The moisture content within a freeze dried material has a direct effect on the glass transition (Tg) of the material.
Moisture content across a shelf or batch may vary, causing discrepencies or even stability issues.
Use Of Freeze Drying Microscopy To Determine Critical ParametersBTL
Freeze-drying microscopy (FDM) allows observation of materials during freeze-drying at the microscopic level. FDM can determine critical parameters like collapse temperature and eutectic temperature prior to lyophilization. It does this by observing changes in sample structure as the temperature is varied, such as when the sample collapses or melts. FDM provides visual information on various freeze-drying phenomena that can be useful for formulation and process development.
Alternatives To Lyophilization Visiongain Lyo SearlesJim Searles
1. The document discusses alternatives to lyophilization for drying pharmaceuticals and biologics, including spray drying, bubble drying, spray-freeze drying, stirred freeze drying, and foam drying.
2. It provides details on various drying processes and technologies such as Aktiv-Dry bubble drying and Niro spray drying systems. Case studies are presented on drying different materials like vaccines, antibodies, and insulin using these alternative methods.
3. Comparative results from studies drying live virus vaccines and monoclonal antibodies using lyophilization, spray drying, and foam drying are described, showing in some cases alternatives like foam drying produced more stable products.
A stabilizing process in which a substance is first frozen and then the quantity of the solvent is reduced, first by sublimation (primary drying stage) and then desorption (secondary drying stage) to values that will no longer support biological activity or chemical reactions
Lyostat4 freeze drying microscope provides brighter, clearer images for easy analysis of formulations for freeze drying. Freeze drying microscopy is used to identify the collapse temperature of a product, which is necessary for product and process development.
Freeze drying, also known as lyophilization, is a process used to preserve thermolabile materials such as foods, biological products, and pharmaceuticals. It works by freezing the material and then reducing the pressure and adding heat to allow the frozen solvent, such as water, to sublimate from the solid phase to gas phase without passing through the liquid phase. The process involves three main stages - freezing, primary drying where sublimation occurs, and secondary drying where remaining bound water is removed. Freeze drying preserves materials by removing water while retaining the material's structure, allowing heat-sensitive substances to be dried and stored without refrigeration.
Definition of drying
Importance of drying
Difference between drying and evaporation
Equipments
References
Definition
A stabilizing process in which a substance is first frozen and then the quantity of the solvent is reduced, first by sublimation (primary drying stage) and then desorption (secondary drying stage) to values that will no longer support biological activity or chemical reactions.
History
Freeze drying was first actively developed during WORLD WAR II transport of serum.
The main aim was to store the products without refrigeration and to remove moisture from thermolabile compounds.
Atlas in 1961 built 6 production freeze drying cabinet for Nestle group in Germany, Holland.
Principle
Lyophilization is carried out using a simple principle of physics sublimation. Sublimation is the transition of a substance from the solid to the vapour state, without first passing through an intermediate liquid phase.
Lyophilization is performed at temperature and pressure conditions below the triple point, to enable sublimation of ice.
The entire process is performed at low temperature and pressure by applying vacuum, hence is suited for drying of thermolabile compounds.
The concentration gradient of water vapour between the drying front and condenser is the driving force for removal of water during lyophilization.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Use Of Freeze Drying Microscopy To Determine Critical ParametersBTL
Freeze-drying microscopy (FDM) allows observation of materials during freeze-drying at the microscopic level. FDM can determine critical parameters like collapse temperature and eutectic temperature prior to lyophilization. It does this by observing changes in sample structure as the temperature is varied, such as when the sample collapses or melts. FDM provides visual information on various freeze-drying phenomena that can be useful for formulation and process development.
Alternatives To Lyophilization Visiongain Lyo SearlesJim Searles
1. The document discusses alternatives to lyophilization for drying pharmaceuticals and biologics, including spray drying, bubble drying, spray-freeze drying, stirred freeze drying, and foam drying.
2. It provides details on various drying processes and technologies such as Aktiv-Dry bubble drying and Niro spray drying systems. Case studies are presented on drying different materials like vaccines, antibodies, and insulin using these alternative methods.
3. Comparative results from studies drying live virus vaccines and monoclonal antibodies using lyophilization, spray drying, and foam drying are described, showing in some cases alternatives like foam drying produced more stable products.
A stabilizing process in which a substance is first frozen and then the quantity of the solvent is reduced, first by sublimation (primary drying stage) and then desorption (secondary drying stage) to values that will no longer support biological activity or chemical reactions
Lyostat4 freeze drying microscope provides brighter, clearer images for easy analysis of formulations for freeze drying. Freeze drying microscopy is used to identify the collapse temperature of a product, which is necessary for product and process development.
Freeze drying, also known as lyophilization, is a process used to preserve thermolabile materials such as foods, biological products, and pharmaceuticals. It works by freezing the material and then reducing the pressure and adding heat to allow the frozen solvent, such as water, to sublimate from the solid phase to gas phase without passing through the liquid phase. The process involves three main stages - freezing, primary drying where sublimation occurs, and secondary drying where remaining bound water is removed. Freeze drying preserves materials by removing water while retaining the material's structure, allowing heat-sensitive substances to be dried and stored without refrigeration.
Definition of drying
Importance of drying
Difference between drying and evaporation
Equipments
References
Definition
A stabilizing process in which a substance is first frozen and then the quantity of the solvent is reduced, first by sublimation (primary drying stage) and then desorption (secondary drying stage) to values that will no longer support biological activity or chemical reactions.
History
Freeze drying was first actively developed during WORLD WAR II transport of serum.
The main aim was to store the products without refrigeration and to remove moisture from thermolabile compounds.
Atlas in 1961 built 6 production freeze drying cabinet for Nestle group in Germany, Holland.
Principle
Lyophilization is carried out using a simple principle of physics sublimation. Sublimation is the transition of a substance from the solid to the vapour state, without first passing through an intermediate liquid phase.
Lyophilization is performed at temperature and pressure conditions below the triple point, to enable sublimation of ice.
The entire process is performed at low temperature and pressure by applying vacuum, hence is suited for drying of thermolabile compounds.
The concentration gradient of water vapour between the drying front and condenser is the driving force for removal of water during lyophilization.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Lyophilization, also known as freeze drying, is a process used to preserve thermolabile materials such as pharmaceuticals and food by removing water from the materials after they are frozen. The process involves freezing the material, reducing pressure to allow the frozen water to sublimate directly from the solid phase to gas phase, and then using low temperatures and pressure to remove remaining water. Freeze drying allows heat-sensitive materials to be dried without significant damage and results in a material that can be stored without refrigeration and reconstituted by adding water. Common applications of lyophilization include preserving vaccines, plasma, bacteria, and thermolabile pharmaceuticals to extend their shelf life.
Lyophilization, or freeze drying, is a process used to preserve thermolabile pharmaceutical products and biological materials. It works by freezing the product and then reducing pressure to allow the frozen water in the product to sublime from a solid to gas without passing through the liquid phase. This allows heat-sensitive materials to be dried without excessive heat damage. The process involves freezing the product, primary drying where ice is removed by sublimation under vacuum, and secondary drying where remaining bound water is removed by desorption. Freeze drying is useful for preserving materials like vaccines, blood products, enzymes and other biologics as it prevents degradation and improves stability at low temperatures.
Freeze dryers work by first freezing the material and then using sublimation to turn frozen water directly into a gas. The key parts are drying chambers, heating coils, a vapor condensing system, and a vacuum pump. Freeze drying preserves the quality, shape, and rehydration properties of materials like foods and biological samples since it occurs below the freezing point and does not require melting. Its applications include heat-sensitive materials like foods, pharmaceuticals, and biological cultures.
Lyophilization, also known as freeze drying, is a process that removes water from a material through sublimation while preserving its structure and composition. It works by first freezing the material and then reducing the pressure and increasing the temperature to allow the frozen water to change directly from solid to gas without passing through the liquid phase. A simple lyophilizer freezes materials on heated shelves, lowers the chamber pressure to 0.06 atmospheres using a vacuum pump, causing the frozen water to sublimate into a gas and condense on a freezing coil outside the chamber. Lyophilization is used to preserve bacterial and viral cultures, dry numerous products, and store water-damaged materials like manuscripts.
Lyophilization, or freeze drying, is a process that removes water from a frozen product under vacuum conditions, allowing ice to change directly from solid to vapor without passing through the liquid phase. The process consists of three main steps - freezing, primary drying where ice sublimates under vacuum, and secondary drying to remove residual moisture. Lyophilization is useful for drying thermolabile compounds as it occurs at low temperatures, resulting in a stable dry powder that can be reconstituted for use.
General consideration for process design of lyophilized productRajeev Sharma
Lyophilization is commonly used to improve stability and shelf life of injectable drugs like proteins, peptides, and liposomes. It involves three steps: freezing, primary drying where ice sublimates under vacuum, and secondary drying to remove bound water. Key considerations for lyophilization process design include excipient selection, filling container and closure system selection, pre-formulation studies, and ensuring the reconstituted product is suitable for injection. Process parameters like freezing rate and temperature, drying temperature and vacuum level must be optimized. Quality attributes of the lyophilized cake and reconstituted drug product are monitored through analytical testing and stability studies.
This document discusses lyophilization or freeze drying, which is a process used to dehydrate foods and pharmaceuticals. It involves freezing the material, reducing pressure to allow the frozen water to sublimate, and then further drying at a higher temperature to remove bound water. The key stages are pre-freezing, primary drying where ice sublimates, and secondary drying to remove bound water. Freeze drying retains nutrients, flavor, and texture better than other drying methods. It allows for long shelf life but is more expensive than other methods. Common industrial freeze dryers include tray and tunnel dryers.
This document provides an overview of the freeze drying (lyophilization) process. It discusses the three main steps: freezing, primary drying, and secondary drying. Freezing involves cooling the material below its freezing point. Primary drying occurs under vacuum where water sublimates from the frozen material. Secondary drying removes unfrozen water under higher temperature and lower pressure. The document also describes the components and working of freeze drying equipment, including the refrigeration system, vacuum system, product chamber, and condenser. Common excipients used in lyophilized formulations are discussed, such as bulking agents, stabilizers, and buffers.
This document provides an overview of lyophilization technology and freeze drying processes. It discusses:
1) The history of freeze drying including uses in medicine, food, and other industries.
2) How lyophilization works to remove water from pharmaceuticals through sublimation under reduced pressure and temperatures, leaving a dry and stable product.
3) The advantages of lyophilizing pharmaceuticals including improved stability, solubility, and ease of dosing compared to conventional drying methods.
4) Key aspects of the lyophilization process including heat and mass transfer dynamics and how process parameters like temperature, pressure and time impact the sublimation rate.
Lyophilization, or freeze drying, is a process used to preserve thermolabile materials such as pharmaceuticals and foods. It involves freezing the material and then reducing pressure and adding heat to allow the frozen solvent, such as water, to sublime from the solid phase to gas. This avoids damage from melting. Key advantages are retaining structure, heat sensitivity, and allowing storage at room temperature. The process uses vacuum chambers, refrigeration systems, and condensers to freeze and dry the material in stages. Common applications are heat-sensitive drugs and vaccines.
Freeze drying, also called lyophilization, is a process where material is frozen and then subjected to high vacuum pressure to sublime the frozen water in the form of vapor. It involves pretreating the product, freezing it, primary drying where ice sublimes under low pressure and heat, and secondary drying to remove remaining unfrozen water. Freeze drying retains most of the food's structure, flavor, and nutrients and produces a lightweight product with a long shelf life.
This document discusses lyophilization technology. It defines lyophilization as a process where a substance is first frozen and then dried under vacuum to remove solvent via sublimation and desorption. The document outlines the history, principle, objectives, steps, equipment, advantages and disadvantages of lyophilization. The key steps are freezing the product, applying a vacuum to enable solvent sublimation without passing through liquid phase, and using low temperatures to drive off moisture. Lyophilization allows thermolabile materials to be dried and improves stability, shelf life and reconstitution of products.
Founded in 1988, Pyramid Laboratories, Inc., is a contract parenteral drug manufacturer and analytical provider that serves both the pharmaceutical and biotechnology industries. Among the Pyramid Laboratories, Inc., offerings is its equipment, including a laboratory-scale lyophilizer as well as a differential scanning calorimeter, along with a team of scientists to optimize the formulation of the product for lyophilization, also known as freeze-drying.
This document discusses freeze drying (lyophilization), including its principles, stages of the process, methods of freezing materials, advantages, and applications. Freeze drying works by first freezing the material to be preserved and then removing water by sublimation under a vacuum. This preserves the material's structure and composition while removing moisture. Common applications of freeze drying include preserving pharmaceuticals, foods, and biological materials as it results in materials that can be stored at room temperature for extended periods of time.
Sublimation is a purification process where a solid transitions directly to its gas phase without passing through a liquid phase. It involves precise control of individual purification steps under vacuum or gas flow conditions. Sublimation is commonly used to purify pharmaceuticals and can also be used to create freeze-dried substances or porous drug tablets using a sublimating material like camphor. Another application is sublimating dye onto fabrics to create designs without affecting the fabric's feel or performance.
Preservation of Probiotic Bacteria by Freeze-Drying, and Achieving Stomach an...BTL
Preservation of Probiotic Bacteria by Freeze-Drying, and Achieving Stomach and Bile Acid Resistance: A TSB-funded research project by BTL, Microbial Development Ltd and the University of Cambridge.
The document discusses freeze drying and lyophilizer maintenance. It begins with an introduction to freeze drying and its importance. It then covers the freeze drying process sequence, calibration of lyophilizers, types of maintenance including preventative and corrective, and maintenance of lyophilizer components. Key aspects of maintenance discussed include calibration, cleaning, leak testing, and ensuring proper operation of systems like refrigeration, vacuum pumps and more. Routine maintenance is emphasized as important for reliable performance and quality results from freeze drying.
Every freeze-drying formulation has a critical temperature. During primary drying the formulation must be kept below this temperature in order to prevent processing defects or complete collapse. Improperly dried products will exhibit reduced levels of activity, decreased solubility, and poor stability - even if they do not look any different.
Freeze drying microscopy enables critical temperatures such as collapse, melting and freezing point to be quickly and easily identified with as little 2ml of the formulation. With this information freeze drying cycles can be designed that are efficient, robust and safe for your product.
Lyotherm2: Thermal Analyses for Freeze Drying CharacterisationBTL
Lyotherm is a novel analytical instrument that combines DTA and Impedance Analysis to provide a thorough understanding of a product's freeze drying characteristics.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
Lyophilization, also known as freeze drying, is a process used to preserve thermolabile materials such as pharmaceuticals and food by removing water from the materials after they are frozen. The process involves freezing the material, reducing pressure to allow the frozen water to sublimate directly from the solid phase to gas phase, and then using low temperatures and pressure to remove remaining water. Freeze drying allows heat-sensitive materials to be dried without significant damage and results in a material that can be stored without refrigeration and reconstituted by adding water. Common applications of lyophilization include preserving vaccines, plasma, bacteria, and thermolabile pharmaceuticals to extend their shelf life.
Lyophilization, or freeze drying, is a process used to preserve thermolabile pharmaceutical products and biological materials. It works by freezing the product and then reducing pressure to allow the frozen water in the product to sublime from a solid to gas without passing through the liquid phase. This allows heat-sensitive materials to be dried without excessive heat damage. The process involves freezing the product, primary drying where ice is removed by sublimation under vacuum, and secondary drying where remaining bound water is removed by desorption. Freeze drying is useful for preserving materials like vaccines, blood products, enzymes and other biologics as it prevents degradation and improves stability at low temperatures.
Freeze dryers work by first freezing the material and then using sublimation to turn frozen water directly into a gas. The key parts are drying chambers, heating coils, a vapor condensing system, and a vacuum pump. Freeze drying preserves the quality, shape, and rehydration properties of materials like foods and biological samples since it occurs below the freezing point and does not require melting. Its applications include heat-sensitive materials like foods, pharmaceuticals, and biological cultures.
Lyophilization, also known as freeze drying, is a process that removes water from a material through sublimation while preserving its structure and composition. It works by first freezing the material and then reducing the pressure and increasing the temperature to allow the frozen water to change directly from solid to gas without passing through the liquid phase. A simple lyophilizer freezes materials on heated shelves, lowers the chamber pressure to 0.06 atmospheres using a vacuum pump, causing the frozen water to sublimate into a gas and condense on a freezing coil outside the chamber. Lyophilization is used to preserve bacterial and viral cultures, dry numerous products, and store water-damaged materials like manuscripts.
Lyophilization, or freeze drying, is a process that removes water from a frozen product under vacuum conditions, allowing ice to change directly from solid to vapor without passing through the liquid phase. The process consists of three main steps - freezing, primary drying where ice sublimates under vacuum, and secondary drying to remove residual moisture. Lyophilization is useful for drying thermolabile compounds as it occurs at low temperatures, resulting in a stable dry powder that can be reconstituted for use.
General consideration for process design of lyophilized productRajeev Sharma
Lyophilization is commonly used to improve stability and shelf life of injectable drugs like proteins, peptides, and liposomes. It involves three steps: freezing, primary drying where ice sublimates under vacuum, and secondary drying to remove bound water. Key considerations for lyophilization process design include excipient selection, filling container and closure system selection, pre-formulation studies, and ensuring the reconstituted product is suitable for injection. Process parameters like freezing rate and temperature, drying temperature and vacuum level must be optimized. Quality attributes of the lyophilized cake and reconstituted drug product are monitored through analytical testing and stability studies.
This document discusses lyophilization or freeze drying, which is a process used to dehydrate foods and pharmaceuticals. It involves freezing the material, reducing pressure to allow the frozen water to sublimate, and then further drying at a higher temperature to remove bound water. The key stages are pre-freezing, primary drying where ice sublimates, and secondary drying to remove bound water. Freeze drying retains nutrients, flavor, and texture better than other drying methods. It allows for long shelf life but is more expensive than other methods. Common industrial freeze dryers include tray and tunnel dryers.
This document provides an overview of the freeze drying (lyophilization) process. It discusses the three main steps: freezing, primary drying, and secondary drying. Freezing involves cooling the material below its freezing point. Primary drying occurs under vacuum where water sublimates from the frozen material. Secondary drying removes unfrozen water under higher temperature and lower pressure. The document also describes the components and working of freeze drying equipment, including the refrigeration system, vacuum system, product chamber, and condenser. Common excipients used in lyophilized formulations are discussed, such as bulking agents, stabilizers, and buffers.
This document provides an overview of lyophilization technology and freeze drying processes. It discusses:
1) The history of freeze drying including uses in medicine, food, and other industries.
2) How lyophilization works to remove water from pharmaceuticals through sublimation under reduced pressure and temperatures, leaving a dry and stable product.
3) The advantages of lyophilizing pharmaceuticals including improved stability, solubility, and ease of dosing compared to conventional drying methods.
4) Key aspects of the lyophilization process including heat and mass transfer dynamics and how process parameters like temperature, pressure and time impact the sublimation rate.
Lyophilization, or freeze drying, is a process used to preserve thermolabile materials such as pharmaceuticals and foods. It involves freezing the material and then reducing pressure and adding heat to allow the frozen solvent, such as water, to sublime from the solid phase to gas. This avoids damage from melting. Key advantages are retaining structure, heat sensitivity, and allowing storage at room temperature. The process uses vacuum chambers, refrigeration systems, and condensers to freeze and dry the material in stages. Common applications are heat-sensitive drugs and vaccines.
Freeze drying, also called lyophilization, is a process where material is frozen and then subjected to high vacuum pressure to sublime the frozen water in the form of vapor. It involves pretreating the product, freezing it, primary drying where ice sublimes under low pressure and heat, and secondary drying to remove remaining unfrozen water. Freeze drying retains most of the food's structure, flavor, and nutrients and produces a lightweight product with a long shelf life.
This document discusses lyophilization technology. It defines lyophilization as a process where a substance is first frozen and then dried under vacuum to remove solvent via sublimation and desorption. The document outlines the history, principle, objectives, steps, equipment, advantages and disadvantages of lyophilization. The key steps are freezing the product, applying a vacuum to enable solvent sublimation without passing through liquid phase, and using low temperatures to drive off moisture. Lyophilization allows thermolabile materials to be dried and improves stability, shelf life and reconstitution of products.
Founded in 1988, Pyramid Laboratories, Inc., is a contract parenteral drug manufacturer and analytical provider that serves both the pharmaceutical and biotechnology industries. Among the Pyramid Laboratories, Inc., offerings is its equipment, including a laboratory-scale lyophilizer as well as a differential scanning calorimeter, along with a team of scientists to optimize the formulation of the product for lyophilization, also known as freeze-drying.
This document discusses freeze drying (lyophilization), including its principles, stages of the process, methods of freezing materials, advantages, and applications. Freeze drying works by first freezing the material to be preserved and then removing water by sublimation under a vacuum. This preserves the material's structure and composition while removing moisture. Common applications of freeze drying include preserving pharmaceuticals, foods, and biological materials as it results in materials that can be stored at room temperature for extended periods of time.
Sublimation is a purification process where a solid transitions directly to its gas phase without passing through a liquid phase. It involves precise control of individual purification steps under vacuum or gas flow conditions. Sublimation is commonly used to purify pharmaceuticals and can also be used to create freeze-dried substances or porous drug tablets using a sublimating material like camphor. Another application is sublimating dye onto fabrics to create designs without affecting the fabric's feel or performance.
Preservation of Probiotic Bacteria by Freeze-Drying, and Achieving Stomach an...BTL
Preservation of Probiotic Bacteria by Freeze-Drying, and Achieving Stomach and Bile Acid Resistance: A TSB-funded research project by BTL, Microbial Development Ltd and the University of Cambridge.
The document discusses freeze drying and lyophilizer maintenance. It begins with an introduction to freeze drying and its importance. It then covers the freeze drying process sequence, calibration of lyophilizers, types of maintenance including preventative and corrective, and maintenance of lyophilizer components. Key aspects of maintenance discussed include calibration, cleaning, leak testing, and ensuring proper operation of systems like refrigeration, vacuum pumps and more. Routine maintenance is emphasized as important for reliable performance and quality results from freeze drying.
Every freeze-drying formulation has a critical temperature. During primary drying the formulation must be kept below this temperature in order to prevent processing defects or complete collapse. Improperly dried products will exhibit reduced levels of activity, decreased solubility, and poor stability - even if they do not look any different.
Freeze drying microscopy enables critical temperatures such as collapse, melting and freezing point to be quickly and easily identified with as little 2ml of the formulation. With this information freeze drying cycles can be designed that are efficient, robust and safe for your product.
Lyotherm2: Thermal Analyses for Freeze Drying CharacterisationBTL
Lyotherm is a novel analytical instrument that combines DTA and Impedance Analysis to provide a thorough understanding of a product's freeze drying characteristics.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
Characterizing the freeze–drying behavior of model protein formulationsHau Vu
1) The document examines the freeze-drying behavior of three model proteins (lysozyme, BSA, IgG) under different conditions using various characterization techniques.
2) It finds some differences in freeze-drying behavior between the proteins at higher concentrations where the proteins influence the formulation more, but the differences are minimized at lower concentrations where excipients dominate.
3) Differences in cake morphology were seen between drying conditions and proteins, but protein structure and stability were equivalent for cakes made using different drying conditions.
Enhanced Process / Product Understanding and Control in Freeze Drying by usin...BTL
This presentation gives an overview into how advanced techniques such as manometric temperature measurement (MTM) and ice nucleation control can be used to enhance understanding of the freeze drying of your product, and provide additional control of its behaviour throughout the freeze drying cycle. This presentation was originally presented at Emerging Technologies in Freeze Drying, Stirling, 3rd April 2012.
The document provides guidance on preparing for a computer systems quality audit by outlining key elements of a quality assurance program including standard operating procedures, a change control program, and computer systems validation. It describes the components and purpose of the change control program and committees. It also lists important documents needed for a computer systems validation program including plans, procedures, and project documents.
BTL "Lyostat" and "Lyotherm" instruments are designed to provide information on "critical temperatures" that are necessary for successful freeze drying product and process development. This presentation gives a brief overview of critical temperatures and explains what the instruments are and how they function.
Microbiological Environmental Monitoring in Pharmaceutical Facilitydelli_intralab
Merupakan jurnal tentang microbiological environment monitoring in pharma facility
Untuk informasi lebih lanjut atau diskusi mengenai environment monitoring, silahkan hubungi delli.intralab@gmail.com
A drying process in which moisture is first converted to ice and then through reduced pressure and increase temperature it is directly converted to water vapor ( sublimation).
Complete process description, process parameters , types of freeze drying, case study of effect of different drying process on apple peels
Regulatory agencies like the FDA, WHO, EU, and PIC/S have established validation guidelines and requirements for the pharmaceutical industry. Process validation is required to provide documented evidence that manufacturing processes produce consistent and quality products meeting specifications. It involves qualification of facilities, equipment, utilities, and processes. Validation studies include design qualification, installation qualification, operational qualification, and performance qualification. Regulatory guidelines cover validation of automated processes, suppliers' test results, sterilization processes, and analytical methods. A validation master plan and validation reports are required documentation.
1) The Validation Master Plan (VMP) is a comprehensive document describing the validation requirements and plan for a pharmaceutical production facility. It was prepared by Vishal H. Parikh for his professor Ms. Krupa Thula.
2) The VMP includes details on qualification protocols, personnel responsibilities, schedules, documentation requirements, and change control procedures to ensure the facility and processes are appropriately validated.
3) The VMP development process involves identifying regulatory standards and developing protocols for installation, operational, and performance qualification to test facility and equipment operations. The VMP then guides ongoing validation activities and system changes.
This document provides an overview of computer validation and compliance with regulatory guidance. It discusses the need for computer validation and outlines key principles from guidance documents such as software validation, use of off-the-shelf software in medical devices, and validation of electronic records and signatures. Validation approaches for different systems and software are covered, including spreadsheets. The document provides references to FDA and international regulatory guidance on these topics.
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
The document provides an overview of a presentation on FDA Design Controls. It introduces the two presenters, David Amor and Jon Speer, who are experts in medical device quality systems and design controls. The presentation will cover topics related to design controls regulations, including intended use, user needs, design inputs, design reviews, risk management, design outputs, design verification and validation, and regulatory submissions. It is meant to help medical device companies understand and comply with FDA design control requirements.
This document discusses process validation in API facilities. It defines validation and describes the different types of validation including analytical tests, equipment, process, and support process validation. It also discusses facility systems validation including design qualification, installation qualification, operational qualification, and performance qualification. The types of validation including prospective, concurrent and retrospective are described. Process validation is important to demonstrate process control and consistency and comply with regulatory requirements. Process validation requires identifying critical process parameters and critical quality attributes.
The document provides an overview of microbial monitoring in a manufacturing area. It discusses:
1) The purpose of an environmental monitoring program is to provide crucial information on the quality of the aseptic processing environment during manufacturing and to prevent the release of contaminated batches.
2) Microbial monitoring tests for viable and non-viable particles in critical areas like cleanrooms, tank rooms, and packaging areas to demonstrate control of microorganisms.
3) Sources of contamination can come from air, personnel, equipment, cleaning agents and more. Monitoring must meet regulatory standards from agencies like FDA, ISO, and USP.
Freeze drying is a process that removes water from foods or other materials by freezing the product and then reducing pressure to allow the frozen water to sublimate from the solid to gas phase. It involves freezing, primary drying where the frozen water sublimates, and secondary drying to remove remaining unfrozen water. Freeze drying is useful for preserving foods, pharmaceuticals, and other temperature-sensitive materials as it avoids damaging heat and allows rehydration to the original state.
The document discusses drying equipment and processes. It describes how drying removes water from foods through circulating hot air to prevent bacterial growth. Tray dryers are introduced as widely used direct dryers that heat products through contact with circulating hot air inside an insulated chamber. The document outlines the two main drying periods and factors that influence drying rates. It also discusses various methods for determining when drying is complete.
Fouling, in technical language, it is the general term of unwanted material which is accumulating on surfaces, such as inside pipes, machines or heat exchanger.
This study evaluated the effects of ultrasound pretreatment on osmotic dehydration of mango cubes. Mangoes were cut into cubes and some samples received ultrasound pretreatment before being subjected to osmotic dehydration in a 45° Brix sucrose solution at 65°C. Samples were analyzed for water loss, solid gain, and effective diffusion coefficients over time. Results showed that ultrasound pretreatment increased water loss, solid gain, and the effective diffusivity of water and solids compared to samples without pretreatment. Modulated temperature differential scanning calorimetry was also used to characterize changes in the food matrix, such as increases in glass transition temperature, with decreasing moisture content.
Mitigation approches of climat change.pptxRamnathPotai
Ramnath Potai presented on approaches to mitigate climate change through studying plant responses. The presentation discussed what climate change is, its causes like greenhouse gas emissions, and its impacts like rising temperatures and sea levels. It described how stresses from climate change like drought, heat, and salinity affect plant growth. The presentation also discussed physiological responses in plants to increased CO2, temperature changes, and altered precipitation patterns. Finally, it proposed mitigation approaches like breeding stress-tolerant crops, agroforestry, and improved water management.
Drying is the process of removing small amounts of liquid, like water or volatile liquids, from a material by applying heat. It involves two operations - heat transfer and mass transfer. There are a few key differences between drying and evaporation, such as drying typically deals with removing small amounts of water from solids while evaporation removes larger amounts of water from liquids. Some common methods of drying include drum drying, spray drying, fluidized bed drying, tray drying, tunnel drying, and vacuum drying. Drying has several purposes like preservation, improving handling and characteristics, reducing costs, and purification of products.
Drying of fruit & vegetables- An approach for entrepreneurship DevelopmentTh Bidyalakshmi Devi
Drying is one of the easiest and commonly used food processing unit operations that can provide entrepreneurship development to a large extent. Drying of agricultural produce and selling of dried products can generate a huge amount of income.
This document contains instructions and questions for two experiments on modeling the water cycle and assessing infiltration. The first experiment uses a graduated cylinder, canning jar, petri dish, thermometer, hot water, water and ice to model evaporation, condensation and precipitation. The second experiment uses bags, sand, water and sunny/shady locations to study the effects of sunlight on evaporation and water movement between land and atmosphere. Post-lab questions ask students to analyze and draw conclusions from the results of each experiment.
GROUP 3 Relative Humidity Presentation.pptxLhilacAtun
Relative humidity is the amount of water vapor in the air relative to the maximum amount that could be present at that temperature. Plants respond physiologically to changes in relative humidity through transpiration and stomatal regulation. High or low humidity can impact plant growth. When humidity is high, transpiration decreases as stomata close, slowing photosynthesis and nutrient uptake. Low humidity may cause excess transpiration and water stress. Plants have adapted structures, physiological processes, and behaviors to cope with different humidity levels, such as dormancy, thickened cuticles, and positioning of stomata.
This document provides an overview of freeze drying, including:
1) Freeze drying involves removing water from a frozen product through sublimation without passing through the liquid phase. This allows for stable products that do not require refrigeration.
2) The freeze drying process has three stages - prefreezing, primary drying where ice is removed through sublimation, and secondary drying to further reduce residual moisture.
3) Key factors that must be carefully controlled are product temperature, system pressure, and collector temperature to encourage sublimation and water vapor flow from the product. Maintaining the proper temperature balance is essential for a successful freeze drying process.
Drying technology used in Pharmaceutical IndustryDebashis Purohit
Mr. Debashis Purohit presented on drying technology used in the pharmaceutical industry. He discussed four main drying techniques: fluidized bed drying, drum drying, rotary drying, and lyophilization (freeze drying). For each technique, he covered the principles, working, advantages, disadvantages, and uses. He concluded with two review articles discussing crystallization processes and freeze drying in more detail.
Freeze drying, also called lyophilization, involves removing water from a frozen product by turning the ice directly into vapor through sublimation. This allows heat-sensitive materials like proteins and antibiotics to be dried without damage.
The freeze drying process involves freezing the product, primary drying where ice sublimates under vacuum, secondary drying to remove bound water, and packaging. It has advantages like preserving heat-sensitive materials and allowing single-dose packaging, but is an expensive and time-consuming process suitable for selected products only. Common freeze dried pharmaceutical products include vaccines, blood products, and injectable drugs.
This document is a report on membrane or osmotic distillation submitted by a group of 5 chemical engineering students at Gujarat Technological University. It provides an introduction to membrane separation processes and membrane distillation. It discusses the process fundamentals, configurations including direct contact membrane distillation, air gap membrane distillation, sweeping gas membrane distillation and vacuum membrane distillation. It also discusses osmotic distillation and the characteristics of membranes used, including materials, pore size, porosity, tortuosity and thickness. Finally, it summarizes various commercial membranes that have been used for membrane distillation.
Applications of Ultrasound to modify and dried fruitsPoojaHorti
This document discusses applications of ultrasound to modify and improve dried fruits. It begins with definitions of ultrasound and discusses fruits that are suitable for drying. It explains that ultrasound drying can reduce energy consumption and drying times for fruits compared to conventional drying methods. Various ultrasound drying methods are described, including ultrasound-assisted convective drying, osmotic dehydration, vacuum drying, and freeze drying. Case studies demonstrate how ultrasound pretreatments and drying can increase the drying rate of fruits like strawberries, improve the quality of dried fruits, and retain polyphenols in apples. The conclusion is that ultrasound is effective for accelerating fruit drying processes and maintaining fruit quality compared to conventional drying.
Desalination of Sea Water using Membrane technologyChandni Sinha
The document discusses various desalination methods for obtaining fresh water from seawater. It begins by introducing the importance of desalination given increasing fresh water scarcity. There are two main types of desalination processes: thermal and membrane. Thermal processes involve boiling saline water to produce distilled water, while membrane processes use semi-permeable membranes to separate fresh water from salt water. The document then goes into detail about various thermal and membrane desalination methods, including multi-stage flash distillation, reverse osmosis, and nanofiltration. It also discusses factors involved in membrane development and selection.
This document discusses various post-harvest processes and technologies that can be used to maintain quality and extend the shelf life of fresh produce. It focuses on factors that affect the respiration and transpiration rates of produce, including temperature, relative humidity, and atmosphere composition. Maintaining optimal temperature and relative humidity levels through pre-cooling, refrigeration, and controlled atmosphere storage is key to reducing deterioration and losses. Other techniques mentioned include curing, coatings, controlled atmospheres, irradiation, and pest control methods. The aim of post-harvest handling is to delay senescence and avoid quality losses to maximize market opportunities.
This document discusses various methods of food drying. It begins by explaining the basic principles of drying, including vaporization and diffusion of moisture from the food surface and interior. It then covers the advantages of drying foods, such as long shelf life and ease of storage and transport. Various drying methods are described, including contact, vacuum, freeze and solar drying. The document provides details on each method and discusses their advantages and limitations. It also covers traditional sun drying and newer technologies like microwave, osmotic and superheated steam drying.
what is climate change...
Direct and indirect effects of climate change on plant processes:
Phenology,
Net carbon assimilation,
Water relation,
Grain development and quality,
Nutrient acquisition and yield
Streamlining Freeze Drying Development with BTL BTL
BTL provides freeze-drying services including product characterization, formulation development, cycle development, and process optimization. Their team has extensive experience developing over 1000 products. They utilize two proprietary instruments, the Lyostat freeze-drying microscope and Lyotherm frozen state analyzer, to empirically determine critical product temperatures to inform development. BTL aims to establish a quantitative and science-led approach to streamline clients' freeze-drying processes.
BTL are world-renowned freeze drying experts. Our experience covers small molecules, large complex biomolecules, cells, organisms, advanced materials and artefacts.
Large quantities of donated blood are discarded due to stability issues. Stocks of rare blood types rarely last more than a week. Therefore there is considerable value in achieving more stable material.
This study was carried out in conjunction with the University of Cambridge and sponsored by the UK TSB.
A Slow Freeze/Thaw Method for Cryopreservation of Mouse EmbryosBTL
This document provides instructions for cryopreserving mouse embryos using a slow freeze/thaw method. It describes preparing the embryos and straws, loading the embryos into straws, seeding the straws to initiate crystallization, and freezing the straws at a controlled rate of 0.5°C per minute to reach -30°C, before plunging them into liquid nitrogen for storage. Attention to details like equipment, labeling, timing and data management are emphasized to ensure high survival rates for the cryopreserved embryos.
Comparison of Lyophilisation Cycles for a BNCT agent using "traditional" and ...BTL
Two freeze drying cycles were designed, one by "traditional" methods, and one by SMART (R) Freeze Drying Technology developed by SP Scientific. The cycles were then analysed for efficacy and efficiency. This study was carried out by the University of Strathclyde.
A look at the issues that can affect lyophilization processes, and an introduction to techniques of thermal analysis for product characterization, formulation design and cycle optimization.
Emerging Technologies In Freeze Drying - Introduction to BPSBTL
The document summarizes an agenda for a conference on emerging technologies in freeze drying. The agenda includes presentations on using freeze drying microscopy to identify critical formulation parameters, using freeze drying in tissue engineering scaffold production, moisture mapping of a freeze dryer, and enabling process control in freeze drying through measurement of temperature, mass, and controlled nucleation technology. The document also provides information about freeze drying equipment manufacturers and service departments represented at the conference for food and pharmaceutical freeze drying applications.
HR search is critical to a company's success because it ensures the correct people are in place. HR search integrates workforce capabilities with company goals by painstakingly identifying, screening, and employing qualified candidates, supporting innovation, productivity, and growth. Efficient talent acquisition improves teamwork while encouraging collaboration. Also, it reduces turnover, saves money, and ensures consistency. Furthermore, HR search discovers and develops leadership potential, resulting in a strong pipeline of future leaders. Finally, this strategic approach to recruitment enables businesses to respond to market changes, beat competitors, and achieve long-term success.
Call8328958814 satta matka Kalyan result satta guessing➑➌➋➑➒➎➑➑➊➍
Satta Matka Kalyan Main Mumbai Fastest Results
Satta Matka ❋ Sattamatka ❋ New Mumbai Ratan Satta Matka ❋ Fast Matka ❋ Milan Market ❋ Kalyan Matka Results ❋ Satta Game ❋ Matka Game ❋ Satta Matka ❋ Kalyan Satta Matka ❋ Mumbai Main ❋ Online Matka Results ❋ Satta Matka Tips ❋ Milan Chart ❋ Satta Matka Boss❋ New Star Day ❋ Satta King ❋ Live Satta Matka Results ❋ Satta Matka Company ❋ Indian Matka ❋ Satta Matka 143❋ Kalyan Night Matka..
Navigating the world of forex trading can be challenging, especially for beginners. To help you make an informed decision, we have comprehensively compared the best forex brokers in India for 2024. This article, reviewed by Top Forex Brokers Review, will cover featured award winners, the best forex brokers, featured offers, the best copy trading platforms, the best forex brokers for beginners, the best MetaTrader brokers, and recently updated reviews. We will focus on FP Markets, Black Bull, EightCap, IC Markets, and Octa.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
Storytelling is an incredibly valuable tool to share data and information. To get the most impact from stories there are a number of key ingredients. These are based on science and human nature. Using these elements in a story you can deliver information impactfully, ensure action and drive change.
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
The Genesis of BriansClub.cm Famous Dark WEb PlatformSabaaSudozai
BriansClub.cm, a famous platform on the dark web, has become one of the most infamous carding marketplaces, specializing in the sale of stolen credit card data.
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Final ank Satta Matka Dpbos Final ank Satta Matta Matka 143 Kalyan Matka Guessing Final Matka Final ank Today Matka 420 Satta Batta Satta 143 Kalyan Chart Main Bazar Chart vip Matka Guessing Dpboss 143 Guessing Kalyan night
Discover timeless style with the 2022 Vintage Roman Numerals Men's Ring. Crafted from premium stainless steel, this 6mm wide ring embodies elegance and durability. Perfect as a gift, it seamlessly blends classic Roman numeral detailing with modern sophistication, making it an ideal accessory for any occasion.
https://rb.gy/usj1a2
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...APCO
The Radar reflects input from APCO’s teams located around the world. It distils a host of interconnected events and trends into insights to inform operational and strategic decisions. Issues covered in this edition include:
How are Lilac French Bulldogs Beauty Charming the World and Capturing Hearts....Lacey Max
“After being the most listed dog breed in the United States for 31
years in a row, the Labrador Retriever has dropped to second place
in the American Kennel Club's annual survey of the country's most
popular canines. The French Bulldog is the new top dog in the
United States as of 2022. The stylish puppy has ascended the
rankings in rapid time despite having health concerns and limited
color choices.”
Best practices for project execution and deliveryCLIVE MINCHIN
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
Frameworks/Models included:
Microsoft’s Digital Transformation Framework
McKinsey’s Ten Guiding Principles of Digital Transformation
Forrester’s Digital Transformation Framework
IDC’s Digital Transformation MaturityScape
MIT’s Digital Transformation Framework
Gartner’s Digital Transformation Framework
Accenture’s Digital Strategy & Enterprise Frameworks
Deloitte’s Digital Industrial Transformation Framework
Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map
Digital Transformation Frameworks: Driving Digital Excellence
Moisture Mapping of Freeze Dryer
1. Moisture mapping using headspace moisture analysis Isobel Cook BSc MRSC Principal Scientist Biopharma Technology Limited – specialists in freeze drying research and development www.btl-solutions.net
2.
3.
4.
5.
6. FMS / KF moisture correlation Water can have different association/affinity within the freeze dried material which varies with the formulation For amorphous sucrose the intercept is at 1% w/w by KF Indicate moisture retained in cake when none observed in headspace. This is not unsurprising given the hygroscopicity of sucrose
7.
8.
9. Vial heat transfer in a freeze dryer Vapour escapes through gap in stopper Top layer dries first Freeze dryer shelf Heat transfer by direct conduction from the shelf to the vial and product Heat transfer by gaseous convection Heat transfer by radiation from side Walls of the freeze dryer Central vials have greater shielding from side wall radiation This observation can be explained by radiation and shielding effects Edge vial effects bigger at lower temperatures
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20. Thank you Any questions? Isobel Cook Principal Scientist BSc MRSC Biopharma Technology Limited – specialists in freeze drying research and development www.btl-solutions.net
21. Presented during “Emerging Technologies in Freeze Drying”, Cambridge, 11 th May 2011. Event organised by BPS and BTL, www.biopharma.co.uk www.btl-solutions.net
Editor's Notes
The Tg is the point at which a material can be observed to undergo structural change, this has a direct effect on the
KF total moisture if 100% soluble in solution
Need to take into account variable factors where possible
Frequency 1400nm
Once a material/system has demonstrated a good KF/HSM correlation then the moisture can be mapped for an entire shelf of a freeze dryer.
The plot indicates that vials close to the edge as well as the front or back of the shelf have moisture contents below 2% (w/w), while higher moisture values were recorded in the centre of the tray.
This observation can be explained by radiation and shielding effects; the vials towards the centre of the tray take longer to dry as they receive less radiative heat from the freeze dryer walls/viewing window as they are shielded by the vials around them
-5 drying, sublimation cooling at ~25degC, variation to do drying at temp of crystallisation, though annealing should have done it
Lower temp keep below crystalization temp, though annealing should have done it