This product guide covers the basics of Millipak® Final Fill Filters. Learn how to maximize product recovery and enhance protection of your high value product.
Parvovirus Filtration Best Practices - 25 Years of Hands-On ExperienceMerck Life Sciences
In this webinar, you will learn:
- how to measure filter performance and capacity,
- how to optimize filter virus removal capability,
- and avoid potential pit-falls
Detailed description:
This webinar will cover all aspects of parvovirus filtration best practices: process development/ optimization, pilot scale-up, and validation and explain the important connections between these activities. The rationale for the recommended best practices will be explained by discussing the underlying mechanisms that control filter performance.
This presentation explores bioprocessing filtration best practices, including design and scale up methods. You will learn:
• What is filtration?
• Filter capacity and fouling models
• Filter sizing approaches
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
This presentation provides an introduction to tangential flow filtration and reviews the following:
- TFF process basics and terminology
- TFF membrane technology
- TFF hardware, devices and systems
- Growing applications and the future
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
Find your filter. What’s best for your process? MilliporeSigma
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
Single-Pass Tangential Flow Filtration (SPTFF) Theory and PracticeMerck Life Sciences
This data-driven presentation explores the theoretical and practical implications of single-pass tangential flow filtration in bioprocessing and will address the following:
• What is single-pass TFF and how does it work?
• How does SPTFF improve process economics?
• How can single-use technology be utilized for speed and safety?
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
Learn how Quality By Design (QBD) principles can be applied to understand the critical processing and feed parameters affecting virus retention, allowing the development of a streamlined validation approach and robust process control strategy for virus clearance via filtration.
In this webinar, you will learn:
•How to simplify validation study design
•Identify critical process and feed parameters affecting virus retention
•How to compile a robust regulatory filing package
Abstract:
ICH Q8 defines Quality by Design (QbD) as “…a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on quality risk management.” Within the context of virus clearance for bioprocesses, QbD principles can be applied to understand the critical processing and feed parameters affecting virus retention, guiding the development of a streamlined validation approach and robust process control strategy for virus clearance unit operations. We will explore how QbD principles can be applied to downstream virus filtration of mAbs and recombinants, the application of these principles within the framework of the Viresolve® Pro Device (parvovirus retentive filter), the benefits through simplifying the validation strategy and increasing the robustness of your regulatory filing package.
Selection, sizing, and operation of bioprocess filtration trains for optimal ...Merck Life Sciences
To increase filter lifetime and improve the economics of filtering bioprocess streams, a prefilter is often installed upstream of a final sterilizing-grade filter. However, determining the economic optimum prefilter and final filter configuration can be challenging. Numerous prefilter options are available, the prefilter to final filter area ratio must be determined, and operating conditions must be selected that will both satisfy the filtration requirements and provide for an economical process that minimizes the filtration system footprint.
One approach towards achieving an optimal filtration system design is to test the bioprocess fluid with several filter configuration combinations and at a range of operating conditions. However, this can be a daunting task and even impractical given the high cost and limited availability of valuable bioprocess fluids. A better approach is to run a limited filtration trial and use a mathematical model that can accurately predict the behavior of the prefilter and final filter under different conditions.
In this webinar we describe a filtration model and test methodology to rapidly and efficiently design an optimal dual-stage filtration process. The model and methodology were applied to Milligard® PES filters, a new class of autoclavable and gamma sterilizable PES membrane prefilters that are designed to protect microfiltration and nanofiltration final filters in bioprocess streams. We show how a model fit to the data from one set of filtration conditions can be used to predict filtration performance at other prefilter to final filter area ratios and operating conditions, and to determine the economic optimum filtration configuration.
In this webinar, you will learn:
- How filters for microfiltration of biological fluids work.
- The effect of operating conditions on filtration performance.
- How to design an optimal series filtration (prefilter and final filter) process.
Parvovirus Filtration Best Practices - 25 Years of Hands-On ExperienceMerck Life Sciences
In this webinar, you will learn:
- how to measure filter performance and capacity,
- how to optimize filter virus removal capability,
- and avoid potential pit-falls
Detailed description:
This webinar will cover all aspects of parvovirus filtration best practices: process development/ optimization, pilot scale-up, and validation and explain the important connections between these activities. The rationale for the recommended best practices will be explained by discussing the underlying mechanisms that control filter performance.
This presentation explores bioprocessing filtration best practices, including design and scale up methods. You will learn:
• What is filtration?
• Filter capacity and fouling models
• Filter sizing approaches
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
This presentation provides an introduction to tangential flow filtration and reviews the following:
- TFF process basics and terminology
- TFF membrane technology
- TFF hardware, devices and systems
- Growing applications and the future
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
Find your filter. What’s best for your process? MilliporeSigma
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
Single-Pass Tangential Flow Filtration (SPTFF) Theory and PracticeMerck Life Sciences
This data-driven presentation explores the theoretical and practical implications of single-pass tangential flow filtration in bioprocessing and will address the following:
• What is single-pass TFF and how does it work?
• How does SPTFF improve process economics?
• How can single-use technology be utilized for speed and safety?
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
Learn how Quality By Design (QBD) principles can be applied to understand the critical processing and feed parameters affecting virus retention, allowing the development of a streamlined validation approach and robust process control strategy for virus clearance via filtration.
In this webinar, you will learn:
•How to simplify validation study design
•Identify critical process and feed parameters affecting virus retention
•How to compile a robust regulatory filing package
Abstract:
ICH Q8 defines Quality by Design (QbD) as “…a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on quality risk management.” Within the context of virus clearance for bioprocesses, QbD principles can be applied to understand the critical processing and feed parameters affecting virus retention, guiding the development of a streamlined validation approach and robust process control strategy for virus clearance unit operations. We will explore how QbD principles can be applied to downstream virus filtration of mAbs and recombinants, the application of these principles within the framework of the Viresolve® Pro Device (parvovirus retentive filter), the benefits through simplifying the validation strategy and increasing the robustness of your regulatory filing package.
Selection, sizing, and operation of bioprocess filtration trains for optimal ...Merck Life Sciences
To increase filter lifetime and improve the economics of filtering bioprocess streams, a prefilter is often installed upstream of a final sterilizing-grade filter. However, determining the economic optimum prefilter and final filter configuration can be challenging. Numerous prefilter options are available, the prefilter to final filter area ratio must be determined, and operating conditions must be selected that will both satisfy the filtration requirements and provide for an economical process that minimizes the filtration system footprint.
One approach towards achieving an optimal filtration system design is to test the bioprocess fluid with several filter configuration combinations and at a range of operating conditions. However, this can be a daunting task and even impractical given the high cost and limited availability of valuable bioprocess fluids. A better approach is to run a limited filtration trial and use a mathematical model that can accurately predict the behavior of the prefilter and final filter under different conditions.
In this webinar we describe a filtration model and test methodology to rapidly and efficiently design an optimal dual-stage filtration process. The model and methodology were applied to Milligard® PES filters, a new class of autoclavable and gamma sterilizable PES membrane prefilters that are designed to protect microfiltration and nanofiltration final filters in bioprocess streams. We show how a model fit to the data from one set of filtration conditions can be used to predict filtration performance at other prefilter to final filter area ratios and operating conditions, and to determine the economic optimum filtration configuration.
In this webinar, you will learn:
- How filters for microfiltration of biological fluids work.
- The effect of operating conditions on filtration performance.
- How to design an optimal series filtration (prefilter and final filter) process.
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Optimization of Tangential Flow Filtration Applications and Scale Up Consider...Merck Life Sciences
This presentation provides an introduction to tangential flow filtration applications for AAV and lentivirus and will review:
• Basics of tangential flow filtration (TFF)
• TFF AAV and lentivirus process overview
• Operating parameters optimization: flux-controlled microfiltration
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
Cell Culture Media Filtration – Filter Selection and SizingMilliporeSigma
The purpose of this application note is to provide estimated filtration areas for different sterilizing-grade filters with a panel of media used for Chinese Hamster Ovary (CHO) cell culture processes.
Normal Flow Filtration: Design and Scale UpMilliporeSigma
This presentation explores bioprocessing filtration best practices, including design and scale up methods. You will learn:
• What is filtration?
• Filter capacity and fouling models
• Filter sizing approaches
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/remotevisit
Validation of Tangential Flow Filtration in Biotech ProcessesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3hUKfd7
The objective of validation of a unit operation is to demonstrate with a high degree of confidence that the process performs consistently. The present seminar will focus on the validation of the unit operation of TFF and will provide an overview of the regulatory landscape, the validation master plan, approaches to membrane re-use, cleaning validation, and best practices.
In this webinar, you will learn:
• Validation of TFF
• Validation master plan
• Membrane reuse and cleaning
• TFF scale down models
Speaker: Dr. Subhasis Banerjee,
Principal Technical Application Expert, Bioprocessing APAC
Scale-up of high area filters for microfiltration of biological fluids - Poin...MilliporeSigma
Presented at INTERPHEX on March 21-23, 2017.
High area filters can present unique challenges when scaling up from discs to cartridges. A model was developed that can be used to estimate scaled-up performance. A new small scale scaling tool is also introduced that closely mimics the filtration behavior of the full scale filter and that can be used to confirm expected scaled-up performance.
Integrity testing is a critical operation, especially for sterilizing grade filters used in biopharmaceutical processing. When performed correctly, an integrity test is a fast, definitive, non-destructive way to assure filter retention performance. Fortunately, there are few ways a non-integral filter will pass the integrity test, eliminating the possibility a non-retentive filter is used undetected. Unfortunately, there are a lot of ways an integral filter can fail the integrity test, resulting in retests, lost time, productivity and potentially lost product.
In this webinar you will:
- Gain confidence in your integrity testing results
- Provide justification for retests
- Understand specific challenges and eliminate them to assure the integrity test can be performed correctly the first time
Sterile filtration of complex injectables by Partha BanerjeeMerck Life Sciences
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Membrane Chromatography Solutions for Single-Use, Intensified mAb PurificationMilliporeSigma
Participate in the interactive webinar: http://bit.ly/NatrixChromMSIG
Explore our webinar library: www.emdmillipore.com/webinars
Improve productivity, flexibility, and economics of mAb purification process with intensified, single-use membrane chromatography.
Sterile filtration of complex injectables by Partha BanerjeeMerck Life Sciences
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Good Manufacturing PracticeFor LVP,SVP, ophthalmic veterinary medicine, bulk chemicals & invitro diagnostic
For Good business Practice
A control process gives reproducibility & product consistency with in known limits
Provides license to do business.
Introduction to Tangential Flow Filtration (TFF)MilliporeSigma
This presentation provides an introduction to tangential flow filtration and reviews the following:
- TFF process basics and terminology
- TFF membrane technology
- TFF hardware, devices and systems
- Growing applications and the future
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
An Efficient and cGMP-friendly Solution to Diafiltration for Intensified or C...Merck Life Sciences
View the recording here: https://bit.ly/2M6cTYD
Abstract:
Diafiltration is a critical unit operation in the downstream purification train for nearly all monoclonal antibodies and other therapeutic biomolecules, with a particular application being the final formulation step. It provides a cost-effective, efficient, and robust method for achieving > 3 logs of buffer exchange. As the biomanufacturing industry strives for more efficient and cost-conscious processes and facilities by adapting templates to be more flexible, handle larger batch sizes, require lower plant footprint, and run in an integrated or continuous mode, diafiltration has been one of the last unit operations to change. Updated technologies for chromatography, clarification, and concentration have been developed in recent years, offering significant improvements over their existing batch processing equivalents. However, it has been challenging to develop a similar intensified and continuous technology for diafiltration that exceeds established expectations around unit operation productivity while maintaining a process that is easily implementable and suitable for GMP manufacturing.
Our approach to intensified, continuous diafiltration bases the process design on membrane utilization, as opposed to flux and process time typically used for batch designs. The result is a flexible solution that offers 6-8-fold decrease in membrane area, up to 3-fold reduction in pump passes and a substantial footprint reduction. Buffer usage, extent of buffer exchange, and product yield are equivalent to a traditional constant-volume diafiltration process. The process development approach, system components, and process control rely on well-established methods and technologies, reducing risk during scaleup and manufacturing implementation.
In this webinar, you will learn:
- A new process design for continuous diafiltration and its operational robustness over a 24-hour run
- Benefits of implementing this version of intensified or continuous diafiltration in your process train
Optimization of Tangential Flow Filtration Applications and Scale Up Consider...MilliporeSigma
This presentation provides an introduction to tangential flow filtration applications for AAV and lentivirus and will review:
• Basics of tangential flow filtration (TFF)
• TFF AAV and lentivirus process overview
• Operating parameters optimization: flux-controlled microfiltration
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/remotevisit
Sterile filtration of complex injectables by Partha BanerjeeMilliporeSigma
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Parvovirus Filtration Best Practices - 25 Years of Hands-On ExperienceMilliporeSigma
In this webinar, you will learn:
- how to measure filter performance and capacity,
- how to optimize filter virus removal capability,
- and avoid potential pit-falls
Detailed description:
This webinar will cover all aspects of parvovirus filtration best practices: process development/ optimization, pilot scale-up, and validation and explain the important connections between these activities. The rationale for the recommended best practices will be explained by discussing the underlying mechanisms that control filter performance.
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Optimization of Tangential Flow Filtration Applications and Scale Up Consider...Merck Life Sciences
This presentation provides an introduction to tangential flow filtration applications for AAV and lentivirus and will review:
• Basics of tangential flow filtration (TFF)
• TFF AAV and lentivirus process overview
• Operating parameters optimization: flux-controlled microfiltration
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
Cell Culture Media Filtration – Filter Selection and SizingMilliporeSigma
The purpose of this application note is to provide estimated filtration areas for different sterilizing-grade filters with a panel of media used for Chinese Hamster Ovary (CHO) cell culture processes.
Normal Flow Filtration: Design and Scale UpMilliporeSigma
This presentation explores bioprocessing filtration best practices, including design and scale up methods. You will learn:
• What is filtration?
• Filter capacity and fouling models
• Filter sizing approaches
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/remotevisit
Validation of Tangential Flow Filtration in Biotech ProcessesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3hUKfd7
The objective of validation of a unit operation is to demonstrate with a high degree of confidence that the process performs consistently. The present seminar will focus on the validation of the unit operation of TFF and will provide an overview of the regulatory landscape, the validation master plan, approaches to membrane re-use, cleaning validation, and best practices.
In this webinar, you will learn:
• Validation of TFF
• Validation master plan
• Membrane reuse and cleaning
• TFF scale down models
Speaker: Dr. Subhasis Banerjee,
Principal Technical Application Expert, Bioprocessing APAC
Scale-up of high area filters for microfiltration of biological fluids - Poin...MilliporeSigma
Presented at INTERPHEX on March 21-23, 2017.
High area filters can present unique challenges when scaling up from discs to cartridges. A model was developed that can be used to estimate scaled-up performance. A new small scale scaling tool is also introduced that closely mimics the filtration behavior of the full scale filter and that can be used to confirm expected scaled-up performance.
Integrity testing is a critical operation, especially for sterilizing grade filters used in biopharmaceutical processing. When performed correctly, an integrity test is a fast, definitive, non-destructive way to assure filter retention performance. Fortunately, there are few ways a non-integral filter will pass the integrity test, eliminating the possibility a non-retentive filter is used undetected. Unfortunately, there are a lot of ways an integral filter can fail the integrity test, resulting in retests, lost time, productivity and potentially lost product.
In this webinar you will:
- Gain confidence in your integrity testing results
- Provide justification for retests
- Understand specific challenges and eliminate them to assure the integrity test can be performed correctly the first time
Sterile filtration of complex injectables by Partha BanerjeeMerck Life Sciences
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Membrane Chromatography Solutions for Single-Use, Intensified mAb PurificationMilliporeSigma
Participate in the interactive webinar: http://bit.ly/NatrixChromMSIG
Explore our webinar library: www.emdmillipore.com/webinars
Improve productivity, flexibility, and economics of mAb purification process with intensified, single-use membrane chromatography.
Sterile filtration of complex injectables by Partha BanerjeeMerck Life Sciences
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Good Manufacturing PracticeFor LVP,SVP, ophthalmic veterinary medicine, bulk chemicals & invitro diagnostic
For Good business Practice
A control process gives reproducibility & product consistency with in known limits
Provides license to do business.
Introduction to Tangential Flow Filtration (TFF)MilliporeSigma
This presentation provides an introduction to tangential flow filtration and reviews the following:
- TFF process basics and terminology
- TFF membrane technology
- TFF hardware, devices and systems
- Growing applications and the future
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
An Efficient and cGMP-friendly Solution to Diafiltration for Intensified or C...Merck Life Sciences
View the recording here: https://bit.ly/2M6cTYD
Abstract:
Diafiltration is a critical unit operation in the downstream purification train for nearly all monoclonal antibodies and other therapeutic biomolecules, with a particular application being the final formulation step. It provides a cost-effective, efficient, and robust method for achieving > 3 logs of buffer exchange. As the biomanufacturing industry strives for more efficient and cost-conscious processes and facilities by adapting templates to be more flexible, handle larger batch sizes, require lower plant footprint, and run in an integrated or continuous mode, diafiltration has been one of the last unit operations to change. Updated technologies for chromatography, clarification, and concentration have been developed in recent years, offering significant improvements over their existing batch processing equivalents. However, it has been challenging to develop a similar intensified and continuous technology for diafiltration that exceeds established expectations around unit operation productivity while maintaining a process that is easily implementable and suitable for GMP manufacturing.
Our approach to intensified, continuous diafiltration bases the process design on membrane utilization, as opposed to flux and process time typically used for batch designs. The result is a flexible solution that offers 6-8-fold decrease in membrane area, up to 3-fold reduction in pump passes and a substantial footprint reduction. Buffer usage, extent of buffer exchange, and product yield are equivalent to a traditional constant-volume diafiltration process. The process development approach, system components, and process control rely on well-established methods and technologies, reducing risk during scaleup and manufacturing implementation.
In this webinar, you will learn:
- A new process design for continuous diafiltration and its operational robustness over a 24-hour run
- Benefits of implementing this version of intensified or continuous diafiltration in your process train
Optimization of Tangential Flow Filtration Applications and Scale Up Consider...MilliporeSigma
This presentation provides an introduction to tangential flow filtration applications for AAV and lentivirus and will review:
• Basics of tangential flow filtration (TFF)
• TFF AAV and lentivirus process overview
• Operating parameters optimization: flux-controlled microfiltration
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/remotevisit
Sterile filtration of complex injectables by Partha BanerjeeMilliporeSigma
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Parvovirus Filtration Best Practices - 25 Years of Hands-On ExperienceMilliporeSigma
In this webinar, you will learn:
- how to measure filter performance and capacity,
- how to optimize filter virus removal capability,
- and avoid potential pit-falls
Detailed description:
This webinar will cover all aspects of parvovirus filtration best practices: process development/ optimization, pilot scale-up, and validation and explain the important connections between these activities. The rationale for the recommended best practices will be explained by discussing the underlying mechanisms that control filter performance.
Improve Process Efficiency in Bioprocess Streams by Prefiltration Optimizatio...Merck Life Sciences
This poster summarizes throughput and bacterial retention performance of prefilters used to reduce bioburden in intermediate downstream process steps.
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
Reducing Contamination Risk and Improving Product Recovery During Final Steri...Merck Life Sciences
Final sterile filtration operations are the focus of extensive regulatory guidance to assure the safety of medicinal products for administration to patients. All sterilizing-grade filters must be tested for integrity after use, and current draft EMA EU Annex 1 requires pre-use, post-sterilization integrity tests (PUPSIT). This poster explores the use of final fill filters to achieve the following:
• Simplify PUPSIT by reducing risk of introducing microbial contaminants to the flow path
• Maximize product recovery
• Create a safer and more efficient final filtration process
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
Reducing Contamination Risk and Improving Product Recovery During Final Steri...MilliporeSigma
Final sterile filtration operations are the focus of extensive regulatory guidance to assure the safety of medicinal products for administration to patients. All sterilizing-grade filters must be tested for integrity after use, and current draft EMA EU Annex 1 requires pre-use, post-sterilization integrity tests (PUPSIT). This poster explores the use of final fill filters to achieve the following:
• Simplify PUPSIT by reducing risk of introducing microbial contaminants to the flow path
• Maximize product recovery
• Create a safer and more efficient final filtration process
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
Improved Product Recovery Using Blow-down and Millipak® Final Fill FiltersMilliporeSigma
This application note compares hold-up volume of both pleated and stacked disc filters and highlight the benefits of filter blow-down for maximizing product recovery.
Implementing and Managing Pre-use Post-sterilization Integrity Testing (PUPSIT)MilliporeSigma
This presentation explores best practices and case studies in aseptic processing, including how to implement and manage PUPSIT. You will learn:
• Integrity Testing – the background on IT itself, why it is important, and how it works
• Filtration setups and single-use technology
• The PUPSIT debate and how PUPSIT can be achieved with current technology, final filling, formulation, filtration
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/remotevisit
Implementing and Managing Pre-use Post-sterilization Integrity Testing (PUPSIT)Merck Life Sciences
This presentation explores best practices and case studies in aseptic processing, including how to implement and manage PUPSIT. You will learn:
• Integrity Testing – the background on IT itself, why it is important, and how it works
• Filtration setups and single-use technology
• The PUPSIT debate and how PUPSIT can be achieved with current technology, final filling, formulation, filtration
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
Single-Use Tangential Flow Filtration for Closed ProcessingMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
The main source of particle contamination in HPLC columns originate in the sample to be analysed. Using a syringe filter before the sample is injected into the analytical instrument ensures that the sample is at its purest before the analysis begins. Greyhound Chromatography offer a wide range of syringe filters, suitable for any sample analysis.
Utilizing Tubular UF Membrane Filtration for Wastewater ReuseBerghof Membranes
Water is a valuable asset to any industry. Implementing an efficient wastewater reuse and treatment system will lower the dependency on fresh water sources.
Millipak® Final Fill Filters Reduce Contamination Risks and Simplify Filtrati...MilliporeSigma
This tech note summarizes the results of microbial challenge studies that confirm the aseptic multi-purpose port (AMPP) prevents microbial contamination entering the flow path. We also show how these results can be leveraged to simplify integrity testing and product recovery following sterile filtration operations.
Greyhound Chromatography's Q-Fil Syringe Filters set the new Quality standard for today’s laboratory syringe filters. Manufactured from the highest quality medical grade, high density polypropylene. Q-Fil Syringe Filters provide excellent chemical compatibility with acids, alcohols, bases, ethers, glycols, ketones and oils.
Every colour-coded filter is printed with details of the membrane material and its pore size on the outside of the filter and every box is labelled with the batch number making them ideal for traceability, GLPs and validation purposes.
Residential cartridge pdf document aqua middle east fzcAdolfsmith69
Aqua is the Biggest Industrial Group swimming pool equipments in Middle East Dubai. we Deal swimming pool equipment and supplies swimming pool equipment and accessories in dubai.
Residential cartridge pdf document aqua middle east fzcAdolfsmith69
Aqua is the Biggest Industrial Group swimming pool equipments in Middle East Dubai. we Deal swimming pool equipment and supplies swimming pool equipment and accessories in dubai.
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...MilliporeSigma
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process.
This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work.
Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Use of Excipients in Downstream Processing to Improve Protein PurificationMilliporeSigma
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms.
This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.
Exploring the protein stabilizing capability of surfactants against agitation...MilliporeSigma
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase.
One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations.
Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms.
The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein F...MilliporeSigma
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection.
This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.
To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Characterization of monoclonal antibodies and Antibody drug conjugates by Sur...MilliporeSigma
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr
Highlights of this webinar:
- Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs.
- SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations.
- Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies.
- The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process
Detailed description:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life.
An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.
The Role of BioPhorum Extractables Data in the Effective Adoption of Single-U...MilliporeSigma
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization
This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study.
Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio
The Future of Pharma- and Biopharmaceutical AuditsMilliporeSigma
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...MilliporeSigma
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
Identity testing by NGS as a means of risk mitigation for viral gene therapiesMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3RijkHC
Detailed description:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.
The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources.
Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.
In this webinar, we'll explore:
• Regulatory requirements for identity testing
• NGS applications for identity testing as compared to traditional methods
• A case study on the impact of not establishing a proper risk-based testing strategy
Presented by: Bradley Hasson, Director of Lab Operations for NGS Services
Latest advancements of melt based 3D printing technologies for oral drug deli...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3A2WcH4
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.
Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented:
The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.
In this webinar, you will learn:
• Latest advancements of melt based 3D printing approaches
• Application examples for the individual technologies
• Deep dive in the MED® 3D printing technology to design dedicated drug release profiles
Presented by:
Dr. Thomas Kipping, Head of Drug Carriers
Dr. Xianghao Zuo, Deputy Director of R&D, Triastek
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
How does the ICH Q5A revision impact viral safety strategies for biologics?MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Insights from a Global Collaboration Accelerating Vaccine Development with an...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine.
In this webinar, you will learn:
• About building a priceless collaborative network with integrated solutions
• Virus-Like Particle Vaccines
• Process Development Overview and Challenges
• Pre-clinical Results and Next Steps
Presented by:
Jose M. Galarza, PhD,
President and Founder of TechnoVax
Naomi Baer,
Business development consultant, Emerging Biotech, BioProcess division
Youssef Gaabouri, Eng. ,
Associate Director, Head of Sales Middle East & Africa, BioProcess division
Risk-Based Qualification of X-Ray Sterilization for Single-Use SystemsMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3vQf0qv
In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods.
The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods.
In this webinar, you will learn about:
• The comparison of gamma and X-ray irradiation sterilization
• A risk-based qualification test strategy
• Data evaluation of gamma versus X-ray sterilized single-use components
Presented by:
Monica Cardona,
Global Senior Program Manager
Paul Killian, Ph.D.,
R&D Director, Analytical Technologies
Rapid Replication Competent Adenovirus (rRCA) Detection: Accelerate your Lot ...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
• Regulatory framework for adenoviral vector products
• Considerations for lot release testing of adenoviral-based therapies
• Advantages of a rapid method for RCA testing on production lot material
Presented by:
Axel Fun, Ph.D.,
Principal Scientist
Alberto Santana, MBA,
Product Manager, Biologics Biosafety Testing
The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K
Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations.
Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
• excellent sugar-like taste profile
• outstanding sweetness factors
• use effectiveness
• enhanced stability
We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception.
In this webinar, you will learn:
• How to optimize the patients' taste experience of your pharmaceuticals
• How sweeteners can be differentiated by their sensory profiles and features
• How our new product offering Neotame can be effectively used in your targeted formulations
Presented by:
Almut von der Brelie,
Senior Manager Strategic Marketing, Excipients for Solid Applications
The Developability Classification System (DCS): Enabling an Optimized Approac...MilliporeSigma
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS).
The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed.
#solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment
How to Accelerate and Enhance ADC TherapiesMilliporeSigma
In this webinar, you will learn about:
The advantages of using advanced intermediates to develop ADC therapies
How to increase ADC solubility and efficiency
Fast, small-scale ADC library generation
Seamless supply chain with reduced complexity and regulatory support
The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window.
Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...
Millipak® Final Fill Filters
1. Benefits
• Maximizes product recovery in final and high
value filtration
• Simplifies operation and reduces risk of microbial
and particulate contamination
• Contains Durapore®
membrane for high flow
rates, low binding and extractables, and broad
chemical compatibility
• Improves integration into single-use assemblies
Membrane Pore Sizes
Available with particulate removal, bioburden
reduction and sterilizing-grade Durapore®
polyvinylidene fluoride (PVDF) membranes
for both liquid and gas applications.
• Hydrophilic Durapore®
membrane: 0.1 µm,
0.22 µm, 0.45 µm, 5.0 µm
• Hydrophobic Durapore®
membrane: 0.22 µm
The life science business of Merck KGaA,
Darmstadt, Germany operates as
MilliporeSigma in the U.S. and Canada
Millipak®
Final Fill Filters
Maximize recovery and enhance protection of your high value product
Millipak®
Final Fill capsules are designed for reliable
sterile filtration of small volume, high value solutions.
In final filling it is critical to maximize product
recovery and maintain sterility.
The capsule's stacked disc design minimizes hold up
volume over standard pleated devices, increasing
product recovery.
These user-friendly filters contain a multi-purpose
port that simplifies venting, integrity testing and
sampling and is validated to maintain an aseptic
flowpath even after multiple actuations.
Millipak®
Final Fill capsules contain the proven and
trusted Durapore®
membrane in multiple pore sizes
offering flexibility for your specific process needs.
2. 2
Maximize Product Recovery
In applications like final filtration where
maximizing product recovery is critical, the
low hold up volume of Millipak®
Final Fill filters
translates to more vials filled, as compared to
traditional pleated filters. Millipak®
Final Fill
filters incorporate Durapore®
membrane
bonded to solid discs instead of the support
material in pleated filters, resulting in lower
holdup volume and reduced risk of particulates,
Figure 1. Consistent high product recoveries
are achieved across filtration areas from
100-1000 cm2
. Millipak®
Final Fill filters
maximize your product recovery, increasing
the efficiency of this critical process step,
Figure 2.
Figure 2
Hold up volume of Millipak®
Final Fill filters as compared to pleated polyethersulfone (PES) or polyvinylidene fluoride
(PVDF) filters of different areas. Values represent the mean and standard deviation from replicate tests.
HoldUpVolume(mL)
Filtration area (cm2
)
00
1010
2020
3030
4040
200200 400400 600600 800800 10001000 12001200 1400140000
Hold Up Volumes of Market Leading Filters
Millipak®
Final Fill filters PES pleated filters PVDF pleated filters
Figure 1
Membrane is bonded to solid discs instead of support
material used in pleated filters, resulting in lower holdup
volume and reduced risk of particulates
Monitor wetting and filtration operations
through the transparent housing
Proven performance with time-tested
Durapore®
membrane
Vent, sample, and integrity test while
preventing contamination with the
Aseptic Multi-Purpose Port (AMPP)
Single-use assembly integration is
simplified with a hook that protects
the AMPP
Enhanced digital integration with the
2-D barcode
Minimize hold-up volume with the
stacked disc design
Millipak®
Final Fill Design Features
3. 3
Robust Protection Combined with
Ease of Use
The Aseptic Multi-Purpose Port (AMPP) has
been designed for ergonomic use with gloves,
and visible ‘open’ and ‘closed’ locking positions.
It contains three O-rings – the lower O-ring
seals the flowpath when the AMPP is closed,
and two upper O-rings maintain an aseptic area
that prevents cross-contamination between the
environment and flowpath. This sterile
boundary is maintained after heavy microbial
challenge and multiple actuations keeping your
process safe from contaminant exposure. This
is critical in final fill, and also for sterility
assurance in redundant filtration trains where
the flowpath upstream of the primary filter
must not be compromised.
Filter venting, integrity testing and sampling can
all be performed through the single AMPP, lowering
the risks associated with multiple filter connection
points and streamlining process design.
Scalable
Multiple filter sizes enable easy scale up and
sizing. All Millipak®
Final Fill filter capsules are
available as non-sterilized (gamma irradiation
and autoclave compatible) or sterilized by
gamma irradiation.
Size Format
Durapore®
Membrane
20
(100 cm2
)
40
(200 cm2
)
60
(300 cm2
)
100
(500 cm2
)
200
(1000 cm2
)
0.1 μm √ √ √ √ √
0.22 μm √ √ √ √ √
0.45 μm √ √ √ √ √
5.0 μm √ √
0.22 μm phobic √ √ √
Mobius®
Single-use Solutions
Millipak®
Final Fill filters are part of the
Mobius®
library. This provides you with
the flexibility to design single-use
assemblies that meet your specific
processing requirements.
The Emprove®
Program – Your Fast
Track through Regulatory Challenges
The Emprove®
Program, complements our
product portfolio, and provides three types
of dossiers to support different stages of
development and manufacturing operations
such as qualification, risk assessment,
and process optimization. This program
consolidates comprehensive product-specific
testing, quality and regulatory information,
making it readily available to our customers
to simplify their compliance needs.
Compliance and Traceability
Millipak®
Final Fill filters are designed,
developed and manufactured in accordance
with a Quality Management System
approved by an accredited registering
body to an ISO®
9001 Quality Systems
Standard. Each unit is 100% integrity
tested during manufacturing and includes
a certificate of quality.
Figure 3
Aseptic Multi-Purpose Port (AMPP).
4. 4
Specifications
Millipak®
Final Fill 20 Millipak®
Final Fill 40 Millipak®
Final Fill 60 Millipak®
Final Fill 100 Millipak®
Final Fill 200
Nominal Dimensions
Maximum length 8.1 cm (3.2 in.) 8.6 cm (3.4 in.) 10.9 cm (4.3 in.) 11.9 cm (4.7 in.) 14.5 cm (5.7 in.)
Body diameter 7.6 cm (3.0 in.) 7.6 cm (3.0 in.) 7.6 cm (3.0 in.) 7.6 cm (3.0 in.) 7.6 cm (3.0 in.)
Body diameter w/
anti-roll edges
/ / / 8.1 cm (3.2 in.) 8.1 cm (3.2 in.)
Filtration Area 100 cm2
(0.11 ft2
) 200 cm2
(0.22 ft2
) 300 cm2
(0.32 ft2
) 500 cm2
(0.54 ft2
) 1000 cm2
(1.08 ft2
)
Aseptic Multi-Purpose
Port
3.2 mm (1/8 in.) hose barb
Materials of
Construction
Filter membrane Durapore®
PVDF (polyvinylidene fluoride) membrane
Support discs Polysulfone
Filter capsule Polysulfone
Aseptic Multi-Purpose
Port (AMPP)
Polyethersulfone
Aseptic Multi-Purpose
Port (AMPP) O-rings
Silicone
Hold Up Volume (mL)
at 70 psi for 1 minute
1.1 1.5 3.2 4.8 7.2
Maximum Inlet Pressure 60 psi (4.1 bar) at 25°C 80 psi (5.5 bar) at 25°C
Maximum
Differential Pressure
Forward: 60 psi (4.1 bar) at 25°C
50 psi (3.5 bar) at 25°C (5 µm)
25 psi (1.7 bar) at 80°C
80 psi (5.5 bar) at 25°C (0.1 µm, 0.22 µm, 0.45 µm, hydrophobic 0.22 µm)
Reverse: 10 psi (0.7 bar) at 25°C
Bubble Point at 23 °C
0.1 μm: ≥ 70 psi (4830 mbar) air with water
0.22 μm: ≥ 50 psi (3450 mbar) air with water
0.45 μm: ≥ 26 psi (1790 mbar) air with water
Hydrophobic
0.22 μm:
≥ 29 psi (2000 mbar) air with water
≥ 18 psi (1240 mbar) in 60/40% IPA/water
≥ 17 psi (1170 mbar) in 70/30% IPA/water
Bacterial Retention for
0.1 μm and 0.22 μm
Quantitative retention of 107
CFU/cm2
Brevundimonas diminuta ATCC®
19146 per ASTM®
F838 methodology.
Bacterial Endotoxin Aqueous extraction contains < 0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting
requirements of USP <85>, EP 2.6.14 and JP 4.01.
Total Organic Carbon
(TOC)/Conductivity
Samples exhibited < 500 ppb TOC per USP <643> and < 1.3 µS/cm conductivity per USP <645> at 25°C after sterilization and a
water flush of:
1.0 L 2.0 L 2.0 L 3.0 L 5.0 L
Sterilization Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 °C. Devices can withstand a dose ≤ 40
kGy gamma exposure.
Toxicity Component materials meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo, USP <87> Biological
Reactivity, in vitro, and ISO 10993-5 Tests for in vitro Cytotoxicity. This product also meets physicochemical specifications, as
described in USP <661> Containers-Plastics.
Particle Shedding Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-Fiber Releasing This product was manufactured with a Durapore®
membrane which meets the criteria for a “non-fiber releasing” filter as defined in
21 CFR 210.3 (b)(6), validated based on large volume parenteral specifications as detailed in USP <788> Particulate Matter in
Injections.
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182, based on information provided
by raw material suppliers.
Quality Management
System
These products are manufactured in a facility which is certified to ISO®
9001:2015 Quality Management Systems.
5. 5
Typical Clean Water Flow Rates
0
10
20
30
40
50
2
Millipak®
Final Fill 20/40/60 Capsule Filters with 0.1 µm
Hydrophilic Durapore®
Membrane
DifferentialPressure(psid)
Flow Rate (L/min)
0 0.5 1 1.5
20 H, Typical 40 H, Typical 60 H/T, Typical
0
10
20
30
40
50
Flow Rate (L/min)
Millipak®
Final Fill 20/40/60 Capsule Filters with 0.22 µm
Hydrophilic Durapore®
Membrane
DifferentialPressure(psid)
20 All Types, Typical 40 All Types, Typical 60 All Types, Typical
0 0.5 1 1.5 2.52 3
0
10
20
30
40
50
Millipak®
Final Fill 20/40/60 Capsule Filters with 0.45 µm
Hydrophilic Durapore®
Membrane
DifferentialPressure(psid)
Flow Rate (L/min)
20 H, Typical 40 H, Typical 60 H, Typical 60 T, Typical
0 2 4 6 8 10
Millipak®
Final Fill 60/200 Capsule Filters with 5.0 µm
Hydrophilic Durapore®
Membrane
DifferentialPressure(psid)
Flow Rate (L/min)
60 H, Typical 60 T, Typical 200 B, Typical 200 T, Typical
0
1
2
3
4
5
0 2 4 6 8 10
0
10
20
30
40
50
Millipak®
Final Fill 100/200 Capsule Filters with 0.1 µm
Hydrophilic Durapore®
Membrane
DifferentialPressure(psid)
Flow Rate (L/min)
100 B/T, Typical 200 B/T, Typical
2 4 6 120 108
0
10
20
30
40
50
Millipak®
Final Fill 100/200 Capsule Filters with 0.22 µm
Hydrophilic Durapore®
Membrane
DifferentialPressure(psid)
Flow Rate (L/min)
100 B, Typical 100 K/L, Typical
200 B, Typical 200 K/L, Typical
100 F/T, Typical
200 F/T, Typical
2 4 6 12 14 16 18 200 108
0
10
20
30
40
50
Millipak®
Final Fill 100/200 Capsule Filters with 0.45 µm
Hydrophilic Durapore®
Membrane
DifferentialPressure(psid)
Flow Rate (L/min)
100 B, Typical 100 T, Typical 200 B, Typical 200 T, Typical
15100 20 255 30
Legend
B = 13 mm (½ in.) stepped hose barb inlet and outlet
C = 19 mm (¾ in.) sanitary flange inlet and
6 mm (¼ in.) hose barb outlet
F = 19 mm (¾ in.) sanitary flange inlet and outlet
H = 6 mm (¼ in.) stepped hose barb inlet and outlet
K = 19mm (¾ in.) sanitary flange inlett and
13 mm (½ in.) hose barb outlet
L = 38 mm (1 ½ in.) sanitary flange inlet and
13 mm (½ in.) stepped hose barb outlet
T = 38 mm (1 ½ in.) sanitary flange inlet and outlet
6. 6
Ordering Information
Millipak®
Final Fill Filters with Hydrophilic Durapore®
0.1 μm/0.45 μm Membrane
* Millipak®
Final Fill 20 filters will be available for order in the near future
Millipak®
Final Fill Filter
M F 3
Membrane Type
VL = Durapore®
0.1 μm
HL = Durapore®
0.45 μm
Size/Sterilization
*02G = 20, non-sterilized
*02S = 20, sterilized by
gamma irradiation
04G = 40, non-sterilized
04S = 40, sterilized by
gamma irradiation
06G = 60, non-sterilized
06S = 60, sterilized by
gamma irradiation
10G = 100, non-sterilized
10S = 100, sterilized by
gamma irradiation
20G = 200, non-sterilized
20S = 200, sterilized by
gamma irradiation
Connection Type
Millipak®
Final Fill 20, 40, 60
H = 6 mm (¼ in.) stepped hose barb inlet and outlet
Millipak®
Final Fill 100, 200
B = 13 mm (½ in.) stepped hose barb inlet and outlet
Millipak®
Final Fill 60, 100, 200
T = 38 mm (1½ in.) sanitary flange inlet and outlet
Quantity per Pkg
3 = 3 per package
Size/Sterilization
*02G = 20, non-sterilized
*02S = 20, sterilized by
gamma irradiation
04G = 40, non-sterilized
04S = 40, sterilized by
gamma irradiation
06G = 60, non-sterilized
06S = 60, sterilized by
gamma irradiation
10G = 100, non-sterilized
10S = 100, sterilized by
gamma irradiation
20G = 200, non-sterilized
20S = 200, sterilized by
gamma irradiation
Connection Type
Millipak®
Final Fill 20, 40, 60
C = 19 mm (¾ in.) sanitary flange inlet and
6 mm (¼ in.) hose barb outlet
H = 6 mm (¼ in.) stepped hose barb inlet and outlet
Millipak®
Final Fill 60, 100, 200
L = 38 mm (1½ in.) sanitary flange inlet and
13 mm (½ in.) stepped hose barb outlet
T = 38 mm (1½ in.) sanitary flange inlet and outlet
Millipak®
Final Fill 100, 200
B = 13 mm (½ in.) stepped hose barb inlet and outlet
K = 19 mm (¾ in.) sanitary flange inlet and 13 mm
(½ in.) hose barb outlet
Millipak®
Final Fill 20, 40, 60, 100, 200
F = 19 mm (¾ in.) sanitary flange inlet and outlet
Millipak®
Final Fill Filter
Membrane Type
GL = Durapore®
0.22 μm
M F G L 3
Millipak®
Final Fill Filters with Hydrophilic Durapore®
0.22 μm Membrane
Quantity per Pkg
3 = 3 per package
7. 7
Size/Sterilization
06G = 60, non-sterilized
06S = 60, sterilized by
gamma irradiation
20G = 200, non-sterilized
20S = 200, sterilized by
gamma irradiation
Connection Type
Millipak®
Final Fill 60
H = 6mm (¼ in.) stepped hose barb inlet and outlet
Millipak®
Final Fill 200
B = 13 mm (½ in.) stepped hose barb inlet and outlet
Millipak®
Final Fill 60, 200
T = 38 mm (1½ in.) sanitary flange inlet and outlet
Millipak®
Final Fill Filter
Membrane Type
SL = Durapore®
5.0 μm
Ordering Information
Millipak®
Final Fill Filters with Hydrophilic Durapore®
5.0 μm Membrane
M F S L 3
Millipak®
Final Fill Filters with Hydrophobic Durapore®
0.22 μm Membrane
Size/Sterilization
*02G = 20, non-sterilized
*02S = 20, sterilized by
gamma irradiation
06G = 60, non-sterilized
06S = 60, sterilized by
gamma irradiation
20G = 200, non-sterilized
20S = 200, sterilized by
gamma irradiation
Connection Type
Millipak®
Final Fill 20, 60
H = 6 mm (¼ in.) stepped hose barb inlet
and outlet
Millipak®
Final Fill 200
B = 13 mm (½ in.) stepped hose barb inlet
and outlet
Millipak®
Final Fill 60, 200
T = 38 mm (1½ in.) sanitary flange inlet
and outlet
Millipak®
Final Fill Filter
Membrane Type
GB = Hydrophobic
Durapore®
0.22 μm
M F G B 3
Quantity per Pkg
3 = 3 per package
Quantity per Pkg
3 = 3 per package
* Millipak®
Final Fill 20 filters will be available for order in the near future