPN) values above 40. Based on the RPN, these factors were further investigated using mixture design methodology. Design space of formulations was depicted as an overlaid contour plot and the optimum formulation to satisfy the desired responses was obtained by determining the expected value of each response. The similarity factor (f2) of the release profile between predicted response and experimental response was 89.463, suggesting that two release profiles are similar. The validity of the design space was also confirmed. Consequently, we were able to develop the RBM GR tablets by implementing the QbD concept. These results provide useful information for development of tablet formulations using the QbD.

49 CFR 611.301 - Small Starts eligibility.

Code of Federal Regulations, 2014 CFR

2014-10-01

... extension to a fixed guideway, or a corridor-based bus rapid transit system, a project must: (1) Be a Small... extension to a fixed guideway, or a corridor-based bus rapid system, a project must: (1) Be a Small Starts...

49 CFR 611.301 - Small Starts eligibility.

Code of Federal Regulations, 2013 CFR

2013-10-01

... extension to a fixed guideway, or a corridor-based bus rapid transit system, a project must: (1) Be a Small... extension to a fixed guideway, or a corridor-based bus rapid system, a project must: (1) Be a Small Starts...

49 CFR 268.1 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... TRANSPORTATION MAGNETIC LEVITATION TRANSPORTATION TECHNOLOGY DEPLOYMENT PROGRAM Overview § 268.1 Definitions. As..., including land, piers, guideways, propulsion equipment and other components attached to guideways, power... described in § 268.3. Maglev means transportation systems employing magnetic levitation that would be...

Forward-Oriented Designing for Learning as a Means to Achieve Educational Quality

ERIC Educational Resources Information Center

Ghislandi, Patrizia M. M.; Raffaghelli, Juliana E.

2015-01-01

In this paper, we reflect on how Design for Learning can create the basis for a culture of educational quality. We explore the process of Design for Learning within a blended, undergraduate university course through a teacher-led inquiry approach, aiming at showing the connections between the process of Design for Learning and academic…

A design procedure for the handling qualities optimization of the X-29A aircraft

NASA Technical Reports Server (NTRS)

Bosworth, John T.; Cox, Timothy H.

1989-01-01

A design technique for handling qualities improvement was developed for the X-29A aircraft. As with any new aircraft, the X-29A control law designers were presented with a relatively high degree of uncertainty in their mathematical models. The presence of uncertainties, and the high level of static instability of the X-29A caused the control law designers to stress stability and robustness over handling qualities. During flight test, the mathematical models of the vehicle were validated or corrected to match the vehicle dynamic behavior. The updated models were then used to fine tune the control system to provide fighter-like handling characteristics. A design methodology was developed which works within the existing control system architecture to provide improved handling qualities and acceptable stability with a minimum of cost in both implementation as well as software verification and validation.

Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation.

PubMed

Monks, K; Molnár, I; Rieger, H-J; Bogáti, B; Szabó, E

2012-04-06

Robust HPLC separations lead to fewer analysis failures and better method transfer as well as providing an assurance of quality. This work presents the systematic development of an optimal, robust, fast UHPLC method for the simultaneous assay of two APIs of an eye drop sample and their impurities, in accordance with Quality by Design principles. Chromatography software is employed to effectively generate design spaces (Method Operable Design Regions), which are subsequently employed to determine the final method conditions and to evaluate robustness prior to validation. Copyright © 2011 Elsevier B.V. All rights reserved.

Correcting groove error in gratings ruled on a 500-mm ruling engine using interferometric control.

PubMed

Mi, Xiaotao; Yu, Haili; Yu, Hongzhu; Zhang, Shanwen; Li, Xiaotian; Yao, Xuefeng; Qi, Xiangdong; Bayinhedhig; Wan, Qiuhua

2017-07-20

Groove error is one of the most important factors affecting grating quality and spectral performance. To reduce groove error, we propose a new ruling-tool carriage system based on aerostatic guideways. We design a new blank carriage system with double piezoelectric actuators. We also propose a completely closed-loop servo-control system with a new optical measurement system that can control the position of the diamond relative to the blank. To evaluate our proposed methods, we produced several gratings, including an echelle grating with 79  grooves/mm, a grating with 768  grooves/mm, and a high-density grating with 6000  grooves/mm. The results show that our methods effectively reduce groove error in ruled gratings.

Valve assembly for internal combustion engine

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

Wakeman, R.J.; Shea, S.F.

1989-09-05

This patent describes an improvement in a valve assembly for an internal combustion engine of the type including a valve having a valve stem, a valve guideway for mounting this valve for reciprocal strokes between opened and seated position, and spring means for biasing the valve into the seated position. The improvement comprising a valve spool of greater cross-sectional diameter as compared to the valve stem, and a valve spool guideway within which the valve spool is movable during the strokes of the valve, an upper surface of the valve spool and a portion of the spool guideway collectively establishingmore » a damper chamber which varies in volume during the valve strokes. a feed passage for introducing oil into the damper chamber, and a bleed passage for discharging oil from the damper chamber. The bleed passages each laterally opening into the valve spool guideway.« less

A design of wireless sensor networks for a power quality monitoring system.

PubMed

Lim, Yujin; Kim, Hak-Man; Kang, Sanggil

2010-01-01

Power grids deal with the business of generation, transmission, and distribution of electric power. Recently, interest in power quality in electrical distribution systems has increased rapidly. In Korea, the communication network to deliver voltage, current, and temperature measurements gathered from pole transformers to remote monitoring centers employs cellular mobile technology. Due to high cost of the cellular mobile technology, power quality monitoring measurements are limited and data gathering intervals are large. This causes difficulties in providing the power quality monitoring service. To alleviate the problems, in this paper we present a communication infrastructure to provide low cost, reliable data delivery. The communication infrastructure consists of wired connections between substations and monitoring centers, and wireless connections between pole transformers and substations. For the wireless connection, we employ a wireless sensor network and design its corresponding data forwarding protocol to improve the quality of data delivery. For the design, we adopt a tree-based data forwarding protocol in order to customize the distribution pattern of the power quality information. We verify the performance of the proposed data forwarding protocol quantitatively using the NS-2 network simulator.

49 CFR 659.39 - Oversight agency reporting to the Federal Transit Administration.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., must make its initial submission to FTA by May 1, 2006. In states with rail fixed guideway systems... must make a new initial submission to FTA within thirty (30) days of the designation. (b) An initial... must submit the following to FTA: (1) A publicly available annual report summarizing its oversight...

Economic evaluation of flying-qualities design criteria for a transport configured with relaxed static stability

NASA Technical Reports Server (NTRS)

Sliwa, S. M.

1980-01-01

Direct constrained parameter optimization was used to optimally size a medium range transport for minimum direct operating cost. Several stability and control constraints were varied to study the sensitivity of the configuration to specifying the unaugmented flying qualities of transports designed to take maximum advantage of relaxed static stability augmentation systems. Additionally, a number of handling qualities related design constants were studied with respect to their impact on the design.

Designing a Clinical Data Warehouse Architecture to Support Quality Improvement Initiatives.

PubMed

Chelico, John D; Wilcox, Adam B; Vawdrey, David K; Kuperman, Gilad J

2016-01-01

Clinical data warehouses, initially directed towards clinical research or financial analyses, are evolving to support quality improvement efforts, and must now address the quality improvement life cycle. In addition, data that are needed for quality improvement often do not reside in a single database, requiring easier methods to query data across multiple disparate sources. We created a virtual data warehouse at NewYork Presbyterian Hospital that allowed us to bring together data from several source systems throughout the organization. We also created a framework to match the maturity of a data request in the quality improvement life cycle to proper tools needed for each request. As projects progress in the Define, Measure, Analyze, Improve, Control stages of quality improvement, there is a proper matching of resources the data needs at each step. We describe the analysis and design creating a robust model for applying clinical data warehousing to quality improvement.

[Application of quality by design in granulation process for ginkgo leaf tablet (Ⅱ)： identification of critical quality attributes].

PubMed

Xu, Bing; Cui, Xiang-Long; Yang, Chan; Wang, Xin; Shi, Xin-Yuan; Qiao, Yan-Jiang

2017-03-01

Quality by design (QbD) highlights the concept of "begin with the end", which means to thoroughly understand the target product quality first, and then guide pharmaceutical process development and quality control throughout the whole manufacturing process. In this paper, the Ginkgo biloba granules intermediates were taken as the research object, and the requirements of the tensile strength of tablets were treated as the goals to establish the methods for identification of granules' critical quality attributes (CQAs) and establishment of CQAs' limits. Firstly, the orthogonal partial least square (OPLS) model was adopted to build the relationship between the micromeritic properties of 29 batches of granules and the tensile strength of ginkgo leaf tablets, and thereby the potential critical quality attributes (pCQAs) were screened by variable importance in the projection (VIP) indexes. Then, a series of OPLS models were rebuilt by reducing pCQAs variables one by one in view of the rule of VIP values from low to high in sequence. The model performance results demonstrated that calibration and predictive performance of the model had no decreasing trend after variables reduction. In consideration of the results from variables selection as well as the collinearity test and testability of the pCQAs, the median particle size (D₅₀) and the bulk density (Da) were identified as critical quality attributes (CQAs). The design space of CQAs was developed based on a multiple linear regression model established between the CQAs (D₅₀ and Da) and the tensile strength. The control constraints of the CQAs were determined as 170 μm< D₅₀<500 μm and 0.30 g•cm⁻³design space, which provided a basis for controlling and optimizing the wet granulation process of the ginkgo leaf tablet.. Copyright© by the Chinese Pharmaceutical Association.

A Review of Dynamic Characteristics of Magnetically Levitated Vehicle Systems.

DTIC Science & Technology

1995-11-01

The dynamic response of magnetically levitated ( maglev ) ground transportation systems has important consequences for safety and ride quality...smoothness and levitation and control systems must be considered if maglev systems are to be economically feasible. The link between the guideway and the...other maglev components is vehicle dynamics. For a commercial maglev system, vehicle dynamics must be analyzed and tested in detail. This report, which

Impact of National Ambient Air Quality Standards Nonattainment Designations on Particulate Pollution and Health.

PubMed

Zigler, Corwin M; Choirat, Christine; Dominici, Francesca

2018-03-01

Despite dramatic air quality improvement in the United States over the past decades, recent years have brought renewed scrutiny and uncertainty surrounding the effectiveness of specific regulatory programs for continuing to improve air quality and public health outcomes. We employ causal inference methods and a spatial hierarchical regression model to characterize the extent to which a designation of "nonattainment" with the 1997 National Ambient Air Quality Standard for ambient fine particulate matter (PM2.5) in 2005 causally affected ambient PM2.5 and health outcomes among over 10 million Medicare beneficiaries in the Eastern United States in 2009-2012. We found that, on average across all retained study locations, reductions in ambient PM2.5 and Medicare health outcomes could not be conclusively attributed to the nonattainment designations against the backdrop of other regional strategies that impacted the entire Eastern United States. A more targeted principal stratification analysis indicates substantial health impacts of the nonattainment designations among the subset of areas where the designations are estimated to have actually reduced ambient PM2.5 beyond levels achieved by regional measures, with noteworthy reductions in all-cause mortality, chronic obstructive pulmonary disorder, heart failure, ischemic heart disease, and respiratory tract infections. These findings provide targeted evidence of the effectiveness of local control measures after nonattainment designations for the 1997 PM2.5 air quality standard.

Automated Guideway Transit System Passenger Security Guidebook

DOT National Transportation Integrated Search

1980-03-01

This uidebook provides AGT system planners, designers and operators with information on available crime countermeasures and their relative effectiveness against transit crime. : Crime countermeasures on current transit systems have been reviewed and ...

Three-dimensional desirability spaces for quality-by-design-based HPLC development.

PubMed

Mokhtar, Hatem I; Abdel-Salam, Randa A; Hadad, Ghada M

2015-04-01

In this study, three-dimensional desirability spaces were introduced as a graphical representation method of design space. This was illustrated in the context of application of quality-by-design concepts on development of a stability indicating gradient reversed-phase high-performance liquid chromatography method for the determination of vinpocetine and α-tocopheryl acetate in a capsule dosage form. A mechanistic retention model to optimize gradient time, initial organic solvent concentration and ternary solvent ratio was constructed for each compound from six experimental runs. Then, desirability function of each optimized criterion and subsequently the global desirability function were calculated throughout the knowledge space. The three-dimensional desirability spaces were plotted as zones exceeding a threshold value of desirability index in space defined by the three optimized method parameters. Probabilistic mapping of desirability index aided selection of design space within the potential desirability subspaces. Three-dimensional desirability spaces offered better visualization and potential design spaces for the method as a function of three method parameters with ability to assign priorities to this critical quality as compared with the corresponding resolution spaces. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A design procedure and handling quality criteria for lateral directional flight control systems

NASA Technical Reports Server (NTRS)

Stein, G.; Henke, A. H.

1972-01-01

A practical design procedure for aircraft augmentation systems is described based on quadratic optimal control technology and handling-quality-oriented cost functionals. The procedure is applied to the design of a lateral-directional control system for the F4C aircraft. The design criteria, design procedure, and final control system are validated with a program of formal pilot evaluation experiments.

Designing a Clinical Data Warehouse Architecture to Support Quality Improvement Initiatives

PubMed Central

Chelico, John D.; Wilcox, Adam B.; Vawdrey, David K.; Kuperman, Gilad J.

2016-01-01

Clinical data warehouses, initially directed towards clinical research or financial analyses, are evolving to support quality improvement efforts, and must now address the quality improvement life cycle. In addition, data that are needed for quality improvement often do not reside in a single database, requiring easier methods to query data across multiple disparate sources. We created a virtual data warehouse at NewYork Presbyterian Hospital that allowed us to bring together data from several source systems throughout the organization. We also created a framework to match the maturity of a data request in the quality improvement life cycle to proper tools needed for each request. As projects progress in the Define, Measure, Analyze, Improve, Control stages of quality improvement, there is a proper matching of resources the data needs at each step. We describe the analysis and design creating a robust model for applying clinical data warehousing to quality improvement. PMID:28269833

Redesigning Design: Field Testing a Revised Design Rubric Based on iNACOL Quality Course Standards

ERIC Educational Resources Information Center

Adelstein, David; Barbour, Michael K.

2016-01-01

Designers have a limited selection of K-12 online course creation standards to choose from that are not blocked behind proprietary or pay walls. For numerous institutions and states, the use of the iNACOL "National Standards for Quality Online Courses" is becoming a widely used resource. This article presents the final phase in a…

The Incorporation of Quality Attributes into Online Course Design in Higher Education

ERIC Educational Resources Information Center

Lenert, Kathleen Anne; Diane P. Janes

2017-01-01

A survey was designed incorporating questions on 28 attributes (compiled through a literature review) and considered to be quality features in online academic courses in higher education. This study sought to investigate the ongoing practice of instructional designers and instructors in the United States with respect to their incorporation of…

Evaluating a community-based program to improve healthcare quality: research design for the Aligning Forces for Quality initiative.

PubMed

Scanlon, Dennis P; Alexander, Jeffrey A; Beich, Jeff; Christianson, Jon B; Hasnain-Wynia, Romana; McHugh, Megan C; Mittler, Jessica N; Shi, Yunfeng; Bodenschatz, Laura J

2012-09-01

The Aligning Forces for Quality (AF4Q) initiative is the Robert Wood Johnson Foundation's (RWJF's) signature effort to increase the overall quality of healthcare in targeted communities throughout the country. In addition to sponsoring this 16-site, complex program, the RWJF funds an independent scientific evaluation to support objective research on the initiative's effectiveness and contributions to basic knowledge in 5 core programmatic areas. The research design, data, and challenges faced in the evaluation of this 10-year initiative are discussed. A descriptive overview of the evaluation research design for a multi-site, community based, healthcare quality improvement initiative is provided. The multiphase research design employed by the evaluation team is discussed. Evaluation provides formative feedback to the RWJF, participants, and other interested audiences in real time; develops approaches to assess innovative and under-studied interventions; furthers the analysis and understanding of effective community-based collaborative work in healthcare; and helps to differentiate the various facilitators, barriers, and contextual dimensions that affect the implementation and outcomes of community-based health interventions. The AF4Q initiative is arguably the largest community-level healthcare improvement demonstration in the United States to date; it is being implemented at a time of rapid change in national healthcare policy. The implementation of large-scale, multi-site initiatives is becoming an increasingly common approach for addressing problems in healthcare. The evaluation research design for the AF4Q initiative, and the lessons learned from its approach, may be valuable to others tasked with evaluating similar community-based initiatives.

76 FR 6056 - Additional Air Quality Designations for the 2006 24-Hour Fine Particle National Ambient Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

...-9261-3] RIN 2060-AQ30 Additional Air Quality Designations for the 2006 24-Hour Fine Particle National..., and Decisions Related to the 1997 Air Quality Designations and Classifications for the Annual Fine... nationwide for all but three areas for the 2006 24-hour fine particle (PM 2.5 ) National Ambient Air Quality...

Rational design of high-yield and superior-quality rice.

PubMed

Zeng, Dali; Tian, Zhixi; Rao, Yuchun; Dong, Guojun; Yang, Yaolong; Huang, Lichao; Leng, Yujia; Xu, Jie; Sun, Chuan; Zhang, Guangheng; Hu, Jiang; Zhu, Li; Gao, Zhenyu; Hu, Xingming; Guo, Longbiao; Xiong, Guosheng; Wang, Yonghong; Li, Jiayang; Qian, Qian

2017-03-20

Rice (Oryza sativa L.) is a staple food for more than half of the world's population. To meet the ever-increasing demand for food, because of population growth and improved living standards, world rice production needs to double by 2030 1 . The development of new elite rice varieties with high yield and superior quality is challenging for traditional breeding approaches, and new strategies need to be developed. Here, we report the successful development of new elite varieties by pyramiding major genes that significantly contribute to grain quality and yield from three parents over five years. The new varieties exhibit higher yield potential and better grain quality than their parental varieties and the China's leading super-hybrid rice, Liang-you-pai-jiu (LYP9 or Pei-ai 64S/93-11). Our results demonstrate that rational design is a powerful strategy for meeting the challenges of future crop breeding, particularly in pyramiding multiple complex traits.

Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process.

PubMed

Hubert, C; Lebrun, P; Houari, S; Ziemons, E; Rozet, E; Hubert, Ph

2014-01-01

The understanding of the method is a major concern when developing a stability-indicating method and even more so when dealing with impurity assays from complex matrices. In the presented case study, a Quality-by-Design approach was applied in order to optimize a routinely used method. An analytical issue occurring at the last stage of a long-term stability study involving unexpected impurities perturbing the monitoring of characterized impurities needed to be resolved. A compliant Quality-by-Design (QbD) methodology based on a Design of Experiments (DoE) approach was evaluated within the framework of a Liquid Chromatography (LC) method. This approach allows the investigation of Critical Process Parameters (CPPs), which have an impact on Critical Quality Attributes (CQAs) and, consequently, on LC selectivity. Using polynomial regression response modeling as well as Monte Carlo simulations for error propagation, Design Space (DS) was computed in order to determine robust working conditions for the developed stability-indicating method. This QbD compliant development was conducted in two phases allowing the use of the Design Space knowledge acquired during the first phase to define the experimental domain of the second phase, which constitutes a learning process. The selected working condition was then fully validated using accuracy profiles based on statistical tolerance intervals in order to evaluate the reliability of the results generated by this LC/ESI-MS stability-indicating method. A comparison was made between the traditional Quality-by-Testing (QbT) approach and the QbD strategy, highlighting the benefit of this QbD strategy in the case of an unexpected impurities issue. On this basis, the advantages of a systematic use of the QbD methodology were discussed. Copyright © 2013 Elsevier B.V. All rights reserved.

Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment.

PubMed

Djuris, Jelena; Djuric, Zorica

2017-11-30

Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbD-based submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented. Copyright © 2017 Elsevier B.V. All rights reserved.

Design and realization of high quality prime farmland planning and management information system

NASA Astrophysics Data System (ADS)

Li, Manchun; Liu, Guohong; Liu, Yongxue; Jiang, Zhixin

2007-06-01

The article discusses the design and realization of a high quality prime farmland planning and management information system based on SDSS. Models in concept integration, management planning are used in High Quality Prime Farmland Planning in order to refine the current model system and the management information system is deigned with a triangular structure. Finally an example of Tonglu county high quality prime farmland planning and management information system is introduced.

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space.

PubMed

Eon-duval, Alex; Valax, Pascal; Solacroup, Thomas; Broly, Hervé; Gleixner, Ralf; Strat, Claire L E; Sutter, James

2012-10-01

The article describes how Quality by Design principles can be applied to the drug substance manufacturing process of an Fc fusion protein. First, the quality attributes of the product were evaluated for their potential impact on safety and efficacy using risk management tools. Similarly, process parameters that have a potential impact on critical quality attributes (CQAs) were also identified through a risk assessment. Critical process parameters were then evaluated for their impact on CQAs, individually and in interaction with each other, using multivariate design of experiment techniques during the process characterisation phase. The global multi-step Design Space, defining operational limits for the entire drug substance manufacturing process so as to ensure that the drug substance quality targets are met, was devised using predictive statistical models developed during the characterisation study. The validity of the global multi-step Design Space was then confirmed by performing the entire process, from cell bank thawing to final drug substance, at its limits during the robustness study: the quality of the final drug substance produced under different conditions was verified against predefined targets. An adaptive strategy was devised whereby the Design Space can be adjusted to the quality of the input material to ensure reliable drug substance quality. Finally, all the data obtained during the process described above, together with data generated during additional validation studies as well as manufacturing data, were used to define the control strategy for the drug substance manufacturing process using a risk assessment methodology. Copyright © 2012 Wiley-Liss, Inc.

Analytical procedure validation and the quality by design paradigm.

PubMed

Rozet, Eric; Lebrun, Pierre; Michiels, Jean-François; Sondag, Perceval; Scherder, Tara; Boulanger, Bruno

2015-01-01

Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a quality by design (QbD) approach, there have been many discussions on the opportunity for analytical procedure developments to follow a similar approach. While development and optimization of analytical procedure following QbD principles have been largely discussed and described, the place of analytical procedure validation in this framework has not been clarified. This article aims at showing that analytical procedure validation is fully integrated into the QbD paradigm and is an essential step in developing analytical procedures that are effectively fit for purpose. Adequate statistical methodologies have also their role to play: such as design of experiments, statistical modeling, and probabilistic statements. The outcome of analytical procedure validation is also an analytical procedure design space, and from it, control strategy can be set.

Quality Control through Design and Process: Gambrel Roof Truss Challenge

ERIC Educational Resources Information Center

Ward, Dell; Jones, James

2011-01-01

Customers determine whether a product fulfills their needs or satisfies them. "Quality control", then, is the process of finding out what the customer wants, along with designing, producing, delivering, and servicing the product--and ultimately satisfying the customer's expectations. For many years, people considered a product to be of good…

Quality by Design approach to spray drying processing of crystalline nanosuspensions.

PubMed

Kumar, Sumit; Gokhale, Rajeev; Burgess, Diane J

2014-04-10

Quality by Design (QbD) principles were explored to understand spray drying process for the conversion of liquid nanosuspensions into solid nano-crystalline dry powders using indomethacin as a model drug. The effects of critical process variables: inlet temperature, flow and aspiration rates on critical quality attributes (CQAs): particle size, moisture content, percent yield and crystallinity were investigated employing a full factorial design. A central cubic design was employed to generate the response surface for particle size and percent yield. Multiple linear regression analysis and ANOVA were employed to identify and estimate the effect of critical parameters, establish their relationship with CQAs, create design space and model the spray drying process. Inlet temperature was identified as the only significant factor (p value <0.05) to affect dry powder particle size. Higher inlet temperatures caused drug surface melting and hence aggregation of the dried nano-crystalline powders. Aspiration and flow rates were identified as significant factors affecting yield (p value <0.05). Higher yields were obtained at higher aspiration and lower flow rates. All formulations had less than 3% (w/w) moisture content. Formulations dried at higher inlet temperatures had lower moisture compared to those dried at lower inlet temperatures. Published by Elsevier B.V.

Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities.

PubMed

Orlandini, Serena; Pasquini, Benedetta; Caprini, Claudia; Del Bubba, Massimo; Pinzauti, Sergio; Furlanetto, Sandra

2015-11-01

A fast and selective CE method for the determination of zolmitriptan (ZOL) and its five potential impurities has been developed applying the analytical Quality by Design principles. Voltage, temperature, buffer concentration, and pH were investigated as critical process parameters that can influence the critical quality attributes, represented by critical resolution values between peak pairs, analysis time, and peak efficiency of ZOL-dimer. A symmetric screening matrix was employed for investigating the knowledge space, and a Box-Behnken design was used to evaluate the main, interaction, and quadratic effects of the critical process parameters on the critical quality attributes. Contour plots were drawn highlighting important interactions between buffer concentration and pH, and the gained information was merged into the sweet spot plots. Design space (DS) was established by the combined use of response surface methodology and Monte Carlo simulations, introducing a probability concept and thus allowing the quality of the analytical performances to be assured in a defined domain. The working conditions (with the interval defining the DS) were as follows: BGE, 138 mM (115-150 mM) phosphate buffer pH 2.74 (2.54-2.94); temperature, 25°C (24-25°C); voltage, 30 kV. A control strategy was planned based on method robustness and system suitability criteria. The main advantages of applying the Quality by Design concept consisted of a great increase of knowledge of the analytical system, obtained throughout multivariate techniques, and of the achievement of analytical assurance of quality, derived by probability-based definition of DS. The developed method was finally validated and applied to the analysis of ZOL tablets. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Designing relevant biochars to revitalize soil quality: Current status and advances

EPA Science Inventory

Biochars chemical and physical properties can be designed to improve specific soil quality issues. In order to make appropriate selections, evaluations are required of different feedstocks, pyrolysis conditions, and gross biochar particle sizes. We conducted laboratory soil incu...

Flared landing approach flying qualities. Volume 1: Experiment design and analysis

NASA Technical Reports Server (NTRS)

Weingarten, Norman C.; Berthe, Charles J., Jr.; Rynaski, Edmund G.; Sarrafian, Shahan K.

1986-01-01

An inflight research study was conducted utilizing the USAF Total Inflight Simulator (TIFS) to investigate longitudinal flying qualities for the flared landing approach phase of flight. The purpose of the experiment was to generate a consistent set of data for: (1) determining what kind of commanded response the pilot prefers in order to flare and land an airplane with precision, and (2) refining a time history criterion that took into account all the necessary variables and their characteristics that would accurately predict flying qualities. The result of the first part provides guidelines to the flight control system designer, using MIL-F-8785-(C) as a guide, that yield the dynamic behavior pilots perfer in flared landings. The results of the second part provides the flying qualities engineer with a newly derived flying qualities predictive tool which appears to be highly accurate. This time domain predictive flying qualities criterion was applied to the flight data as well as six previous flying qualities studies, and the results indicate that the criterion predicted the flying qualities level 81% of the time and the Cooper-Harper pilot rating, within + or - 1, 60% of the time.

[Application of quality by design in granulation process for Ginkgo leaf tablet (Ⅲ)： process control strategy based on design space].

PubMed

Cui, Xiang-Long; Xu, Bing; Sun, Fei; Dai, Sheng-Yun; Shi, Xin-Yuan; Qiao, Yan-Jiang

2017-03-01

In this paper, under the guidance of quality by design (QbD) concept, the control strategy of the high shear wet granulation process of the ginkgo leaf tablet based on the design space was established to improve the process controllability and product quality consistency. The median granule size (D50) and bulk density (Da) of granules were identified as critical quality attributes (CQAs) and potential critical process parameters (pCPPs) were determined by the failure modes and effect analysis (FMEA). The Plackeet-Burmann experimental design was used to screen pCPPs and the results demonstrated that the binder amount, the wet massing time and the wet mixing impeller speed were critical process parameters (CPPs). The design space of the high shear wet granulation process was developed within pCPPs range based on the Box-Behnken design and quadratic polynomial regression models. ANOVA analysis showed that the P-values of model were less than 0.05 and the values of lack of fit test were more than 0.1, indicating that the relationship between CQAs and CPPs could be well described by the mathematical models. D₅₀ could be controlled within 170 to 500 μm, and the bulk density could be controlled within 0.30 to 0.44 g•cm⁻³ by using any CPPs combination within the scope of design space. Besides, granules produced by process parameters within the design space region could also meet the requirement of tensile strength of the ginkgo leaf tablet.. Copyright© by the Chinese Pharmaceutical Association.

Design of a ground-water-quality monitoring network for the Salinas River basin, California

USGS Publications Warehouse

Showalter, P.K.; Akers, J.P.; Swain, L.A.

1984-01-01

A regional ground-water quality monitoring network for the entire Salinas River drainage basin was designed to meet the needs of the California State Water Resources Control Board. The project included phase 1--identifying monitoring networks that exist in the region; phase 2--collecting information about the wells in each network; and phase 3--studying the factors--such as geology, land use, hydrology, and geohydrology--that influence the ground-water quality, and designing a regional network. This report is the major product of phase 3. Based on the authors ' understanding of the ground-water-quality monitoring system and input from local offices, an ideal network was designed. The proposed network includes 317 wells and 8 stream-gaging stations. Because limited funds are available to implement the monitoring network, the proposed network is designed to correspond to the ideal network insofar as practicable, and is composed mainly of 214 wells that are already being monitored by a local agency. In areas where network wells are not available, arrangements will be made to add wells to local networks. The data collected by this network will be used to assess the ground-water quality of the entire Salinas River drainage basin. After 2 years of data are collected, the network will be evaluated to test whether it is meeting the network objectives. Subsequent network evaluations will be done very 5 years. (USGS)

Interactions between Magnetically Levitated Vehicles and Elevated Guideway Structures

DOT National Transportation Integrated Search

1992-07-01

The dynamic performance characteristic of magnetically levitated vehicles and vehicle trains relating to ride quality and magnetic gap variations have been determined using computer simulation models for one-dimensional, two-dimensional and finite le...

An intelligent case-adjustment algorithm for the automated design of population-based quality auditing protocols.

PubMed

Advani, Aneel; Jones, Neil; Shahar, Yuval; Goldstein, Mary K; Musen, Mark A

2004-01-01

We develop a method and algorithm for deciding the optimal approach to creating quality-auditing protocols for guideline-based clinical performance measures. An important element of the audit protocol design problem is deciding which guide-line elements to audit. Specifically, the problem is how and when to aggregate individual patient case-specific guideline elements into population-based quality measures. The key statistical issue involved is the trade-off between increased reliability with more general population-based quality measures versus increased validity from individually case-adjusted but more restricted measures done at a greater audit cost. Our intelligent algorithm for auditing protocol design is based on hierarchically modeling incrementally case-adjusted quality constraints. We select quality constraints to measure using an optimization criterion based on statistical generalizability coefficients. We present results of the approach from a deployed decision support system for a hypertension guideline.

Implementation of "Quality by Design (QbD)" Approach for the Development of 5-Fluorouracil Loaded Thermosensitive Hydrogel.

PubMed

Dalwadi, Chintan; Patel, Gayatri

2016-01-01

The purpose of this study was to investigate Quality by Design (QbD) principle for the preparation of hydrogel products to prove both practicability and utility of executing QbD concept to hydrogel based controlled release systems. Product and process understanding will help in decreasing the variability of critical material and process parameters, which give quality product output and reduce the risk. This study includes the identification of the Quality Target Product Profiles (QTPPs) and Critical Quality Attributes (CQAs) from literature or preliminary studies. To identify and control the variability in process and material attributes, two tools of QbD was utilized, Quality Risk Management (QRM) and Experimental Design. Further, it helps to identify the effect of these attributes on CQAs. Potential risk factors were identified from fishbone diagram and screened by risk assessment and optimized by 3-level 2- factor experimental design with center points in triplicate, to analyze the precision of the target process. This optimized formulation was further characterized by gelling time, gelling temperature, rheological parameters, in-vitro biodegradation and in-vitro drug release. Design space was created using experimental design tool that gives the control space and working within this controlled space reduces all the failure modes below the risk level. In conclusion, QbD approach with QRM tool provides potent and effectual pyramid to enhance the quality into the hydrogel.

Universal Design as a Booster for Housing Quality and Architectural Practice.

PubMed

Denizou, Karine

2016-01-01

Norwegian central government has for the last decade increasingly focused on universal design. Fundamental changes in the Norwegian building code and corresponding regulations in 2010 give an apparently clear framework for the implementation of accessibility and universal design. However, it seems that neither increased awareness of accessibility requirements and universal design, nor compliance with the building code guarantees improvement of housing quality and usability. The Norwegian regulations have gone further in the direction of performance requirements than most other countries. This applies to all types of requirements, including requirements for usability, functionality and accessibility. Hardly any specifications are to be found in the regulations. Ideally, this lack of specifications should give designers the opportunity to develop innovative answers and hence to respond to different contexts and needs. Still, many architects and builders ask for clear specifications, in order to simplify and speed up design processes and make control of solutions easier. Many architects understand guidelines as minimum requirements, and are thus reproducing the identical solutions without considering the context and the needs of the users. They see accessibility as another regulatory pressure and requirements as restrictions rather than positive incentives. However, there are examples of designers who have internalised the regulatory framework and thus are able to create and integrate inclusive design in their daily work. Based on recent research conducted by SINTEF Building and Infrastructure and financed by the Norwegian State Housing Bank, this paper presents examples of practice where dwellings have been developed within a framework of universal design. Focus of the research has been on the approach of the design team and their understanding and use of the regulatory framework in order to create better homes in dialogue with the building authorities. Main

Experimental Designs and Psychometric Techniques for the Study of Ride Quality

DOT National Transportation Integrated Search

1977-05-01

A major variable in both the cost of any new transportation system and rider acceptance of the system is the ride quality of its vehicles. At this time, there exists no set of objective criteria which would allow the transportation system designer to...

A slow fashion design model for bluejeans using house of quality approach

NASA Astrophysics Data System (ADS)

Nergis, B.; Candan, C.; Sarısaltık, S.; Seneloglu, N.; Bozuk, R.; Amzayev, K.

2017-10-01

The purpose of this study was to develop a slow fashion design model using the house of quality model (HOQ) to provide fashion designers a tool to improve the overall sustainability of denim jeans for Y generation consumers in Turkish market. In doing so, a survey was conducted to collect data on the design & performance expectations as well as the perception of slow fashion in design process of denim jeans of the targeted consumer group. The results showed that Y generation in the market gave the most importance to the sustainable production techniques when identifying slow fashion.

The robust design for improving crude palm oil quality in Indonesian Mill

NASA Astrophysics Data System (ADS)

Maretia Benu, Siti; Sinulingga, Sukaria; Matondang, Nazaruddin; Budiman, Irwan

2018-04-01

This research was conducted in palm oil mill in Sumatra Utara Province, Indonesia. Currently, the main product of this mill is Crude Palm Oil (CPO) and hasn’t met the expected standard quality. CPO is the raw material for many fat derivative products. The generally stipulated quality criteria are dirt count, free fatty acid, and moisture of CPO. The aim of this study is to obtain the optimal setting for factor’s affect the quality of CPO. The optimal setting will result in an improvement of product’s quality. In this research, Experimental Design with Taguchi Method is used. Steps of this method are identified influence factors, select the orthogonal array, processed data using ANOVA test and signal to noise ratio, and confirmed the research using Quality Loss Function. The result of this study using Taguchi Method is to suggest to set fruit maturity at 75.4-86.9%, digester temperature at 95°C and press at 21 Ampere to reduce quality deviation until 42.42%.

Effluent quality from 200 on-site sewage systems: design values for guidelines.

PubMed

Charles, K J; Ashbolt, N J; Roser, D J; McGuinness, R; Deere, D A

2005-01-01

The quality of effluent from an on-site sewage treatment system is a critical factor in designing the disposal area and, hence, ensuring the sustained performance of the system. Contaminant concentrations in effluent are typically specified in regulatory guidelines or standards; however, the accuracy of these guideline values are brought into question due to the poor performance of septic tanks and the high failure rates of disposal systems reported here and elsewhere. Results from studies of septic tank effluent quality indicated that the effluent is of poorer quality than currently suggested by guidelines. Aerated wastewater treatment systems were found to perform to accreditation guidelines; however, insufficient nutrient data is presently available to assess nutrient loads. It is proposed that the 80th percentile of system performance be adopted as the design value for sizing effluent disposal areas to minimise failure associated with overloading. For septic tanks this equates to 660 mg L(-1) SS, 330 mg L(-1) BOD, 250 mg L(-1) TN and 36 mg L(-1) TP.

Statistical issues in quality control of proteomic analyses: good experimental design and planning.

PubMed

Cairns, David A

2011-03-01

Quality control is becoming increasingly important in proteomic investigations as experiments become more multivariate and quantitative. Quality control applies to all stages of an investigation and statistics can play a key role. In this review, the role of statistical ideas in the design and planning of an investigation is described. This involves the design of unbiased experiments using key concepts from statistical experimental design, the understanding of the biological and analytical variation in a system using variance components analysis and the determination of a required sample size to perform a statistically powerful investigation. These concepts are described through simple examples and an example data set from a 2-D DIGE pilot experiment. Each of these concepts can prove useful in producing better and more reproducible data. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Quality by design approach for understanding the critical quality attributes of cyclosporine ophthalmic emulsion.

PubMed

Rahman, Ziyaur; Xu, Xiaoming; Katragadda, Usha; Krishnaiah, Yellela S R; Yu, Lawrence; Khan, Mansoor A

2014-03-03

Restasis is an ophthalmic cyclosporine emulsion used for the treatment of dry eye syndrome. There are no generic products for this product, probably because of the limitations on establishing in vivo bioequivalence methods and lack of alternative in vitro bioequivalence testing methods. The present investigation was carried out to understand and identify the appropriate in vitro methods that can discriminate the effect of formulation and process variables on critical quality attributes (CQA) of cyclosporine microemulsion formulations having the same qualitative (Q1) and quantitative (Q2) composition as that of Restasis. Quality by design (QbD) approach was used to understand the effect of formulation and process variables on critical quality attributes (CQA) of cyclosporine microemulsion. The formulation variables chosen were mixing order method, phase volume ratio, and pH adjustment method, while the process variables were temperature of primary and raw emulsion formation, microfluidizer pressure, and number of pressure cycles. The responses selected were particle size, turbidity, zeta potential, viscosity, osmolality, surface tension, contact angle, pH, and drug diffusion. The selected independent variables showed statistically significant (p < 0.05) effect on droplet size, zeta potential, viscosity, turbidity, and osmolality. However, the surface tension, contact angle, pH, and drug diffusion were not significantly affected by independent variables. In summary, in vitro methods can detect formulation and manufacturing changes and would thus be important for quality control or sameness of cyclosporine ophthalmic products.

Rating the methodological quality of single-subject designs and n-of-1 trials: introducing the Single-Case Experimental Design (SCED) Scale.

PubMed

Tate, Robyn L; McDonald, Skye; Perdices, Michael; Togher, Leanne; Schultz, Regina; Savage, Sharon

2008-08-01

Rating scales that assess methodological quality of clinical trials provide a means to critically appraise the literature. Scales are currently available to rate randomised and non-randomised controlled trials, but there are none that assess single-subject designs. The Single-Case Experimental Design (SCED) Scale was developed for this purpose and evaluated for reliability. Six clinical researchers who were trained and experienced in rating methodological quality of clinical trials developed the scale and participated in reliability studies. The SCED Scale is an 11-item rating scale for single-subject designs, of which 10 items are used to assess methodological quality and use of statistical analysis. The scale was developed and refined over a 3-year period. Content validity was addressed by identifying items to reduce the main sources of bias in single-case methodology as stipulated by authorities in the field, which were empirically tested against 85 published reports. Inter-rater reliability was assessed using a random sample of 20/312 single-subject reports archived in the Psychological Database of Brain Impairment Treatment Efficacy (PsycBITE). Inter-rater reliability for the total score was excellent, both for individual raters (overall ICC = 0.84; 95% confidence interval 0.73-0.92) and for consensus ratings between pairs of raters (overall ICC = 0.88; 95% confidence interval 0.78-0.95). Item reliability was fair to excellent for consensus ratings between pairs of raters (range k = 0.48 to 1.00). The results were replicated with two independent novice raters who were trained in the use of the scale (ICC = 0.88, 95% confidence interval 0.73-0.95). The SCED Scale thus provides a brief and valid evaluation of methodological quality of single-subject designs, with the total score demonstrating excellent inter-rater reliability using both individual and consensus ratings. Items from the scale can also be used as a checklist in the design, reporting and critical

Quality by design approach: application of artificial intelligence techniques of tablets manufactured by direct compression.

PubMed

Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Ozer, Ozgen; Güneri, Tamer; York, Peter

2012-12-01

The publication of the International Conference of Harmonization (ICH) Q8, Q9, and Q10 guidelines paved the way for the standardization of quality after the Food and Drug Administration issued current Good Manufacturing Practices guidelines in 2003. "Quality by Design", mentioned in the ICH Q8 guideline, offers a better scientific understanding of critical process and product qualities using knowledge obtained during the life cycle of a product. In this scope, the "knowledge space" is a summary of all process knowledge obtained during product development, and the "design space" is the area in which a product can be manufactured within acceptable limits. To create the spaces, artificial neural networks (ANNs) can be used to emphasize the multidimensional interactions of input variables and to closely bind these variables to a design space. This helps guide the experimental design process to include interactions among the input variables, along with modeling and optimization of pharmaceutical formulations. The objective of this study was to develop an integrated multivariate approach to obtain a quality product based on an understanding of the cause-effect relationships between formulation ingredients and product properties with ANNs and genetic programming on the ramipril tablets prepared by the direct compression method. In this study, the data are generated through the systematic application of the design of experiments (DoE) principles and optimization studies using artificial neural networks and neurofuzzy logic programs.

Hypothesis driven drug design: improving quality and effectiveness of the design-make-test-analyse cycle.

PubMed

Plowright, Alleyn T; Johnstone, Craig; Kihlberg, Jan; Pettersson, Jonas; Robb, Graeme; Thompson, Richard A

2012-01-01

In drug discovery, the central process of constructing and testing hypotheses, carefully conducting experiments and analysing the associated data for new findings and information is known as the design-make-test-analyse cycle. Each step relies heavily on the inputs and outputs of the other three components. In this article we report our efforts to improve and integrate all parts to enable smooth and rapid flow of high quality ideas. Key improvements include enhancing multi-disciplinary input into 'Design', increasing the use of knowledge and reducing cycle times in 'Make', providing parallel sets of relevant data within ten working days in 'Test' and maximising the learning in 'Analyse'. Copyright © 2011 Elsevier Ltd. All rights reserved.

Feasibility of low-cost magnetic rail designs by integrating ferrite magnets and NdFeB magnets for HTS Maglev systems

NASA Astrophysics Data System (ADS)

Sun, R. X.; Deng, Z. G.; Gou, Y. F.; Li, Y. J.; Zheng, J.; Wang, S. Y.; Wang, J. S.

2015-09-01

Permanent magnet guideway (PMG) is an indispensable part of high temperature superconducting (HTS) Maglev systems. Present PMGs are made of NdFeB magnets with excellent performance and cost much. As another permanent magnet material, the ferrite magnet is weak at magnetic energy product and coercive force, but inexpensive. So, it is a possible way to integrate the ferrite and NdFeB magnets for cutting down the cost of present PMGs. In the paper, the equivalent on magnetic field intensity between ferrite magnets and NdFeB magnets was evaluated by finite element simulation. According to the calculation results, the magnetic field of the PMG integrating ferrite magnets and NdFeB magnets can be increased remarkably comparing with the pure ferrite PMG. It indicates that low-cost PMG designs by integrating the two permanent magnet materials are feasible for the practical HTS Maglev system.

Developing a quality by design approach to model tablet dissolution testing: an industrial case study.

PubMed

Yekpe, Ketsia; Abatzoglou, Nicolas; Bataille, Bernard; Gosselin, Ryan; Sharkawi, Tahmer; Simard, Jean-Sébastien; Cournoyer, Antoine

2018-07-01

This study applied the concept of Quality by Design (QbD) to tablet dissolution. Its goal was to propose a quality control strategy to model dissolution testing of solid oral dose products according to International Conference on Harmonization guidelines. The methodology involved the following three steps: (1) a risk analysis to identify the material- and process-related parameters impacting the critical quality attributes of dissolution testing, (2) an experimental design to evaluate the influence of design factors (attributes and parameters selected by risk analysis) on dissolution testing, and (3) an investigation of the relationship between design factors and dissolution profiles. Results show that (a) in the case studied, the two parameters impacting dissolution kinetics are active pharmaceutical ingredient particle size distributions and tablet hardness and (b) these two parameters could be monitored with PAT tools to predict dissolution profiles. Moreover, based on the results obtained, modeling dissolution is possible. The practicality and effectiveness of the QbD approach were demonstrated through this industrial case study. Implementing such an approach systematically in industrial pharmaceutical production would reduce the need for tablet dissolution testing.

Variables associated with sleep quality in chronic tension-type headache: A cross-sectional and longitudinal design.

PubMed

Benito-González, Elena; Palacios-Ceña, Maria; Fernández-Muñoz, Juan J; Castaldo, Matteo; Wang, Kelun; Catena, Antonella; Arendt-Nielsen, Lars; Fernández-de-Las-Peñas, César

2018-01-01

To investigate variables associated at baseline (cross-sectional design) and at one year (longitudinal design) with the quality of sleep in chronic tension-type headache (CTTH). One hundred and eighty (n = 180) and 135 individuals with CTTH participated in the cross-sectional and longitudinal design respectively. Clinical features were collected with a 4-weeks headache diary at baseline and one-year follow-up. Sleep quality was assessed at baseline and 1-year follow-up with the Pittsburgh Sleep Quality Index. Anxiety and depression (Hospital Anxiety and Depression Scale-HADS), burden of headache (Headache Disability Inventory-HDI), quality of life (SF-36 questionnaire), and pressure pain thresholds (PPTs) at trigeminal, extra-trigeminal and widespread area were assessed at baseline. Hierarchical regression analyses were conducted to determine the associations between variables at baseline and 1-year follow-up with sleep quality. At baseline positive correlations between sleep quality and headache intensity, headache frequency, headache duration, emotional and physical burden of headache and depression were observed. The regression analyses found that depression and emotional burden of headache explained 27.5% of the variance in sleep quality at baseline (r2 = .262; F = 23.72 P < .001). At one-year, sleep quality was significantly associated with baseline burden of headache, depression, widespread PPTs, vitality and mental health domains. Regression analyses revealed that vitality, PPT over the second metacarpal and PPT over the neck explained 30.0% of the variance of sleep quality at one-year (r2 = .269, F = 9.71, P < .001). It seems that sleep quality exhibits a complex interaction in individuals with CTTH since depression and the emotional burden were associated with sleep quality at baseline, but vitality and PPTs over extra-trigeminal areas were associated with the quality of sleep at one-year.

Design and Implementation of the Harvard Fellowship in Patient Safety and Quality.

PubMed

Gandhi, Tejal K; Abookire, Susan A; Kachalia, Allen; Sands, Kenneth; Mort, Elizabeth; Bommarito, Grace; Gagne, Jane; Sato, Luke; Weingart, Saul N

2016-01-01

The Harvard Fellowship in Patient Safety and Quality is a 2-year physician-oriented training program with a strong operational orientation, embedding trainees in the quality departments of participating hospitals. It also integrates didactic and experiential learning and offers the option of obtaining a master's degree in public health. The program focuses on methodologically rigorous improvement and measurement, with an emphasis on the development and implementation of innovative practice. The operational orientation is intended to foster the professional development of future quality and safety leaders. The purpose of this article is to describe the design and development of the fellowship. © The Author(s) 2014.

Downstream processing from hot-melt extrusion towards tablets: A quality by design approach.

PubMed

Grymonpré, W; Bostijn, N; Herck, S Van; Verstraete, G; Vanhoorne, V; Nuhn, L; Rombouts, P; Beer, T De; Remon, J P; Vervaet, C

2017-10-05

Since the concept of continuous processing is gaining momentum in pharmaceutical manufacturing, a thorough understanding on how process and formulation parameters can impact the critical quality attributes (CQA) of the end product is more than ever required. This study was designed to screen the influence of process parameters and drug load during HME on both extrudate properties and tableting behaviour of an amorphous solid dispersion formulation using a quality-by-design (QbD) approach. A full factorial experimental design with 19 experiments was used to evaluate the effect of several process variables (barrel temperature: 160-200°C, screw speed: 50-200rpm, throughput: 0.2-0.5kg/h) and drug load (0-20%) as formulation parameter on the hot-melt extrusion (HME) process, extrudate and tablet quality of Soluplus ® -Celecoxib amorphous solid dispersions. A prominent impact of the formulation parameter on the CQA of the extrudates (i.e. solid state properties, moisture content, particle size distribution) and tablets (i.e. tabletability, compactibility, fragmentary behaviour, elastic recovery) was discovered. The resistance of the polymer matrix to thermo-mechanical stress during HME was confirmed throughout the experimental design space. In addition, the suitability of Raman spectroscopy as verification method for the active pharmaceutical ingredient (API) concentration in solid dispersions was evaluated. Incorporation of the Raman spectroscopy data in a PLS model enabled API quantification in the extrudate powders with none of the DOE-experiments resulting in extrudates with a CEL content deviating>3% of the label claim. This research paper emphasized that HME is a robust process throughout the experimental design space for obtaining amorphous glassy solutions and for tabletting of such formulations since only minimal impact of the process parameters was detected on the extrudate and tablet properties. However, the quality of extrudates and tablets can be optimized

Extension of quality-by-design concept to the early development phase of pharmaceutical R&D processes.

PubMed

Csóka, Ildikó; Pallagi, Edina; Paál, Tamás L

2018-03-27

Here, we propose the extension of the quality-by-design (QbD) concept to also fit the early development phases of pharmaceuticals by adding elements that are currently widely applied, but not yet included in the QbD model in a structured way. These are the introduction of a 'zero' preformulation phase (i.e., selection of drug substance, possible dosage forms and administration routes based on the evaluated therapeutic need); building in stakeholders' (industry, patient, and regulatory) requirements into the quality target product profile (QTTP); and the use of modern quality management tools during the composition and process design phase [collecting critical quality attributes (CQAs) and selection of CPPs) for (still laboratory-scale) design space (DS) development. Moreover, during industrial scale-up, CQAs (as well as critical process parameters; CPPs) can be changed; however, we recommend that the existing QbD elements are reconsidered and updated after this phase. Copyright © 2018 Elsevier Ltd. All rights reserved.

Quality Assurance for Postgraduate Programs: Design of a Model Applied on a University in Chile

ERIC Educational Resources Information Center

Careaga Butter, Marcelo; Meyer Aguilera, Eduardo; Badilla Quintana, María Graciela; Jiménez Pérez, Laura; Sepúlveda Valenzuela, Eileen

2017-01-01

The quality of Education in Chile is a controversial topic that has been in the public debate in the last several years. To ensure quality in graduate programs, accreditation is compulsory. The current article presents a model to improve the process of self-regulation. The main objective was to design a Model of Quality Assurance for Postgraduate…

Evaluating an integrated approach to clinical quality improvement: clinical guidelines, quality measurement, and supportive system design.

PubMed

Cretin, S; Farley, D O; Dolter, K J; Nicholas, W

2001-08-01

Implementing clinical practice guidelines to change patient outcomes presents a challenge. Studies of single interventions focused on changing provider behavior demonstrate modest effects, suggesting that effective guideline implementation requires a multifaceted approach. Traditional biomedical research designs are not well suited to evaluating systems interventions. RAND and the Army Medical Department collaborated to develop and evaluate a system for implementing guidelines and documenting their effects on patient care. The evaluation design blended quality improvement, case study, and epidemiologic methods. A formative evaluation of implementation process and an outcome evaluation of patient impact were combined. Guidelines were implemented in 3 successive demonstrations targeting low back pain, asthma, and diabetes. This paper reports on the first wave of 4 facilities implementing a low back pain guideline. Organizational climate and culture, motivation, leadership commitment, and resources were assessed. Selected indicators of processes and outcomes of care were compared before, during, and after guideline implementation at the demonstration facilities and at comparison facilities. Logistic regression analysis was used to test for guideline effects on patient care. Process evaluation documented varied approaches to quality improvement across sites. Outcome evaluation revealed a significant downward trend in the percentage of acute low back pain patients referred to physical therapy or chiropractic care (10.7% to 7.2%) at demonstration sites and no such trend at control sites. Preliminary results suggest the power of this design to stimulate improvements in guideline implementation while retaining the power to evaluate rigorously effects on patient care.

Integrating Quality Matters into Hybrid Course Design: A Principles of Marketing Case Study

ERIC Educational Resources Information Center

Young, Mark R.

2014-01-01

Previous research supports the idea that the success of hybrid or online delivery modes is more a function of course design than delivery media. This article describes a case study of a hybrid Principles of Marketing course that implemented a comprehensive redesign based on design principles espoused by the Quality Matters Program, a center for…

Design of an instrument to measure the quality of care in Physical Therapy.

PubMed

Cavalheiro, Leny Vieira; Eid, Raquel Afonso Caserta; Talerman, Claudia; Prado, Cristiane do; Gobbi, Fátima Cristina Martorano; Andreoli, Paola Bruno de Araujo

2015-01-01

To design an instrument composed of domains that would demonstrate physical therapy activities and generate a consistent index to represent the quality of care in physical therapy. The methodology Lean Six Sigma was used to design the tool. The discussion involved seven different management groups staff. By means of brainstorming and Cause & Effect Matrix, we set up the process map. Five requirements composed the quality of care index in physical therapy, after application of the tool called Cause & Effect Matrix. The following requirements were assessed: physical therapist performance, care outcome indicator, adherence to physical therapy protocols, measure whether the prognosis and treatment outcome was achieved and Infrastructure. The proposed design allowed evaluating several items related to physical therapy service, enabling customization, reproducibility and benchmarking with other organizations. For management, this index provides the opportunity to identify areas for improvement and the strengths of the team and process of physical therapy care.

Automatic Rotational Sky Quality Meter (R-SQM) Design and Software for Astronomical Observatories

NASA Astrophysics Data System (ADS)

Dogan, E.; Ozbaldan, E. E.; Shameoni, Niaei M.; Yesilyaprak, C.

2016-12-01

We have presented the new design of Sky Quality Meter (SQM) device that is an automatic rotational model of sky quality meter (R-SQM) carried out by DAG (Eastern Anatolia Observatory) Technical Team. R-SQM is required for determining the long-term changes of sky quality of an astronomical observatory and consists of four SQM devices mounted on a rotating shaft with different angles for scanning all sky. This system is controlled by a Raspberry Pi control card and a step motor with its driver and a special software.

Implementation of quality by design toward processing of food products.

PubMed

Rathore, Anurag S; Kapoor, Gautam

2017-05-28

Quality by design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control. It is an approach based on principles of sound science and quality risk management. As the food processing industry continues to embrace the idea of in-line, online, and/or at-line sensors and real-time characterization for process monitoring and control, the existing gaps with regard to our ability to monitor multiple parameters/variables associated with the manufacturing process will be alleviated over time. Investments made for development of tools and approaches that facilitate high-throughput analytical and process development, process analytical technology, design of experiments, risk analysis, knowledge management, and enhancement of process/product understanding would pave way for operational and economic benefits later in the commercialization process and across other product pipelines. This article aims to achieve two major objectives. First, to review the progress that has been made in the recent years on the topic of QbD implementation in processing of food products and second, present a case study that illustrates benefits of such QbD implementation.

Design of the data quality control system for the ALICE O2

NASA Astrophysics Data System (ADS)

von Haller, Barthélémy; Lesiak, Patryk; Otwinowski, Jacek; ALICE Collaboration

2017-10-01

ALICE (A Large Ion Collider Experiment) is the heavy-ion detector designed to study the physics of strongly interacting matter and the quark-gluon plasma at the CERN Large Hadron Collider (LHC). A major upgrade of the experiment is planned for 2019-20. In order to cope with a 100 times higher data rate and with the continuous readout of the Time Projection Chamber (TPC), it is necessary to upgrade the Online and Offline computing to a new common system called O2. The online Data Quality Monitoring (DQM) and the offline Quality Assurance (QA) are critical aspects of the data acquisition and reconstruction software chains. The former intends to provide shifters with precise and complete information in order to quickly identify and overcome problems while the latter aims at providing good quality data for physics analyses. DQM and QA typically involve the gathering of data, its distributed analysis by user-defined algorithms, the merging of the resulting objects and their visualization. This paper discusses the architecture and the design of the data Quality Control system that regroups the DQM and QA. In addition it presents the main design requirements and early results of a working prototype. A special focus is put on the merging of monitoring objects generated by the QC tasks. The merging is a crucial and challenging step of the O2 system, not only for QC but also for the calibration. Various scenarios and implementations have been made and large-scale tests carried out. This document presents the final results of this extensive work on merging. We conclude with the plan of work for the coming years that will bring the QC to production by 2019.

Testing the quality of images for permanent magnet desktop MRI systems using specially designed phantoms.

PubMed

Qiu, Jianfeng; Wang, Guozhu; Min, Jiao; Wang, Xiaoyan; Wang, Pengcheng

2013-12-21

Our aim was to measure the performance of desktop magnetic resonance imaging (MRI) systems using specially designed phantoms, by testing imaging parameters and analysing the imaging quality. We designed multifunction phantoms with diameters of 18 and 60 mm for desktop MRI scanners in accordance with the American Association of Physicists in Medicine (AAPM) report no. 28. We scanned the phantoms with three permanent magnet 0.5 T desktop MRI systems, measured the MRI image parameters, and analysed imaging quality by comparing the data with the AAPM criteria and Chinese national standards. Image parameters included: resonance frequency, high contrast spatial resolution, low contrast object detectability, slice thickness, geometrical distortion, signal-to-noise ratio (SNR), and image uniformity. The image parameters of three desktop MRI machines could be measured using our specially designed phantoms, and most parameters were in line with MRI quality control criterion, including: resonance frequency, high contrast spatial resolution, low contrast object detectability, slice thickness, geometrical distortion, image uniformity and slice position accuracy. However, SNR was significantly lower than in some references. The imaging test and quality control are necessary for desktop MRI systems, and should be performed with the applicable phantom and corresponding standards.

Design, manufacture and performance evaluation of HTS electromagnets for the hybrid magnetic levitation system

NASA Astrophysics Data System (ADS)

Chu, S. Y.; Hwang, Y. J.; Choi, S.; Na, J. B.; Kim, Y. J.; Chang, K. S.; Bae, D. K.; Lee, C. Y.; Ko, T. K.

2011-11-01

A high speed electromagnetic suspension (EMS) maglev has emerged as the solution to speed limit problem that conventional high-speed railroad has. In the EMS maglev, small levitation gap needs uniform guide-way which leads to increase the construction cost. The large levitation gap can reduce the construction cost. However it is hard for normal conducting electromagnet to produce larger magneto-motive force (MMF) for generating levitation force as increased levitation gap. This is because normal conductors have limited rating current to their specific volume. Therefore, the superconducting electromagnet can be one of the solutions for producing both large levitation gap and sufficient MMF. The superconducting electromagnets have incomparably high allowable current density than what normal conductors have. In this paper, the prototype of high temperature superconducting (HTS) electromagnets were designed and manufactured applicable to hybrid electromagnetic suspension system (H-EMS). The H-EMS consists of control coils for levitation control and superconducting coils for producing MMF for levitation. The required MMF for generating given levitation force was calculated by both equations of ideal U-core magnet and magnetic field analysis using the finite element method (FEM). The HTS electromagnets were designed as double pancakes with Bi-2223/Ag tapes. Experiments to confirm its operating performance were performed in liquid nitrogen (LN2).

Integrating Kano’s Model into Quality Function Deployment for Product Design: A Comprehensive Review

NASA Astrophysics Data System (ADS)

Ginting, Rosnani; Hidayati, Juliza; Siregar, Ikhsan

2018-03-01

Many methods and techniques are adopted by some companies to improve the competitiveness through the fulfillment of customer satisfaction by enhancement and improvement the product design quality. Over the past few years, several researcher have studied extensively combining Quality Function Deployment and Kano’s model as design techniques by focusing on translating consumer desires into a product design. This paper presents a review and analysis of several literatures that associated to the integration methodology of Kano into the QFD process. Various of international journal articles were selected, collected and analyzed through a number of relevant scientific publications. In-depth analysis was performed, and focused in this paper on the results, advantages and drawbacks of its methodology. In addition, this paper also provides the analysis that acquired in this study related to the development of the methodology. It is hopedd this paper can be a reference for other researchers and manufacturing companies to implement the integration method of QFD- Kano for product design.

Design of an instrument to measure the quality of care in Physical Therapy

PubMed Central

Cavalheiro, Leny Vieira; Eid, Raquel Afonso Caserta; Talerman, Claudia; do Prado, Cristiane; Gobbi, Fátima Cristina Martorano; Andreoli, Paola Bruno de Araujo

2015-01-01

ABSTRACT Objective: To design an instrument composed of domains that would demonstrate physical therapy activities and generate a consistent index to represent the quality of care in physical therapy. Methods: The methodology Lean Six Sigma was used to design the tool. The discussion involved seven different management groups staff. By means of brainstorming and Cause & Effect Matrix, we set up the process map. Results: Five requirements composed the quality of care index in physical therapy, after application of the tool called Cause & Effect Matrix. The following requirements were assessed: physical therapist performance, care outcome indicator, adherence to physical therapy protocols, measure whether the prognosis and treatment outcome was achieved and Infrastructure. Conclusion: The proposed design allowed evaluating several items related to physical therapy service, enabling customization, reproducibility and benchmarking with other organizations. For management, this index provides the opportunity to identify areas for improvement and the strengths of the team and process of physical therapy care. PMID:26154548

A quality by design approach to investigate the effect of mannitol and dicalcium phosphate qualities on roll compaction.

PubMed

Souihi, Nabil; Dumarey, Melanie; Wikström, Håkan; Tajarobi, Pirjo; Fransson, Magnus; Svensson, Olof; Josefson, Mats; Trygg, Johan

2013-04-15

Roll compaction is a continuous process for solid dosage form manufacturing increasingly popular within pharmaceutical industry. Although roll compaction has become an established technique for dry granulation, the influence of material properties is still not fully understood. In this study, a quality by design (QbD) approach was utilized, not only to understand the influence of different qualities of mannitol and dicalcium phosphate (DCP), but also to predict critical quality attributes of the drug product based solely on the material properties of that filler. By describing each filler quality in terms of several representative physical properties, orthogonal projections to latent structures (OPLS) was used to understand and predict how those properties affected drug product intermediates as well as critical quality attributes of the final drug product. These models were then validated by predicting product attributes for filler qualities not used in the model construction. The results of this study confirmed that the tensile strength reduction, known to affect plastic materials when roll compacted, is not prominent when using brittle materials. Some qualities of these fillers actually demonstrated improved compactability following roll compaction. While direct compression qualities are frequently used for roll compacted drug products because of their excellent flowability and good compaction properties, this study revealed that granules from these qualities were more poor flowing than the corresponding powder blends, which was not seen for granules from traditional qualities. The QbD approach used in this study could be extended beyond fillers. Thus any new compound/ingredient would first be characterized and then suitable formulation characteristics could be determined in silico, without running any additional experiments. Copyright © 2013 Elsevier B.V. All rights reserved.

Aerodynamic and engineering design of a 1.5 s high quality microgravity drop tower facility

NASA Astrophysics Data System (ADS)

Belser, Valentin; Breuninger, Jakob; Reilly, Matthew; Laufer, René; Dropmann, Michael; Herdrich, Georg; Hyde, Truell; Röser, Hans-Peter; Fasoulas, Stefanos

2016-12-01

Microgravity experiments are essential for research in space science, biology, fluid mechanics, combustion, and material sciences. One way to conduct microgravity experiments on Earth is by using drop tower facilities. These facilities combine a high quality of microgravity, adequate payload masses and have the advantage of virtually unlimited repeatability under same experimental conditions, at a low cost. In a collaboration between the Institute of Space Systems (IRS) at the University of Stuttgart and Baylor University (BU) in Waco, Texas, a new drop tower is currently under development at the Center for Astrophysics, Space Physics and Engineering Research (CASPER). The design parameters of the drop tower ask for at least 1.5 s in free fall duration while providing a quality of at least 10-5 g. Previously, this quality has only been achieved in vacuum drop tower facilities where the capsule experiences virtually zero aerodynamic drag during its free fall. Since this design comes at high costs, a different drop tower design concept, which does not require an evacuated drop shaft, was chosen. It features a dual-capsule system in which the experiment capsule is shielded from aerodynamic forces by surrounding it with a drag shield during the drop. As no other dual-capsule drop tower has been able to achieve a quality as good as or better than 10-5 g previous work optimized the design with an aerodynamic perspective by using computational fluid dynamics (CFD) simulations to determine the ideal shape and size of the outer capsule and to specify the aerodynamically crucial dimensions for the overall system. Experiments later demonstrated that the required quality of microgravity can be met with the proposed design. The main focus of this paper is the mechanical realization of the capsule as well as the development and layout of the surrounding components, such as the release mechanism, the deceleration device and the drop shaft. Because the drop tower facility is a

Composite materials for rail transit systems

NASA Technical Reports Server (NTRS)

Griffin, O. Hayden, Jr.; Guerdal, Zafer; Herakovich, Carl T.

1987-01-01

The potential is explored for using composite materials in urban mass transit systems. The emphasis was to identify specific advantages of composite materials in order to determine their actual and potential usage for carbody and guideway structure applications. The literature was reviewed, contacts were made with major domestic system operators, designers, and builders, and an analysis was made of potential composite application to railcar construction. Composites were found to be in use throughout the transit industry, usually in secondary or auxiliary applications such as car interior and nonstructural exterior panels. More recently, considerable activity has been initiated in the area of using composites in the load bearing elements of civil engineering structures such as highway bridges. It is believed that new and improved manufacturing refinements in pultrusion and filament winding will permit the production of beam sections which can be used in guideway structures. The inherent corrosion resistance and low maintenance characteristics of composites should result in lowered maintenance costs over a prolonged life of the structure.

Experiment results of high temperature superconducting Maglev vehicle

NASA Astrophysics Data System (ADS)

Wang, J. S.; Wang, S. Y.; Ren, Z. Y.; Jiang, H.; Zhu, M.; Wang, X. R.; Shen, X. M.; Song, H. H.

2003-04-01

The first man-loading high temperature superconducting (HTS) magnetic levitation (Maglev) test vehicle in the world has normally operated over one year after its birth on December 31, 2000. Heretofore over 23 000 passengers have taken the vehicle, and it operates very well from first running to now. The HTS Maglev vehicle is over guideway, which consists of two parallel permanent magnetic tracks. The levitation force of the entire Maglev vehicle is measured. Three times measurement results on December 24, 2000, July 1, 2001, and December 24, 2001 are reported respectively, it will be seen from this that the levitation forces do not change nearly after long running. Total levitation force of entire vehicle is 1050 kg at the 8 mm net levitation gap, which the gap between the bottom of liquid nitrogen vessels and guideway face. A measuring equipment of the guidance force of the entire Maglev vehicle is designed and manufactured. The guidance force of the vehicle is obtained by the equipment.

Quality-by-design-based ultra high performance liquid chromatography related substances method development by establishing the proficient design space for sumatriptan and naproxen combination.

PubMed

Patel, Prinesh N; Karakam, Vijaya Saradhi; Samanthula, Gananadhamu; Ragampeta, Srinivas

2015-10-01

Quality-by-design-based methods hold greater level of confidence for variations and greater success in method transfer. A quality-by-design-based ultra high performance liquid chromatography method was developed for the simultaneous assay of sumatriptan and naproxen along with their related substances. The first screening was performed by fractional factorial design comprising 44 experiments for reversed-phase stationary phases, pH, and organic modifiers. The results of screening design experiments suggested phenyl hexyl column and acetonitrile were the best combination. The method was further optimized for flow rate, temperature, and gradient time by experimental design of 20 experiments and the knowledge space was generated for effect of variable on response (number of peaks ≥ 1.50 - resolution). Proficient design space was generated from knowledge space by applying Monte Carlo simulation to successfully integrate quantitative robustness metrics during optimization stage itself. The final method provided the robust performance which was verified and validated. Final conditions comprised Waters® Acquity phenyl hexyl column with gradient elution using ammonium acetate (pH 4.12, 0.02 M) buffer and acetonitrile at 0.355 mL/min flow rate and 30°C. The developed method separates all 13 analytes within a 15 min run time with fewer experiments compared to the traditional quality-by-testing approach. ©2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

The use of the general image quality equation in the design and evaluation of imaging systems

NASA Astrophysics Data System (ADS)

Cota, Steve A.; Florio, Christopher J.; Duvall, David J.; Leon, Michael A.

2009-08-01

The design of any modern imaging system is the end result of many trade studies, each seeking to optimize image quality within real world constraints such as cost, schedule and overall risk. The National Imagery Interpretability Rating Scale (NIIRS) is a useful measure of image quality, because, by characterizing the overall interpretability of an image, it combines into one metric those contributors to image quality to which a human interpreter is most sensitive. The main drawback to using a NIIRS rating as a measure of image quality in engineering trade studies is the fact that it is tied to the human observer and cannot be predicted from physical principles and engineering parameters alone. The General Image Quality Equation (GIQE) of Leachtenauer et al. 1997 [Appl. Opt. 36, 8322-8328 (1997)] is a regression of actual image analyst NIIRS ratings vs. readily calculable engineering metrics, and provides a mechanism for using the expected NIIRS rating of an imaging system in the design and evaluation process. In this paper, we will discuss how we use the GIQE in conjunction with The Aerospace Corporation's Parameterized Image Chain Analysis & Simulation SOftware (PICASSO) to evaluate imager designs, taking a hypothetical high resolution commercial imaging system as an example.

Application of a quality by design approach to the cell culture process of monoclonal antibody production, resulting in the establishment of a design space.

PubMed

Nagashima, Hiroaki; Watari, Akiko; Shinoda, Yasuharu; Okamoto, Hiroshi; Takuma, Shinya

2013-12-01

This case study describes the application of Quality by Design elements to the process of culturing Chinese hamster ovary cells in the production of a monoclonal antibody. All steps in the cell culture process and all process parameters in each step were identified by using a cause-and-effect diagram. Prospective risk assessment using failure mode and effects analysis identified the following four potential critical process parameters in the production culture step: initial viable cell density, culture duration, pH, and temperature. These parameters and lot-to-lot variability in raw material were then evaluated by process characterization utilizing a design of experiments approach consisting of a face-centered central composite design integrated with a full factorial design. Process characterization was conducted using a scaled down model that had been qualified by comparison with large-scale production data. Multivariate regression analysis was used to establish statistical prediction models for performance indicators and quality attributes; with these, we constructed contour plots and conducted Monte Carlo simulation to clarify the design space. The statistical analyses, especially for raw materials, identified set point values, which were most robust with respect to the lot-to-lot variability of raw materials while keeping the product quality within the acceptance criteria. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

Designing quality course management systems that foster intra-professional education.

PubMed

Bowers, Helen F

2006-12-01

This paper draws on the experiences of the author in designing and implementing quality course management policies and procedures for vocational and higher educational programs, both overseas and in Australia. In particular, the paper focuses on those programs of study that require practicums within the curriculum. Whether these are clinical nursing placements, physiotherapy hands-on practical blocks or teacher training instruction, there are many principles of adult education that can be applied to the design and development of course management systems that foster inter-professional education. It is important that the components of any such system allow for a multi-faceted approach that relates collaborative learning to collaborative practice and supports a team of professionals through the skilled use of group-based learning, interactive assessments and inter-organisational processes and practices. The term 'course management system' is used here to describe all those policies and procedures that form the framework of any higher education department or faculty that has the overall responsibility for developing curriculum, teaching and learning resources that ensure quality educational outcomes for its students. In these days of multi-skilling, the benefits of inter-professional education may be significant. To guarantee that standards are kept high and learning outcomes are achievable, the management of an educational system must cover many areas of professional practice. It needs to be supported by all stakeholders in the organisation so that there is an environment of understanding, good interpersonal communication, supportive inter-group relations and an atmosphere of professionalism that is pervasive. This paper introduces a third definition to the model and suggests that intra-professional education be added to form a tripartite foundation for quality professional learning outcomes.

Application of quality by design (QbD) to formulation and processing of naproxen pellets by extrusion-spheronization.

PubMed

Wang, Junlin; Kan, Shuling; Chen, Tong; Liu, Jianping

2015-03-01

The aim of this research was to apply quality by design (QbD) to the development of naproxen loaded core pellets which can be used as the potential core for colon-specific pellets. In the early stages of this study, prior knowledge and preliminary studies were systematically incorporated into the risk assessment using failure mode and effect analysis (FMEA) and fishbone diagram. Then Plackett-Burman design was used to screen eight potential high risk factors (spheronization speed, spheronization time, extrusion speed, drying method, CCMC-Na concentration, lactose concentration, water concentration and Tween 80 concentration) obtained from the above risk assessment. It was discovered that out of the eight potential high risk factors only three factors (spheronization speed, extrusion speed and CCMC-Na concentration) had significant effects on the quality of the pellets. This allowed the use of Box-Behnken design (BBD) to fully elucidate the relationship between the variables and critical quality attribute (CQA). Finally, the final control space was established within which the quality of the pellets can meet the requirement of colon-specific drug delivery system. This study demonstrated that naproxen loaded core pellets were successfully designed using QbD principle.

Community Building, Emergent Design and Expecting the Unexpected: Creating a Quality eLearning Experience

ERIC Educational Resources Information Center

Thompson, Terrie Lynn; MacDonald, Colla J.

2005-01-01

Given the extraordinary interest and growth in eLearning as a learning tool and as an industry, it is not surprising there is lively debate on quality. A research-based and tested eLearning model was used to design and evaluate an online M.Ed. course in order to study factors that influence the quality of an eLearning event. Several data…

Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared orodispersible films.

PubMed

Visser, J Carolina; Dohmen, Willem M C; Hinrichs, Wouter L J; Breitkreutz, Jörg; Frijlink, Henderik W; Woerdenbag, Herman J

2015-05-15

The quality by design (QbD) approach was applied for optimizing the formulation of extemporaneously prepared orodispersible films (ODFs) using Design-Expert® Software. The starting formulation was based on earlier experiments and contained the film forming agents hypromellose and carbomer 974P and the plasticizer glycerol (Visser et al., 2015). Trometamol and disodium EDTA were added to stabilize the solution. To optimize this formulation a quality target product profile was established in which critical quality attributes (CQAs) such as mechanical properties and disintegration time were defined and quantified. As critical process parameters (CPP) that were evaluated for their effect on the CQAs the percentage of hypromellose and the percentage of glycerol as well as the drying time were chosen. Response surface methodology (RMS) was used to evaluate the effects of the CPPs on the CQAs of the final product. The main factor affecting tensile strength and Young's modulus was the percentage of glycerol. Elongation at break was mainly influenced by the drying temperature. Disintegration time was found to be sensitive to the percentage of hypromellose. From the results a design space could be created. As long as the formulation and process variables remain within this design space, a product is obtained with desired characteristics and that meets all set quality requirements. Copyright © 2015 Elsevier B.V. All rights reserved.

Applying Quality Indicators to Single-Case Research Designs Used in Special Education: A Systematic Review

ERIC Educational Resources Information Center

Moeller, Jeremy D.; Dattilo, John; Rusch, Frank

2015-01-01

This study examined how specific guidelines and heuristics have been used to identify methodological rigor associated with single-case research designs based on quality indicators developed by Horner et al. Specifically, this article describes how literature reviews have applied Horner et al.'s quality indicators and evidence-based criteria.…

Quality by design: optimization of a liquid filled pH-responsive macroparticles using Draper-Lin composite design.

PubMed

Rafati, Hasan; Talebpour, Zahra; Adlnasab, Laleh; Ebrahimi, Samad Nejad

2009-07-01

In this study, pH responsive macroparticles incorporating peppermint oil (PO) were prepared using a simple emulsification/polymer precipitation technique. The formulations were examined for their properties and the desired quality was then achieved using a quality by design (QBD) approach. For this purpose, a Draper-Lin small composite design study was employed in order to investigate the effect of four independent variables, including the PO to water ratio, the concentration of pH sensitive polymer (hydroxypropyl methylcellulose phthalate), acid and plasticizer concentrations, on the encapsulation efficiency and PO loading. The analysis of variance showed that the polymer concentration was the most important variable on encapsulation efficiency (p < 0.05). The multiple regression analysis of the results led to equations that adequately described the influence of the independent variables on the selected responses. Furthermore, the desirability function was employed as an effective tool for transforming each response separately and encompassing all of these responses in an overall desirability function for global optimization of the encapsulation process. The optimized macroparticles were predicted to yield 93.4% encapsulation efficiency and 72.8% PO loading, which were remarkably close to the experimental values of 89.2% and 69.5%, consequently.

A combined geostatistical-optimization model for the optimal design of a groundwater quality monitoring network

NASA Astrophysics Data System (ADS)

Kolosionis, Konstantinos; Papadopoulou, Maria P.

2017-04-01

Monitoring networks provide essential information for water resources management especially in areas with significant groundwater exploitation due to extensive agricultural activities. In this work, a simulation-optimization framework is developed based on heuristic optimization methodologies and geostatistical modeling approaches to obtain an optimal design for a groundwater quality monitoring network. Groundwater quantity and quality data obtained from 43 existing observation locations at 3 different hydrological periods in Mires basin in Crete, Greece will be used in the proposed framework in terms of Regression Kriging to develop the spatial distribution of nitrates concentration in the aquifer of interest. Based on the existing groundwater quality mapping, the proposed optimization tool will determine a cost-effective observation wells network that contributes significant information to water managers and authorities. The elimination of observation wells that add little or no beneficial information to groundwater level and quality mapping of the area can be obtain using estimations uncertainty and statistical error metrics without effecting the assessment of the groundwater quality. Given the high maintenance cost of groundwater monitoring networks, the proposed tool could used by water regulators in the decision-making process to obtain a efficient network design that is essential.

Application of quality by design concepts in the development of fluidized bed granulation and tableting processes.

PubMed

Djuris, Jelena; Medarevic, Djordje; Krstic, Marko; Djuric, Zorica; Ibric, Svetlana

2013-06-01

This study illustrates the application of experimental design and multivariate data analysis in defining design space for granulation and tableting processes. According to the quality by design concepts, critical quality attributes (CQAs) of granules and tablets, as well as critical parameters of granulation and tableting processes, were identified and evaluated. Acetaminophen was used as the model drug, and one of the study aims was to investigate the possibility of the development of immediate- or extended-release acetaminophen tablets. Granulation experiments were performed in the fluid bed processor using polyethylene oxide polymer as a binder in the direct granulation method. Tablets were compressed in the laboratory excenter tablet press. The first set of experiments was organized according to Plackett-Burman design, followed by the full factorial experimental design. Principal component analysis and partial least squares regression were applied as the multivariate analysis techniques. By using these different methods, CQAs and process parameters were identified and quantified. Furthermore, an in-line method was developed to monitor the temperature during the fluidized bed granulation process, to foresee possible defects in granules CQAs. Various control strategies that are based on the process understanding and assure desired quality attributes of the product are proposed. Copyright © 2013 Wiley Periodicals, Inc.

40 CFR 130.9 - Designation and de-designation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... QUALITY PLANNING AND MANAGEMENT § 130.9 Designation and de-designation. (a) Designation. Areawide planning... specified in Water Quality Management (WQM) plans. Areawide planning agencies shall monitor DMA activities... continue water quality planning activities within the designated boundaries. (c) Impact of de-designation...

A design procedure for the handling qualities optimization of the X-29A aircraft

NASA Technical Reports Server (NTRS)

Bosworth, John T.; Cox, Timothy H.

1989-01-01

The techniques used to improve the pitch-axis handling qualities of the X-29A wing-canard-planform fighter aircraft are reviewed. The aircraft and its FCS are briefly described, and the design method, which works within the existing FCS architecture, is characterized in detail. Consideration is given to the selection of design goals and design variables, the definition and calculation of the cost function, the validation of the mathematical model on the basis of flight-test data, and the validation of the improved design by means of nonlinear simulations. Flight tests of the improved design are shown to verify the simulation results.

Application of Quality by Design to the characterization of the cell culture process of an Fc-Fusion protein.

PubMed

Rouiller, Yolande; Solacroup, Thomas; Deparis, Véronique; Barbafieri, Marco; Gleixner, Ralf; Broly, Hervé; Eon-Duval, Alex

2012-06-01

The production bioreactor step of an Fc-Fusion protein manufacturing cell culture process was characterized following Quality by Design principles. Using scientific knowledge derived from the literature and process knowledge gathered during development studies and manufacturing to support clinical trials, potential critical and key process parameters with a possible impact on product quality and process performance, respectively, were determined during a risk assessment exercise. The identified process parameters were evaluated using a design of experiment approach. The regression models generated from the data allowed characterizing the impact of the identified process parameters on quality attributes. The main parameters having an impact on product titer were pH and dissolved oxygen, while those having the highest impact on process- and product-related impurities and variants were pH and culture duration. The models derived from characterization studies were used to define the cell culture process design space. The design space limits were set in such a way as to ensure that the drug substance material would consistently have the desired quality. Copyright © 2012 Elsevier B.V. All rights reserved.

Shift work and quality of sleep: effect of working in designed dynamic light.

PubMed

Jensen, Hanne Irene; Markvart, Jakob; Holst, René; Thomsen, Tina Damgaard; Larsen, Jette West; Eg, Dorthe Maria; Nielsen, Lisa Seest

2016-01-01

To examine the effect of designed dynamic light on staff's quality of sleep with regard to sleep efficiency, level of melatonin in saliva, and subjective perceptions of quality of sleep. An intervention group working in designed dynamic light was compared with a control group working in ordinary institutional light at two comparable intensive care units (ICUs). The study included examining (1) melatonin profiles obtained from saliva samples, (2) quality of sleep in terms of sleep efficiency, number of awakenings and subjective assessment of sleep through the use of sleep monitors and sleep diaries, and (3) subjective perceptions of well-being, health, and sleep quality using a questionnaire. Light conditions were measured at both locations. A total of 113 nurses (88 %) participated. There were no significant differences between the two groups regarding personal characteristics, and no significant differences in total sleep efficiency or melatonin level were found. The intervention group felt more rested (OR 2.03, p = 0.003) and assessed their condition on awakening as better than the control group (OR 2.35, p = 0.001). Intervention-ICU nurses received far more light both during day and evening shifts compared to the control-ICU. The study found no significant differences in monitored sleep efficiency and melatonin level. Nurses from the intervention-ICU subjectively assessed their sleep as more effective than participants from the control-ICU.

Policy for Establishing Separate Air Quality Designations for Areas of Indian Country Memorandum

EPA Pesticide Factsheets

This 2011 memorandum provides EPA's policy regarding designating areas of Indian country separately from adjacent areas for the National Ambient Air Quality Standards (NAAQS), when requested by the relevant tribe for a particular area of Indian country.

Quality Matters™: An Educational Input in an Ongoing Design-Based Research Project

ERIC Educational Resources Information Center

Adair, Deborah; Shattuck, Kay

2015-01-01

Quality Matters (QM) has been transforming established best practices and online education-based research into an applicable, scalable course level improvement process for the last decade. In this article, the authors describe QM as an ongoing design-based research project and an educational input for improving online education.

On designing for quality

NASA Technical Reports Server (NTRS)

Vajingortin, L. D.; Roisman, W. P.

1991-01-01

The problem of ensuring the required quality of products and/or technological processes often becomes more difficult due to the fact that there is not general theory of determining the optimal sets of value of the primary factors, i.e., of the output parameters of the parts and units comprising an object and ensuring the correspondence of the object's parameters to the quality requirements. This is the main reason for the amount of time taken to finish complex vital article. To create this theory, one has to overcome a number of difficulties and to solve the following tasks: the creation of reliable and stable mathematical models showing the influence of the primary factors on the output parameters; finding a new technique of assigning tolerances for primary factors with regard to economical, technological, and other criteria, the technique being based on the solution of the main problem; well reasoned assignment of nominal values for primary factors which serve as the basis for creating tolerances. Each of the above listed tasks is of independent importance. An attempt is made to give solutions for this problem. The above problem dealing with quality ensuring an mathematically formalized aspect is called the multiple inverse problem.

Design and Development of a Nearable Wireless System to Control Indoor Air Quality and Indoor Lighting Quality.

PubMed

Salamone, Francesco; Belussi, Lorenzo; Danza, Ludovico; Galanos, Theodore; Ghellere, Matteo; Meroni, Italo

2017-05-04

The article describes the results of the project "open source smart lamp" aimed at designing and developing a smart object able to manage and control the indoor environmental quality (IEQ) of the built environment. A first version of this smart object, built following a do-it-yourself (DIY) approach using a microcontroller, an integrated temperature and relative humidity sensor, and techniques of additive manufacturing, allows the adjustment of the indoor thermal comfort quality (ICQ), by interacting directly with the air conditioner. As is well known, the IEQ is a holistic concept including indoor air quality (IAQ), indoor lighting quality (ILQ) and acoustic comfort, besides thermal comfort. The upgrade of the smart lamp bridges the gap of the first version of the device providing the possibility of interaction with the air exchange unit and lighting system in order to get an overview of the potential of a nearable device in the management of the IEQ. The upgraded version was tested in a real office equipped with mechanical ventilation and an air conditioning system. This office was occupied by four workers. The experiment is compared with a baseline scenario and the results show how the application of the nearable device effectively optimizes both IAQ and ILQ.

Design and Development of a Nearable Wireless System to Control Indoor Air Quality and Indoor Lighting Quality

PubMed Central

Salamone, Francesco; Belussi, Lorenzo; Danza, Ludovico; Galanos, Theodore; Ghellere, Matteo; Meroni, Italo

2017-01-01

The article describes the results of the project “open source smart lamp” aimed at designing and developing a smart object able to manage and control the indoor environmental quality (IEQ) of the built environment. A first version of this smart object, built following a do-it-yourself (DIY) approach using a microcontroller, an integrated temperature and relative humidity sensor, and techniques of additive manufacturing, allows the adjustment of the indoor thermal comfort quality (ICQ), by interacting directly with the air conditioner. As is well known, the IEQ is a holistic concept including indoor air quality (IAQ), indoor lighting quality (ILQ) and acoustic comfort, besides thermal comfort. The upgrade of the smart lamp bridges the gap of the first version of the device providing the possibility of interaction with the air exchange unit and lighting system in order to get an overview of the potential of a nearable device in the management of the IEQ. The upgraded version was tested in a real office equipped with mechanical ventilation and an air conditioning system. This office was occupied by four workers. The experiment is compared with a baseline scenario and the results show how the application of the nearable device effectively optimizes both IAQ and ILQ. PMID:28471398

Quantifying the Impact of Feedstock Quality on the Design of Bioenergy Supply Chain Networks

DOE PAGES

Castillo-Villar, Krystel; Minor-Popocatl, Hertwin; Webb, Erin

2016-03-01

Logging residues, which refer to the unused portions of trees cut during logging, are important sources of biomass for the emerging biofuel industry and are critical feedstocks for the first-type biofuel facilities (e.g., corn-ethanol facilities). Logging residues are under-utilized sources of biomass for energetic purposes. To support the scaling-up of the bioenergy industry, it is essential to design cost-effective biofuel supply chains that not only minimize costs, but also consider the biomass quality characteristics. The biomass quality is heavily dependent upon the moisture and the ash contents. Ignoring the biomass quality characteristics and its intrinsic costs may yield substantial economicmore » losses that will only be discovered after operations at a biorefinery have begun. Here this paper proposes a novel bioenergy supply chain network design model that minimizes operational costs and includes the biomass quality-related costs. The proposed model is unique in the sense that it supports decisions where quality is not unrealistically assumed to be perfect. The effectiveness of the proposed methodology is proven by assessing a case study in the state of Tennessee, USA. The results demonstrate that the ash and moisture contents of logging residues affect the performance of the supply chain (in monetary terms). Higher-than-target moisture and ash contents incur in additional quality-related costs. The quality-related costs in the optimal solution (with final ash content of 1% and final moisture of 50%) account for 27% of overall supply chain cost. In conclusion, based on the numeral experimentation, the total supply chain cost increased 7%, on average, for each additional percent in the final ash content.« less

Quantifying the Impact of Feedstock Quality on the Design of Bioenergy Supply Chain Networks

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

Castillo-Villar, Krystel; Minor-Popocatl, Hertwin; Webb, Erin

Logging residues, which refer to the unused portions of trees cut during logging, are important sources of biomass for the emerging biofuel industry and are critical feedstocks for the first-type biofuel facilities (e.g., corn-ethanol facilities). Logging residues are under-utilized sources of biomass for energetic purposes. To support the scaling-up of the bioenergy industry, it is essential to design cost-effective biofuel supply chains that not only minimize costs, but also consider the biomass quality characteristics. The biomass quality is heavily dependent upon the moisture and the ash contents. Ignoring the biomass quality characteristics and its intrinsic costs may yield substantial economicmore » losses that will only be discovered after operations at a biorefinery have begun. Here this paper proposes a novel bioenergy supply chain network design model that minimizes operational costs and includes the biomass quality-related costs. The proposed model is unique in the sense that it supports decisions where quality is not unrealistically assumed to be perfect. The effectiveness of the proposed methodology is proven by assessing a case study in the state of Tennessee, USA. The results demonstrate that the ash and moisture contents of logging residues affect the performance of the supply chain (in monetary terms). Higher-than-target moisture and ash contents incur in additional quality-related costs. The quality-related costs in the optimal solution (with final ash content of 1% and final moisture of 50%) account for 27% of overall supply chain cost. In conclusion, based on the numeral experimentation, the total supply chain cost increased 7%, on average, for each additional percent in the final ash content.« less

Design of a digital ride quality augmentation system for commuter aircraft

NASA Technical Reports Server (NTRS)

Hammond, T. A.; Amin, S. P.; Paduano, J. D.; Downing, D. R.

1984-01-01

Commuter aircraft typically have low wing loadings, and fly at low altitudes, and so they are susceptible to undesirable accelerations caused by random atmospheric turbulence. Larger commercial aircraft typically have higher wing loadings and fly at altitudes where the turbulence level is lower, and so they provide smoother rides. This project was initiated based on the goal of making the ride of the commuter aircraft as smooth as the ride experienced on the major commercial airliners. The objectives of this project were to design a digital, longitudinal mode ride quality augmentation system (RQAS) for a commuter aircraft, and to investigate the effect of selected parameters on those designs.

Sustainable microbial water quality monitoring programme design using phage-lysis and multivariate techniques.

PubMed

Nnane, Daniel Ekane

2011-11-15

Contamination of surface waters is a pervasive threat to human health, hence, the need to better understand the sources and spatio-temporal variations of contaminants within river catchments. River catchment managers are required to sustainably monitor and manage the quality of surface waters. Catchment managers therefore need cost-effective low-cost long-term sustainable water quality monitoring and management designs to proactively protect public health and aquatic ecosystems. Multivariate and phage-lysis techniques were used to investigate spatio-temporal variations of water quality, main polluting chemophysical and microbial parameters, faecal micro-organisms sources, and to establish 'sentry' sampling sites in the Ouse River catchment, southeast England, UK. 350 river water samples were analysed for fourteen chemophysical and microbial water quality parameters in conjunction with the novel human-specific phages of Bacteroides GB-124 (Bacteroides GB-124). Annual, autumn, spring, summer, and winter principal components (PCs) explained approximately 54%, 75%, 62%, 48%, and 60%, respectively, of the total variance present in the datasets. Significant loadings of Escherichia coli, intestinal enterococci, turbidity, and human-specific Bacteroides GB-124 were observed in all datasets. Cluster analysis successfully grouped sampling sites into five clusters. Importantly, multivariate and phage-lysis techniques were useful in determining the sources and spatial extent of water contamination in the catchment. Though human faecal contamination was significant during dry periods, the main source of contamination was non-human. Bacteroides GB-124 could potentially be used for catchment routine microbial water quality monitoring. For a cost-effective low-cost long-term sustainable water quality monitoring design, E. coli or intestinal enterococci, turbidity, and Bacteroides GB-124 should be monitored all-year round in this river catchment. Copyright © 2011 Elsevier B.V. All

Evaluating a complex, multi-site, community-based program to improve healthcare quality: the summative research design for the Aligning Forces for Quality initiative.

PubMed

Scanlon, Dennis P; Wolf, Laura J; Alexander, Jeffrey A; Christianson, Jon B; Greene, Jessica; Jean-Jacques, Muriel; McHugh, Megan; Shi, Yunfeng; Leitzell, Brigitt; Vanderbrink, Jocelyn M

2016-08-01

The Aligning Forces for Quality (AF4Q) initiative was the Robert Wood Johnson Foundation's (RWJF's) signature effort to increase the overall quality of healthcare in targeted communities throughout the country. In addition to sponsoring this 16-site complex program, RWJF funded an independent scientific evaluation to support objective research on the initiative's effectiveness and contributions to basic knowledge in 5 core programmatic areas. The research design, data, and challenges faced during the summative evaluation phase of this near decade-long program are discussed. A descriptive overview of the summative research design and its development for a multi-site, community-based, healthcare quality improvement initiative is provided. The summative research design employed by the evaluation team is discussed. The evaluation team's summative research design involved a data-driven assessment of the effectiveness of the AF4Q program at large, assessments of the impact of AF4Q in the specific programmatic areas, and an assessment of how the AF4Q alliances were positioned for the future at the end of the program. The AF4Q initiative was the largest privately funded community-based healthcare improvement initiative in the United States to date and was implemented at a time of rapid change in national healthcare policy. The implementation of large-scale, multi-site initiatives is becoming an increasingly common approach for addressing problems in healthcare. The summative evaluation research design for the AF4Q initiative, and the lessons learned from its approach, may be valuable to others tasked with evaluating similarly complex community-based initiatives.

Near-Road Air Quality Monitoring: Factors Affecting Network Design and Interpretation of Data

EPA Science Inventory

The growing number of health studies identifying adverse health effects for populations spending significant amounts of time near large roadways has increased the interest in monitoring air quality in this microenvironment. Designing near-road air monitoring networks or interpret...

Noise from high speed maglev systems: Noise sources, noise criteria, preliminary design guidelines for noise control, recommendations for acoustical test facility for maglev research. Final report, July 1991-October 1992

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

Hanson, C.E.; Abbot, P.; Dyer, I.

1993-01-01

Noise levels from magnetically-levitated trains (maglev) at very high speed may be high enough to cause environmental noise impact in residential areas. Aeroacoustic sources dominate the sound at high speeds and guideway vibrations generate noticeable sound at low speed. In addition to high noise levels, the startle effect as a result of sudden onset of sound from a rapidly moving nearby maglev vehicle may lead to increased annoyance to neighbors of a maglev system. The report provides a base for determining the noise consequences and potential mitigation for a high speed maglev system in populated areas of the United States.more » Four areas are included in the study: (1) definition of noise sources; (2) development of noise criteria; (3) development of design guidelines; and (4) recommendations for a noise testing facility.« less

Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study).

PubMed

Walsh, Timothy S; Kydonaki, Kalliopi; Antonelli, Jean; Stephen, Jacqueline; Lee, Robert J; Everingham, Kirsty; Hanley, Janet; Uutelo, Kimmo; Peltola, Petra; Weir, Christopher J

2016-03-04

To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs). 8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis. Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period. The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured. Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed. The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex

Office of Student Financial Aid Quality Improvement Program: Design and Implementation Plan.

ERIC Educational Resources Information Center

Advanced Technology, Inc., Reston, VA.

The purpose and direction of the quality improvement program of the U.S. Department of Education's Office of Student Financial Aid (OSFA) are described. The improvement program was designed to develop a systematic approach to identify, measure, and correct errors in the student aid delivery system. Information is provided on the general approach…

Anti-terrorist vehicle crash impact energy absorbing barrier

DOEpatents

Swahlan, David J.

1989-01-01

An anti-terrorist vehicle crash barrier includes side support structures, crushable energy absorbing aluminum honeycomb modules, and an elongated impact-resistant beam extending between, and at its opposite ends through vertical guideways defined by, the side support structures. An actuating mechanism supports the beam at its opposite ends for movement between a lowered barrier-withdrawn position in which a traffic-supporting side of the beam is aligned with a traffic-bearing surface permitting vehicular traffic between the side support structures and over the beam, and a raised barrier-imposed position in which the beam is aligned with horizontal guideways defined in the side support structures above the traffic-bearing surface, providing an obstruction to vehicular traffic between the side support structures. The beam is movable rearwardly in the horizontal guideways with its opposite ends disposed transversely therethrough upon being impacted at its forward side by an incoming vehicle. The crushable modules are replaceably disposed in the horizontal guideways between aft ends thereof and the beam. The beam, replaceable modules, side support structures and actuating mechanism are separate and detached from one another such that the beam and replaceable modules are capable of coacting to disable and stop an incoming vehicle without causing structural damage to the side support structures and actuating mechanism.

Quality by Design (QbD) Approach for Development of Co-Processed Excipient Pellets (MOMLETS) By Extrusion-Spheronization Technique.

PubMed

Patel, Hetal; Patel, Kishan; Tiwari, Sanjay; Pandey, Sonia; Shah, Shailesh; Gohel, Mukesh

2016-01-01

Microcrystalline cellulose (MCC) is an excellent excipient for the production of pellets by extrusion spheronization. However, it causes slow release rate of poorly water soluble drugs from pellets. Co-processed excipient prepared by spray drying (US4744987; US5686107; WO2003051338) and coprecipitation technique (WO9517831) are patented. The objective of present study was to develop co-processed MCC pellets (MOMLETS) by extrusion-spheronization technique using the principle of Quality by Design (QbD). Co-processed excipient core pellets (MOMLETS) were developed by extrusion spheronization technique using Quality by Design (QbD) approach. BCS class II drug (telmisartan) was layered onto it in a fluidized bed processor. Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA) for pellets were identified. Risk assessment was reported using Ishikawa diagram. Plackett Burman design was used to check the effect of seven independent variables; superdisintegrant, extruder speed, ethanol: water, spheronizer speed, extruder screen, pore former and MCC: lactose; on percentage drug release at 30 min. Pareto chart and normal probability plot was constructed to identify the significant factors. Box-Behnken design (BBD) using three most significant factors (Extruder screen size, type of superdisintegrant and type of pore former) was used as an optimization design. The control space was identified in which desired quality of the pellets can be obtained. Co-processed excipient core pellets (MOMLETS) were successfully developed by QbD approach. Versatility, Industrial scalability and simplicity are the main features of the proposed research. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Standards Based Design: Teaching K-12 Educators to Build Quality Online Courses

ERIC Educational Resources Information Center

Quiroz, René E.; Ritter, Nicola L.; Li, Yun; Newton, Rhonda C.; Palkar, Trupti

2016-01-01

The number of online courses, programs, and schools are growing exponentially in K-12 education. Given the unique nature of online courses and the distinct skills necessary to create a quality online course, it is essential that effective professional development be provided for teachers designing online courses. Online courses need to be of the…

Quality Rating and Improvement System (QRIS) Validation Study Designs. CEELO FastFacts

ERIC Educational Resources Information Center

Schilder, D.

2013-01-01

In this "Fast Facts," a state has received Race to the Top Early Learning Challenge funds and is seeking information to inform the design of the Quality Rating and Improvement System (QRIS) validation study. The Center on Enhancing Early Learning Outcomes (CEELO) responds that according to Resnick (2012), validation of a QRIS is an…

Incorporating Total Quality Management in an Engineering Design Course. Report 5-1993.

ERIC Educational Resources Information Center

Wilczynski, V.; And Others

One definition of creativity is the conviction that each and every existing idea can be improved. It is proposed that creativity in an engineering design process can be encouraged by the adoption of Total Quality Management (TQM) methods based on a commitment to continuous improvement. This paper addresses the introduction and application of TQM…

Quality improvement of melt extruded laminar systems using mixture design.

PubMed

Hasa, D; Perissutti, B; Campisi, B; Grassi, M; Grabnar, I; Golob, S; Mian, M; Voinovich, D

2015-07-30

This study investigates the application of melt extrusion for the development of an oral retard formulation with a precise drug release over time. Since adjusting the formulation appears to be of the utmost importance in achieving the desired drug release patterns, different formulations of laminar extrudates were prepared according to the principles of Experimental Design, using a design for mixtures to assess the influence of formulation composition on the in vitro drug release from the extrudates after 1h and after 8h. The effect of each component on the two response variables was also studied. Ternary mixtures of theophylline (model drug), monohydrate lactose and microcrystalline wax (as thermoplastic binder) were extruded in a lab scale vertical ram extruder in absence of solvents at a temperature below the melting point of the binder (so that the crystalline state of the drug could be maintained), through a rectangular die to obtain suitable laminar systems. Thanks to the desirability approach and a reliability study for ensuring the quality of the formulation, a very restricted optimal zone was defined within the experimental domain. Among the mixture components, the variation of microcrystalline wax content played the most significant role in overall influence on the in vitro drug release. The formulation theophylline:lactose:wax, 57:14:29 (by weight), selected based on the desirability zone, was subsequently used for in vivo studies. The plasma profile, obtained after oral administration of the laminar extruded system in hard gelatine capsules, revealed the typical trend of an oral retard formulation. The application of the mixture experimental design associated to a desirability function permitted to optimize the extruded system and to determine the composition space that ensures final product quality. Copyright © 2015 Elsevier B.V. All rights reserved.

An Analysis of Departure Behaviors of High-Quality Career Designated First-Term Marine Officers

DTIC Science & Technology

2016-03-01

the Officer Retention Board (ORB) near the end of their first term. We show that TBS performance directly relates to officer performance over his/her...SUBJECT TERMS USMC, Marine Corps, Officer Retention Board, Meritorious Designation Program, The Basic School, Retention , officer quality, career...receive meritorious designation, while the remainder of the population competes on the Officer Retention Board (ORB) near the end of their first term. We

Evaluation of water-quality characteristics and sampling design for streams in North Dakota, 1970–2008

USGS Publications Warehouse

Galloway, Joel M.; Vecchia, Aldo V.; Vining, Kevin C.; Densmore, Brenda K.; Lundgren, Robert F.

2012-01-01

In response to the need to examine the large amount of historic water-quality data comprehensively across North Dakota and evaluate the efficiency of the State-wide sampling programs, a study was done by the U.S. Geological Survey in cooperation with the North Dakota State Water Commission and the North Dakota Department of Health to describe the water-quality data collected for the various programs and determine an efficient State-wide sampling design for monitoring future water-quality conditions. Although data collected for the North Dakota State Water Commission High-Low Sampling Program, the North Dakota Department of Health Ambient Water-Quality Network, and other projects and programs provide valuable information on the quality of water in streams in North Dakota, the objectives vary among the programs, some of the programs overlap spatially and temporally, and the various sampling designs may not be the most efficient or relevant to the objectives of the individual programs as they have changed through time. One objective of a State-wide sampling program was to evaluate ways to describe the spatial variability of water-quality conditions across the State in the most efficient manner. Weighted least-squares regression analysis was used to relate the average absolute difference between paired downstream and upstream concentrations, expressed as a percent of the average downstream concentration, to the average absolute difference in daily flow between the downstream and upstream pairs, expressed as a percent of the average downstream flow. The analysis showed that a reasonable spatial network would consist of including the most downstream sites in large basins first, followed by the next upstream site(s) that roughly bisect the downstream flows at the first sites, followed by the next upstream site(s) that roughly bisect flows for the second sites. Sampling sites to be included in a potential State-wide network were prioritized into 3 design levels: level 1

Development and evaluation of paclitaxel nanoparticles using a quality-by-design approach.

PubMed

Yerlikaya, Firat; Ozgen, Aysegul; Vural, Imran; Guven, Olgun; Karaagaoglu, Ergun; Khan, Mansoor A; Capan, Yilmaz

2013-10-01

The aims of this study were to develop and characterize paclitaxel nanoparticles, to identify and control critical sources of variability in the process, and to understand the impact of formulation and process parameters on the critical quality attributes (CQAs) using a quality-by-design (QbD) approach. For this, a risk assessment study was performed with various formulation and process parameters to determine their impact on CQAs of nanoparticles, which were determined to be average particle size, zeta potential, and encapsulation efficiency. Potential risk factors were identified using an Ishikawa diagram and screened by Plackett-Burman design and finally nanoparticles were optimized using Box-Behnken design. The optimized formulation was further characterized by Fourier transform infrared spectroscopy, X-ray diffractometry, differential scanning calorimetry, scanning electron microscopy, atomic force microscopy, and gas chromatography. It was observed that paclitaxel transformed from crystalline state to amorphous state while totally encapsulating into the nanoparticles. The nanoparticles were spherical, smooth, and homogenous with no dichloromethane residue. In vitro cytotoxicity test showed that the developed nanoparticles are more efficient than free paclitaxel in terms of antitumor activity (more than 25%). In conclusion, this study demonstrated that understanding formulation and process parameters with the philosophy of QbD is useful for the optimization of complex drug delivery systems. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

Geohydrology of the Antelope Valley Area, California and design for a ground-water-quality monitoring network

USGS Publications Warehouse

Duell, L.F.

1987-01-01

A basinwide ideal network and an actual network were designed to identify ambient groundwater quality, trends in groundwater quality, and degree of threat from potential pollution sources in Antelope Valley, California. In general, throughout the valley groundwater quality has remained unchanged, and no specific trends are apparent. The main source of groundwater for the valley is generally suitable for domestic, irrigation, and most industrial uses. Water quality data for selected constituents of some network wells and surface-water sites are presented. The ideal network of 77 sites was selected on the basis of site-specific criteria, geohydrology, and current land use (agricultural, residential, and industrial). These sites were used as a guide in the design of the actual network consisting of 44 existing wells. Wells are currently being monitored and were selected whenever possible because of budgetary constraints. Of the remaining ideal sites, 20 have existing wells not part of a current water quality network, and 13 are locations where no wells exist. The methodology used for the selection of sites, constituents monitored, and frequency of analysis will enable network users to make appropriate future changes to the monitoring network. (USGS)

Initial Investigation of Reaction Control System Design on Spacecraft Handling Qualities for Earth Orbit Docking

NASA Technical Reports Server (NTRS)

Bailey, Randall E.; Jackson, E. Bruce; Goodrich, Kenneth H.; Ragsdale, W. Al; Neuhaus, Jason; Barnes, Jim

2008-01-01

A program of research, development, test, and evaluation is planned for the development of Spacecraft Handling Qualities guidelines. In this first experiment, the effects of Reaction Control System design characteristics and rotational control laws were evaluated during simulated proximity operations and docking. Also, the influence of piloting demands resulting from varying closure rates was assessed. The pilot-in-the-loop simulation results showed that significantly different spacecraft handling qualities result from the design of the Reaction Control System. In particular, cross-coupling between translational and rotational motions significantly affected handling qualities as reflected by Cooper-Harper pilot ratings and pilot workload, as reflected by Task-Load Index ratings. This influence is masked but only slightly by the rotational control system mode. While rotational control augmentation using Rate Command Attitude Hold can reduce the workload (principally, physical workload) created by cross-coupling, the handling qualities are not significantly improved. The attitude and rate deadbands of the RCAH introduced significant mental workload and control compensation to evaluate when deadband firings would occur, assess their impact on docking performance, and apply control inputs to mitigate that impact.

Data path design and image quality aspects of the next generation multifunctional printer

NASA Astrophysics Data System (ADS)

Brassé, M. H. H.; de Smet, S. P. R. C.

2008-01-01

Multifunctional devices (MFDs) are increasingly used as a document hub. The MFD is used as a copier, scanner, printer, and it facilitates digital document distribution and sharing. This imposes new requirements on the design of the data path and its image processing. Various design aspects need to be taken into account, including system performance, features, image quality, and cost price. A good balance is required in order to develop a competitive MFD. A modular datapath architecture is presented that supports all the envisaged use cases. Besides copying, colour scanning is becoming an important use case of a modern MFD. The copy-path use case is described and it is shown how colour scanning can also be supported with a minimal adaptation to the architecture. The key idea is to convert the scanner data to an opponent colour space representation at the beginning of the image processing pipeline. The sub-sampling of chromatic information allows for the saving of scarce hardware resources without significant perceptual loss of quality. In particular, we have shown that functional FPGA modules from the copy application can also be used for the scan-to-file application. This makes the presented approach very cost-effective while complying with market conform image quality standards.

Northern Great Plains Network water quality monitoring design for tributaries to the Missouri National Recreational River

USGS Publications Warehouse

Rowe, Barbara L.; Wilson, Stephen K.; Yager, Lisa; Wilson, Marcia H.

2013-01-01

The National Park Service (NPS) organized more than 270 parks with important natural resources into 32 ecoregional networks to conduct Inventory and Monitoring (I&M) activities for assessment of natural resources within park units. The Missouri National Recreational River (NRR) is among the 13 parks in the NPS Northern Great Plain Network (NGPN). Park managers and NGPN staff identified surface water resources as a high priority vital sign to monitor in park units. The objectives for the Missouri NRR water quality sampling design are to (1) assess the current status and long-term trends of select water quality parameters; and (2) document trends in streamflow at high-priority stream systems. Due to the large size of the Missouri River main stem, the NGPN water quality design for the Missouri NRR focuses on wadeable tributaries within the park unit. To correlate with the NGPN water quality protocols, monitoring of the Missouri NRR consists of measurement of field core parameters including dissolved oxygen, pH, specific conductance, and temperature; and streamflow. The purpose of this document is to discuss factors examined for selection of water quality monitoring on segments of the Missouri River tributaries within the Missouri NRR.Awareness of the complex history of the Missouri NRR aids in the current understanding and direction for designing a monitoring plan. Historical and current monitoring data from agencies and entities were examined to assess potential NGPN monitoring sites. In addition, the U.S. Environmental Protection Agency 303(d) list was examined for the impaired segments on tributaries to the Missouri River main stem. Because major tributaries integrate water quality effects from complex combinations of land use and environmental settings within contributing areas, a 20-mile buffer of the Missouri NRR was used to establish environmental settings that may impact the water quality of tributaries that feed the Missouri River main stem. For selection of

Choosing a Cluster Sampling Design for Lot Quality Assurance Sampling Surveys

PubMed Central

Hund, Lauren; Bedrick, Edward J.; Pagano, Marcello

2015-01-01

Lot quality assurance sampling (LQAS) surveys are commonly used for monitoring and evaluation in resource-limited settings. Recently several methods have been proposed to combine LQAS with cluster sampling for more timely and cost-effective data collection. For some of these methods, the standard binomial model can be used for constructing decision rules as the clustering can be ignored. For other designs, considered here, clustering is accommodated in the design phase. In this paper, we compare these latter cluster LQAS methodologies and provide recommendations for choosing a cluster LQAS design. We compare technical differences in the three methods and determine situations in which the choice of method results in a substantively different design. We consider two different aspects of the methods: the distributional assumptions and the clustering parameterization. Further, we provide software tools for implementing each method and clarify misconceptions about these designs in the literature. We illustrate the differences in these methods using vaccination and nutrition cluster LQAS surveys as example designs. The cluster methods are not sensitive to the distributional assumptions but can result in substantially different designs (sample sizes) depending on the clustering parameterization. However, none of the clustering parameterizations used in the existing methods appears to be consistent with the observed data, and, consequently, choice between the cluster LQAS methods is not straightforward. Further research should attempt to characterize clustering patterns in specific applications and provide suggestions for best-practice cluster LQAS designs on a setting-specific basis. PMID:26125967

Choosing a Cluster Sampling Design for Lot Quality Assurance Sampling Surveys.

PubMed

Hund, Lauren; Bedrick, Edward J; Pagano, Marcello

2015-01-01

Lot quality assurance sampling (LQAS) surveys are commonly used for monitoring and evaluation in resource-limited settings. Recently several methods have been proposed to combine LQAS with cluster sampling for more timely and cost-effective data collection. For some of these methods, the standard binomial model can be used for constructing decision rules as the clustering can be ignored. For other designs, considered here, clustering is accommodated in the design phase. In this paper, we compare these latter cluster LQAS methodologies and provide recommendations for choosing a cluster LQAS design. We compare technical differences in the three methods and determine situations in which the choice of method results in a substantively different design. We consider two different aspects of the methods: the distributional assumptions and the clustering parameterization. Further, we provide software tools for implementing each method and clarify misconceptions about these designs in the literature. We illustrate the differences in these methods using vaccination and nutrition cluster LQAS surveys as example designs. The cluster methods are not sensitive to the distributional assumptions but can result in substantially different designs (sample sizes) depending on the clustering parameterization. However, none of the clustering parameterizations used in the existing methods appears to be consistent with the observed data, and, consequently, choice between the cluster LQAS methods is not straightforward. Further research should attempt to characterize clustering patterns in specific applications and provide suggestions for best-practice cluster LQAS designs on a setting-specific basis.

A Control Law Design Method Facilitating Control Power, Robustness, Agility, and Flying Qualities Tradeoffs: CRAFT

NASA Technical Reports Server (NTRS)

Murphy, Patrick C.; Davidson, John B.

1998-01-01

A multi-input, multi-output control law design methodology, named "CRAFT", is presented. CRAFT stands for the design objectives addressed, namely, Control power, Robustness, Agility, and Flying Qualities Tradeoffs. The methodology makes use of control law design metrics from each of the four design objective areas. It combines eigenspace assignment, which allows for direct specification of eigenvalues and eigenvectors, with a graphical approach for representing the metrics that captures numerous design goals in one composite illustration. Sensitivity of the metrics to eigenspace choice is clearly displayed, enabling the designer to assess the cost of design tradeoffs. This approach enhances the designer's ability to make informed design tradeoffs and to reach effective final designs. An example of the CRAFT methodology applied to an advanced experimental fighter and discussion of associated design issues are provided.

Translational Research in South Africa: Evaluating Implementation Quality Using a Factorial Design

PubMed Central

Smith, Edward A.; Collins, Linda M.; Graham, John W.; Lai, Mary; Wegner, Lisa; Vergnani, Tania; Matthews, Catherine; Jacobs, Joachim

2012-01-01

Background HealthWise South Africa: Life Skills for Adolescents (HW) is an evidence-based substance use and sexual risk prevention program that emphasizes the positive use of leisure time. Since 2000, this program has evolved from pilot testing through an efficacy trial involving over 7,000 youth in the Cape Town area. Beginning in 2011, through 2015, we are undertaking a new study that expands HW to all schools in the Metro South Education District. Objective This paper describes a research study designed in partnership with our South African collaborators that examines three factors hypothesized to affect the quality and fidelity of HW implementation: enhanced teacher training; teacher support, structure and supervision; and enhanced school environment. Methods Teachers and students from 56 schools in the Cape Town area will participate in this study. Teacher observations are the primary means of collecting data on factors affecting implementation quality. These factors address the practical concerns of teachers and schools related to likelihood of use and cost-effectiveness, and are hypothesized to be “active ingredients” related to high-quality program implementation in real-world settings. An innovative factorial experimental design was chosen to enable estimation of the individual effect of each of the three factors. Results Because this paper describes the conceptualization of our study, results are not yet available. Conclusions The results of this study may have both substantive and methodological implications for advancing Type 2 translational research. PMID:22707870

Quality by Design approach for studying the impact of formulation and process variables on product quality of oral disintegrating films.

PubMed

Mazumder, Sonal; Pavurala, Naresh; Manda, Prashanth; Xu, Xiaoming; Cruz, Celia N; Krishnaiah, Yellela S R

2017-07-15

The present investigation was carried out to understand the impact of formulation and process variables on the quality of oral disintegrating films (ODF) using Quality by Design (QbD) approach. Lamotrigine (LMT) was used as a model drug. Formulation variable was plasticizer to film former ratio and process variables were drying temperature, air flow rate in the drying chamber, drying time and wet coat thickness of the film. A Definitive Screening Design of Experiments (DoE) was used to identify and classify the critical formulation and process variables impacting critical quality attributes (CQA). A total of 14 laboratory-scale DoE formulations were prepared and evaluated for mechanical properties (%elongation at break, yield stress, Young's modulus, folding endurance) and other CQA (dry thickness, disintegration time, dissolution rate, moisture content, moisture uptake, drug assay and drug content uniformity). The main factors affecting mechanical properties were plasticizer to film former ratio and drying temperature. Dissolution rate was found to be sensitive to air flow rate during drying and plasticizer to film former ratio. Data were analyzed for elucidating interactions between different variables, rank ordering the critical materials attributes (CMA) and critical process parameters (CPP), and for providing a predictive model for the process. Results suggested that plasticizer to film former ratio and process controls on drying are critical to manufacture LMT ODF with the desired CQA. Published by Elsevier B.V.

Ensuring the Quality of Evidence: Using the Best Design to Answer Health IT Questions.

PubMed

Weir, Charlene R

2016-01-01

The quality of logic in a research design determines the value of the results and our confidence regarding the validity of the findings. The purpose of this contribution is to review the principles of research design as they apply to research and evaluation in health IT. We review the architecture of research design, the definitions of cause, sources of bias and confounds, and the importance of measurement as related to the various types of health IT questions. The goal is to provide practitioners a roadmap for making decisions for their own specific study. The contribution is organized around the Threats to Validity taxonomy and explains how different design models address these threats through the use of blocking, factorial design, control groups and time series analysis. The contribution discusses randomized experiments, and includes regression discontinuity designs and various quasi-experimental designs with a special emphasis on how to improve pre/post designs. At the end, general recommendations are provided for improving weaker designs and general research procedures.

Developing a workstation-based, real-time simulation for rapid handling qualities evaluations during design

NASA Technical Reports Server (NTRS)

Anderson, Frederick; Biezad, Daniel J.

1994-01-01

This paper describes the Rapid Aircraft DynamIcs AssessmeNt (RADIAN) project - an integration of the Aircraft SYNThesis (ACSTNT) design code with the USAD DATCOM code that estimates stability derivatives. Both of these codes are available to universities. These programs are then linked to flight simulation and flight controller synthesis tools and resulting design is evaluated on a graphics workstation. The entire process reduces the preliminary design time by an order of magnitude and provides an initial handling qualities evaluation of the design coupled to a control law. The integrated design process is applicable to both conventional aircraft taken from current textbooks and to unconventional designs emphasizing agility and propulsive control of attitude. The interactive and concurrent nature of the design process has been well received by industry and by design engineers at NASA. The process is being implemented into the design curriculum and is being used by students who view it as a significant advance over prior methods.

Re-design of apple pia packaging using quality function deployment method

NASA Astrophysics Data System (ADS)

Pulungan, M. H.; Nadira, N.; Dewi, I. A.

2018-03-01

This study was aimed to identify the attributes for premium apple pia packaging, to determine the technical response to be carried out by Permata Agro Mandiri Small and Medium Enterprise (SME) and to design a new apple pie packaging acceptable by the SME. The Quality Function Deployment (QFD) method was employed to improve the apple pia packaging design, which consisted of seven stages in data analysis. The results indicated that whats attribute required by the costumers include graphic design, dimensions, capacity, shape, strength, and resistance of packaging. While, the technical responses to be conducted by the SMEs were as follows: attractive visual packaging designs, attractive colors, clear images and information, packaging size dimensions, a larger capacity packaging (more product content), ergonomic premium packaging, not easily torn, and impact resistant packaging materials. The findings further confirmed that the design of premium apple pia packaging accepted by the SMES was the one with the capacity of ten apple pia or 200 g weight, and with rectangular or beam shape form. The packaging material used was a duplex carton with 400 grammage (g/m2), the outer part of the packaging was coated with plastic and the inside was added with duplex carton. The acceptable packaging dimension was 30 cm x 5 cm x 3 cm (L x W x H) with a mix of black and yellow color in the graphical design.

An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine.

PubMed

Mishra, Saurabh M; Rohera, Bhagwan D

2017-11-01

The objective of the present study was to design and develop a formulation for orally disintegrating tablets (ODTs) of carbamazepine using quality by design principles. The target product profile (TPP) and quality target product profile (QTPP) of ODTs were identified. Risk assessment was carried out by leveraging prior knowledge and experience to define the criticality of factors based on their impact by Ishikawa fishbone diagram and preliminary hazard analysis tool. Box-Behnken response surface methodology was used to study the effect of critical factors on various attributes of ODTs. The independent factors selected were compression pressure (X 1 ), concentration of sublimating agent (volatile material) (X 2 ), disintegrant concentration (X 3 ) and the responses were tablet crushing strength, tablet porosity, disintegration time, water absorption time, tablet friability and drug dissolution. ANOVA and lack of fit test illustrated that selected independent variables had significant effect on the response variables, and excellent correlation was observed between actual and predicted values. Optimization by desirability function indicated that compression pressure, X 1 (1534 lbs), ammonium bicarbonate concentration, X 2 (7.68%) and Kollidon ® CL-SF concentration, X 3 (6%) were optimum to prepare ODT formulation of carbamazepine of desired attributes complying with QTPP. Thus, in the present study, a high level of assurance was established for ODT product quality and performance.

Green design application on campus to enhance student’s quality of life

NASA Astrophysics Data System (ADS)

Tamiami, H.; Khaira, F.; Fachrudin, A.

2018-02-01

Green design becomes an important thing to applied in the building. Green building will provide comfortability and enhance Quality of Life (QoL) for the users. The purpose of this research is to analyze how green design application on campus to enhance student’s QoL. This research conducted in three campuses which located in North Sumatera Province, namely Universitas Sumatera Utara (USU), Universitas Negeri Medan (Unimed) and Universitas Medan Area (UMA) which have a lot of vegetation, open space, and multi-mass buildings. This research compared the green design application to QoL from three universities. Green design in this research that become independent variables focus on the energy efficiency and conservation (EEC), indoor health and comfort (IHC) and building environment management (BEM) with dependent variable is QoL. This research uses quantitative methods with questionnaire survey techniques. The population is students from the three universities with the sample of each University is 50 samples. The analysis uses multiple regression analysis. The results show that green design application may enhance QoL of students. The campus should have a good green design application to enhance QoL of students and give them comfortability.

Strategies for a Creative Future with Computer Science, Quality Design and Communicability

NASA Astrophysics Data System (ADS)

Cipolla Ficarra, Francisco V.; Villarreal, Maria

In the current work is presented the importance of the two-way triad between computer science, design and communicability. It is demonstrated how the principles of quality of software engineering are not universal since they are disappearing inside university training. Besides, a short analysis of the term "creativity" males apparent the existence of plagiarism as a human factor that damages the future of communicability applied to the on-line and off-line contents of the open software. A set of measures and guidelines are presented so that the triad works again correctly in the next years to foster the qualitative design of the interactive systems on-line and/or off-line.

The Concepts of Quality, Quality Assurance and Quality Enhancement

ERIC Educational Resources Information Center

Elassy, Noha

2015-01-01

Purpose: This paper aims to critically review and discuss different definitions of the concepts of quality, quality assurance (QA) and quality enhancement (QE) in higher education (HE) with presenting critical perspectives of the literature. Design/methodology/approach: The paper looks at literature concerns with the meaning of quality, QA and QE,…

Water-quality assessment of part of the Upper Mississippi River basin, Minnesota and Wisconsin, environmental setting and study design

USGS Publications Warehouse

Stark, J.R.; Andrews, W.J.; Fallon, J.D.; Fong, A.L.; Goldstein, R.M.; Hanson, P.E.; Kroening, S.E.; Lee, K.E.

1996-01-01

Environmental stratification consists of dividing the study unit into subareas with homogeneous characteristics to assess natural and anthropogenic factors affecting water quality. The assessment of water quality in streams and in aquifers is based on the sampling design that compares water quality within homogeneous subareas defined by subbasins or aquifer boundaries. The study unit is stratified at four levels for the surface-water component: glacial deposit composition, surficial geology, general land use and land cover, and secondary land use. Ground-water studies emphasize shallow ground water where quality is most likely influenced by overlying land use and land cover. Stratification for ground-water sampling is superimposed on the distribution of shallow aquifers. For each aquifer and surface-water basin this stratification forms the basis for the proposed sampling design used in the Upper Mississippi River Basin National Water-Quality Assessment.

Design Features for Internet-Based Quality of Life Instrument in Inflammatory Bowel Disease

PubMed Central

Jonsson, Jens

1999-01-01

The idea of enabling user interaction in an Internet-based quality of life application comes with intention to solve problems common for conventional ways of communicating with patients. Here we are presenting results of the feasibility study, which regarded design and introduction of new forms to acquire patient information. Imagesp1092-a

Quality by design (QbD), Process Analytical Technology (PAT), and design of experiment applied to the development of multifunctional sunscreens.

PubMed

Peres, Daniela D'Almeida; Ariede, Maira Bueno; Candido, Thalita Marcilio; de Almeida, Tania Santos; Lourenço, Felipe Rebello; Consiglieri, Vladi Olga; Kaneko, Telma Mary; Velasco, Maria Valéria Robles; Baby, André Rolim

2017-02-01

Multifunctional formulations are of great importance to ensure better skin protection from harm caused by ultraviolet radiation (UV). Despite the advantages of Quality by Design and Process Analytical Technology approaches to the development and optimization of new products, we found in the literature only a few studies concerning their applications in cosmetic product industry. Thus, in this research work, we applied the QbD and PAT approaches to the development of multifunctional sunscreens containing bemotrizinol, ethylhexyl triazone, and ferulic acid. In addition, UV transmittance method was applied to assess qualitative and quantitative critical quality attributes of sunscreens using chemometrics analyses. Linear discriminant analysis allowed classifying unknown formulations, which is useful for investigation of counterfeit and adulteration. Simultaneous quantification of ethylhexyl triazone, bemotrizinol, and ferulic acid presented at the formulations was performed using PLS regression. This design allowed us to verify the compounds in isolation and in combination and to prove that the antioxidant action of ferulic acid as well as the sunscreen actions, since the presence of this component increased 90% of antioxidant activity in vitro.

Improving the Quality of Online Discussion: The Effects of Strategies Designed Based on Cognitive Load Theory Principles

ERIC Educational Resources Information Center

Darabi, Aubteen; Jin, Li

2013-01-01

This article focuses on heavy cognitive load as the reason for the lack of quality associated with conventional online discussion. Using the principles of cognitive load theory, four online discussion strategies were designed specifically aiming at reducing the discussants' cognitive load and thus enhancing the quality of their online discussion.…

76 FR 14812 - Additional Air Quality Designations for the 2006 24-Hour Fine Particle National Ambient Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-HQ-OAR-2007-0562; EPA-HQ-OAR-2010-0163; FRL-9261-3] RIN-2060-AQ30 Additional Air Quality Designations for the 2006 24-Hour Fine Particle National... Particles National Ambient Air Quality Standards Correction In rule document 2011-2269 appearing on pages...

Hydrophobic polymers for orodispersible films: a quality by design approach.

PubMed

Borges, Ana Filipa; Silva, Branca M A; Silva, Cláudia; Coelho, Jorge F J; Simões, Sérgio

2016-10-01

To develop orodispersible films (ODF) based on hydrophobic polymers with higher stability to ordinary environmental humidity conditions without compromising their fast disintegration time. A quality by design approach was applied to screen three different formulations each one based on a different hydrophobic polymer: polyvinyl acetate, methacrylate-based copolymer and shellac. The screening formulations were characterized regarding their mechanical properties, residual water content, disintegration time and appearance, in order to find a suitable ODF formulation according to established critical quality attributes. The selected critical process parameters for the selection of appropriate ODF formulations were the percentage of the different excipients and the plasticizer type. Three hydrophobic-based matrices with fast disintegration were developed. These were generically composed by a hydrophobic polymer, a stabilizer, a disintegrant and a plasticizer. It verified that the common components within the three different formulations behave differently depending on the system/chemical environment that they were included. It was shown that it is possible to develop oral films based on hydrophobic polymers with fast disintegration time, good texture and appearance, breaking a paradigm of the ODF research field.

A Quality by Design approach to investigate tablet dissolution shift upon accelerated stability by multivariate methods.

PubMed

Huang, Jun; Goolcharran, Chimanlall; Ghosh, Krishnendu

2011-05-01

This paper presents the use of experimental design, optimization and multivariate techniques to investigate root-cause of tablet dissolution shift (slow-down) upon stability and develop control strategies for a drug product during formulation and process development. The effectiveness and usefulness of these methodologies were demonstrated through two application examples. In both applications, dissolution slow-down was observed during a 4-week accelerated stability test under 51°C/75%RH storage condition. In Application I, an experimental design was carried out to evaluate the interactions and effects of the design factors on critical quality attribute (CQA) of dissolution upon stability. The design space was studied by design of experiment (DOE) and multivariate analysis to ensure desired dissolution profile and minimal dissolution shift upon stability. Multivariate techniques, such as multi-way principal component analysis (MPCA) of the entire dissolution profiles upon stability, were performed to reveal batch relationships and to evaluate the impact of design factors on dissolution. In Application II, an experiment was conducted to study the impact of varying tablet breaking force on dissolution upon stability utilizing MPCA. It was demonstrated that the use of multivariate methods, defined as Quality by Design (QbD) principles and tools in ICH-Q8 guidance, provides an effective means to achieve a greater understanding of tablet dissolution upon stability. Copyright © 2010 Elsevier B.V. All rights reserved.

Indoor Air Quality in 24 California Residences Designed as High-Performance Homes

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

Less, Brennan; Mullen, Nasim; Singer, Brett

2015-07-01

Today’s high performance green homes are reaching previously unheard of levels of airtightness and are using new materials, technologies and strategies, whose impacts on Indoor Air Quality (IAQ) cannot be fully anticipated from prior studies. This research study used pollutant measurements, home inspections, diagnostic testing and occupant surveys to assess IAQ in 24 new or deeply retrofitted homes designed to be high performance green buildings in California.

Design of the subject of quality engineering and security of the product of the degree in engineering in industrial design and development of product based in the methodology of the case

NASA Astrophysics Data System (ADS)

González, M. R.; Lambán, M. P.

2012-04-01

This paper presents the result of designing the subject Quality Engineering and Security of the Product, belonging to the Degree of Engineering in Industrial Design and Product Development, on the basis of the case methodology. Practical sessions of this subject are organized using the whole documents of the Quality System Management of the virtual company BeaLuc S.A.

Design, implementation, and quality control in the Pathways American-Indian multicenter trial

PubMed Central

Stone, Elaine J.; Norman, James E.; Davis, Sally M.; Stewart, Dawn; Clay, Theresa E.; Caballero, Ben; Lohman, Timothy G.; Murray, David M.

2016-01-01

Background Pathways was the first multicenter American-Indian school-based study to test the effectiveness of an obesity prevention program promoting healthy eating and physical activity. Methods Pathways employed a nested cohort design in which 41 schools were randomized to intervention or control conditions and students within these schools were followed as a cohort (1,704 third graders at baseline). The study’s primary endpoint was percent body fat. Secondary endpoints were levels of fat in school lunches; time spent in physical activity; and knowledge, attitudes, and behaviors regarding diet and exercise. Quality control (QC) included design of data management systems which provided standardization and quality assurance of data collection and processing. Data QC procedures at study centers included manuals of operation, training and certification, and monitoring of performance. Process evaluation was conducted to monitor dose and fidelity of the interventions. Registration and tracking systems were used for students and schools. Results No difference in mean percent body fat at fifth grade was found between the intervention and control schools. Percent of calories from fat and saturated fat in school lunches was significantly reduced in the intervention schools as was total energy intake from 24-hour recalls. Significant increases in self-reported physical activity levels and knowledge of healthy behaviors were found for the intervention school students. Conclusions The Pathways study results provide evidence demonstrating the role schools can play in public health promotion. Its study design and QC systems and procedures provide useful models for other similar school based multi- or single-site studies. PMID:14636805

Designing climate-resilient rice with ideal grain quality suited for high-temperature stress

PubMed Central

Sreenivasulu, Nese; Butardo, Vito M.; Misra, Gopal; Cuevas, Rosa Paula; Anacleto, Roslen; Kavi Kishor, Polavarpu B.

2015-01-01

To ensure rice food security, the target outputs of future rice breeding programmes should focus on developing climate-resilient rice varieties with emphasis on increased head rice yield coupled with superior grain quality. This challenge is made greater by a world that is increasingly becoming warmer. Such environmental changes dramatically impact head rice and milling yield as well as increasing chalkiness because of impairment in starch accumulation and other storage biosynthetic pathways in the grain. This review highlights the knowledge gained through gene discovery via quantitative trait locus (QTL) cloning and structural–functional genomic strategies to reduce chalk, increase head rice yield, and develop stable lines with optimum grain quality in challenging environments. The newly discovered genes and the knowledge gained on the influence of specific alleles related to stability of grain quality attributes provide a robust platform for marker-assisted selection in breeding to design heat-tolerant rice varieties with superior grain quality. Using the chalkiness trait in rice as a case study, we demonstrate here that the emerging field of systems genetics can help fast-track the identification of novel alleles and gene targets that can be pyramided for the development of environmentally robust rice varieties that possess improved grain quality. PMID:25662847

Designing Excellence and Quality Model for Training Centers of Primary Health Care: A Delphi Method Study.

PubMed

Tabrizi, Jafar-Sadegh; Farahbakhsh, Mostafa; Shahgoli, Javad; Rahbar, Mohammad Reza; Naghavi-Behzad, Mohammad; Ahadi, Hamid-Reza; Azami-Aghdash, Saber

2015-10-01

Excellence and quality models are comprehensive methods for improving the quality of healthcare. The aim of this study was to design excellence and quality model for training centers of primary health care using Delphi method. In this study, Delphi method was used. First, comprehensive information were collected using literature review. In extracted references, 39 models were identified from 34 countries and related sub-criteria and standards were extracted from 34 models (from primary 39 models). Then primary pattern including 8 criteria, 55 sub-criteria, and 236 standards was developed as a Delphi questionnaire and evaluated in four stages by 9 specialists of health care system in Tabriz and 50 specialists from all around the country. Designed primary model (8 criteria, 55 sub-criteria, and 236 standards) were concluded with 8 criteria, 45 sub-criteria, and 192 standards after 4 stages of evaluations by specialists. Major criteria of the model are leadership, strategic and operational planning, resource management, information analysis, human resources management, process management, costumer results, and functional results, where the top score was assigned as 1000 by specialists. Functional results had the maximum score of 195 whereas planning had the minimum score of 60. Furthermore the most and the least sub-criteria was for leadership with 10 sub-criteria and strategic planning with 3 sub-criteria, respectively. The model that introduced in this research has been designed following 34 reference models of the world. This model could provide a proper frame for managers of health system in improving quality.

Quality design of belite–melilite clinker

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

Kurokawa, Daisuke, E-mail: daisuke_kurokawa@taiheiyo-cement.co.jp; Department of Materials Science and Engineering, Nagoya Institute of Technology, Nagoya 466-8555; Honma, Kenichi

2013-12-15

We have developed a new cement clinker, consisting mainly of belite and melilite, which is capable of increasing the amount of recycled waste as a part of its raw materials. We analyzed clinkers with a wide range of compositions, and clarified the quantitative relationship between the chemical and mineral compositions. Clinkers consisting mostly of belite and melilite were successfully obtained at the CaO/SiO{sub 2} mass ratio of 1.7 to 1.9. Test cements were prepared using these clinkers and mixed with OPC for the evaluation of fluidity and strength. The belite–melilite cement was found to have good fluidity, and the belite–melilitemore » cement mixed with OPC at up to 30% exhibited a satisfactory long term strength equivalent to the OPC, demonstrating the potential as an alternative to OPC. Electron probe microanalysis revealed the relatively high concentration of diphosphorus pentaoxide in belite, suggesting this component might contribute to the strength enhancement of the cement. -- Highlights: •A new cement clinker consisting mainly of belite and melilite was designed. •The clinker enables the use of various recycled wastes as part of its raw materials. •The relationship between the chemical and mineral compositions was clarified. •This cement mixed with OPC at up to 30% exhibited a good quality equivalent to OPC.« less

Development of a simulation model of semi-active suspension for monorail

NASA Astrophysics Data System (ADS)

Hasnan, K.; Didane, D. H.; Kamarudin, M. A.; Bakhsh, Qadir; Abdulmalik, R. E.

2016-11-01

The new Kuala Lumpur Monorail Fleet Expansion Project (KLMFEP) uses semiactive technology in its suspension system. It is recognized that the suspension system influences the ride quality. Thus, among the way to further improve the ride quality is by fine- tuning the semi-active suspension system on the new KL Monorail. The semi-active suspension for the monorail specifically in terms of improving ride quality could be exploited further. Hence a simulation model which will act as a platform to test the design of a complete suspension system particularly to investigate the ride comfort performance is required. MSC Adams software was considered as the tool to develop the simulation platform, where all parameters and data are represented by mathematical equations; whereas the new KL Monorail being the reference model. In the simulation, the model went through step disturbance on the guideway for stability and ride comfort analysis. The model has shown positive results where the monorail is in stable condition as an outcome from stability analysis. The model also scores a Rating 1 classification in ISO 2631 Ride Comfort performance which is very comfortable as an overall outcome from ride comfort analysis. The model is also adjustable, flexibile and understandable by the engineers within the field for the purpose of further development.

Critical to quality in telemedicine service management: application of DFSS (Design for Six Sigma) and SERVQUAL).

PubMed

Yun, Eun Kyoung; Chun, Kee Moon

2008-01-01

Telemedicine generally refers to the use of communications and information technologies for the delivery of health care. owever, telemedicine is not merely a simple combination of health care and technology. The researchers propose a systematic approach for assessing needs of telemedicine customers, called critical-to-quality (CTQ) in Six Sigma, with a purpose of continuous quality improvement. The combination approach using DFSS (Design for Six Sigma) and SERVQUAL (Service Quality Framework) was applied to define the critical quality attributes of telemedicine service management and to match them with the current telemedicine process. With a step-by-step procedure, telemedicine service process was reviewed and all the important CTQ candidates identified via a case study. The findings suggest that nurses need further understanding and research methods that will improve and manage the quality of health care service in various medical fields.

High Quality Acquisition of Surface Electromyography - Conditioning Circuit Design

NASA Astrophysics Data System (ADS)

Shobaki, Mohammed M.; Malik, Noreha Abdul; Khan, Sheroz; Nurashikin, Anis; Haider, Samnan; Larbani, Sofiane; Arshad, Atika; Tasnim, Rumana

2013-12-01

The acquisition of Surface Electromyography (SEMG) signals is used for many applications including the diagnosis of neuromuscular diseases, and prosthesis control. The diagnostic quality of the SEMG signal is highly dependent on the conditioning circuit of the SEMG acquisition system. This paper presents the design of an SEMG conditioning circuit that can guarantee to collect high quality signal with high SNR such that it is immune to environmental noise. The conditioning circuit consists of four stages; consisting of an instrumentation amplifier that is used with a gain of around 250; 4th order band pass filter in the 20-500Hz frequency range as the two initial stages. The third stage is an amplifier with adjustable gain using a variable resistance; the gain could be changed from 1000 to 50000. In the final stage the signal is translated to meet the input requirements of data acquisition device or the ADC. Acquisition of accurate signals allows it to be analyzed for extracting the required characteristic features for medical and clinical applications. According to the experimental results, the value of SNR for collected signal is 52.4 dB which is higher than the commercial system, the power spectrum density (PSD) graph is also presented and it shows that the filter has eliminated the noise below 20 Hz.

From Design and Implementation to Impact of Quality Assurance: An Overview of Some Studies into What Impacts Improvement

ERIC Educational Resources Information Center

Westerheijden, Don F.; Hulpiau, Veerle; Waeytens, Kim

2007-01-01

Attention shifted in recent years from design and implementation to use and usefulness of quality assurance. Scientific studies focus increasingly on quality assurance's impact on curricula and individual teachers. Which factors influence follow-up activities and what is their relation to improvement of education? One factor that we single out is…

Ecological relevance of current water quality assessment unit designations in impaired rivers

USGS Publications Warehouse

Layhee, Megan J.; Sepulveda, Adam; Ray, Andrew; Mladenka, Greg; Van Every, Lynn

2016-01-01

Managers often nest sections of water bodies together into assessment units (AUs) to monitor and assess water quality criteria. Ideally, AUs represent an extent of waters with similar ecological, watershed, habitat and land-use conditions and no overlapping characteristics with other waters. In the United States, AUs are typically based on political or hydrologic boundaries rather than on ecologically relevant features, so it can be difficult to detect changes in impairment status. Our goals were to evaluate if current AU designation criteria of an impaired water body in southeastern Idaho, USA that, like many U.S. waters, has three-quarters of its mainstem length divided into two AUs. We focused our evaluation in southeastern Idaho's Portneuf River, an impaired river and three-quarters of the river is divided into two AUs. We described biological and environmental conditions at multiple reaches within each AU. We used these data to (1) test if variability at the reach-scale is greater within or among AUs and, (2) to evaluate alternate AU boundaries based on multivariate analyses of reach-scale data. We found that some biological conditions had greater variability within an AU than between AUs. Multivariate analyses identified alternative, 2- and 3-group, AUs that reduced this variability. Our results suggest that the current AU designations in the mainstem Portneuf River contain ecologically distinct sections of river and that the existing AU boundaries should be reconsidered in light of the ecological conditions measured at the reach scale. Variation in biological integrity within designated AUs may complicate water quality and biological assessments, influence management decisions or affect where monitoring or mitigation resources are directed.

Designing climate-resilient rice with ideal grain quality suited for high-temperature stress.

PubMed

Sreenivasulu, Nese; Butardo, Vito M; Misra, Gopal; Cuevas, Rosa Paula; Anacleto, Roslen; Kavi Kishor, Polavarpu B

2015-04-01

To ensure rice food security, the target outputs of future rice breeding programmes should focus on developing climate-resilient rice varieties with emphasis on increased head rice yield coupled with superior grain quality. This challenge is made greater by a world that is increasingly becoming warmer. Such environmental changes dramatically impact head rice and milling yield as well as increasing chalkiness because of impairment in starch accumulation and other storage biosynthetic pathways in the grain. This review highlights the knowledge gained through gene discovery via quantitative trait locus (QTL) cloning and structural-functional genomic strategies to reduce chalk, increase head rice yield, and develop stable lines with optimum grain quality in challenging environments. The newly discovered genes and the knowledge gained on the influence of specific alleles related to stability of grain quality attributes provide a robust platform for marker-assisted selection in breeding to design heat-tolerant rice varieties with superior grain quality. Using the chalkiness trait in rice as a case study, we demonstrate here that the emerging field of systems genetics can help fast-track the identification of novel alleles and gene targets that can be pyramided for the development of environmentally robust rice varieties that possess improved grain quality. © The Author 2015. Published by Oxford University Press on behalf of the Society for Experimental Biology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Predicted accommodative response from image quality in young eyes fitted with different dual-focus designs.

PubMed

Faria-Ribeiro, Miguel; Amorim-de-Sousa, Ana; González-Méijome, José M

2018-05-01

To investigate the separated and combined influences of inner zone (IZ) diameter and effective add power of dual-focus contact lenses (CL) in the image quality at distance and near viewing, in a functional accommodating model eye. Computational wave-optics methods were used to define zonal bifocal pupil functions, representing the optic zones of nine dual-focus centre-distance CLs. The dual-focus pupil functions were defined having IZ diameters of 2.10 mm, 3.36 mm and 4.00 mm, with add powers of 1.5 D, 2.0 D and 2.5 D (dioptres), for each design, that resulted in a ratio of 64%/36% between the distance and treatment zone areas, bounded by a 6 mm entrance pupil. A through-focus routine was implemented in MATLAB to simulate the changes in image quality, calculated from the Visual Strehl ratio, as the eye with the dual-focus accommodates, from 0 to -3.00 D target vergences. Accommodative responses were defined as the changes in the defocus coefficient, combined with a change in fourth and sixth order spherical aberration, which produced a peak in image quality at each target vergence. Distance viewing image quality was marginally affected by IZ diameter but not by add power. Near image quality obtained when focussing the image formed by the near optics was only higher by a small amount compared to the other two IZ diameters. The mean ± standard deviation values obtained with the three adds were 0.28 ± 0.02, 0.23 ± 0.02 and 0.22 ± 0.02, for the small, medium and larger IZ diameters, respectively. On the other hand, near image quality predicted by focussing the image formed by the distance optics was considerably lower relatively to the other two IZ diameters. The mean ± standard deviation values obtained with the three adds were 0.15 ± 0.01, 0.38 ± 0.00 and 0.54 ± 0.01, for the small, medium and larger IZ diameters, respectively. During near viewing through dual-focus CLs, image quality depends on the diameter of the most inner zone of the CL, while add power

Magnetic levitation configuration incorporating levitation, guidance and linear synchronous motor

DOEpatents

Coffey, H.T.

1993-10-19

A propulsion and suspension system for an inductive repulsion type magnetically levitated vehicle which is propelled and suspended by a system which includes propulsion windings which form a linear synchronous motor and conductive guideways, adjacent to the propulsion windings, where both combine to partially encircling the vehicle-borne superconducting magnets. A three phase power source is used with the linear synchronous motor to produce a traveling magnetic wave which in conjunction with the magnets propel the vehicle. The conductive guideway combines with the superconducting magnets to provide for vehicle levitation. 3 figures.

Magnetic levitation configuration incorporating levitation, guidance and linear synchronous motor

DOEpatents

Coffey, Howard T.

1993-01-01

A propulsion and suspension system for an inductive repulsion type magnetically levitated vehicle which is propelled and suspended by a system which includes propulsion windings which form a linear synchronous motor and conductive guideways, adjacent to the propulsion windings, where both combine to partially encircling the vehicle-borne superconducting magnets. A three phase power source is used with the linear synchronous motor to produce a traveling magnetic wave which in conjunction with the magnets propel the vehicle. The conductive guideway combines with the superconducting magnets to provide for vehicle leviation.

Application of the Quality by Design Approach to the Freezing Step of Freeze-Drying: Building the Design Space.

PubMed

Arsiccio, Andrea; Pisano, Roberto

2018-06-01

The present work shows a rational method for the development of the freezing step of a freeze-drying cycle. The current approach to the selection of freezing conditions is still empirical and nonsystematic, thus resulting in poor robustness of control strategy. The final aim of this work is to fill this gap, describing a rational procedure, based on mathematical modeling, for properly choosing the freezing conditions. Mechanistic models are used for the prediction of temperature profiles during freezing and dimension of ice crystals being formed. Mathematical description of the drying phase of freeze-drying is also coupled with the results obtained by freezing models, thus providing a comprehensive characterization of the lyophilization process. In this framework, deep understanding of the phenomena involved is required, and according to the Quality by Design approach, this knowledge can be used to build the design space. The step-by-step procedure for building the design space for freezing is thus described, and examples of applications are provided. The calculated design space is validated upon experimental data, and we show that it allows easy control of the freezing process and fast selection of appropriate operating conditions. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Presentation of flight control design and handling quality commonality by separate surface stability augmentation for the family of commuter airplanes

NASA Technical Reports Server (NTRS)

Hensley, Douglas; Creighton, Thomas; Haddad, Raphael; Hendrich, Louis; Morgan, Louise; Russell, Mark; Swift, Gerald

1987-01-01

The methodology and results for a flight control design and implementation for common handling qualities by Separate Surface Stability Augmentation (SSSA) for the family of commuter airplanes are contained. The open and closed loop dynamics and the design results of augmenting for common handling qualities are presented. The physical and technology requirements are presented for implementing the SSSA system. The conclusion of this report and recommendations for changes or improvement are discussed.

Evaluating the quality of a cell counting measurement process via a dilution series experimental design.

PubMed

Sarkar, Sumona; Lund, Steven P; Vyzasatya, Ravi; Vanguri, Padmavathy; Elliott, John T; Plant, Anne L; Lin-Gibson, Sheng

2017-12-01

Cell counting measurements are critical in the research, development and manufacturing of cell-based products, yet determining cell quantity with accuracy and precision remains a challenge. Validating and evaluating a cell counting measurement process can be difficult because of the lack of appropriate reference material. Here we describe an experimental design and statistical analysis approach to evaluate the quality of a cell counting measurement process in the absence of appropriate reference materials or reference methods. The experimental design is based on a dilution series study with replicate samples and observations as well as measurement process controls. The statistical analysis evaluates the precision and proportionality of the cell counting measurement process and can be used to compare the quality of two or more counting methods. As an illustration of this approach, cell counting measurement processes (automated and manual methods) were compared for a human mesenchymal stromal cell (hMSC) preparation. For the hMSC preparation investigated, results indicated that the automated method performed better than the manual counting methods in terms of precision and proportionality. By conducting well controlled dilution series experimental designs coupled with appropriate statistical analysis, quantitative indicators of repeatability and proportionality can be calculated to provide an assessment of cell counting measurement quality. This approach does not rely on the use of a reference material or comparison to "gold standard" methods known to have limited assurance of accuracy and precision. The approach presented here may help the selection, optimization, and/or validation of a cell counting measurement process. Published by Elsevier Inc.

A quality by design (QbD) study on enoxaparin sodium loaded polymeric microspheres for colon-specific delivery.

PubMed

Hales, Dana; Vlase, Laurian; Porav, Sebastian Alin; Bodoki, Andreea; Barbu-Tudoran, Lucian; Achim, Marcela; Tomuță, Ioan

2017-03-30

The aim of this study was to apply quality by design (QbD) for pharmaceutical development of enoxaparin sodium microspheres for colon-specific delivery. The Process Parameters (CPPs) and Critical Quality Attributes (CQAs) were identified. A central composite experimental design was used in order to develop the design space of microspheres for colon-specific delivery that have the desired Quality Target Product Profile (QTPP). The CPPs studied were Eudragit® FS-30D/Eudragit® RS-PO ratio, poly(vinyl alcohol) (PVA) concentration and sodium chloride (NaCl) concentration. The encapsulation efficiency increased with NaCl concentration increase, the percentages of enoxaparin sodium reaching 94% for some formulations. Increasing the ratio Eudragit® FS-30D/Eudragit® RS-PO ensured a relatively complete release of enoxaparin sodium in the environment simulating the colonic pH. Based on these results, the optimum conditions were decided and the optimum formulation was prepared. The results obtained for the latter in terms of in vitro enoxaparin sodium release were good, the microparticles releasing only 9.42% enoxaparin sodium in acidic environment and 15.16% in the medium which simulated duodenal pH, but allowing the release of up to 89.24% in the medium which simulated colonic pH. The in vitro release profile of enoxaparin sodium was close to the ideal one, therefore the system was successfully designed using QbD approach. Copyright © 2017 Elsevier B.V. All rights reserved.

A tutorial for developing a topical cream formulation based on the Quality by Design approach.

PubMed

Simões, Ana; Veiga, Francisco; Vitorino, Carla; Figueiras, Ana

2018-06-20

The pharmaceutical industry has entered in a new era, as there is a growing interest in increasing the quality standards of dosage forms, through the implementation of more structured development and manufacturing approaches. For many decades, the manufacturing of drug products was controlled by a regulatory framework to guarantee the quality of the final product through a fixed process and exhaustive testing. Limitations related to the Quality by Test (QbT) system have been widely acknowledged. The emergence of Quality by Design (QbD) as a systematic and risk-based approach introduced a new quality concept based on a good understanding of how raw materials and process parameters influence the final quality profile. Although the QbD system has been recognized as a revolutionary approach to product development and manufacturing, its full implementation in the pharmaceutical field is still limited. This is particularly evident in the case of semisolid complex formulation development. The present review aims at establishing a practical QbD framework to describe all stages comprised in the pharmaceutical development of a conventional cream in a comprehensible manner. Copyright © 2018. Published by Elsevier Inc.

Fault tolerant computer control for a Maglev transportation system

NASA Technical Reports Server (NTRS)

Lala, Jaynarayan H.; Nagle, Gail A.; Anagnostopoulos, George

1994-01-01

Magnetically levitated (Maglev) vehicles operating on dedicated guideways at speeds of 500 km/hr are an emerging transportation alternative to short-haul air and high-speed rail. They have the potential to offer a service significantly more dependable than air and with less operating cost than both air and high-speed rail. Maglev transportation derives these benefits by using magnetic forces to suspend a vehicle 8 to 200 mm above the guideway. Magnetic forces are also used for propulsion and guidance. The combination of high speed, short headways, stringent ride quality requirements, and a distributed offboard propulsion system necessitates high levels of automation for the Maglev control and operation. Very high levels of safety and availability will be required for the Maglev control system. This paper describes the mission scenario, functional requirements, and dependability and performance requirements of the Maglev command, control, and communications system. A distributed hierarchical architecture consisting of vehicle on-board computers, wayside zone computers, a central computer facility, and communication links between these entities was synthesized to meet the functional and dependability requirements on the maglev. Two variations of the basic architecture are described: the Smart Vehicle Architecture (SVA) and the Zone Control Architecture (ZCA). Preliminary dependability modeling results are also presented.

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

PubMed

Badawy, Sherif I F; Narang, Ajit S; LaMarche, Keirnan R; Subramanian, Ganeshkumar A; Varia, Sailesh A; Lin, Judy; Stevens, Tim; Shah, Pankaj A

2016-01-01

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product. Copyright © 2016. Published by Elsevier Inc.

A quality by design approach to understand formulation and process variability in pharmaceutical melt extrusion processes.

PubMed

Patwardhan, Ketaki; Asgarzadeh, Firouz; Dassinger, Thomas; Albers, Jessica; Repka, Michael A

2015-05-01

In this study, the principles of quality by design (QbD) have been uniquely applied to a pharmaceutical melt extrusion process for an immediate release formulation with a low melting model drug, ibuprofen. Two qualitative risk assessment tools - Fishbone diagram and failure mode effect analysis - were utilized to strategically narrow down the most influential parameters. Selected variables were further assessed using a Plackett-Burman screening study, which was upgraded to a response surface design consisting of the critical factors to study the interactions between the study variables. In process torque, glass transition temperature (Tg ) of the extrudates, assay, dissolution and phase change were measured as responses to evaluate the critical quality attributes (CQAs) of the extrudates. The effect of each study variable on the measured responses was analysed using multiple regression for the screening design and partial least squares for the optimization design. Experimental limits for formulation and process parameters to attain optimum processing have been outlined. A design space plot describing the domain of experimental variables within which the CQAs remained unchanged was developed. A comprehensive approach for melt extrusion product development based on the QbD methodology has been demonstrated. Drug loading concentrations between 40- 48%w/w and extrusion temperature in the range of 90-130°C were found to be the most optimum. © 2015 Royal Pharmaceutical Society.

Implementation of quality by design principles in the development of microsponges as drug delivery carriers: Identification and optimization of critical factors using multivariate statistical analyses and design of experiments studies.

PubMed

Simonoska Crcarevska, Maja; Dimitrovska, Aneta; Sibinovska, Nadica; Mladenovska, Kristina; Slavevska Raicki, Renata; Glavas Dodov, Marija

2015-07-15

Microsponges drug delivery system (MDDC) was prepared by double emulsion-solvent-diffusion technique using rotor-stator homogenization. Quality by design (QbD) concept was implemented for the development of MDDC with potential to be incorporated into semisolid dosage form (gel). Quality target product profile (QTPP) and critical quality attributes (CQA) were defined and identified, accordingly. Critical material attributes (CMA) and Critical process parameters (CPP) were identified using quality risk management (QRM) tool, failure mode, effects and criticality analysis (FMECA). CMA and CPP were identified based on results obtained from principal component analysis (PCA-X&Y) and partial least squares (PLS) statistical analysis along with literature data, product and process knowledge and understanding. FMECA identified amount of ethylcellulose, chitosan, acetone, dichloromethane, span 80, tween 80 and water ratio in primary/multiple emulsions as CMA and rotation speed and stirrer type used for organic solvent removal as CPP. The relationship between identified CPP and particle size as CQA was described in the design space using design of experiments - one-factor response surface method. Obtained results from statistically designed experiments enabled establishment of mathematical models and equations that were used for detailed characterization of influence of identified CPP upon MDDC particle size and particle size distribution and their subsequent optimization. Copyright © 2015 Elsevier B.V. All rights reserved.

[Design and implementation of a questionnaire to evaluate the dietary quality of school meals].

PubMed

de Mateo Silleras, Beatriz; Camina Martín, M Alicia; Ojeda Sainz, Berta; Carreño Enciso, Laura; de la Cruz Marcos, Sandra; Marugán de Miguelsanz, José Manuel; Redondo del Río, Paz

2014-10-03

The school canteen provides a substantial proportion of the daily nutritional intake for many children. There are nutritional standards for school meals, however, it is still difficult to assess the dietary quality. To design a questionnaire for assessing the dietary quality of school meals, quickly and easily. A dietary questionnaire (COMES) was designed on the basis of the current recommendations. COMES consist of 15 items related to the food-frequency and to other characteristics of school meals. Then, a longitudinal prospective study was performed in order to analyze, with COMES, 36 school meals of 4 catering companies from Castilla y León during the academic years 2006-2007 to 2010-2011. Differences in dietary quality menus according to the management system of catering companies (in situ vs. transported) were analyzed by using the Mann-Whitney and the Kruskal-Wallis tests. The significance was reached at p <0,05. The frequency intake of meat, dairy and prepared products was higher to the recommended in 97,2%, 94,4% and 27,8% of the analyzed menus, respectively. By contrast, the frequency intake of fish, fruit, legume, and vegetable garnishes were lower to the recommended in 83,3%, 94,4%, 91,7% and 75% of menus, respectively. Nevertheless, recommendations established by our consensus document for school meals are complied for all food groups, except for dairy and fruits. The variety of foods and culinary techniques were appropriate. No significant differences were found in the COMES score according to the management system (p=0,87), although catering system provides higher dietary quality. A new tool to assess quickly and easily the nutritional quality of school meals has been proposed. The assessment of the frequency intake of the most problematic foods for schoolchildren with this scale is much more demanding than the current recommendations. Even so, menus analyzed showed an acceptable quality in terms of variety of foods and culinary techniques, although

A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.

PubMed

Martin-Moe, Sheryl; Lim, Fredric J; Wong, Rita L; Sreedhara, Alavattam; Sundaram, Jagannathan; Sane, Samir U

2011-08-01

Quality by design (QbD) is a science- and risk-based approach to drug product development. Although pharmaceutical companies have historically used many of the same principles during development, this knowledge was not always formally captured or proactively submitted to regulators. In recent years, the US Food and Drug Administration has also recognized the need for more controls in the drug manufacturing processes, especially for biological therapeutics, and it has recently launched an initiative for Pharmaceutical Quality for the 21st Century to modernize pharmaceutical manufacturing and improve product quality. In the biopharmaceutical world, the QbD efforts have been mainly focused on active pharmaceutical ingredient processes with little emphasis on drug product development. We present a systematic approach to biopharmaceutical drug product development using a monoclonal antibody as an example. The approach presented herein leverages scientific understanding of products and processes, risk assessments, and rational experimental design to deliver processes that are consistent with QbD philosophy without excessive incremental effort. Data generated using these approaches will not only strengthen data packages to support specifications and manufacturing ranges but hopefully simplify implementation of postapproval changes. We anticipate that this approach will positively impact cost for companies, regulatory agencies, and patients, alike. Copyright © 2011 Wiley-Liss, Inc.

The Design of an Autonomous Underwater Vehicle for Water Quality Monitoring

NASA Astrophysics Data System (ADS)

Li, Yulong; Liu, Rong; Liu, Shujin

2018-01-01

This paper describes the development of a civilian-used autonomous underwater vehicle (AUV) for water quality monitoring at reservoirs and watercourses that can obtain realtime visual and locational information. The mechanical design was completed with CAD software Solidworks. Four thrusters—two horizontal and two vertical—on board enable the vehicle to surge, heave, yaw, and pitch. A specialized water sample collection compartment is designed to perform water collection at target locations. The vehicle has a central controller—STM32—and a sub-coordinate controller—Arduino MEGA 2560—that coordinates multiple sensors including an inertial sensor, ultrasonic sensors, etc. Global Navigation Satellite System (GNSS) and the inertial sensor enable the vehicle’s localization. Remote operators monitor and control the vehicle via a host computer system. Operators choose either semi-autonomous mode in which they set target locations or manual mode. The experimental results show that the vehicle is able to perform well in either mode.

Design and methods of the Midwest Stream Quality Assessment (MSQA), 2013

USGS Publications Warehouse

Garrett, Jessica D.; Frey, Jeffrey W.; Van Metre, Peter C.; Journey, Celeste A.; Nakagaki, Naomi; Button, Daniel T.; Nowell, Lisa H.

2017-10-18

During 2013, the U.S. Geological Survey (USGS) National Water-Quality Assessment Project (NAWQA), in collaboration with the USGS Columbia Environmental Research Center, the U.S. Environmental Protection Agency (EPA) National Rivers and Streams Assessment (NRSA), and the EPA Office of Pesticide Programs assessed stream quality across the Midwestern United States. This Midwest Stream Quality Assessment (MSQA) simultaneously characterized watershed and stream-reach water-quality stressors along with instream biological conditions, to better understand regional stressor-effects relations. The MSQA design focused on effects from the widespread agriculture in the region and urban development because of their importance as ecological stressors of particular concern to Midwest region resource managers.A combined random stratified selection and a targeted selection based on land-use data were used to identify and select sites representing gradients in agricultural intensity across the region. During a 14-week period from May through August 2013, 100 sites were selected and sampled 12 times for contaminants, nutrients, and sediment. This 14-week water-quality “index” period culminated with an ecological survey of habitat, periphyton, benthic macroinvertebrates, and fish at all sites. Sediment was collected during the ecological survey for analysis of sediment chemistry and toxicity testing. Of the 100 sites, 50 were selected for the MSQA random stratified group from 154 NRSA sites planned for the region, and the other 50 MSQA sites were selected as targeted sites to more evenly cover agricultural and urban stressor gradients in the study area. Of the 50 targeted sites, 12 were in urbanized watersheds and 21 represented “good” biological conditions or “least disturbed” conditions. The remaining 17 targeted sites were selected to improve coverage of the agricultural intensity gradient or because of historical data collection to provide temporal context for the

An Electronic Service Quality Reference Model for Designing E-Commerce Websites Which Maximizes Customer Satisfaction

ERIC Educational Resources Information Center

Shaheen, Amer N.

2011-01-01

This research investigated Electronic Service Quality (E-SQ) features that contribute to customer satisfaction in an online environment. The aim was to develop an approach which improves E-CRM processes and enhances online customer satisfaction. The research design adopted mixed methods involving qualitative and quantitative methods to…

Design of workshops in air quality management for senior managers in Mexico (Taller de la calidad del aire para mandos superiores)

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

Auberle, W.M.; Alvarez, V.M.; Leary, J.

1999-07-01

A collaborative program among agencies and professionals in Mexico and the US is designing, developing and delivering specialized workshops for Mexican officials responsible for air quality management. The initial project is development and pilot delivery (Spring 1999) of a workshop for senior officials of SEMARNAP plus selected state and municipal officials. This paper describes the process for design of professional development programs in air quality management for Mexican officials. Key issues include optimum learning styles and delivery techniques; available time of senior managers for education; need for new materials versus adaptation of existing air quality management information; and utilization ofmore » the Internet and asynchronous methods to supplement the traditional workshop format. The paper describes the results of this analysis and design features and content of the initial workshop.« less

DATA QUALITY OBJECTIVES AND STATISTICAL DESIGN SUPPORT FOR DEVELOPMENT OF A MONITORING PROTOCOL FOR RECREATIONAL WATERS

EPA Science Inventory

The purpose of this report is to describe the outputs of the Data Quality Objectives (DQOs) Process and discussions about developing a statistical design that will be used to implement the research study of recreational beach waters.

Applying quality by design (QbD) concept for fabrication of chitosan coated nanoliposomes.

PubMed

Pandey, Abhijeet P; Karande, Kiran P; Sonawane, Raju O; Deshmukh, Prashant K

2014-03-01

In the present investigation, a quality by design (QbD) strategy was successfully applied to the fabrication of chitosan-coated nanoliposomes (CH-NLPs) encapsulating a hydrophilic drug. The effects of the processing variables on the particle size, encapsulation efficiency (%EE) and coating efficiency (%CE) of CH-NLPs (prepared using a modified ethanol injection method) were investigated. The concentrations of lipid, cholesterol, drug and chitosan; stirring speed, sonication time; organic:aqueous phase ratio; and temperature were identified as the key factors after risk analysis for conducting a screening design study. A separate study was designed to investigate the robustness of the predicted design space. The particle size, %EE and %CE of the optimized CH-NLPs were 111.3 nm, 33.4% and 35.2%, respectively. The observed responses were in accordance with the predicted response, which confirms the suitability and robustness of the design space for CH-NLP formulation. In conclusion, optimization of the selected key variables will help minimize the problems related to size, %EE and %CE that are generally encountered when scaling up processes for NLP formulations. The robustness of the design space will help minimize both intra-batch and inter-batch variations, which are quite common in the pharmaceutical industry.

[Research advances in secondary development of Chinese patent medicines based on quality by design concept].

PubMed

Gong, Xing-Chu; Chen, Teng; Qu, Hai-Bin

2017-03-01

Quality by design (QbD) concept is an advanced pharmaceutical quality control concept. The application of QbD concept in the research and development of pharmaceutical processes of traditional Chinese medicines (TCM) mainly contains five parts, including the definition of critical processes and their evaluation criteria, the determination of critical process parameters and critical material attributes, the establishment of quantitative models, the development of design space, as well as the application and continuous improvement of control strategy. In this work, recent research advances in QbD concept implementation methods in the secondary development of Chinese patent medicines were reviewed, and five promising fields of the implementation of QbD concept were pointed out, including the research and development of TCM new drugs and Chinese medicine granules for formulation, modeling of pharmaceutical processes, development of control strategy based on industrial big data, strengthening the research of process amplification rules, and the development of new pharmaceutical equipment.. Copyright© by the Chinese Pharmaceutical Association.

Eco-innovative design approach: Integrating quality and environmental aspects in prioritizing and solving engineering problems

NASA Astrophysics Data System (ADS)

Chakroun, Mahmoud; Gogu, Grigore; Pacaud, Thomas; Thirion, François

2014-09-01

This study proposes an eco-innovative design process taking into consideration quality and environmental aspects in prioritizing and solving technical engineering problems. This approach provides a synergy between the Life Cycle Assessment (LCA), the nonquality matrix, the Theory of Inventive Problem Solving (TRIZ), morphological analysis and the Analytical Hierarchy Process (AHP). In the sequence of these tools, LCA assesses the environmental impacts generated by the system. Then, for a better consideration of environmental aspects, a new tool is developed, the non-quality matrix, which defines the problem to be solved first from an environmental point of view. The TRIZ method allows the generation of new concepts and contradiction resolution. Then, the morphological analysis offers the possibility of extending the search space of solutions in a design problem in a systematic way. Finally, the AHP identifies the promising solution(s) by providing a clear logic for the choice made. Their usefulness has been demonstrated through their application to a case study involving a centrifugal spreader with spinning discs.

Optimization of a superconducting linear levitation system using a soft ferromagnet

NASA Astrophysics Data System (ADS)

Agramunt-Puig, Sebastia; Del-Valle, Nuria; Navau, Carles; Sanchez, Alvaro

2013-04-01

The use of guideways that combine permanent magnets and soft ferromagnetic materials is a common practice in magnetic levitation transport systems (maglevs) with bulk high-temperature superconductors. Theoretical tools to simulate in a realistic way both the behavior of all elements (permanent magnets, soft ferromagnet and superconductor) and their mutual effects are helpful to optimize the designs of real systems. Here we present a systematic study of the levitation of a maglev with translational symmetry consisting of a superconducting bar and a guideway with two identic permanent magnets and a soft ferromagnetic material between them. The system is simulated with a numerical model based on the energy minimization method that allows to analyze the mutual interaction of the superconductor, assumed to be in the critical state, and a soft ferromagnet with infinite susceptibility. Results indicate that introducing a soft ferromagnet within the permanent magnets not only increases the levitation force but also improves the stability. Besides, an estimation of the relative sizes and shapes of the soft ferromagnet, permanent magnets and the superconductor in order to obtain large levitation force with full stability is provided.

The Effect of Interior Design Improvements on the Quality of Learning for Graduate Level Military Officer Students

DTIC Science & Technology

1991-05-13

for the model classroom. Nevertheless, findings about the impact of interior design improvements 14 on student perceptions about the physical...from the impact of the model classroom interior design improvements on student perceptions about their physical learning environment. Delimitations of...their perceptions about places through personal experience. The intensity and quality of these personal experiences have a greater impact on people’s

Sliding-gate valve

DOEpatents

Usnick, George B.; Ward, Gene T.; Blair, Henry O.; Roberts, James W.; Warner, Terry N.

1979-01-01

This invention is a novel valve of the slidable-gate type. The valve is designed especially for long-term use with highly abrasive slurries. The sealing surfaces of the gate are shielded by the valve seats when the valve is fully open or closed, and the gate-to-seat clearance is swept with an inflowing purge gas while the gate is in transit. A preferred form of the valve includes an annular valve body containing an annular seat assembly defining a flow channel. The seat assembly comprises a first seat ring which is slidably and sealably mounted in the body, and a second seat ring which is tightly fitted in the body. These rings cooperatively define an annular gap which, together with passages in the valve body, forms a guideway extending normal to the channel. A plate-type gate is mounted for reciprocation in the guideway between positions where a portion of the plate closes the channel and where a circular aperture in the gate is in register with the channel. The valve casing includes opposed chambers which extend outwardly from the body along the axis of the guideway to accommodate the end portions of the gate. The chambers are sealed from atmosphere; when the gate is in transit, purge gas is admitted to the chambers and flows inwardly through the gate-to-seat-ring, clearance, minimizing buildup of process solids therein. A shaft reciprocated by an external actuator extends into one of the sealed chambers through a shaft seal and is coupled to an end of the gate. Means are provided for adjusting the clearance between the first seat ring and the gate while the valve is in service.

A Validation of Object-Oriented Design Metrics as Quality Indicators

NASA Technical Reports Server (NTRS)

Basili, Victor R.; Briand, Lionel C.; Melo, Walcelio

1997-01-01

This paper presents the results of a study in which we empirically investigated the suits of object-oriented (00) design metrics introduced in another work. More specifically, our goal is to assess these metrics as predictors of fault-prone classes and, therefore, determine whether they can be used as early quality indicators. This study is complementary to the work described where the same suite of metrics had been used to assess frequencies of maintenance changes to classes. To perform our validation accurately, we collected data on the development of eight medium-sized information management systems based on identical requirements. All eight projects were developed using a sequential life cycle model, a well-known 00 analysis/design method and the C++ programming language. Based on empirical and quantitative analysis, the advantages and drawbacks of these 00 metrics are discussed. Several of Chidamber and Kamerer's 00 metrics appear to be useful to predict class fault-proneness during the early phases of the life-cycle. Also, on our data set, they are better predictors than 'traditional' code metrics, which can only be collected at a later phase of the software development processes.

Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit.

PubMed

Selen, Arzu; Cruañes, Maria T; Müllertz, Anette; Dickinson, Paul A; Cook, Jack A; Polli, James E; Kesisoglou, Filippos; Crison, John; Johnson, Kevin C; Muirhead, Gordon T; Schofield, Timothy; Tsong, Yi

2010-09-01

A biopharmaceutics and Quality by Design (QbD) conference was held on June 10-12, 2009 in Rockville, Maryland, USA to provide a forum and identify approaches for enhancing product quality for patient benefit. Presentations concerned the current biopharmaceutical toolbox (i.e., in vitro, in silico, pre-clinical, in vivo, and statistical approaches), as well as case studies, and reflections on new paradigms. Plenary and breakout session discussions evaluated the current state and envisioned a future state that more effectively integrates QbD and biopharmaceutics. Breakout groups discussed the following four topics: Integrating Biopharmaceutical Assessment into the QbD Paradigm, Predictive Statistical Tools, Predictive Mechanistic Tools, and Predictive Analytical Tools. Nine priority areas, further described in this report, were identified for advancing integration of biopharmaceutics and support a more fundamentally based, integrated approach to setting product dissolution/release acceptance criteria. Collaboration among a broad range of disciplines and fostering a knowledge sharing environment that places the patient's needs as the focus of drug development, consistent with science- and risk-based spirit of QbD, were identified as key components of the path forward.

Design, implementation, and initial results from a water-quality monitoring network for Atlanta, Georgia, USA

USGS Publications Warehouse

Horowitz, A.J.; Elrick, K.A.; Smith, J.J.

2005-01-01

In cooperation with the City of Atlanta, Georgia, the US Geological Survey has designed and implemented a water-quantity and quality monitoring network that measures a variety of biological and chemical constituents in water and suspended sediment. The network consists of 20 long-term monitoring sites and is intended to assess water-quality trends in response to planned infrastructural improvements. Initial results from the network indicate that nonpoint-source contributions may be more significant than point-source contributions for selected sediment associated trace elements and nutrients. There also are indications of short-term discontinuous point-source contributions of these same constituents during baseflow.

Assessment of Quality Assurance Measures for Radioactive Material Transport Packages not Requiring Competent Authority Design Approval - 13282

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

Komann, Steffen; Groeke, Carsten; Droste, Bernhard

The majority of transports of radioactive materials are carried out in packages which don't need a package design approval by a competent authority. Low-active radioactive materials are transported in such packages e.g. in the medical and pharmaceutical industry and in the nuclear industry as well. Decommissioning of NPP's leads to a strong demand for packages to transport low and middle active radioactive waste. According to IAEA regulations the 'non-competent authority approved package types' are the Excepted Packages and the Industrial Packages of Type IP-1, IP-2 and IP-3 and packages of Type A. For these types of packages an assessment bymore » the competent authority is required for the quality assurance measures for the design, manufacture, testing, documentation, use, maintenance and inspection (IAEA SSR 6, Chap. 306). In general a compliance audit of the manufacturer of the packaging is required during this assessment procedure. Their regulatory level in the IAEA regulations is not comparable with the 'regulatory density' for packages requiring competent authority package design approval. Practices in different countries lead to different approaches within the assessment of the quality assurance measures in the management system as well as in the quality assurance program of a special package design. To use the package or packaging in a safe manner and in compliance with the regulations a management system for each phase of the life of the package or packaging is necessary. The relevant IAEA-SSR6 chap. 801 requires documentary verification by the consignor concerning package compliance with the requirements. (authors)« less

Quality, Organization Design, and Standards.

ERIC Educational Resources Information Center

Gardner, James F.

1992-01-01

This paper discusses regulations and voluntary standards within the context of organizational mission and management leadership for quality in human services. Regulation is seen as a measure of organizational formalism; formalism is seen as an attribute of the machine organization; and both are contrasted to organic control organization models and…

Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets.

PubMed

Claycamp, H Gregg; Kona, Ravikanth; Fahmy, Raafat; Hoag, Stephen W

2016-04-01

Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative assessments of risk with respect to the design space, i.e., calculating the probability of failure for a given severity, are needed to fully characterize design space boundaries. Quantitative risk assessment methods in design and operational spaces are a significant aid to evaluating proposed design space boundaries. The goal of this paper is to demonstrate a relatively simple strategy for design space definition using a simplified Bayesian Monte Carlo simulation. This paper builds on a previous paper that used failure mode and effects analysis (FMEA) qualitative risk assessment and Plackett-Burman design of experiments to identity the critical quality attributes. The results show that the sequential use of qualitative and quantitative risk assessments can focus the design of experiments on a reduced set of critical material and process parameters that determine a robust design space under conditions of limited laboratory experimentation. This approach provides a strategy by which the degree of risk associated with each known parameter can be calculated and allocates resources in a manner that manages risk to an acceptable level.

Design of Cycle 3 of the National Water-Quality Assessment Program, 2013-23: Part 2: Science plan for improved water-quality information and management

USGS Publications Warehouse

Rowe, Gary L.; Belitz, Kenneth; Demas, Charlie R.; Essaid, Hedeff I.; Gilliom, Robert J.; Hamilton, Pixie A.; Hoos, Anne B.; Lee, Casey J.; Munn, Mark D.; Wolock, David W.

2013-01-01

This report presents a science strategy for the third decade of the National Water-Quality Assessment (NAWQA) Program, which since 1991, has been responsible for providing nationally consistent information on the quality of the Nation's streams and groundwater; how water quality is changing over time; and the major natural and human factors that affect current water quality conditions and trends. The strategy is based on an extensive evaluation of the accomplishments of NAWQA over its first two decades, the current status of water-quality monitoring activities by USGS and its partners, and an updated analysis of stakeholder priorities. The plan is designed to address priority issues and national needs identified by NAWQA stakeholders and the National Research Council (2012) irrespective of budget constraints. This plan describes four major goals for the third decade (Cycle 3), the approaches for monitoring, modeling, and scientific studies, key partnerships required to achieve these goals, and products and outcomes that will result from planned assessment activities. The science plan for 2013–2023 is a comprehensive approach to meet stakeholder priorities for: (1) rebuilding NAWQA monitoring networks for streams, rivers, and groundwater, and (2) upgrading models used to extrapolate and forecast changes in water-quality and stream ecosystem condition in response to changing climate and land use. The Cycle 3 plan continues approaches that have been central to the Program’s long-term success, but adjusts monitoring intensities and study designs to address critical information needs and identified data gaps. Restoration of diminished monitoring networks and new directions in modeling and interpretative studies address growing and evolving public and stakeholder needs for water-quality information and improved management, particularly in the face of increasing challenges related to population growth, increasing demands for water, and changing land use and climate

40 CFR 130.9 - Designation and de-designation.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Section 130.9 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER... continue water quality planning activities within the designated boundaries. (c) Impact of de-designation... responsibility for continued water quality planning and oversight of implementation within the area. (d...

Data Model and Relational Database Design for Highway Runoff Water-Quality Metadata

USGS Publications Warehouse

Granato, Gregory E.; Tessler, Steven

2001-01-01

A National highway and urban runoff waterquality metadatabase was developed by the U.S. Geological Survey in cooperation with the Federal Highway Administration as part of the National Highway Runoff Water-Quality Data and Methodology Synthesis (NDAMS). The database was designed to catalog available literature and to document results of the synthesis in a format that would facilitate current and future research on highway and urban runoff. This report documents the design and implementation of the NDAMS relational database, which was designed to provide a catalog of available information and the results of an assessment of the available data. All the citations and the metadata collected during the review process are presented in a stratified metadatabase that contains citations for relevant publications, abstracts (or previa), and reportreview metadata for a sample of selected reports that document results of runoff quality investigations. The database is referred to as a metadatabase because it contains information about available data sets rather than a record of the original data. The database contains the metadata needed to evaluate and characterize how valid, current, complete, comparable, and technically defensible published and available information may be when evaluated for application to the different dataquality objectives as defined by decision makers. This database is a relational database, in that all information is ultimately linked to a given citation in the catalog of available reports. The main database file contains 86 tables consisting of 29 data tables, 11 association tables, and 46 domain tables. The data tables all link to a particular citation, and each data table is focused on one aspect of the information collected in the literature search and the evaluation of available information. This database is implemented in the Microsoft (MS) Access database software because it is widely used within and outside of government and is familiar to many

Quality Certification, Institutions and Innovation in Local Agro-Food Systems: Protected Designations of Origin of Olive Oil in Spain

ERIC Educational Resources Information Center

Canada, Javier Sanz; Vazquez, Alfredo Macias

2005-01-01

This article examines the interrelations between establishment of territorial quality certification systems (Protected Designations of Origin or PDOs), diffusion of innovations through local agro-food chains, and the role of the institutions overseeing geographical designations. Empirical analysis is applied to olive oil PDOs in Spain and entails…

Design of monoalcohol - Copolymer system for high quality silver nanowires.

PubMed

Sugiyama, Shintaro; Yokoyama, Shun; Cuya Huaman, Jhon L; Ida, Shohei; Matsumoto, Takatoshi; Kodama, Daisuke; Sato, Kimitaka; Miyamura, Hiroshi; Hirokawa, Yoshitsugu; Balachandran, Jeyadevan

2018-05-14

Research to improve the dimensional properties of silver nanowires (Ag NWs) for transparent conductive film (TCF) applications are being carried out intensively. However, the protocol for the designed synthesis of high-quality Ag NWs is yet to be developed due to the inadequacy of knowledge on the role of parameters. Here, we attempt to elucidate the role played by the parameters and propose a monoalcohol-copolymer based system for the designed synthesis of Ag NWs superior in quality to the one synthesized using conventional ethylene glycol (EG)-polyvinylpyrrolidone (PVP) system. The key findings of the study are as follows: (1) the solubility of Ag source and the partially formed AgCl particles in monoalcohols was found to play an important role not only in the reduction to metallic Ag but also on the uniaxial growth, (2) the adsorption of capping agents on Ag NWs was carried through O and N atoms in the base molecule and their binding energies indicated that the strength is the key parameter to obtain Ag NWs with high aspect ratio, (3) the properties of nanowire could be enhanced through copolymerization of VP and base molecules that have O- and N-based ligands, and (4) the influence of copolymerization on the physical and chemical properties of the surface active agent has been theoretically and experimentally verified. Consequently, we succeeded in the development of a new technique to synthesize high yield of Ag NWs with improved aspect ratio than EG-PVP system by using benzyl alcohol as reducing solvent and N-vinylpyrrolidone/N,N-diethylaminoethyl metacrylate copolymer as a capping agent. The optical transmittance and electrical resistivity of TCFs prepared using the Ag NWs with an average diameter of 43 nm, and an average length of 13 μm were 98.6% and R: 49.1 Ω/□, respectively. Copyright © 2018 Elsevier Inc. All rights reserved.

EPA Finalizes Initial Area Designations for the 2012 National Air Quality Standard for Fine Particles - Dec 2014

EPA Pesticide Factsheets

After considering state and tribal recommendations, reviewing the most recent certified fine particle air quality data, and emissions that contribute fine particle pollution, EPA has completed initial designations for the 2012 annual fine particle standard

The effects of aircraft design on STOL ride quality

NASA Technical Reports Server (NTRS)

Jones, C. R.; Jacobson, I. D.

1975-01-01

Effects of aircraft dynamic characteristics on passenger ride quality are investigated to determine ride-quality isocontours similar to aircraft handling-qualities contours. Measurements are made on a moving-base simulator while varying the aircraft short-period and Dutch Roll frequencies and dampings. Both pilot ratings and subjective ride-quality ratings are obtained during flight. Ride and handling qualities were found to be complementary for the Dutch Roll mode, but not for the short-period mode. Regions of optimal ride and handling qualities are defined for the short-period mode, and the effects of turbulence levels studied.

75 FR 78952 - Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-17

... Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; Commonwealth of Virginia... Declaration and Withdrawal of EPA Plan Approval AGENCY: Environmental Protection Agency (EPA). ACTION... request for EPA withdrawal of its section 111(d)/129 plan (the plan) approval for HMIWI units. Submittal...

Design of Interline Unified Power Quality Conditioner for Power Quality Disturbances using Simulink

NASA Astrophysics Data System (ADS)

Kumaraswamy, G.; Reddy, Y. Rajasekhar; Harikrishna, Ch.

2012-10-01

Proliferation of electronic equipment in commercial and industrial processes has resulted in increasingly sensitive electrical loads to be fed from power distribution system which introduce contamination to voltage and current waveforms at the point of common coupling of industrial loads. The unified power quality conditioner (UPQC) is connected between two different feeders (lines), hence this method of connection of the UPQC is called as Interline UPQC (IUPQC).This paper proposes a new connection for a UPQC to improve the power quality of two feeders in a distribution system. Interline Unified Power Quality Conditioner (IUPQC), specifically aims at the integration of series VSC and Shunt VSC to provide high quality power supply by means of voltage sag/swell compensation, harmonic elimination and power factor correction in a power distribution network, so that improved power quality can be made available at the point of common coupling. The structure, control and capability of the IUPQC are discussed in this paper. The efficiency of the proposed configuration has been verified through simulation using MATLAB/ SIMULINK.

75 FR 57186 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2010-0203-201035; FRL-9202-9] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes... determination that the Birmingham, Alabama, nonattainment area has attained the 24-hour fine particulate matter...

76 FR 31239 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... 40 CFR 52.1004(c), suspends the requirements for this area to submit an attainment demonstration... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2011-0084-201135; FRL- 9312-5] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning...

78 FR 72040 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-02

... ambient ozone monitoring stations in the Atlanta Area from 2008-2011, as recorded in Air Quality System... redesignation request to change the legal designation of the Atlanta Area from nonattainment to attainment for... to change. Comment 2: The Commenter contends that Georgia's redesignation submittal is flawed because...

Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities.

PubMed

Jovanović, Marko; Rakić, Tijana; Tumpa, Anja; Jančić Stojanović, Biljana

2015-06-10

This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm × 4.6 mm, 5 μm particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 °C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm. Copyright © 2015 Elsevier B.V. All rights reserved.

Designing for movement quality in exergames: lessons learned from observing senior citizens playing stepping games.

PubMed

Skjæret, Nina; Nawaz, Ather; Ystmark, Kristine; Dahl, Yngve; Helbostad, Jorunn L; Svanæs, Dag; Vereijken, Beatrix

2015-01-01

Exergames are increasingly used as an exercise intervention to reduce fall risk in elderly. However, few exergames have been designed specifically for elderly, and we lack knowledge about the characteristics of the movements elicited by exergames and thereby about their potential to train functions important for fall risk reduction. This study investigates game elements and older players' movement characteristics during stepping exergames in order to inform exergame design for movement quality in the context of fall preventive exercise. Fourteen senior citizens (mean age 73 years ± 5.7, range 65 - 85) played 3 stepping exergames in a laboratory. Each of the exergames was described with respect to 7 game elements (physical space, sensing hardware technology, game graphics and sound, model of user, avatar/mapping of movements, game mechanism and game narrative). Five movement characteristics (weight shift; variation in step length, speed, and movement direction; visual independency) were scored on a 5-point Likert scale based on video observations of each player and each game. Disagreement between raters was resolved by agreement. Differences in scores for the 3 exergames were analyzed with a multivariate one-way ANOVA. The Mole received the highest sum score and the best score on each of the 5 movement characteristics (all p values <0.0005). LightRace scored the lowest of the 3 exergames on weight shift and variation in movement direction (both p values <0.0005), while DanceDanceRevolution scored lowest on step length variation and visual independency (p < 0.03 and p < 0.0005, respectively), and lower than The Mole on speed variation (p < 0.05). The physical space players used when exergaming and the on-screen representation of the player, affected movement quality positively as indexed by multiple weight shifts and variation in stepping size, direction, and speed. Furthermore, players' movements improved when playing speed-affected game progression and when the

Engineering of budesonide-loaded lipid-polymer hybrid nanoparticles using a quality-by-design approach.

PubMed

Leng, Donglei; Thanki, Kaushik; Fattal, Elias; Foged, Camilla; Yang, Mingshi

2017-08-25

Chronic obstructive pulmonary disease (COPD) is a complex disease, characterized by persistent airflow limitation and chronic inflammation. The purpose of this study was to design lipid-polymer hybrid nanoparticles (LPNs) loaded with the corticosteroid, budesonide, which could potentially be combined with small interfering RNA (siRNA) for COPD management. Here, we prepared LPNs based on the biodegradable polymer poly(dl-lactic-co-glycolic acid) (PLGA) and the cationic lipid dioleyltrimethylammonium propane (DOTAP) using a double emulsion solvent evaporation method. A quality-by-design (QbD) approach was adopted to define the optimal formulation parameters. The quality target product profile (QTPP) of the LPNs was identified based on risk assessment. Two critical formulation parameters (CFPs) were identified, including the theoretical budesonide loading and the theoretical DOTAP loading. The CFPs were linked to critical quality attributes (CQAs), which included the intensity-based hydrodynamic particle diameter (z-average), the polydispersity index (PDI), the zeta-potential, the budesonide encapsulation efficiency, the actual budesonide loading and the DOTAP encapsulation efficiency. A response surface methodology (RSM) was applied for the experimental design to evaluate the influence of the CFPs on the CQAs, and to identify the optimal operation space (OOS). All nanoparticle dispersions displayed monodisperse size distributions (PDI<0.2) with z-averages of approximately 150nm, suggesting that the size is not dependent on the investigated CFPs. In contrast, the zeta-potential was highly dependent on the theoretical DOTAP loading. Upon increased DOTAP loading, the zeta-potential reached a maximal point, after which it remained stable at the maximum value. This suggests that the LPN surface is covered by DOTAP, and that the DOTAP loading is saturable. The actual budesonide loading of the LPNs was mainly dependent on the initial amount of budesonide, and a clear

An integrated probe design for measuring food quality in a microwave environment

NASA Astrophysics Data System (ADS)

O'Farrell, M.; Sheridan, C.; Lewis, E.; Zhao, W. Z.; Sun, T.; Grattan, K. T. V.

2007-07-01

The work presented describes the development of a novel integrated optical sensor system for the simultaneous and online measurement of the colour and temperature of food as it cooks in a large-scale microwave and hybrid oven systems. The integrated probe contains two different sensor concepts, one to monitor temperature and based on Fibre Bragg Grating (FBG) technology and a second for meat quality, based on reflection spectroscopy in the visible wavelength range. The combination of the two sensors into a single probe requires a careful configuration of the sensor approaches in the creation of an integrated probe design.

76 FR 36873 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-23

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2010-1036-201138; FRL-9322-4] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes... Atlanta, Georgia 1997 8-hour ozone nonattainment area has attained the 1997 8- hour ozone national ambient...

76 FR 31858 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... accordance with 40 CFR 52.1004(c), suspends the requirements for this area to submit an attainment... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2011-0055-201136; FRL-9313-8] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes...

Engineering of an inhalable DDA/TDB liposomal adjuvant: a quality-by-design approach towards optimization of the spray drying process.

PubMed

Ingvarsson, Pall Thor; Yang, Mingshi; Mulvad, Helle; Nielsen, Hanne Mørck; Rantanen, Jukka; Foged, Camilla

2013-11-01

The purpose of this study was to identify and optimize spray drying parameters of importance for the design of an inhalable powder formulation of a cationic liposomal adjuvant composed of dimethyldioctadecylammonium (DDA) bromide and trehalose-6,6'-dibehenate (TDB). A quality by design (QbD) approach was applied to identify and link critical process parameters (CPPs) of the spray drying process to critical quality attributes (CQAs) using risk assessment and design of experiments (DoE), followed by identification of an optimal operating space (OOS). A central composite face-centered design was carried out followed by multiple linear regression analysis. Four CQAs were identified; the mass median aerodynamic diameter (MMAD), the liposome stability (size) during processing, the moisture content and the yield. Five CPPs (drying airflow, feed flow rate, feedstock concentration, atomizing airflow and outlet temperature) were identified and tested in a systematic way. The MMAD and the yield were successfully modeled. For the liposome size stability, the ratio between the size after and before spray drying was modeled successfully. The model for the residual moisture content was poor, although, the moisture content was below 3% in the entire design space. Finally, the OOS was drafted from the constructed models for the spray drying of trehalose stabilized DDA/TDB liposomes. The QbD approach for the spray drying process should include a careful consideration of the quality target product profile. This approach implementing risk assessment and DoE was successfully applied to optimize the spray drying of an inhalable DDA/TDB liposomal adjuvant designed for pulmonary vaccination.

Application of Quality by Design (QbD) Principles to Extractables/Leachables Assessment. Establishing a Design Space for Terminally Sterilized Aqueous Drug Products Stored in a Plastic Packaging System.

PubMed

Jenke, Dennis

2010-01-01

The concept of quality by design (QbD) reflects the current global regulatory thinking related to pharmaceutical products. A cornerstone of the QbD paradigm is the concept of a design space, where the design space is a multidimensional combination of input variables and process parameters that have been demonstrated to provide the assurance of product quality. If a design space can be established for a pharmaceutical process or product, then operation within the design space confirms that the product or process output possesses the required quality attributes. This concept of design space can be applied to the safety (leachables) assessment of drug products manufactured and stored in packaging systems. Critical variables in such a design space would include those variables that affect the interaction of the drug product and its packaging, including (a) composition of the drug product, (b) composition of the packaging system, (c) configuration of the packaging system, and (d) the conditions of contact. This paper proposes and justifies such a leachables design space for aqueous drug products packaged in a specific plastic packaging system. Such a design space has the following boundaries:Aqueous drug products with a pH in the range of 2 to 8 and that contain no polarity-impacting agents such as organic solubilizers and stabilizers (addressing variable a). Packaging systems manufactured from materials that meet the system's existing material specifications (addressing variable b). Nominal fill volumes from 50 to 1000 mL (addressing variable c). Products subjected to terminal sterilization and then stored at room temperature for a period of up to 24 months (addressing variable d). The ramification of such a design space is that any drug product that falls within these boundaries is deemed to be compatible with the packaging system, from the perspective of safety, without the requirement of supporting drug product testing. When drug products are packaged in plastic

Teaching quality improvement.

PubMed

Murray, Marry Ellen; Douglas, Stephen; Girdley, Diana; Jarzemsky, Paula

2010-08-01

Practicing nurses are required to engage in quality improvement work as a part of their clinical practice, but few undergraduate nursing education programs offer course work and applied experience in this area. This article presents a description of class content and teaching strategies, assignments, and evaluation strategies designed to achieve the Quality and Safety Education in Nursing competencies related to quality improvement and interdisciplinary teams. Students demonstrate their application of the quality improvement process by designing and implementing a small-scale quality improvement project that they report in storyboard format on a virtual conference Web site.

Application of quality-by-design approach to optimize diallyl disulfide-loaded solid lipid nanoparticles.

PubMed

Talluri, Siddhartha Venkata; Kuppusamy, Gowthamarajan; Karri, Veera Venkata Satyanarayana Reddy; Yamjala, Karthik; Wadhwani, Ashish; Madhunapantula, SubbaRao V; Pindiprolu, Saikiran S S

2017-05-01

The current work was carried out by the principles of quality-by-design approach to develop an optimized solid lipid nanoparticles (SLNs) formulation of diallyl disulfide (DADS) through systematic statistical study. And its antitumor activity of DADS was also evaluated on breast cancer cell lines. To understand the effect of formulation variables (critical parameters) on the responses (critical quality attributes) of SLN, a 3-factor, 3-level Box-Behnken design, was explored to predict the responses such as particle size (Y1) and % entrapment efficiency (EE) (Y2) when concentration of surfactant (X1), amount of lipid (X2), and volume of solvent (X3) were selected as independent variables. Particle size analysis revealed that all the batches were within the nanometer range. DADS was released from the SLN much more rapidly at pH 4.5 than at pH 7.4, which is a desirable characteristic for tumor-targeted drug delivery. The cytotoxicity, reactive oxygen species (ROS), determination revealed that the antitumor activity of DADS is enhanced with SLN compared to DADS-free drug, and apoptosis is the mechanism underlying the cytotoxicity. The present study indicated the remarkable potential of DADS-SLN in enhancing the anticancer effect of DADS in breast cancer cells in vitro.

Quality-by-Design approach to monitor the operation of a batch bioreactor in an industrial avian vaccine manufacturing process.

PubMed

Largoni, Martina; Facco, Pierantonio; Bernini, Donatella; Bezzo, Fabrizio; Barolo, Massimiliano

2015-10-10

Monitoring batch bioreactors is a complex task, due to the fact that several sources of variability can affect a running batch and impact on the final product quality. Additionally, the product quality itself may not be measurable on line, but requires sampling and lab analysis taking several days to be completed. In this study we show that, by using appropriate process analytical technology tools, the operation of an industrial batch bioreactor used in avian vaccine manufacturing can be effectively monitored as the batch progresses. Multivariate statistical models are built from historical databases of batches already completed, and they are used to enable the real time identification of the variability sources, to reliably predict the final product quality, and to improve process understanding, paving the way to a reduction of final product rejections, as well as to a reduction of the product cycle time. It is also shown that the product quality "builds up" mainly during the first half of a batch, suggesting on the one side that reducing the variability during this period is crucial, and on the other side that the batch length can possibly be shortened. Overall, the study demonstrates that, by using a Quality-by-Design approach centered on the appropriate use of mathematical modeling, quality can indeed be built "by design" into the final product, whereas the role of end-point product testing can progressively reduce its importance in product manufacturing. Copyright © 2015 Elsevier B.V. All rights reserved.

Engineering of a novel adjuvant based on lipid-polymer hybrid nanoparticles: A quality-by-design approach.

PubMed

Rose, Fabrice; Wern, Jeanette Erbo; Ingvarsson, Pall Thor; van de Weert, Marco; Andersen, Peter; Follmann, Frank; Foged, Camilla

2015-07-28

The purpose of this study was to design a novel and versatile adjuvant intended for mucosal vaccination based on biodegradable poly(DL-lactic-co-glycolic acid) (PLGA) nanoparticles (NPs) modified with the cationic surfactant dimethyldioctadecylammonium (DDA) bromide and the immunopotentiator trehalose-6,6'-dibehenate (TDB) (CAF01) to tailor humoral and cellular immunity characterized by antibodies and Th1/Th17 responses. Such responses are important for the protection against diseases caused by intracellular bacteria such as Chlamydia trachomatis and Mycobacterium tuberculosis. The hybrid NPs were engineered using an oil-in-water single emulsion method and a quality-by-design approach was adopted to define the optimal operating space (OOS). Four critical process parameters (CPPs) were identified, including the acetone concentration in the water phase, the stabilizer [polyvinylalcohol (PVA)] concentration, the lipid-to-total solid ratio, and the total concentration. The CPPs were linked to critical quality attributes consisting of the particle size, polydispersity index (PDI), zeta-potential, thermotropic phase behavior, yield and stability. A central composite face-centered design was performed followed by multiple linear regression analysis. The size, PDI, enthalpy of the phase transition and yield were successfully modeled, whereas the models for the zeta-potential and the stability were poor. Cryo-transmission electron microscopy revealed that the main structural effect on the nanoparticle architecture is caused by the use of PVA, and two different morphologies were identified: i) A PLGA core coated with one or several concentric lipid bilayers, and ii) a PLGA nanoshell encapsulating lipid membrane structures. The optimal formulation, identified from the OOS, was evaluated in vivo. The hybrid NPs induced antibody and Th1/Th17 immune responses that were similar in quality and magnitude to the response induced by DDA/TDB liposomes, showing that the adjuvant

76 FR 18650 - Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-05

... determination, in accordance with 40 CFR 52.1004(c), suspends the requirements for this area to submit an... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2010-0798-201048; FRL-9288-8] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes...

The first man-loading high temperature superconducting Maglev test vehicle in the world

NASA Astrophysics Data System (ADS)

Wang, Jiasu; Wang, Suyu; Zeng, Youwen; Huang, Haiyu; Luo, Fang; Xu, Zhipei; Tang, Qixue; Lin, Guobin; Zhang, Cuifang; Ren, Zhongyou; Zhao, Guomin; Zhu, Degui; Wang, Shaohua; Jiang, He; Zhu, Min; Deng, Changyan; Hu, Pengfei; Li, Chaoyong; Liu, Fang; Lian, Jisan; Wang, Xiaorong; Wang, Lianghui; Shen, Xuming; Dong, Xiaogang

2002-10-01

The first man-loading high temperature superconducting Maglev test vehicle in the world is reported. This vehicle was first tested successfully on December 31, 2000 in the Applied Superconductivity Laboratory, Southwest Jiaotong University, China. Heretofore over 17,000 passengers took the vehicle, and it operates very well from beginning to now. The function of suspension is separated from one of propulsion. The high temperature superconducting Maglev provides inherent stable forces both in the levitation and in the guidance direction. The vehicle is 3.5 m long, 1.2 m wide, and 0.8 m high. When five people stand on vehicle and the total weight is 530 kg, the net levitation gap is more than 20 mm. The whole vehicle system includes three parts, vehicle body, guideway and controlling system. The high temperature superconducting Maglev equipment on board is the most important for the system. The onboard superconductors are melt-textured YBaCuO bulks. The superconductors are fixed on the bottom of liquid nitrogen vessels and cooled by liquid nitrogen. The guideway consists of two parallel permanent magnetic tracks, whose surface concentrating magnetic field is up to 1.2 T. The guideway is 15.5 m long.

Quality of Reporting and Study Design of CKD Cohort Studies Assessing Mortality in the Elderly Before and After STROBE: A Systematic Review

PubMed Central

Brück, Katharina; Methven, Shona; Evans, Rebecca; Stel, Vianda S.; Jager, Kitty J.; Hooft, Lotty; Ben-Shlomo, Yoav; Caskey, Fergus

2016-01-01

Background The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement was published in October 2007 to improve quality of reporting of observational studies. The aim of this review was to assess the impact of the STROBE statement on observational study reporting and study design quality in the nephrology literature. Study Design Systematic literature review. Setting & Population European and North American, Pre-dialysis Chronic Kidney Disease (CKD) cohort studies. Selection Criteria for Studies Studies assessing the association between CKD and mortality in the elderly (>65 years) published from 1st January 2002 to 31st December 2013 were included, following systematic searching of MEDLINE & EMBASE. Predictor Time period before and after the publication of the STROBE statement. Outcome Quality of study reporting using the STROBE statement and quality of study design using the Newcastle Ottawa Scale (NOS), Scottish Intercollegiate Guidelines Network (SIGN) and Critical Appraisal Skills Programme (CASP) tools. Results 37 papers (11 Pre & 26 Post STROBE) were identified from 3621 potential articles. Only four of the 22 STROBE items and their sub-criteria (objectives reporting, choice of quantitative groups and description of and carrying out sensitivity analysis) showed improvements, with the majority of items showing little change between the period before and after publication of the STROBE statement. Pre- and post-period analysis revealed a Manuscript STROBE score increase (median score 77.8% (Inter-quartile range [IQR], 64.7–82.0) vs 83% (IQR, 78.4–84.9, p = 0.05). There was no change in quality of study design with identical median scores in the two periods for NOS (Manuscript NOS score 88.9), SIGN (Manuscript SIGN score 83.3) and CASP (Manuscript CASP score 91.7) tools. Limitations Only 37 Studies from Europe and North America were included from one medical specialty. Assessment of study design largely reliant on good

Automated Theorem Proving in High-Quality Software Design

NASA Technical Reports Server (NTRS)

Schumann, Johann; Swanson, Keith (Technical Monitor)

2001-01-01

The amount and complexity of software developed during the last few years has increased tremendously. In particular, programs are being used more and more in embedded systems (from car-brakes to plant-control). Many of these applications are safety-relevant, i.e. a malfunction of hardware or software can cause severe damage or loss. Tremendous risks are typically present in the area of aviation, (nuclear) power plants or (chemical) plant control. Here, even small problems can lead to thousands of casualties and huge financial losses. Large financial risks also exist when computer systems are used in the area of telecommunication (telephone, electronic commerce) or space exploration. Computer applications in this area are not only subject to safety considerations, but also security issues are important. All these systems must be designed and developed to guarantee high quality with respect to safety and security. Even in an industrial setting which is (or at least should be) aware of the high requirements in Software Engineering, many incidents occur. For example, the Warshaw Airbus crash, was caused by an incomplete requirements specification. Uncontrolled reuse of an Ariane 4 software module was the reason for the Ariane 5 disaster. Some recent incidents in the telecommunication area, like illegal "cloning" of smart-cards of D2GSM handies, or the extraction of (secret) passwords from German T-online users show that also in this area serious flaws can happen. Due to the inherent complexity of computer systems, most authors claim that only a rigorous application of formal methods in all stages of the software life cycle can ensure high quality of the software and lead to real safe and secure systems. In this paper, we will have a look, in how far automated theorem proving can contribute to a more widespread application of formal methods and their tools, and what automated theorem provers (ATPs) must provide in order to be useful.

[Designing and implementation of a web-based quality monitoring system for plasma glucose measurement in multicenter population study].

PubMed

Liu, Yong; Wang, Limin; Pang, Richard; Mo, Nanxun; Hu, Yan; Deng, Qian; Hu, Zhaohui

2015-05-01

The aim of this paper is to describe the designing and implementation of a web-based plasma glucose measurement quality monitoring system to assess the analytical quality of plasma glucose measurements in multicenter population study and provide evidence for the future studies. In the chronic non-communicable disease and related factor surveillance in China, a web based quality monitoring system for plasma glucose measurement was established to conduct evaluation on plasma glucose monitoring quality and effectiveness in 302 surveillance centers, including quality control data entry, transmission and feedback. The majority of the surveillance centers met the quality requirements and passed the evaluation of reproducibility and precision of plasma glucose measurement, only a few centers required intensive training and re-assessment. In order to ensure the completeness and reliability of plasma glucose measurement in the surveillance centers, the establishment of web-based plasma glucose measurement quality control system can facilitate the identification of the qualified surveillance centers and evaluation of plasma glucose measurement quality in different regions. Communication and training are important in ensuring plasma glucose measurement quality. It is necessary to further improve this web-based plasma glucose measurement quality monitoring system in the future to reduce the method specific plasma glucose measurement bias.

Shared decision making in designing new healthcare environments-time to begin improving quality.

PubMed

Elf, Marie; Fröst, Peter; Lindahl, Göran; Wijk, Helle

2015-03-21

Successful implementation of new methods and models of healthcare to achieve better patient outcomes and safe, person-centered care is dependent on the physical environment of the healthcare architecture in which the healthcare is provided. Thus, decisions concerning healthcare architecture are critical because it affects people and work processes for many years and requires a long-term financial commitment from society. In this paper, we describe and suggest several strategies (critical factors) to promote shared-decision making when planning and designing new healthcare environments. This paper discusses challenges and hindrances observed in the literature and from the authors extensive experiences in the field of planning and designing healthcare environments. An overview is presented of the challenges and new approaches for a process that involves the mutual exchange of knowledge among various stakeholders. Additionally, design approaches that balance the influence of specific and local requirements with general knowledge and evidence that should be encouraged are discussed. We suggest a shared-decision making and collaborative planning and design process between representatives from healthcare, construction sector and architecture based on evidence and end-users' perspectives. If carefully and systematically applied, this approach will support and develop a framework for creating high quality healthcare environments.

Aircraft ride quality controller design using new robust root clustering theory for linear uncertain systems

NASA Technical Reports Server (NTRS)

Yedavalli, R. K.

1992-01-01

The aspect of controller design for improving the ride quality of aircraft in terms of damping ratio and natural frequency specifications on the short period dynamics is addressed. The controller is designed to be robust with respect to uncertainties in the real parameters of the control design model such as uncertainties in the dimensional stability derivatives, imperfections in actuator/sensor locations and possibly variations in flight conditions, etc. The design is based on a new robust root clustering theory developed by the author by extending the nominal root clustering theory of Gutman and Jury to perturbed matrices. The proposed methodology allows to get an explicit relationship between the parameters of the root clustering region and the uncertainty radius of the parameter space. The current literature available for robust stability becomes a special case of this unified theory. The bounds derived on the parameter perturbation for robust root clustering are then used in selecting the robust controller.

Designing and implementing a trust-wide quality assurance programme.

PubMed

Coope, Sally-Ann

2018-04-02

Derbyshire Community Health Services (DCHS) NHS Foundation Trust provides a wide range of community-based health services. After the Care Quality Commission (CQC) found gaps in the trust's assurance process, its board decided to develop a method of continuous quality improvements that could be used as a basis for the trust's quality assurance system. The trust adapted and built on an acute model so it was suitable for community services. The final assurance system, Quality Always, has four elements: the clinical assessment and accreditation scheme; leadership development; 'champions' within clinical teams to support and promote the scheme; and dashboards to record and monitor progress. A system to recognise and reward achievement was essential for success. Quality Always has resulted in better care quality, an improved CQC rating, a sense of achievement among staff, the development of support networks, learning (especially among support staff) and good practice being shared.

Designing to Promote Access, Quality, and Student Support in an Advanced Certificate Programme for Rural Teachers in South Africa

ERIC Educational Resources Information Center

Fresen, Jill W.; Hendrikz, Johan

2009-01-01

This paper reports on the re-design of the Advanced Certificate in Education (ACE) programme, which is offered by the University of Pretoria through distance education (DE) to teachers in rural South Africa. In 2007, a team re-designed the programme with the goal of promoting access, quality, and student support. The team included an independent…

Trifocal intraocular lenses: a comparison of the visual performance and quality of vision provided by two different lens designs.

PubMed

Gundersen, Kjell G; Potvin, Rick

2017-01-01

To compare two different diffractive trifocal intraocular lens (IOL) designs, evaluating longer-term refractive outcomes, visual acuity (VA) at various distances, low contrast VA and quality of vision. Patients with binocularly implanted trifocal IOLs of two different designs (FineVision [FV] and Panoptix [PX]) were evaluated 6 months to 2 years after surgery. Best distance-corrected and uncorrected VA were tested at distance (4 m), intermediate (80 and 60 cm) and near (40 cm). A binocular defocus curve was collected with the subject's best distance correction in place. The preferred reading distance was determined along with the VA at that distance. Low contrast VA at distance was also measured. Quality of vision was measured with the National Eye Institute Visual Function Questionnaire near subset and the Quality of Vision questionnaire. Thirty subjects in each group were successfully recruited. The binocular defocus curves differed only at vergences of -1.0 D (FV better, P =0.02), -1.5 and -2.00 D (PX better, P <0.01 for both). Best distance-corrected and uncorrected binocular vision were significantly better for the PX lens at 60 cm ( P <0.01) with no significant differences at other distances. The preferred reading distance was between 42 and 43 cm for both lenses, with the VA at the preferred reading distance slightly better with the PX lens ( P =0.04). There were no statistically significant differences by lens for low contrast VA ( P =0.1) or for quality of vision measures ( P >0.3). Both trifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the PX lens provided better intermediate vision at 60 cm. This may be important to users of tablets and other handheld devices. Quality of vision appeared similar between the two lens designs.

A conceptual curriculum framework designed to ensure quality student health visitor training in practice.

PubMed

Hollinshead, Jayne; Stirling, Linda

2014-07-01

This paper describes the challenges faced by a trust in England following the introduction of the Health Visitor Implementation Plan. Two practice education facilitators designed a conceptual curriculum framework to ensure quality student health visitor education in practice. This curriculum complimented the excellent academic course already delivered by the University. A justification is provided for the design of the curriculum framework, including a rationale for the introduction of specific training sessions. Student and practice teacher feedback demonstrate the success of the introduction of this programme to ensure the development of student health visitors fit for practice. The conclusion places emphasis on the importance of continuous evaluation of the training programme to meet the needs of the students and the service.

75 FR 8871 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-26

... quality monitoring data for the 2007-2009 ozone seasons that demonstrate that the 8-hour ozone NAAQS has... technical information and/or data that you used. 5. If you estimate potential costs or burdens, explain how... FR 23857), EPA published a final rule designating and classifying areas under the 8-hour ozone NAAQS...

Experimental design and quality assurance: in situ fluorescence instrumentation

USGS Publications Warehouse

Conmy, Robyn N.; Del Castillo, Carlos E.; Downing, Bryan D.; Chen, Robert F.

2014-01-01

Both instrument design and capabilities of fluorescence spectroscopy have greatly advanced over the last several decades. Advancements include solid-state excitation sources, integration of fiber optic technology, highly sensitive multichannel detectors, rapid-scan monochromators, sensitive spectral correction techniques, and improve data manipulation software (Christian et al., 1981, Lochmuller and Saavedra, 1986; Cabniss and Shuman, 1987; Lakowicz, 2006; Hudson et al., 2007). The cumulative effect of these improvements have pushed the limits and expanded the application of fluorescence techniques to numerous scientific research fields. One of the more powerful advancements is the ability to obtain in situ fluorescence measurements of natural waters (Moore, 1994). The development of submersible fluorescence instruments has been made possible by component miniaturization and power reduction including advances in light sources technologies (light-emitting diodes, xenon lamps, ultraviolet [UV] lasers) and the compatible integration of new optical instruments with various sampling platforms (Twardowski et at., 2005 and references therein). The development of robust field sensors skirt the need for cumbersome and or time-consuming filtration techniques, the potential artifacts associated with sample storage, and coarse sampling designs by increasing spatiotemporal resolution (Chen, 1999; Robinson and Glenn, 1999). The ability to obtain rapid, high-quality, highly sensitive measurements over steep gradients has revolutionized investigations of dissolved organic matter (DOM) optical properties, thereby enabling researchers to address novel biogeochemical questions regarding colored or chromophoric DOM (CDOM). This chapter is dedicated to the origin, design, calibration, and use of in situ field fluorometers. It will serve as a review of considerations to be accounted for during the operation of fluorescence field sensors and call attention to areas of concern when making

Designing a Broadband Pump for High-Quality Micro-Lasers via Modified Net Radiation Method.

PubMed

Nechayev, Sergey; Reusswig, Philip D; Baldo, Marc A; Rotschild, Carmel

2016-12-07

High-quality micro-lasers are key ingredients in non-linear optics, communication, sensing and low-threshold solar-pumped lasers. However, such micro-lasers exhibit negligible absorption of free-space broadband pump light. Recently, this limitation was lifted by cascade energy transfer, in which the absorption and quality factor are modulated with wavelength, enabling non-resonant pumping of high-quality micro-lasers and solar-pumped laser to operate at record low solar concentration. Here, we present a generic theoretical framework for modeling the absorption, emission and energy transfer of incoherent radiation between cascade sensitizer and laser gain media. Our model is based on linear equations of the modified net radiation method and is therefore robust, fast converging and has low complexity. We apply this formalism to compute the optimal parameters of low-threshold solar-pumped lasers. It is revealed that the interplay between the absorption and self-absorption of such lasers defines the optimal pump absorption below the maximal value, which is in contrast to conventional lasers for which full pump absorption is desired. Numerical results are compared to experimental data on a sensitized Nd 3+ :YAG cavity, and quantitative agreement with theoretical models is found. Our work modularizes the gain and sensitizing components and paves the way for the optimal design of broadband-pumped high-quality micro-lasers and efficient solar-pumped lasers.

Designing a Broadband Pump for High-Quality Micro-Lasers via Modified Net Radiation Method

PubMed Central

Nechayev, Sergey; Reusswig, Philip D.; Baldo, Marc A.; Rotschild, Carmel

2016-01-01

High-quality micro-lasers are key ingredients in non-linear optics, communication, sensing and low-threshold solar-pumped lasers. However, such micro-lasers exhibit negligible absorption of free-space broadband pump light. Recently, this limitation was lifted by cascade energy transfer, in which the absorption and quality factor are modulated with wavelength, enabling non-resonant pumping of high-quality micro-lasers and solar-pumped laser to operate at record low solar concentration. Here, we present a generic theoretical framework for modeling the absorption, emission and energy transfer of incoherent radiation between cascade sensitizer and laser gain media. Our model is based on linear equations of the modified net radiation method and is therefore robust, fast converging and has low complexity. We apply this formalism to compute the optimal parameters of low-threshold solar-pumped lasers. It is revealed that the interplay between the absorption and self-absorption of such lasers defines the optimal pump absorption below the maximal value, which is in contrast to conventional lasers for which full pump absorption is desired. Numerical results are compared to experimental data on a sensitized Nd3+:YAG cavity, and quantitative agreement with theoretical models is found. Our work modularizes the gain and sensitizing components and paves the way for the optimal design of broadband-pumped high-quality micro-lasers and efficient solar-pumped lasers. PMID:27924844

Towing Tank Tests on a Ram Wing in a Rectangular Guideway

DOT National Transportation Integrated Search

1973-07-01

The object of the study was to set the theoretical and experimental basis for a preliminary design of a ram wing vehicle. A simplified one-dimensional mathematical model is developed in an attempt to estimate the stability derivatives of this type of...

Improving Quality for Child Care Centers in Greater Philadelphia: An Evaluation of Success by 6®. Program Design Appendix. Publication #2016-07C

ERIC Educational Resources Information Center

Warner-Richter, Mallory; Lowe, Claire; Tout, Kathryn; Epstein, Dale; Li, Weilin

2016-01-01

The Success By 6® (SB6) initiative is designed to support early care and education centers in improving and sustaining quality in Pennsylvania's Keystone STARS Quality Rating and Improvement System (QRIS). The SB6 evaluation report examines implementation and outcomes. The findings have implications for SB6 continous quality improvement process…

The comparison of laser surface designing and pigment printing methods for the product quality

NASA Astrophysics Data System (ADS)

Ozguney, Arif Taner

2007-07-01

Developing new designs by using the computer and transferring the designs that are obtained to textile surfaces will not only increase and facilitate the production in a more practical manner, but also help you create identical designs. This means serial manufacturing of the products at standard quality and increasing their added values. Moreover, creating textile designs using the laser will also contribute to the value of the product as far as the consumer is concerned because it will not cause any wearing off and deformation in the texture of the fabric unlike the other methods. In the system that has been designed, the laser beam at selected wavelength and intensity was directed onto a selected textile surface and a computer-controlled laser beam source was used to change the colour substances on the textile surface. Pigment printing is also used for designing in textile and apparel sector. In this method, designs are transferred to the fabric manually by using dyestuff. In this study, the denim fabric used for the surfacing trial was 100% cotton, with a weft count per centimeter of 20 and a warp count per centimeter of 27, with fabric weight of 458 g/m 2. The first step was to prepare 40 pieces of denim samples, half of which were prepared manually pigment printing and the other half by using the laser beam. After this, some test applications were done. The tensile strength, tensile extension and some fastness values of designed pieces with two methods were compared according to the international standards.

Optimal design of monitoring networks for multiple groundwater quality parameters using a Kalman filter: application to the Irapuato-Valle aquifer.

PubMed

Júnez-Ferreira, H E; Herrera, G S; González-Hita, L; Cardona, A; Mora-Rodríguez, J

2016-01-01

A new method for the optimal design of groundwater quality monitoring networks is introduced in this paper. Various indicator parameters were considered simultaneously and tested for the Irapuato-Valle aquifer in Mexico. The steps followed in the design were (1) establishment of the monitoring network objectives, (2) definition of a groundwater quality conceptual model for the study area, (3) selection of the parameters to be sampled, and (4) selection of a monitoring network by choosing the well positions that minimize the estimate error variance of the selected indicator parameters. Equal weight for each parameter was given to most of the aquifer positions and a higher weight to priority zones. The objective for the monitoring network in the specific application was to obtain a general reconnaissance of the water quality, including water types, water origin, and first indications of contamination. Water quality indicator parameters were chosen in accordance with this objective, and for the selection of the optimal monitoring sites, it was sought to obtain a low-uncertainty estimate of these parameters for the entire aquifer and with more certainty in priority zones. The optimal monitoring network was selected using a combination of geostatistical methods, a Kalman filter and a heuristic optimization method. Results show that when monitoring the 69 locations with higher priority order (the optimal monitoring network), the joint average standard error in the study area for all the groundwater quality parameters was approximately 90 % of the obtained with the 140 available sampling locations (the set of pilot wells). This demonstrates that an optimal design can help to reduce monitoring costs, by avoiding redundancy in data acquisition.

78 FR 22501 - Designation of Areas for Air Quality Planning Purposes; State of Nevada; Total Suspended Particulate

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-R09-OAR-2013-0104; FRL-9802-5] Designation of Areas for Air Quality Planning Purposes; State of Nevada; Total Suspended Particulate AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to delete certain area...

Designing a two-rank acceptance sampling plan for quality inspection of geospatial data products

NASA Astrophysics Data System (ADS)

Tong, Xiaohua; Wang, Zhenhua; Xie, Huan; Liang, Dan; Jiang, Zuoqin; Li, Jinchao; Li, Jun

2011-10-01

To address the disadvantages of classical sampling plans designed for traditional industrial products, we originally propose a two-rank acceptance sampling plan (TRASP) for the inspection of geospatial data outputs based on the acceptance quality level (AQL). The first rank sampling plan is to inspect the lot consisting of map sheets, and the second is to inspect the lot consisting of features in an individual map sheet. The TRASP design is formulated as an optimization problem with respect to sample size and acceptance number, which covers two lot size cases. The first case is for a small lot size with nonconformities being modeled by a hypergeometric distribution function, and the second is for a larger lot size with nonconformities being modeled by a Poisson distribution function. The proposed TRASP is illustrated through two empirical case studies. Our analysis demonstrates that: (1) the proposed TRASP provides a general approach for quality inspection of geospatial data outputs consisting of non-uniform items and (2) the proposed acceptance sampling plan based on TRASP performs better than other classical sampling plans. It overcomes the drawbacks of percent sampling, i.e., "strictness for large lot size, toleration for small lot size," and those of a national standard used specifically for industrial outputs, i.e., "lots with different sizes corresponding to the same sampling plan."

Launch vehicle systems design analysis

NASA Technical Reports Server (NTRS)

Ryan, Robert; Verderaime, V.

1993-01-01

Current launch vehicle design emphasis is on low life-cycle cost. This paper applies total quality management (TQM) principles to a conventional systems design analysis process to provide low-cost, high-reliability designs. Suggested TQM techniques include Steward's systems information flow matrix method, quality leverage principle, quality through robustness and function deployment, Pareto's principle, Pugh's selection and enhancement criteria, and other design process procedures. TQM quality performance at least-cost can be realized through competent concurrent engineering teams and brilliance of their technical leadership.

Quality by design: optimization of a freeze-drying cycle via design space in case of heterogeneous drying behavior and influence of the freezing protocol.

PubMed

Pisano, Roberto; Fissore, Davide; Barresi, Antonello A; Brayard, Philippe; Chouvenc, Pierre; Woinet, Bertrand

2013-02-01

This paper shows how to optimize the primary drying phase, for both product quality and drying time, of a parenteral formulation via design space. A non-steady state model, parameterized with experimentally determined heat and mass transfer coefficients, is used to define the design space when the heat transfer coefficient varies with the position of the vial in the array. The calculations recognize both equipment and product constraints, and also take into account model parameter uncertainty. Examples are given of cycles designed for the same formulation, but varying the freezing conditions and the freeze-dryer scale. These are then compared in terms of drying time. Furthermore, the impact of inter-vial variability on design space, and therefore on the optimized cycle, is addressed. With this regard, a simplified method is presented for the cycle design, which reduces the experimental effort required for the system qualification. The use of mathematical modeling is demonstrated to be very effective not only for cycle development, but also for solving problem of process transfer. This study showed that inter-vial variability remains significant when vials are loaded on plastic trays, and how inter-vial variability can be taken into account during process design.

Quality by design case study: an integrated multivariate approach to drug product and process development.

PubMed

Huang, Jun; Kaul, Goldi; Cai, Chunsheng; Chatlapalli, Ramarao; Hernandez-Abad, Pedro; Ghosh, Krishnendu; Nagi, Arwinder

2009-12-01

To facilitate an in-depth process understanding, and offer opportunities for developing control strategies to ensure product quality, a combination of experimental design, optimization and multivariate techniques was integrated into the process development of a drug product. A process DOE was used to evaluate effects of the design factors on manufacturability and final product CQAs, and establish design space to ensure desired CQAs. Two types of analyses were performed to extract maximal information, DOE effect & response surface analysis and multivariate analysis (PCA and PLS). The DOE effect analysis was used to evaluate the interactions and effects of three design factors (water amount, wet massing time and lubrication time), on response variables (blend flow, compressibility and tablet dissolution). The design space was established by the combined use of DOE, optimization and multivariate analysis to ensure desired CQAs. Multivariate analysis of all variables from the DOE batches was conducted to study relationships between the variables and to evaluate the impact of material attributes/process parameters on manufacturability and final product CQAs. The integrated multivariate approach exemplifies application of QbD principles and tools to drug product and process development.

The quality of the evidence base for clinical pathway effectiveness: room for improvement in the design of evaluation trials.

PubMed

Rotter, Thomas; Kinsman, Leigh; James, Erica; Machotta, Andreas; Steyerberg, Ewout W

2012-06-18

The purpose of this article is to report on the quality of the existing evidence base regarding the effectiveness of clinical pathway (CPW) research in the hospital setting. The analysis is based on a recently published Cochrane review of the effectiveness of CPWs. An integral component of the review process was a rigorous appraisal of the methodological quality of published CPW evaluations. This allowed the identification of strengths and limitations of the evidence base for CPW effectiveness. We followed the validated Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria for randomized and non-randomized clinical pathway evaluations. In addition, we tested the hypotheses that simple pre-post studies tend to overestimate CPW effects reported. Out of the 260 primary studies meeting CPW content criteria, only 27 studies met the EPOC study design criteria, with the majority of CPW studies (more than 70 %) excluded from the review on the basis that they were simple pre-post evaluations, mostly comparing two or more annual patient cohorts. Methodologically poor study designs are often used to evaluate CPWs and this compromises the quality of the existing evidence base. Cochrane EPOC methodological criteria, including the selection of rigorous study designs along with detailed descriptions of CPW development and implementation processes, are recommended for quantitative evaluations to improve the evidence base for the use of CPWs in hospitals.

Implementation of quality by design approach in manufacturing process optimization of dry granulated, immediate release, coated tablets - a case study.

PubMed

Teżyk, Michał; Jakubowska, Emilia; Milanowski, Bartłomiej; Lulek, Janina

2017-10-01

The aim of this study was to optimize the process of tablets compression and identification of film-coating critical process parameters (CPPs) affecting critical quality attributes (CQAs) using quality by design (QbD) approach. Design of experiment (DOE) and regression methods were employed to investigate hardness, disintegration time, and thickness of uncoated tablets depending on slugging and tableting compression force (CPPs). Plackett-Burman experimental design was applied to identify critical coating process parameters among selected ones that is: drying and preheating time, atomization air pressure, spray rate, air volume, inlet air temperature, and drum pressure that may influence the hardness and disintegration time of coated tablets. As a result of the research, design space was established to facilitate an in-depth understanding of existing relationship between CPPs and CQAs of intermediate product (uncoated tablets). Screening revealed that spray rate and inlet air temperature are two most important factors that affect the hardness of coated tablets. Simultaneously, none of the tested coating factors have influence on disintegration time. The observation was confirmed by conducting film coating of pilot size batches.

Defining and improving quality management in Dutch diabetes care groups and outpatient clinics: design of the study

PubMed Central

2013-01-01

Background Worldwide, the organisation of diabetes care is changing. As a result general practices and diabetes teams in hospitals are becoming part of new organisations in which multidisciplinary care programs are implemented. In the Netherlands, 97 diabetes care groups and 104 outpatient clinics are working with a diabetes care program. Both types of organisations aim to improve the quality of diabetes care. Therefore, it is essential to understand the comprehensive elements needed for optimal quality management at organisational level. This study aims to assess the current level of diabetes quality management in both care groups and outpatient clinics and its improvement after providing feedback on their quality management system and tailored support. Methods/design This study is a before-after study with a one-year follow-up comparing the levels of quality management before and after an intervention to improve diabetes quality management. To assess the status of quality management, online questionnaires were developed based on current literature. They consist of six domains: organisation of care, multidisciplinary teamwork, patient centeredness, performance management, quality improvement policy and management strategies. Based on the questionnaires, respondents will receive feedback on their score in a radar diagram and an elucidating table. They will also be granted access to an online toolbox with instruments that proved to be effective in quality of care improvement and with practical examples. If requested, personal support in implementing these tools will be available. After one year quality management will be measured again using the same questionnaire. Discussion This study will reveal a nationwide picture of quality management in diabetes care groups and outpatient clinics in the Netherlands and evaluate the effect of offering tailored support. The operationalisation of quality management on organisational level may be of interest for other countries

Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine.

PubMed

Tumpa, Anja; Stajić, Ana; Jančić-Stojanović, Biljana; Medenica, Mirjana

2017-02-05

This paper deals with the development of hydrophilic interaction liquid chromatography (HILIC) method with gradient elution, in accordance with Analytical Quality by Design (AQbD) methodology, for the first time. The method is developed for olanzapine and its seven related substances. Following step by step AQbD methodology, firstly as critical process parameters (CPPs) temperature, starting content of aqueous phase and duration of linear gradient are recognized, and as critical quality attributes (CQAs) separation criterion S of critical pairs of substances are investigated. Rechtschaffen design is used for the creation of models that describe the dependence between CPPs and CQAs. The design space that is obtained at the end is used for choosing the optimal conditions (set point). The method is fully validated at the end to verify the adequacy of the chosen optimal conditions and applied to real samples. Copyright © 2016 Elsevier B.V. All rights reserved.

Using implementation tools to design and conduct quality improvement projects for faster and more effective improvement.

PubMed

Ovretveit, John; Mittman, Brian; Rubenstein, Lisa; Ganz, David A

2017-10-09

Purpose The purpose of this paper is to enable improvers to use recent knowledge from implementation science to carry out improvement changes more effectively. It also highlights the importance of converting research findings into practical tools and guidance for improvers so as to make research easier to apply in practice. Design/methodology/approach This study provides an illustration of how a quality improvement (QI) team project can make use of recent findings from implementation research so as to make their improvement changes more effective and sustainable. The guidance is based on a review and synthesis of improvement and implementation methods. Findings The paper illustrates how research can help a quality project team in the phases of problem definition and preparation, in design and planning, in implementation, and in sustaining and spreading a QI. Examples of the use of different ideas and methods are cited where they exist. Research limitations/implications The example is illustrative and there is little limited experimental evidence of whether using all the steps and tools in the one approach proposed do enable a quality team to be more effective. Evidence supporting individual guidance proposals is cited where it exists. Practical implications If the steps proposed and illustrated in the paper were followed, it is possible that quality projects could avoid waste by ensuring the conditions they need for success are in place, and sustain and spread improvement changes more effectively. Social implications More patients could benefit more quickly from more effective implementation of proven interventions. Originality/value The paper is the first to describe how improvement and implementation science can be combined in a tangible way that practical improvers can use in their projects. It shows how QI project teams can take advantage of recent advances in improvement and implementation science to make their work more effective and sustainable.

Designing train-speed trajectory with energy efficiency and service quality

NASA Astrophysics Data System (ADS)

Jia, Jiannan; Yang, Kai; Yang, Lixing; Gao, Yuan; Li, Shukai

2018-05-01

With the development of automatic train operations, optimal trajectory design is significant to the performance of train operations in railway transportation systems. Considering energy efficiency and service quality, this article formulates a bi-objective train-speed trajectory optimization model to minimize simultaneously the energy consumption and travel time in an inter-station section. This article is distinct from previous studies in that more sophisticated train driving strategies characterized by the acceleration/deceleration gear, the cruising speed, and the speed-shift site are specifically considered. For obtaining an optimal train-speed trajectory which has equal satisfactory degree on both objectives, a fuzzy linear programming approach is applied to reformulate the objectives. In addition, a genetic algorithm is developed to solve the proposed train-speed trajectory optimization problem. Finally, a series of numerical experiments based on a real-world instance of Beijing-Tianjin Intercity Railway are implemented to illustrate the practicability of the proposed model as well as the effectiveness of the solution methodology.

Evaluating the Properties of Poly(lactic-co-glycolic acid) Nanoparticle Formulations Encapsulating a Hydrophobic Drug by Using the Quality by Design Approach.

PubMed

Kozaki, Masato; Kobayashi, Shin-Ichiro; Goda, Yukihiro; Okuda, Haruhiro; Sakai-Kato, Kumiko

2017-01-01

We applied the Quality by Design (QbD) approach to the development of poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulations encapsulating triamcinolone acetonide, and the critical process parameters (CPPs) were identified to clarify the correlations between critical quality attributes and CPPs. Quality risk management was performed by using an Ishikawa diagram and experiments with a fractional factorial design (ANOVA). The CPPs for particle size were PLGA concentration and rotation speed, and the CPP for relative drug loading efficiency was the poor solvent to good solvent volume ratio. By assessing the mutually related factors in the form of ratios, many factors could be efficiently considered in the risk assessment. We found a two-factor interaction between rotation speed and rate of addition of good solvent by using a fractional factorial design with resolution V. The system was then extended by using a central composite design, and the results obtained were visualized by using the response surface method to construct a design space. Our research represents a case study of the application of the QbD approach to pharmaceutical development, including formulation screening, by taking actual production factors into consideration. Our findings support the feasibility of using a similar approach to nanoparticle formulations under development. We could establish an efficient method of analyzing the CPPs of PLGA nanoparticles by using a QbD approach.

40 CFR 130.9 - Designation and de-designation.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Designation and de-designation. 130.9... QUALITY PLANNING AND MANAGEMENT § 130.9 Designation and de-designation. (a) Designation. Areawide planning... approval in accordance with section 208(a)(7) of the Act. (b) De-designation. The Governor may modify or...

Research gaps in routine health information system design barriers to data quality and use in low- and middle-income countries: A literature review.

PubMed

Kumar, Manish; Gotz, David; Nutley, Tara; Smith, Jason B

2018-01-01

Despite the potential impact of health information system (HIS) design barriers on health data quality and use and, ultimately, health outcomes in low- and middle-income countries (LMICs), no comprehensive literature review has been conducted to study them in this context. We therefore conducted a formal literature review to understand system design barriers to data quality and use in LMICs and to identify any major research gaps related understanding how system design affects data use. We conducted an electronic search across 4 scientific databases-PubMed, Web of Science, Embase, and Global Health-and consulted a data use expert. Following a systematic inclusion and exclusion process, 316 publications (316 abstracts and 18 full papers) were included in the review. We found a paucity of scientific publications that explicitly describe system design factors that hamper data quality or data use for decision making. Although user involvement, work flow, human-computer interactions, and user experience are critical aspects of system design, our findings suggest that these issues are not discussed or conceptualized in the literature. Findings also showed that individual training efforts focus primarily on imparting data analysis skills. The adverse impact of HIS design barriers on data integrity and health system performance may be even bigger in LMICs than elsewhere, leading to errors in population health management and clinical care. We argue for integrating systems thinking into HIS strengthening efforts to reduce the HIS design-user reality gap. Copyright © 2017 John Wiley & Sons, Ltd.

Study Quality in SLA: A Cumulative and Developmental Assessment of Designs, Analyses, Reporting Practices, and Outcomes in Quantitative L2 Research

ERIC Educational Resources Information Center

Plonsky, Luke

2011-01-01

I began this study with two assumptions. Assumption 1: Study quality matters. If the means by which researchers design, carry out, and report on their studies lack in rigor or transparency, theory and practice are likely to be misguided or at least decelerated. Assumption 2 is an implication of Assumption 1: Quality should be measured rather than…

Construction of quality-assured infant feeding process of care data repositories: definition and design (Part 1).

PubMed

Garcí A-de-León-Chocano, Ricardo; Sáez, Carlos; Muñoz-Soler, Verónica; Garcí A-de-León-González, Ricardo; García-Gómez, Juan M

2015-12-01

This is the first paper of a series of two regarding the construction of data quality (DQ) assured repositories for the reuse of information on infant feeding from birth until two years old. This first paper justifies the need for such repositories and describes the design of a process to construct them from Electronic Health Records (EHR). As a result, Part 1 proposes a computational process to obtain quality-assured datasets represented by a canonical structure extracted from raw data from multiple EHR. For this, 13 steps were defined to ensure the harmonization, standardization, completion, de-duplication, and consistency of the dataset content. Moreover, the quality of the input and output data for each of these steps is controlled according to eight DQ dimensions: predictive value, correctness, duplication, consistency, completeness, contextualization, temporal-stability and spatial-stability. The second paper of the series will describe the application of this computational process to construct the first quality-assured repository for the reuse of information on infant feeding in the perinatal period aimed at the monitoring of clinical activities and research. Copyright © 2015 Elsevier Ltd. All rights reserved.

Education and Research Laboratories as a Means of Enhancing the Quality of Professional Engineering Education in Design and Production of Composite Parts

ERIC Educational Resources Information Center

Khaliulin, Valentin I.; Gershtein, Elena M.

2016-01-01

Relevance of this research is determined by quality improvement of professional engineering education. The purpose of this paper is to offer practical recommendations for those interested in establishment of education and research laboratories as a means of enhancing the quality of professional engineering education in design and production of…

NorthStar, a support tool for the design and evaluation of quality improvement interventions in healthcare.

PubMed

Akl, Elie A; Treweek, Shaun; Foy, Robbie; Francis, Jill; Oxman, Andrew D

2007-06-26

The Research-Based Education and Quality Improvement (ReBEQI) European partnership aims to establish a framework and provide practical tools for the selection, implementation, and evaluation of quality improvement (QI) interventions. We describe the development and preliminary evaluation of the software tool NorthStar, a major product of the ReBEQI project. We focused the content of NorthStar on the design and evaluation of QI interventions. A lead individual from the ReBEQI group drafted each section, and at least two other group members reviewed it. The content is based on published literature, as well as material developed by the ReBEQI group. We developed the software in both a Microsoft Windows HTML help system version and a web-based version. In a preliminary evaluation, we surveyed 33 potential users about the acceptability and perceived utility of NorthStar. NorthStar consists of 18 sections covering the design and evaluation of QI interventions. The major focus of the intervention design sections is on how to identify determinants of practice (factors affecting practice patterns), while the major focus of the intervention evaluation sections is on how to design a cluster randomised trial. The two versions of the software can be transferred by email or CD, and are available for download from the internet. The software offers easy navigation and various functions to access the content. Potential users (55% response rate) reported above-moderate levels of confidence in carrying out QI research related tasks if using NorthStar, particularly when developing a protocol for a cluster randomised trial NorthStar is an integrated, accessible, practical, and acceptable tool to assist developers and evaluators of QI interventions.

Upper internals arrangement for a pressurized water reactor

DOEpatents

Singleton, Norman R; Altman, David A; Yu, Ching; Rex, James A; Forsyth, David R

2013-07-09

In a pressurized water reactor with all of the in-core instrumentation gaining access to the core through the reactor head, each fuel assembly in which the instrumentation is introduced is aligned with an upper internals instrumentation guide-way. In the elevations above the upper internals upper support assembly, the instrumentation is protected and aligned by upper mounted instrumentation columns that are part of the instrumentation guide-way and extend from the upper support assembly towards the reactor head in hue with a corresponding head penetration. The upper mounted instrumentation columns are supported laterally at one end by an upper guide tube and at the other end by the upper support plate.

Study on figure-eight-shaped coil electrodynamic suspension magnetic levitation systems without cross-connection

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

Ribani, P.L.; Urbano, N.

2000-01-01

Two figure-eight-shaped coils for electrodynamic suspension (EDS) magnetic levitation (MAGLEV) systems without cross-connection are proposed and analyzed. The guideway coils are positioned under the MAGLEV vehicle; they are parallel to the horizontal plane. The interaction of a magnetic module on the vehicle, composed of three or four superconducting (SC) coils, with a guideway module, comprised of two figure-eight coils, is studied by means of the dynamic circuit theory. The currents in the SC coils are supposed to be constant in time while they move as a rigid body, with a constant velocity. Some results are presented and compared with thosemore » for a standard side-wall cross-connected system.« less

Quality of Reporting and Study Design of CKD Cohort Studies Assessing Mortality in the Elderly Before and After STROBE: A Systematic Review.

PubMed

Rao, Anirudh; Brück, Katharina; Methven, Shona; Evans, Rebecca; Stel, Vianda S; Jager, Kitty J; Hooft, Lotty; Ben-Shlomo, Yoav; Caskey, Fergus

2016-01-01

The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement was published in October 2007 to improve quality of reporting of observational studies. The aim of this review was to assess the impact of the STROBE statement on observational study reporting and study design quality in the nephrology literature. Systematic literature review. European and North American, Pre-dialysis Chronic Kidney Disease (CKD) cohort studies. Studies assessing the association between CKD and mortality in the elderly (>65 years) published from 1st January 2002 to 31st December 2013 were included, following systematic searching of MEDLINE & EMBASE. Time period before and after the publication of the STROBE statement. Quality of study reporting using the STROBE statement and quality of study design using the Newcastle Ottawa Scale (NOS), Scottish Intercollegiate Guidelines Network (SIGN) and Critical Appraisal Skills Programme (CASP) tools. 37 papers (11 Pre & 26 Post STROBE) were identified from 3621 potential articles. Only four of the 22 STROBE items and their sub-criteria (objectives reporting, choice of quantitative groups and description of and carrying out sensitivity analysis) showed improvements, with the majority of items showing little change between the period before and after publication of the STROBE statement. Pre- and post-period analysis revealed a Manuscript STROBE score increase (median score 77.8% (Inter-quartile range [IQR], 64.7-82.0) vs 83% (IQR, 78.4-84.9, p = 0.05). There was no change in quality of study design with identical median scores in the two periods for NOS (Manuscript NOS score 88.9), SIGN (Manuscript SIGN score 83.3) and CASP (Manuscript CASP score 91.7) tools. Only 37 Studies from Europe and North America were included from one medical specialty. Assessment of study design largely reliant on good reporting. This study highlights continuing deficiencies in the reporting of STROBE items and their sub-criteria in cohort

Design and development of high performance solar photovoltaic inverter with advanced modulation techniques to improve power quality

NASA Astrophysics Data System (ADS)

Alexander Stonier, Albert

2017-02-01

In addition to the focus towards growing demand on electrical energy due to the increase in population, industries, consumer loads, etc., the need for improving the quality of electrical power also needs to be considered. The design and development of solar photovoltaic (PV) inverter with reduced harmonic distortions is proposed. Unlike the conventional solar PV inverters, the proposed inverter provides the advantages of reduced harmonic distortions thereby intend towards the improvement in power quality. This inverter comprises of multiple stages which provides the required 230VRMS, 50 Hz in spite of variations in solar PV due to temperature and irradiance. The reduction of harmonics is governed by applying proper switching sequences required for the inverter switches. The detailed analysis is carried out by employing different switching techniques and observing its performance. With a separate mathematical model for a solar PV, simulations are performed in MATLAB software. To show the advantage of the system proposed, a 3 kWp photovoltaic plant coupled with multilevel inverter is demonstrated in hardware. The novelty resides in the design of a single chip controller which can provide the switching sequence based on the requirement and application. As per the results obtained, the solar-fed multistage inverter improves the quality of power which makes this inverter suitable for both stand-alone and grid-connected systems.

Design and implementation of the National Water-Quality Assessment Program: a United States example: understanding the limitations of using compliance-monitoring data to assess the water quality of a large river basin

USGS Publications Warehouse

Wangsness, David J.

1997-01-01

In the 1980s it was determined that existing ambient and compliance-monitoring data could not satisfactorily evaluate the results of hundreds of billions of dollars spent for water-pollution abatement in the United States. At the request of the US Congress, a new programme, the National Water-Quality Assessment, was designed and implemented by government agency, the US Geological Survey (USGS). The Assessment has reported status and trends in surface- and ground-water quality at national, regional, and local scales since 1991. The legislative basis for US monitoring and data-sharing policies are identified as well as the successive phases of the design and implementation of the USGS Assessment. Application to the Danube Basin is suggested. Much of the water-quality monitoring conducted in the United States is designed to comply with Federal and State laws mandated primarily by the Clean Water Act of 1987 and the Safe Drinking Water Act of 1986. Monitoring programs generally focus on rivers upstream and downstream of point-source discharges and at water-supply intakes. Few data are available for aquifer systems, and chemical analyses are often limited to those constituents required by law. In most cases, the majority of the available chemical and streamflow data have provided the information necessary to meet the objectives of the compliance-monitoring programs, but do not necessarily provide the information requires for basin-wide assessments of the water quality at the local, regional, or national scale.

Preliminary Design Phases, Part of Indoor Air Quality Design Tools for Schools

EPA Pesticide Factsheets

The typical design process for schools begins with programming and selection of the architectural-engineering team. It then proceeds through schematic design, design development, contract documents, construction, commissioning and occupancy.

Enhancing causal interpretations of quality improvement interventions

PubMed Central

Cable, G

2001-01-01

In an era of chronic resource scarcity it is critical that quality improvement professionals have confidence that their project activities cause measured change. A commonly used research design, the single group pre-test/post-test design, provides little insight into whether quality improvement interventions cause measured outcomes. A re-evaluation of a quality improvement programme designed to reduce the percentage of bilateral cardiac catheterisations for the period from January 1991 to October 1996 in three catheterisation laboratories in a north eastern state in the USA was performed using an interrupted time series design with switching replications. The accuracy and causal interpretability of the findings were considerably improved compared with the original evaluation design. Moreover, the re-evaluation provided tangible evidence in support of the suggestion that more rigorous designs can and should be more widely employed to improve the causal interpretability of quality improvement efforts. Evaluation designs for quality improvement projects should be constructed to provide a reasonable opportunity, given available time and resources, for causal interpretation of the results. Evaluators of quality improvement initiatives may infrequently have access to randomised designs. Nonetheless, as shown here, other very rigorous research designs are available for improving causal interpretability. Unilateral methodological surrender need not be the only alternative to randomised experiments. Key Words: causal interpretations; quality improvement; interrupted time series design; implementation fidelity PMID:11533426

Effects of impervious area and BMP implementation and design on storm runoff and water quality in eight small watersheds

USGS Publications Warehouse

Aulenbach, Brent T.; Landers, Mark N.; Musser, Jonathan W.; Painter, Jaime A.

2017-01-01

The effects of increases in effective impervious area (EIA) and the implementation of water quality protection designed detention pond best management practices (BMPs) on storm runoff and stormwater quality were assessed in Gwinnett County, Georgia, for the period 2001-2008. Trends among eight small watersheds were compared, using a time trend study design. Significant trends were detected in three storm hydrologic metrics and in five water quality constituents that were adjusted for variability in storm characteristics and climate. Trends in EIA ranged from 0.10 to 1.35, and changes in EIA treated by BMPs ranged from 0.19 to 1.32; both expressed in units of percentage of drainage area per year. Trend relations indicated that for every 1% increase in watershed EIA, about 2.6, 1.1, and 1.5% increases in EIA treated by BMPs would be required to counteract the effects of EIA added to the watersheds on peak streamflow, stormwater yield, and storm streamflow runoff, respectively. Relations between trends in EIA, BMP implementation, and water quality were counterintuitive. This may be the result of (1) changes in constituent inputs in the watersheds, especially downstream of areas treated by BMPs; (2) BMPs may have increased the duration of stormflow that results in downstream channel erosion; and/or (3) spurious relationships between increases in EIA, BMP implementation, and constituent inputs with development rates.

A design space exploration for control of Critical Quality Attributes of mAb.

PubMed

Bhatia, Hemlata; Read, Erik; Agarabi, Cyrus; Brorson, Kurt; Lute, Scott; Yoon, Seongkyu

2016-10-15

A unique "design space (DSp) exploration strategy," defined as a function of four key scenarios, was successfully integrated and validated to enhance the DSp building exercise, by increasing the accuracy of analyses and interpretation of processed data. The four key scenarios, defining the strategy, were based on cumulative analyses of individual models developed for the Critical Quality Attributes (23 Glycan Profiles) considered for the study. The analyses of the CQA estimates and model performances were interpreted as (1) Inside Specification/Significant Model (2) Inside Specification/Non-significant Model (3) Outside Specification/Significant Model (4) Outside Specification/Non-significant Model. Each scenario was defined and illustrated through individual models of CQA aligning the description. The R(2), Q(2), Model Validity and Model Reproducibility estimates of G2, G2FaGbGN, G0 and G2FaG2, respectively, signified the four scenarios stated above. Through further optimizations, including the estimation of Edge of Failure and Set Point Analysis, wider and accurate DSps were created for each scenario, establishing critical functional relationship between Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). A DSp provides the optimal region for systematic evaluation, mechanistic understanding and refining of a QbD approach. DSp exploration strategy will aid the critical process of consistently and reproducibly achieving predefined quality of a product throughout its lifecycle. Copyright © 2016 Elsevier B.V. All rights reserved.

Quality by design for herbal drugs: a feedforward control strategy and an approach to define the acceptable ranges of critical quality attributes.

PubMed

Yan, Binjun; Li, Yao; Guo, Zhengtai; Qu, Haibin

2014-01-01

The concept of quality by design (QbD) has been widely accepted and applied in the pharmaceutical manufacturing industry. There are still two key issues to be addressed in the implementation of QbD for herbal drugs. The first issue is the quality variation of herbal raw materials and the second issue is the difficulty in defining the acceptable ranges of critical quality attributes (CQAs). To propose a feedforward control strategy and a method for defining the acceptable ranges of CQAs for the two issues. In the case study of the ethanol precipitation process of Danshen (Radix Salvia miltiorrhiza) injection, regression models linking input material attributes and process parameters to CQAs were built first and an optimisation model for calculating the best process parameters according to the input materials was established. Then, the feasible material space was defined and the acceptable ranges of CQAs for the previous process were determined. In the case study, satisfactory regression models were built with cross-validated regression coefficients (Q(2) ) all above 91 %. The feedforward control strategy was applied successfully to compensate the quality variation of the input materials, which was able to control the CQAs in the 90-110 % ranges of the desired values. In addition, the feasible material space for the ethanol precipitation process was built successfully, which showed the acceptable ranges of the CQAs for the concentration process. The proposed methodology can help to promote the implementation of QbD for herbal drugs. Copyright © 2013 John Wiley & Sons, Ltd.

Fostering Teachers' Design Expertise in Teacher Design Teams: Conducive Design and Support Activities

ERIC Educational Resources Information Center

Huizinga, Tjark; Handelzalts, Adam; Nieveen, Nienke; Voogt, Joke

2015-01-01

Supporting Teacher Design Teams (TDTs) during local curriculum development efforts is essential. To be able to provide high-quality support, insights are needed about how TDTs carry out design activities and how support is valued by the members of TDTs and how it affects their design expertise. In this study, the design and support processes of…

The Problem: Relevance, Quality, and Homogeneity of Trial Designs, Outcomes, and Reporting.

PubMed

Göstemeyer, Gerd; Levey, Colin

2018-01-01

Clinical trials are the cornerstone of evidence-based medicine. By directly comparing different interventions they produce evidence on their relative efficacy and effectiveness This, in turn, can inform secondary research and guideline development to facilitate evidence-based clinical decision making. However, the quality of evidence stemming from clinical trials is frequently poor. Here, the pathway of evidence from basic research to the generation of implementable clinical guidelines will be described. Relevant factors related to trial design and reporting, such as the choice of trial comparators, outcomes and outcome measures, will be described and their influence on evidence synthesis will be discussed. Finally, recommendations on how to improve trials in order to increase their usefulness for evidence generation will be given. © 2018 S. Karger AG, Basel.

Development of antiproliferative long-circulating liposomes co-encapsulating doxorubicin and curcumin, through the use of a quality-by-design approach.

PubMed

Tefas, Lucia Ruxandra; Sylvester, Bianca; Tomuta, Ioan; Sesarman, Alina; Licarete, Emilia; Banciu, Manuela; Porfire, Alina

2017-01-01

The aim of this work was to use the quality-by-design (QbD) approach in the development of long-circulating liposomes co-loaded with curcumin (CUR) and doxorubicin (DOX) and to evaluate the cytotoxic potential of these liposomes in vitro using C26 murine colon carcinoma cell line. Based on a risk assessment, six parameters, namely the phospholipid, CUR and DOX concentrations, the phospholipid:cholesterol molar ratio, the temperature during the evaporation and hydration steps and the pH of the phosphate buffer, were identified as potential risk factors for the quality of the final product. The influence of these variables on the critical quality attributes of the co-loaded liposomal CUR and DOX was investigated: particle size, zeta potential, drug loading and entrapment efficiency. For this, a 2 6-2 factorial design was employed to establish a proper regression model and to generate the contour plots for the responses. The obtained data served to establish the design space for which different combinations of variables yielded liposomes with characteristics within predefined specifications. The validation of the model was carried out by preparing two liposomal formulations corresponding to the robust set point from within the design space and one outside the design space and calculating the percentage bias between the predicted and actual experimental results. The in vitro antiproliferative test showed that at higher CUR concentrations, the liposomes co-encapsulating CUR and DOX had a greater cytotoxic effect than DOX-loaded liposomes. Overall, this study showed that QbD is a useful instrument for controlling and optimizing the manufacturing process of liposomes co-loaded with CUR and DOX and that this nanoparticulate system possesses a great potential for use in colon cancer therapy.

Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic.

PubMed

Rathore, Anurag S

2016-05-01

Quality by Design (QbD) is currently receiving increased attention from the pharmaceutical community. As a result, most major biotech manufacturers are in varying stages of implementing QbD. Here, I present a case study that illustrates the step-by-step development using QbD of a purification process for the production of a biosimilar product: granulocyte colony-stimulating factor (GCSF). I also highlight and discuss the advantages that QbD-based process development offers over traditional approaches. The case study is intended to help those who wish to implement QbD towards the development and commercialization of biotech products. Copyright © 2016 Elsevier Ltd. All rights reserved.

Design and operation of a low-cost and compact autonomous buoy system for use in coastal aquaculture and water quality monitoring.

PubMed

Schmidt, Wiebke; Raymond, David; Parish, David; Ashton, Ian G C; Miller, Peter I; Campos, Carlos J A; Shutler, Jamie D

2018-01-01

The need to ensure future food security and issues of varying estuarine water quality is driving the expansion of aquaculture into near-shore coastal waters. It is prudent to fully evaluate new or proposed aquaculture sites, prior to any substantial financial investment in infrastructure and staffing. Measurements of water temperature, salinity and dissolved oxygen can be used to gain insight into the physical, chemical and biological water quality conditions within a farm site, towards identifying its suitability for farming, both for the stock species of interest and for assessing the potential risk from harmful or toxic algae. The latter can cause closure of shellfish harvesting. Unfortunately, commercial scientific monitoring systems can be cost prohibitive for small organisations and companies to purchase and operate. Here we describe the design, construction and deployment of a low cost (<£ 5000) monitoring buoy suitable for use within a near-shore aquaculture farm or bathing waters. The mooring includes a suite of sensors designed for supporting and understanding variations in near-shore physical, chemical and biological water quality. The system has been designed so that it can be operated and maintained by non-scientific staff, whilst still providing good quality scientific data. Data collected from two deployments totalling 14 months, one in a coastal bay location, another in an estuary, have illustrated the robust design and provided insight into the suitability of these sites for aquaculture and the potential occurrence of a toxin causing algae ( Dinophysis spp.). The instruments maintained good accuracy during the deployments when compared to independent in situ measurements (e.g. RMSE 0.13-0.16 °C, bias 0.03-0.08 °C) enabling stratification and biological features to be identified, along with confirming that the waters were suitable for mussel ( Mytilus spp.) and lobster ( Homarus gammarus ) aquaculture, whilst sites showed conditions agreeable

Evidence-Based and Value-Based Decision Making About Healthcare Design: An Economic Evaluation of the Safety and Quality Outcomes.

PubMed

Zadeh, Rana; Sadatsafavi, Hessam; Xue, Ryan

2015-01-01

This study describes a vision and framework that can facilitate the implementation of evidence-based design (EBD), scientific knowledge base into the process of the design, construction, and operation of healthcare facilities and clarify the related safety and quality outcomes for the stakeholders. The proposed framework pairs EBD with value-driven decision making and aims to improve communication among stakeholders by providing a common analytical language. Recent EBD research indicates that the design and operation of healthcare facilities contribute to an organization's operational success by improving safety, quality, and efficiency. However, because little information is available about the financial returns of evidence-based investments, such investments are readily eliminated during the capital-investment decision-making process. To model the proposed framework, we used engineering economy tools to evaluate the return on investments in six successful cases, identified by a literature review, in which facility design and operation interventions resulted in reductions in hospital-acquired infections, patient falls, staff injuries, and patient anxiety. In the evidence-based cases, calculated net present values, internal rates of return, and payback periods indicated that the long-term benefits of interventions substantially outweighed the intervention costs. This article explained a framework to develop a research-based and value-based communication language on specific interventions along the planning, design and construction, operation, and evaluation stages. Evidence-based and value-based design frameworks can be applied to communicate the life-cycle costs and savings of EBD interventions to stakeholders, thereby contributing to more informed decision makings and the optimization of healthcare infrastructures. © The Author(s) 2015.

Design and implementation of community engagement interventions towards healthcare quality improvement in Ghana: a methodological approach.

PubMed

Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Arhinful, Daniel Kojo

2016-12-01

Nearly four decades after the Alma-Ata declaration of 1978 on the need for active client/community participation in healthcare, not much has been achieved in this regard particularly in resource constrained countries like Ghana, where over 70 % of communities in rural areas access basic healthcare from primary health facilities. Systematic Community Engagement (SCE) in healthcare quality assessment remains a grey area in many health systems in Africa, albeit the increasing importance in promoting universal access to quality basic healthcare services. Design and implement SCE interventions that involve existing community groups engaged in healthcare quality assessment in 32 intervention primary health facilities. The SCE interventions form part of a four year randomized controlled trial (RCT) in the Greater Accra and Western regions of Ghana. Community groups (n = 52) were purposively recruited and engaged to assess non-technical components of healthcare quality, recommend quality improvement plans and reward best performing facilities. The interventions comprised of five cyclical implementation steps executed for nearly a year. Wilcoxon sign rank test was used to ascertain differences in group perceptions of service quality during the first and second assessments, and ordered logistic regression analysis performed to determine factors associated with groups' perception of healthcare quality. Healthcare quality was perceived to be lowest in non-technical areas such as: information provision to clients, directional signs in clinics, drug availability, fairness in queuing, waiting times, and information provision on use of suggestion boxes and feedback on clients' complaints. Overall, services in private health facilities were perceived to be better than public facilities (p < 0.05). Community groups dominated by artisans and elderly members (60 + years) had better perspectives on healthcare quality than youthful groups (Coef. =1.78; 95 % CI = [-0.16 3

The Design of Mechatronics Simulator for Improving the Quality of Student Learning Course in Mechatronics

NASA Astrophysics Data System (ADS)

Kustija, J.; Hasbullah; Somantri, Y.

2018-02-01

Learning course on mechatronics specifically the Department of Electrical Engineering Education FPTK UPI still using simulation-aided instructional materials and software. It is still not maximizing students’ competencies in mechatronics courses required to skilfully manipulate the real will are implemented both in industry and in educational institutions. The purpose of this study is to submit a design of mechatronic simulator to improve student learning outcomes at the course mechatronics viewed aspects of cognitive and psychomotor. Learning innovation products resulting from this study is expected to be a reference and a key pillar for all academic units at UPI in implementing the learning environment. The method used in this research is quantitative method with the approach of Research and Development (R and D). Steps being taken in this study includes a preliminary study, design and testing of the design of mechatronic simulator that will be used in the course of mechatronics in DPTE FPTK UPI. Results of mechatronic design simulator which has been in testing using simulation modules and is expected to motivate students to improve the quality of learning good study results in the course of mechatronic expected to be realized.

NorthStar, a support tool for the design and evaluation of quality improvement interventions in healthcare

PubMed Central

Akl, Elie A; Treweek, Shaun; Foy, Robbie; Francis, Jill; Oxman, Andrew D

2007-01-01

Background The Research-Based Education and Quality Improvement (ReBEQI) European partnership aims to establish a framework and provide practical tools for the selection, implementation, and evaluation of quality improvement (QI) interventions. We describe the development and preliminary evaluation of the software tool NorthStar, a major product of the ReBEQI project. Methods We focused the content of NorthStar on the design and evaluation of QI interventions. A lead individual from the ReBEQI group drafted each section, and at least two other group members reviewed it. The content is based on published literature, as well as material developed by the ReBEQI group. We developed the software in both a Microsoft Windows HTML help system version and a web-based version. In a preliminary evaluation, we surveyed 33 potential users about the acceptability and perceived utility of NorthStar. Results NorthStar consists of 18 sections covering the design and evaluation of QI interventions. The major focus of the intervention design sections is on how to identify determinants of practice (factors affecting practice patterns), while the major focus of the intervention evaluation sections is on how to design a cluster randomised trial. The two versions of the software can be transferred by email or CD, and are available for download from the internet. The software offers easy navigation and various functions to access the content. Potential users (55% response rate) reported above-moderate levels of confidence in carrying out QI research related tasks if using NorthStar, particularly when developing a protocol for a cluster randomised trial Conclusion NorthStar is an integrated, accessible, practical, and acceptable tool to assist developers and evaluators of QI interventions. PMID:17594495

Riparian buffer design guidelines for water quality and wildlife habitat functions on agricultural landscapes in the Intermountain West

Treesearch

Craig W. Johnson; Susan Buffler

2008-01-01

Intermountain West planners, designers, and resource managers are looking for science-based procedures for determining buffer widths and management techniques that will optimize the benefits riparian ecosystems provide. This study reviewed the riparian buffer literature, including protocols used to determine optimum buffer widths for water quality and wildlife habitat...

Using an innovative combination of quality-by-design and green analytical chemistry approaches for the development of a stability indicating UHPLC method in pharmaceutical products.

PubMed

Boussès, Christine; Ferey, Ludivine; Vedrines, Elodie; Gaudin, Karen

2015-11-10

An innovative combination of green chemistry and quality by design (QbD) approach is presented through the development of an UHPLC method for the analysis of the main degradation products of dextromethorphan hydrobromide. QbD strategy was integrated to the field of green analytical chemistry to improve method understanding while assuring quality and minimizing environmental impacts, and analyst exposure. This analytical method was thoroughly evaluated by applying risk assessment and multivariate analysis tools. After a scouting phase aimed at selecting a suitable stationary phase and an organic solvent in accordance with green chemistry principles, quality risk assessment tools were applied to determine the critical process parameters (CPPs). The effects of the CPPs on critical quality attributes (CQAs), i.e., resolutions, efficiencies, and solvent consumption were further evaluated by means of a screening design. A response surface methodology was then carried out to model CQAs as function of the selected CPPs and the optimal separation conditions were determined through a desirability analysis. Resulting contour plots enabled to establish the design space (DS) (method operable design region) where all CQAs fulfilled the requirements. An experimental validation of the DS proved that quality within the DS was guaranteed; therefore no more robustness study was required before the validation. Finally, this UHPLC method was validated using the concept of total error and was used to analyze a pharmaceutical drug product. Copyright © 2015 Elsevier B.V. All rights reserved.

Monitoring-well network and sampling design for ground-water quality, Wind River Indian Reservation, Wyoming

USGS Publications Warehouse

Mason, Jon P.; Sebree, Sonja K.; Quinn, Thomas L.

2005-01-01

The Wind River Indian Reservation, located in parts of Fremont and Hot Springs Counties, Wyoming, has a total land area of more than 3,500 square miles. Ground water on the Wind River Indian Reservation is a valuable resource for Shoshone and Northern Arapahoe tribal members and others who live on the Reservation. There are many types of land uses on the Reservation that have the potential to affect the quality of ground-water resources. Urban areas, rural housing developments, agricultural lands, landfills, oil and natural gas fields, mining, and pipeline utility corridors all have the potential to affect ground-water quality. A cooperative study was developed between the U.S. Geological Survey and the Wind River Environmental Quality Commission to identify areas of the Reservation that have the highest potential for ground-water contamination and develop a comprehensive plan to monitor these areas. An arithmetic overlay model for the Wind River Indian Reservation was created using seven geographic information system data layers representing factors with varying potential to affect ground-water quality. The data layers used were: the National Land Cover Dataset, water well density, aquifer sensitivity, oil and natural gas fields and petroleum pipelines, sites with potential contaminant sources, sites that are known to have ground-water contamination, and National Pollutant Discharge Elimination System sites. A prioritization map for monitoring ground-water quality on the Reservation was created using the model. The prioritization map ranks the priority for monitoring ground-water quality in different areas of the Reservation as low, medium, or high. To help minimize bias in selecting sites for a monitoring well network, an automated stratified random site-selection approach was used to select 30 sites for ground-water quality monitoring within the high priority areas. In addition, the study also provided a sampling design for constituents to be monitored, sampling

Water-quality trend analysis and sampling design for streams in North Dakota, 1971-2000