This document discusses establishing links between spray drying process parameters and product performance through design space generation. It provides an overview of a systematic development path for design space construction involving five elements: design, measure, explore, develop, and implement. The explore element focuses on using experimental data and models to refine the design space and relate process conditions to critical product attributes. Two case studies are described: 1) spray drying a coated particle blend for reconstitution and 2) spray congealing a direct compression tablet formulation. Key process steps and their impact on resulting particle properties are outlined.
A spray dryer uses the spray method to transform materials like solutions and slurries into fine droplets that are dried quickly when exposed to a hot gas stream. Spray drying allows for rapid evaporation and is used across industries like chemicals, petroleum, and mining to dry heat-sensitive materials without degradation. The process produces uniformly sized powder particles suitable for tableting due to their improved flow properties and low moisture content.
The document provides information on spray drying processes. It discusses that spray drying is a method to produce dry powders from liquids or slurries by rapidly drying with hot gas. Key aspects of spray drying include atomizing the feed into droplets, contacting the droplets with drying gas, evaporation of moisture from the droplets, and separating the dried powder. Different types of spray dryers and factors like flow patterns, atomization methods, and applications are described.
Manufacturing and Exporting a wide range of drying plants and systems such as Spray Drying Systems, Pressure Nozzles, Two Fluid Nozzles, Rotary Atomizer, Spin Flash Dryers, Rotary Dryers, Fluid Bed Dryers, Spray Dryers, Falling Film Evaporator, Rising Film Evaporator, Forced Circulation Systems, Drying Chambers, Pilot Dryers, Drying Plants, Laboratory Spray Dryers (LSD-01). These are appreciated for their durable performance, smooth functionality and heavy duty application.
This document discusses different types of nozzles used in spray drying processes. It describes rotary atomizers, pressure nozzle atomizers, two-fluid nozzle atomizers, and pneumatic nozzles. Rotary atomizers can handle large feed rates but use more energy. Pressure nozzles have a simple design but are prone to clogging. Two-fluid nozzles produce a range of droplet sizes using compressed air. Pneumatic nozzles also produce very small particles but use more energy. Common applications of spray drying nozzles include dairy products, foods, chemicals, and more.
- Spray drying and drum drying are two common methods for dehydrating milk into powder.
- In spray drying, milk is evaporated, sprayed into hot air as fine droplets, and dried. In drum drying, concentrated milk is applied to heated rotating drums and dried.
- Milk powder has a longer shelf life than liquid milk and can be stored and transported more easily while retaining similar nutritional value when reconstituted. However, drying requires a large amount of energy.
A spray dryer uses the spray method to transform materials like solutions and slurries into fine droplets that are dried quickly when exposed to a hot gas stream. Spray drying allows for rapid evaporation and is used across industries like chemicals, petroleum, and mining to dry heat-sensitive materials without degradation. The process produces uniformly sized powder particles suitable for tableting due to their improved flow properties and low moisture content.
The document provides information on spray drying processes. It discusses that spray drying is a method to produce dry powders from liquids or slurries by rapidly drying with hot gas. Key aspects of spray drying include atomizing the feed into droplets, contacting the droplets with drying gas, evaporation of moisture from the droplets, and separating the dried powder. Different types of spray dryers and factors like flow patterns, atomization methods, and applications are described.
Manufacturing and Exporting a wide range of drying plants and systems such as Spray Drying Systems, Pressure Nozzles, Two Fluid Nozzles, Rotary Atomizer, Spin Flash Dryers, Rotary Dryers, Fluid Bed Dryers, Spray Dryers, Falling Film Evaporator, Rising Film Evaporator, Forced Circulation Systems, Drying Chambers, Pilot Dryers, Drying Plants, Laboratory Spray Dryers (LSD-01). These are appreciated for their durable performance, smooth functionality and heavy duty application.
This document discusses different types of nozzles used in spray drying processes. It describes rotary atomizers, pressure nozzle atomizers, two-fluid nozzle atomizers, and pneumatic nozzles. Rotary atomizers can handle large feed rates but use more energy. Pressure nozzles have a simple design but are prone to clogging. Two-fluid nozzles produce a range of droplet sizes using compressed air. Pneumatic nozzles also produce very small particles but use more energy. Common applications of spray drying nozzles include dairy products, foods, chemicals, and more.
- Spray drying and drum drying are two common methods for dehydrating milk into powder.
- In spray drying, milk is evaporated, sprayed into hot air as fine droplets, and dried. In drum drying, concentrated milk is applied to heated rotating drums and dried.
- Milk powder has a longer shelf life than liquid milk and can be stored and transported more easily while retaining similar nutritional value when reconstituted. However, drying requires a large amount of energy.
The document summarizes the objectives, equipment, theory, methodology, and procedures for conducting an experiment using a spray dryer. The objectives are to calculate heat effects and determine dry solids recovery efficiency. Equipment includes a spray dryer, compressor, materials like detergent and water. The methodology describes preparing a detergent slurry, collecting experimental data during startup and operation, and shut down procedures.
Biedrība “Latvijas SOS Bērnu ciematu asociācija” 2012.gadā no septembra līdz decembrim īstenoja “Vienaudžu izpētes projektu “Patstāvīgas dzīves uzsākšana pēc ārpusģimenes aprūpes””. Pētījumā izlases veidā tika intervēti 100 jaunieši, kuri gatavojas patstāvīgai dzīvei pēc aprūpes vai ir jau uzsākuši patstāvīgu dzīvi vecumā no 15 – 29 gadiem no visas Latvijas. Intervijas veica 10 jaunieši vecumā no 18 – 21 gadam, kuriem ir pieredze dzīvojot dažādos ārpusģimenes aprūpes veidos (audžuģimene, SOS bērnu ciemats, institūcijas).
Viens no galvenajiem pētījuma secinājumiem, ko jaunieši norāda ir finansiāla atbalsta trūkums, tai pat laikā norādot, ka arī emocionāls un morāls atbalsts viņiem ir ļoti būtisks. Lielākā daļa patstāvīgā dzīvē esošie jaunieši norāda, ka galvenā mācība dzīvē ir, ka paļauties var tikai uz sevi un neviens cits nepalīdzēs. Vienlaikus jaunieši min tādas grūtības kā mācību apvienošana ar darbu, jo nav neviena, kurš varētu atbalstīt, izņemot pašvaldību sniegto minimālo finansiālo palīdzību, kā arī atsevišķos gadījumos problēmas ar dzīvojamo platību. Viena no lielākajām problēmāma ar kuru jaunieši saskaras ir kredīti, kurus liela daļa aizņēmusies, bet nespēj atdot.
Pētījums tika veikts kampaņas „Patstāvīga dzīve” ietvaros, kuru asociācija realizē kopš 2011.gada, lai pilnveidotu atbalsta sistēmu jauniešiem, kuri uzsāk patstāvīgu dzīvi pēc aprūpes. Balstoties uz pētījuma rezultātiem tika sagatavoti rakstiski priekšlikumi, kuri ir iesniegti Labklājības ministrijā un Valsts bērnu tiesību aizsardzības inspekcijā un 2013.gadā tiks veidotas diskusijas un semināri speciālistiem.
Este documento trata sobre vigilancia tecnológica e inteligencia competitiva. Explica conceptos clave como vigilancia del entorno, organización de la vigilancia en la empresa, herramientas básicas como bases de datos y patentes, e inteligencia competitiva. También menciona el método Delphi y ofrece ejemplos para ilustrar estos temas.
Dokumen tersebut merangkum profil dan karier politik Joko Widodo sebagai Gubernur DKI Jakarta. Dokumen tersebut juga menampilkan hasil survei publik yang menunjukkan sikap positif mayoritas masyarakat terhadap kepemimpinan Jokowi, isu-isu hot yang sering dibahas terkait dirinya seperti mobil murah, dan perdebatan apakah dirinya layak maju sebagai calon presiden pada 2014.
Este documento proporciona información sobre antivirus y virus informáticos. Explica los síntomas que indican la presencia de un virus, define antivirus y firewall, y describe varios tipos comunes de malware como virus, gusanos, phishing y ransomware. También enumera ejemplos populares de software antivirus y explica características clave de estos programas.
Este documento presenta el programa de la cuarta edición de Innova Bilbao, un evento de dos días sobre innovación que tendrá lugar los días 15 y 16 de abril en el Museo Guggenheim de Bilbao. Veinticuatro especialistas de diferentes ámbitos como la cultura, la política, la economía y el emprendimiento ofrecerán sus perspectivas sobre temas como la comunicación digital, el marketing, el posicionamiento en internet y las redes sociales. El objetivo es que los asistentes aprendan sobre innovación y puedan aplicar estas enseñanzas a sus respect
Este documento define las tecnologías de la información y la comunicación (TIC) y explica que se refiere a los recursos, procedimientos y técnicas utilizados para procesar, almacenar y transmitir información. Luego proporciona ejemplos históricos de innovaciones en informática, información y comunicación, incluidos el abaco, la calculadora mecánica, la radio, la televisión a color y los teléfonos móviles. El documento concluye agradeciendo la atención del lector.
Este documento presenta el plan de estudios de un curso de biología marina y laboratorio. El curso se centra en tres deportes principales: básquetbol, voleibol y balonmano. Cada unidad didáctica cubre las reglas básicas, habilidades técnicas y juegos cooperativos/competitivos de cada deporte. También incluye una unidad transversal sobre el cuerpo humano, salud, higiene y nutrición. El profesor utilizará estrategias como discusión en grupo y trabajo de pares para
El documento compara programas de Office, señalando que Word es para procesamiento de texto mientras que Excel es para hojas de cálculo, aunque ambos permiten pasar archivos entre sí. También indica que Publisher se usa para publicidad y marketing, PowerPoint para presentaciones multimedia, y que la mayoría de programas de Office son compatibles entre sí.
El documento presenta información sobre el perfil del comprador online en España según estudios. Explica que son hombres entre 25-49 años, urbanos, de nivel socioeconómico medio-alto y frecuentes usuarios de internet. También analiza factores que fidelizan a los compradores online como satisfacerlos con el producto/servicio, volver a darles oportunidades de compra y ser siempre la mejor opción. Finalmente, presenta algunas tiendas online españolas y sus estadísticas.
Cifras 2015. Mujeres y hombres en Euskadi 2015Irekia - EJGV
Este documento presenta cifras estadísticas sobre la situación de mujeres y hombres en el País Vasco en 2015. Incluye datos demográficos, de educación, empleo, recursos económicos, salud y participación. En educación, destaca que las mujeres superan a los hombres en tasas de graduación universitaria. En empleo, las tasas de actividad y empleo son más altas entre los hombres, mientras que ellas asumen más trabajo reproductivo no remunerado. En salud, ellas viven más pero enfrentan mayores
The document outlines the course objectives and content for a product design and development course. The course aims to provide basic concepts of product design, features, and architecture. It covers five units: introduction to integrated product and process development; concept generation and selection; product architecture; industrial design; and design for manufacturing and product development. Assessment involves students developing a physical prototype with a demonstrable market need, requiring fewer than 10 parts and no major technological breakthroughs, on a limited budget and using campus labs. Maintaining documentation is emphasized to support effective project planning and management.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
Time is of the Essence: Creating a New Synergy Between Single-Use Adopters an...MilliporeSigma
Biopharmaceutical companies race to achieve milestones, advance promising molecules, improve productivity and reduce costs. In addition to perfecting the biology, companies must grapple with challenges such as standardization of process technology, supply security and process economics, especially in light of the burgeoning interest and adoption of single-use systems. Efficient implementation of single-use systems is more than incorporating disposable components into the process. It requires a new approach by suppliers of these systems to nimbly and effectively address such challenges.
This session will highlight best practices for creating a new synergy between biopharmaceutical companies and single-use suppliers to strike the right balance of design flexibility, supply predictability and reliable lead times necessary to beat the clock. A case study describing a more efficient and practical “bottoms-up” approach to configuring and delivering single-use assemblies will be presented.
In this webinar, you will learn:
- How to choose single-use assemblies that are best suited for your process
- Risk reduction strategies that incorporate stock or specialized single-use assemblies vs. custom solutions
- Best practices to strike the right balance of design flexibility and supply predictability
Time is of the Essence: Creating a New Synergy Between Single-Use Adopters an...Merck Life Sciences
Biopharmaceutical companies race to achieve milestones, advance promising molecules, improve productivity and reduce costs. In addition to perfecting the biology, companies must grapple with challenges such as standardization of process technology, supply security and process economics, especially in light of the burgeoning interest and adoption of single-use systems. Efficient implementation of single-use systems is more than incorporating disposable components into the process. It requires a new approach by suppliers of these systems to nimbly and effectively address such challenges.
This session will highlight best practices for creating a new synergy between biopharmaceutical companies and single-use suppliers to strike the right balance of design flexibility, supply predictability and reliable lead times necessary to beat the clock. A case study describing a more efficient and practical “bottoms-up” approach to configuring and delivering single-use assemblies will be presented.
In this webinar, you will learn:
- How to choose single-use assemblies that are best suited for your process
- Risk reduction strategies that incorporate stock or specialized single-use assemblies vs. custom solutions
- Best practices to strike the right balance of design flexibility and supply predictability
Industrial Bioprocessing Simulation and Modelling
The document discusses industrial bioprocessing, simulation, and modeling. It provides an overview of bioprocessing history and applications. Process simulation and modeling tools are used to optimize efficiency without extensive experimentation. Downstream processing aims to purify products through techniques like filtration. Process design considers product properties and impurities. Scale-up requires maintaining parameters like bed height and velocity. Career opportunities exist in engineering and science roles in biopharmaceutical industries, with salary packages ranging from 3.25-8 LPA depending on level.
final no-2 U too brutus persentation[1].pptxssusera46859
The document discusses product design and process selection. It describes new product development which involves problem assessment, design specification, idea generation, screening ideas, and business analysis. The key steps of product design are concept design, detailed design, prototype production and testing, manufacturing, and commercialization. Process selection determines the type of production process. Process development involves process research, pilot development, capacity consideration, commercial plant transfer, and enhanced capacity optimization.
Quality by Design (QbD) is a scientific approach that formalizes product design and streamlines troubleshooting. It uses a systematic approach to ensure quality by developing a thorough understanding of a product's compatibility with all manufacturing components and processes. Instead of relying solely on finished product testing, QbD provides insights throughout development. As a result, quality issues can be efficiently analyzed and their root causes quickly identified.
The document discusses requirements management and connected development environments. It promotes managing requirements as integrated artifacts in a central repository rather than documents. This allows all stakeholders to collaborate on requirements and be automatically notified of any changes. Key benefits include ensuring all teams are working from the same requirements, eliminating guessing about requirements status or changes, and enabling effective impact analysis when requirements change. The document provides examples of managing requirements throughout the entire lifecycle from initial capture through implementation and maintenance.
The document summarizes the objectives, equipment, theory, methodology, and procedures for conducting an experiment using a spray dryer. The objectives are to calculate heat effects and determine dry solids recovery efficiency. Equipment includes a spray dryer, compressor, materials like detergent and water. The methodology describes preparing a detergent slurry, collecting experimental data during startup and operation, and shut down procedures.
Biedrība “Latvijas SOS Bērnu ciematu asociācija” 2012.gadā no septembra līdz decembrim īstenoja “Vienaudžu izpētes projektu “Patstāvīgas dzīves uzsākšana pēc ārpusģimenes aprūpes””. Pētījumā izlases veidā tika intervēti 100 jaunieši, kuri gatavojas patstāvīgai dzīvei pēc aprūpes vai ir jau uzsākuši patstāvīgu dzīvi vecumā no 15 – 29 gadiem no visas Latvijas. Intervijas veica 10 jaunieši vecumā no 18 – 21 gadam, kuriem ir pieredze dzīvojot dažādos ārpusģimenes aprūpes veidos (audžuģimene, SOS bērnu ciemats, institūcijas).
Viens no galvenajiem pētījuma secinājumiem, ko jaunieši norāda ir finansiāla atbalsta trūkums, tai pat laikā norādot, ka arī emocionāls un morāls atbalsts viņiem ir ļoti būtisks. Lielākā daļa patstāvīgā dzīvē esošie jaunieši norāda, ka galvenā mācība dzīvē ir, ka paļauties var tikai uz sevi un neviens cits nepalīdzēs. Vienlaikus jaunieši min tādas grūtības kā mācību apvienošana ar darbu, jo nav neviena, kurš varētu atbalstīt, izņemot pašvaldību sniegto minimālo finansiālo palīdzību, kā arī atsevišķos gadījumos problēmas ar dzīvojamo platību. Viena no lielākajām problēmāma ar kuru jaunieši saskaras ir kredīti, kurus liela daļa aizņēmusies, bet nespēj atdot.
Pētījums tika veikts kampaņas „Patstāvīga dzīve” ietvaros, kuru asociācija realizē kopš 2011.gada, lai pilnveidotu atbalsta sistēmu jauniešiem, kuri uzsāk patstāvīgu dzīvi pēc aprūpes. Balstoties uz pētījuma rezultātiem tika sagatavoti rakstiski priekšlikumi, kuri ir iesniegti Labklājības ministrijā un Valsts bērnu tiesību aizsardzības inspekcijā un 2013.gadā tiks veidotas diskusijas un semināri speciālistiem.
Este documento trata sobre vigilancia tecnológica e inteligencia competitiva. Explica conceptos clave como vigilancia del entorno, organización de la vigilancia en la empresa, herramientas básicas como bases de datos y patentes, e inteligencia competitiva. También menciona el método Delphi y ofrece ejemplos para ilustrar estos temas.
Dokumen tersebut merangkum profil dan karier politik Joko Widodo sebagai Gubernur DKI Jakarta. Dokumen tersebut juga menampilkan hasil survei publik yang menunjukkan sikap positif mayoritas masyarakat terhadap kepemimpinan Jokowi, isu-isu hot yang sering dibahas terkait dirinya seperti mobil murah, dan perdebatan apakah dirinya layak maju sebagai calon presiden pada 2014.
Este documento proporciona información sobre antivirus y virus informáticos. Explica los síntomas que indican la presencia de un virus, define antivirus y firewall, y describe varios tipos comunes de malware como virus, gusanos, phishing y ransomware. También enumera ejemplos populares de software antivirus y explica características clave de estos programas.
Este documento presenta el programa de la cuarta edición de Innova Bilbao, un evento de dos días sobre innovación que tendrá lugar los días 15 y 16 de abril en el Museo Guggenheim de Bilbao. Veinticuatro especialistas de diferentes ámbitos como la cultura, la política, la economía y el emprendimiento ofrecerán sus perspectivas sobre temas como la comunicación digital, el marketing, el posicionamiento en internet y las redes sociales. El objetivo es que los asistentes aprendan sobre innovación y puedan aplicar estas enseñanzas a sus respect
Este documento define las tecnologías de la información y la comunicación (TIC) y explica que se refiere a los recursos, procedimientos y técnicas utilizados para procesar, almacenar y transmitir información. Luego proporciona ejemplos históricos de innovaciones en informática, información y comunicación, incluidos el abaco, la calculadora mecánica, la radio, la televisión a color y los teléfonos móviles. El documento concluye agradeciendo la atención del lector.
Este documento presenta el plan de estudios de un curso de biología marina y laboratorio. El curso se centra en tres deportes principales: básquetbol, voleibol y balonmano. Cada unidad didáctica cubre las reglas básicas, habilidades técnicas y juegos cooperativos/competitivos de cada deporte. También incluye una unidad transversal sobre el cuerpo humano, salud, higiene y nutrición. El profesor utilizará estrategias como discusión en grupo y trabajo de pares para
El documento compara programas de Office, señalando que Word es para procesamiento de texto mientras que Excel es para hojas de cálculo, aunque ambos permiten pasar archivos entre sí. También indica que Publisher se usa para publicidad y marketing, PowerPoint para presentaciones multimedia, y que la mayoría de programas de Office son compatibles entre sí.
El documento presenta información sobre el perfil del comprador online en España según estudios. Explica que son hombres entre 25-49 años, urbanos, de nivel socioeconómico medio-alto y frecuentes usuarios de internet. También analiza factores que fidelizan a los compradores online como satisfacerlos con el producto/servicio, volver a darles oportunidades de compra y ser siempre la mejor opción. Finalmente, presenta algunas tiendas online españolas y sus estadísticas.
Cifras 2015. Mujeres y hombres en Euskadi 2015Irekia - EJGV
Este documento presenta cifras estadísticas sobre la situación de mujeres y hombres en el País Vasco en 2015. Incluye datos demográficos, de educación, empleo, recursos económicos, salud y participación. En educación, destaca que las mujeres superan a los hombres en tasas de graduación universitaria. En empleo, las tasas de actividad y empleo son más altas entre los hombres, mientras que ellas asumen más trabajo reproductivo no remunerado. En salud, ellas viven más pero enfrentan mayores
The document outlines the course objectives and content for a product design and development course. The course aims to provide basic concepts of product design, features, and architecture. It covers five units: introduction to integrated product and process development; concept generation and selection; product architecture; industrial design; and design for manufacturing and product development. Assessment involves students developing a physical prototype with a demonstrable market need, requiring fewer than 10 parts and no major technological breakthroughs, on a limited budget and using campus labs. Maintaining documentation is emphasized to support effective project planning and management.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
Time is of the Essence: Creating a New Synergy Between Single-Use Adopters an...MilliporeSigma
Biopharmaceutical companies race to achieve milestones, advance promising molecules, improve productivity and reduce costs. In addition to perfecting the biology, companies must grapple with challenges such as standardization of process technology, supply security and process economics, especially in light of the burgeoning interest and adoption of single-use systems. Efficient implementation of single-use systems is more than incorporating disposable components into the process. It requires a new approach by suppliers of these systems to nimbly and effectively address such challenges.
This session will highlight best practices for creating a new synergy between biopharmaceutical companies and single-use suppliers to strike the right balance of design flexibility, supply predictability and reliable lead times necessary to beat the clock. A case study describing a more efficient and practical “bottoms-up” approach to configuring and delivering single-use assemblies will be presented.
In this webinar, you will learn:
- How to choose single-use assemblies that are best suited for your process
- Risk reduction strategies that incorporate stock or specialized single-use assemblies vs. custom solutions
- Best practices to strike the right balance of design flexibility and supply predictability
Time is of the Essence: Creating a New Synergy Between Single-Use Adopters an...Merck Life Sciences
Biopharmaceutical companies race to achieve milestones, advance promising molecules, improve productivity and reduce costs. In addition to perfecting the biology, companies must grapple with challenges such as standardization of process technology, supply security and process economics, especially in light of the burgeoning interest and adoption of single-use systems. Efficient implementation of single-use systems is more than incorporating disposable components into the process. It requires a new approach by suppliers of these systems to nimbly and effectively address such challenges.
This session will highlight best practices for creating a new synergy between biopharmaceutical companies and single-use suppliers to strike the right balance of design flexibility, supply predictability and reliable lead times necessary to beat the clock. A case study describing a more efficient and practical “bottoms-up” approach to configuring and delivering single-use assemblies will be presented.
In this webinar, you will learn:
- How to choose single-use assemblies that are best suited for your process
- Risk reduction strategies that incorporate stock or specialized single-use assemblies vs. custom solutions
- Best practices to strike the right balance of design flexibility and supply predictability
Industrial Bioprocessing Simulation and Modelling
The document discusses industrial bioprocessing, simulation, and modeling. It provides an overview of bioprocessing history and applications. Process simulation and modeling tools are used to optimize efficiency without extensive experimentation. Downstream processing aims to purify products through techniques like filtration. Process design considers product properties and impurities. Scale-up requires maintaining parameters like bed height and velocity. Career opportunities exist in engineering and science roles in biopharmaceutical industries, with salary packages ranging from 3.25-8 LPA depending on level.
final no-2 U too brutus persentation[1].pptxssusera46859
The document discusses product design and process selection. It describes new product development which involves problem assessment, design specification, idea generation, screening ideas, and business analysis. The key steps of product design are concept design, detailed design, prototype production and testing, manufacturing, and commercialization. Process selection determines the type of production process. Process development involves process research, pilot development, capacity consideration, commercial plant transfer, and enhanced capacity optimization.
Quality by Design (QbD) is a scientific approach that formalizes product design and streamlines troubleshooting. It uses a systematic approach to ensure quality by developing a thorough understanding of a product's compatibility with all manufacturing components and processes. Instead of relying solely on finished product testing, QbD provides insights throughout development. As a result, quality issues can be efficiently analyzed and their root causes quickly identified.
The document discusses requirements management and connected development environments. It promotes managing requirements as integrated artifacts in a central repository rather than documents. This allows all stakeholders to collaborate on requirements and be automatically notified of any changes. Key benefits include ensuring all teams are working from the same requirements, eliminating guessing about requirements status or changes, and enabling effective impact analysis when requirements change. The document provides examples of managing requirements throughout the entire lifecycle from initial capture through implementation and maintenance.
In this presentation, we will discuss the concept and interrelation between product and process design and product life cycle. We will also talk about key decisions required in process design and evaluation of process design.
To know more about Welingkar School’s Distance Learning Program and courses offered, visit: http://www.welingkaronline.org/distance-learning/online-mba.html
The document discusses product design and development. It describes the six phases of the product development process: product planning, concept development, system-level design, detail design, testing and refinement, and production ramp-up. Key aspects of each phase are identified. The document also discusses product verification, validation, testing, and the roles involved in product development teams. Product development involves a range of technical, marketing, and financial activities, while product design focuses specifically on meeting technical requirements.
Quality By Design Total Quality ManagementBint E Asif
The document discusses key aspects of Quality by Design (QbD), including:
- Definitions of quality and QbD
- Benefits of QbD such as faster product development and better quality
- Tools used in QbD such as design of experiments, statistical process control, and computer-aided manufacturing
- Potential misconceptions around QbD such as confusing it with inspection techniques or believing it guarantees success
- Pitfalls to avoid like changing specifications during design or using tight tolerances to force a one-pass design
The Software Product Development Process every business should knowPixel Crayons
This PPT describes the software product development lifecycle. After reading this PPT, you will be aware about the Software production lifecycle and its associate process. Have a look at it:
The document discusses pilot plant scale up. It defines a pilot plant as transforming a lab scale formula into a viable product through developing a reliable manufacturing process. The objectives of pilot plant scale up are to test the process on a model before committing money to full production, examine the formula's ability to withstand larger scale and modifications, evaluate and validate the process and equipment, identify critical process features, provide manufacturing guidelines and instructions to avoid scale-up problems. The document outlines steps in scale up and discusses pilot plant design and scaling up liquid and semi-solid dosage forms.
implementation of product design and development on floor cleaner VenugopalraoSuravara
This document outlines the thesis layout for a product development project. It includes sections for an abstract, introduction, literature review, methodology, design and analysis, results and discussion, conclusion, and references. The methodology section describes the product development process, including opportunity identification, product planning, identifying customer needs, concept generation, selection and testing, product architecture, design for manufacturing, and design for environment. It then provides details on the design of a self-reconfigurable floor cleaning tiling robot, including CAD modeling and structural analysis using different materials. The document concludes that carbon fiber is the best material for the robot's roller brushes based on stress and deformation results.
This document discusses the implications if product performance and specifications are not met during new product development. It begins by defining product performance and describing the typical new product development process, which consists of 5 phases: need identification and conceptual design, detail design, component development, prototype development, and production. It emphasizes the importance of establishing desired product performance based on business objectives early in the process. It also discusses how predicted and actual product performance should match the desired specifications for a new product to be successful. If performance does not meet specifications, the development process may need to iterate back to earlier phases to make changes. Overall, not meeting product specifications can result in higher costs, reduced revenue, and delays in product launch.
6 Tips to Accelerate MedTech Time To Clinical DataAndy Rogers
Key Tech saved CoolTech, a startup MedTech company greater than $1 million in development costs and reduced the time required to get to clinical data by six months.
In our newest case study, we outline our expertise in driving speed to clinical data and reducing development costs and time substantially.
Karthikeyan Jayaprakash is a mechanical design engineer with 4.8 years of experience in medical product design and development. He has skills in SolidWorks, AutoCAD, mechanical design, NX Unigraphics, and other areas. Some of his project experiences include designing a charging dock for dental lasers, developing a pressure profile test fixture for laparoscopic devices, and converting legacy designs to new CAD software. He aims to contribute his knowledge and experience through teamwork to help companies achieve their objectives.
Product design and value engineering (PDVE) Ch 1 introductionChirag Patel
This chapter discusses product design and value engineering. It introduces key concepts like concurrent engineering, quality function deployment, and design for X. It describes techniques for product development including failure mode and effects analysis and computation tools. These tools help optimize the design, manufacturing, and life cycle of the product. The chapter also covers characteristics of firms providing these services and challenges of product development.
Introduction to Engineering Design ProcessLk Rigor
Mapúa Institute of Technology
Codes and Specifications
COE134/B2 Group 1
Source:
Haik, Y. and T. Shahin. (2011). "Engineering Design Process." Stamford: Cengage Learning.
Similar to Scott Ellis Ai Ch E 2010 Annual Meeting Qb D Strategy (20)
19. 19
Coated Particle Blend
• Rationale for selection of spray drying process:
• Produce particles with a spherical, smooth morphology to facilitate
efficient particle coating.
• Produce small particles with narrow size distribution to provide good
mouth feel.
• Produce particles with median size comparable to other excipients to
ensure efficient blending and content uniformity.
• Challenge:
• To achieve target drug load, particles must be spray dried from an
aqueous suspension containing about 35% (w/w) API + 15% binder. API is
jet‐milled before use. The combination of high feedstock solids content
+ small API particle size results in a highly thixotropic feedstock.
Processing this feedstock requires additional technology development.
AIChE 2010 Annual Meeting – Copyright Scott Ellis Ph.D. – Use by Permission Only
22. 22
Particle Blend – Results
• Taste and mouth feel requirements were established through
taste panel studies (Element 2: Measure).
• Small, smooth particles had best taste and mouth feel (easier to coat
uniformly; no thin spots; not “gritty”).
• Design spaces were developed for the spray drying and coating
processes:
• Particle size / distribution / morphology were mapped against feed
viscosity, atomizer speed, and drying rate.
• In vitro release rates were mapped against particle properties for given
fluid bed coating conditions.
• Coating design space was overlapped with spray drying design space to
establish common performance window.
• Size distribution needed for fluid bed coating was narrower than the size
distribution achievable by spray drying, driving need for a sieving step.
• Desired minimal in vitro release rate was reconciled against need for fast
in vivo bioavailability through common response surface DOE.
AIChE 2010 Annual Meeting – Copyright Scott Ellis Ph.D. – Use by Permission Only
23. 23
Particle Blend – Process Notes
• Key process variables:
• Atomizer rotational speed
• Particle size and distribution are reduced at higher speeds.
• Drying rate
• Particle morphology becomes less uniform at higher evaporation rates.
Ideal rate may conflict with dryer residence time.
• Feedstock viscosity / flow rate
• Control ensures uniform flow to atomizer.
• Maximize flow rate to minimize viscosity / improve atomization.
• Other notes:
• In‐line viscosity monitoring is an important tool for control of particle
consistency.
• Atomizer hardware design / characterization is important for handling
of non‐Newtonian suspensions – should be captured through a parallel
development effort.
AIChE 2010 Annual Meeting – Copyright Scott Ellis Ph.D. – Use by Permission Only
25. 25
Direct Compression Tablet
• Rationale for selection of spray congealing process:
• Produce small particles to improve release rate of poorly soluble drug
(higher surface area).
• API is a waxy solid not amenable to traditional milling, granulation, and
drying techniques.
• API can be melted with no loss of activity or stability.
• Challenges:
• Particle flowability is poor, but may be improved through addition of
small amount of glidant as dispersed solid. Glidant must be stable at
process temperatures.
• Handling and spraying a moderate‐viscosity (slightly non‐Newtonian)
melt is uncommon and requires additional technology development.
AIChE 2010 Annual Meeting – Copyright Scott Ellis Ph.D. – Use by Permission Only
28. 28
Direct Compression Tablet – Results
• Minimum drug bioavailability was set in Product Requirements
exercise (Element 1: Design).
• Enabled backward analysis to define minimum in vitro dissolution rate
(heuristic approach).
• A “window” of attributes was determined by evaluating a range
of particle sizes, distributions, and glidant contents.
• Dissolution rate became more variable with increasing particle size
distribution >> defined maximum allowable distribution for a given
median size.
• Dissolution rate increased with decreasing median size and increasing
surface area.
• Tablet hardness control became more difficult with decreasing median size
>> need to re‐loop with a third DOE combining all product attributes vs.
particle size (response surface optimization).
• Glidant content had no apparent impact on dissolution rate.
AIChE 2010 Annual Meeting – Copyright Scott Ellis Ph.D. – Use by Permission Only
29. 29
Direct Compression Tablet – Process Notes
• DOE on process conditions vs. particle properties
• Decoupled spray congealing process performance from final product
attributes – simplified data analysis.
• Key process variables:
• Atomizer rotational speed
• Direct impact on median particle size and distribution.
• Cooling capacity
• Complete particle solidification is needed before particles contact vessel
walls (or deformation / agglomeration may occur).
• Feedstock viscosity
• Control ensures uniform flow to atomizer.
• Interesting PAT opportunity: Fluctuations in feedstock temperature
result in small changes in viscosity. This parameter may then be
measured in‐line to ensure feedstock consistency and product dose
content uniformity.
AIChE 2010 Annual Meeting – Copyright Scott Ellis Ph.D. – Use by Permission Only