This document summarizes a report published by the Bio-Process Systems Alliance (BPSA) regarding recommendations for testing, evaluation, and control of particulates from single-use process equipment. The BPSA is a trade association that facilitates implementation of single-use technologies through various initiatives. The report was created by a working group consisting of subject matter experts from single-use technology suppliers and end users. It provides guidance on characterizing and minimizing particulate levels throughout the lifecycle of single-use technologies, including manufacturing, storage, handling and end use. It also discusses investigation and mitigation of particulate deviations. The BPSA recommends further work to develop standardized measurement methods, application-specific requirements, a catalog of particle types,
Enablers to increase predictability and service in a demanding and complex commercial supply chain, presentation made to MERCK SUN Conference, September 2013
Better Bioprocessing Efficiency Through Centralized OrchestrationMilliporeSigma
Use this link to participate in the interactive on-demand webinar: http://bit.ly/Bio4COrchestrator
Detailed description:
In this talk, we discuss how orchestration software improves bioprocessing efficiency through the centralized configuration and management of connected unit operations for process and workflow automation across the plant floor.
A browser-based software solution, Bio4C™ Orchestrator software connects to individual unit operations from a centralized orchestration layer for remote access to systems, recipes, reports, user accounts and alarms from a holistic process dashboard.
Watch the presentation of this webinar here: https://bit.ly/3tDy8Ei
Recent PDA/BioPhorum publications outline risks for PUPSIT in sterilizing filtration. This webinar will summarize the key points and best practices for implementing PUPSIT.
PDA and BioPhorum have partnered to form a task force whose goal was to provide the industry and regulators with scientific data and analysis on the potential risks and benefits of implementing PUPSIT to improve sterility assurance. This webinar will describe the data generated by the task force studies and discuss considerations and best practices when implementing PUPSIT.
In this webinar, you will learn:
• How changing industry perspectives help overcome regulatory concerns and may influence regulatory perspective
• How improved process understanding affects risk assessment
• How improved final fill assembly design simplifies PUPSIT
Tackling the challenges of single-use manufacturing for ADCsMilliporeSigma
Watch the full webinar here: https://bit.ly/2Ix3uud
In this webinar, you will learn:
• How SU assemblies are used in the ADC development space
• Recommendations for consistent transfer of SU processes to manufacturing
• Understand if SU technology is right for your product
• Evaluate the pros and cons of SU for ADCs
Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth with multiple new commercial products in 2020. Adoption of SU systems has been slow due to concerns for safe handling of organic solvents and the toxic small molecule payload. Recent advances in Single-use technology have overcome these concerns and now provide understanding of the suitability, scalability, and fluid compatibility of both the single-use components as well as the supporting hardware and controls. In this webinar, we show how the single-use technology can deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield.
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...Merck Life Sciences
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process.
In this webinar, you will learn:
- Risk assessment of extractables
- Single-use component evaluation
- Complexity when evaluating multiple assemblies
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...MilliporeSigma
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
Quality System Expectations : Single-Use Materialsgueste42f6b5
Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.
Enablers to increase predictability and service in a demanding and complex commercial supply chain, presentation made to MERCK SUN Conference, September 2013
Better Bioprocessing Efficiency Through Centralized OrchestrationMilliporeSigma
Use this link to participate in the interactive on-demand webinar: http://bit.ly/Bio4COrchestrator
Detailed description:
In this talk, we discuss how orchestration software improves bioprocessing efficiency through the centralized configuration and management of connected unit operations for process and workflow automation across the plant floor.
A browser-based software solution, Bio4C™ Orchestrator software connects to individual unit operations from a centralized orchestration layer for remote access to systems, recipes, reports, user accounts and alarms from a holistic process dashboard.
Watch the presentation of this webinar here: https://bit.ly/3tDy8Ei
Recent PDA/BioPhorum publications outline risks for PUPSIT in sterilizing filtration. This webinar will summarize the key points and best practices for implementing PUPSIT.
PDA and BioPhorum have partnered to form a task force whose goal was to provide the industry and regulators with scientific data and analysis on the potential risks and benefits of implementing PUPSIT to improve sterility assurance. This webinar will describe the data generated by the task force studies and discuss considerations and best practices when implementing PUPSIT.
In this webinar, you will learn:
• How changing industry perspectives help overcome regulatory concerns and may influence regulatory perspective
• How improved process understanding affects risk assessment
• How improved final fill assembly design simplifies PUPSIT
Tackling the challenges of single-use manufacturing for ADCsMilliporeSigma
Watch the full webinar here: https://bit.ly/2Ix3uud
In this webinar, you will learn:
• How SU assemblies are used in the ADC development space
• Recommendations for consistent transfer of SU processes to manufacturing
• Understand if SU technology is right for your product
• Evaluate the pros and cons of SU for ADCs
Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth with multiple new commercial products in 2020. Adoption of SU systems has been slow due to concerns for safe handling of organic solvents and the toxic small molecule payload. Recent advances in Single-use technology have overcome these concerns and now provide understanding of the suitability, scalability, and fluid compatibility of both the single-use components as well as the supporting hardware and controls. In this webinar, we show how the single-use technology can deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield.
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...Merck Life Sciences
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process.
In this webinar, you will learn:
- Risk assessment of extractables
- Single-use component evaluation
- Complexity when evaluating multiple assemblies
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...MilliporeSigma
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
Quality System Expectations : Single-Use Materialsgueste42f6b5
Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.
Potential Impact of Draft Annex 1 on Sterilizing FiltrationMilliporeSigma
Access the interactive recording here: https://bit.ly/2mvFxs7
Abstract:
The support for EMA GMPs related to sterile medicinal products is Annex 1. EMA, PICS and WHO have collaborated on the largest and most comprehensive revision of Annex 1 since it was first written in 1997.
There are a number of proposed changes to the sections in Annex 1 dealing with filtration, integrity testing and single-use.
This presentation will compare the current version with the proposed changes and highlight areas of specific interest to companies who either manufacture in or export to EMA countries, PICS member countries, and WHO compliant countries.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
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.
In this webinar, you will learn:
How Single-Use helps to simplify ADC manufacturing
Safety and Integrity of the complete process
Flexibility and adaptability to changing needs
How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC
Detailed description:
The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
Using Single-use Technology to Overcome the Challenges of ADC ProcessingMerck Life Sciences
Participate in the interactive webinar: http://bit.ly/SU-ADCWebinar
Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship.
Explore our webinar library: www.merckmillipore.com/webinars
USP <665> draft standard : A rational risk-based approach to characterization...MilliporeSigma
This webinar will cover risk-based characterization of filters and single-use systems used in biopharmaceutical manufacturing according to USP <665>.
Novel innovative biomanufacturing systems such as single-use assemblies often comprise of polymeric materials. There is a lack of standards for characterization of these polymeric systems. USP <665> draft standard is the first standard in development addressing this topic. This chapter recommends risk assessment with respect to patient safety, risk level assignment and risk level appropriate characterization of components.
In this webinar we will discuss:
● Risk assessment to assign a risk level
● Risk level based testing
● Our approach for compliance
● Emprove™ Dossiers for Filters and Single-use systems
PVA for sustained release: theory and practiceMilliporeSigma
Watch this webinar here: https://bit.ly/32cbiHt
This webinar will introduce PVA as an optimized excipient for sustained release formulations. Combining direct-compression compatibility with a robust and reliable matrix formation, PVA has the potential to enhance sustained release formulations.
By modifying the drug release characteristics, significant therapeutic benefits can be achieved, such as improved efficacy of the therapeutic agent, reduced adverse effects, optimization of the dosing scheme and overall improvement in patient compliance. There are numerous approaches for modified release, each with its own benefits and drawbacks. This webinar will present PVA, a fully-synthetic polymer, for optimized sustained release matrix formulations. Combining robust and reliable gel-forming behavior with optimized tableting properties, PVA provides solutions for the most challenging sustained release formulations.
In this webinar, you will learn:
• How the gel-formation properties of PVA introduce sustained release
• Why compatibility with direct compression leads to simplified formulations
• That PVA can provide flexibility in sustained release formulation development
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...MilliporeSigma
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technolog...Merck Life Sciences
Watch the interactive on-demand webinar here: https://bit.ly/2G8KSMu
The cost to develop and manufacture monoclonal antibodies has been highlighted as a substantial hurdle towards the widespread availability of these effective therapies for patients. Facility costs, utilization and labor are key contributing factors to the overall cost of these critical medicines. A proven method to increase utilization of a facility, increase process and quality robustness and lower overall costs of manufacturing is through the automation of a manufacturing process. The transformative impact that digital technologies have had on other industries’ manufacturing operations through IT and OT can be applied to the evolution happening in biopharma today. Examples of commonly used unit operations such as bioreactor, mixing and chromatography will be presented to illustrate incremental improvements that can be achieved today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.
In this webinar, you will learn:
- Incremental improvements that can be achieved today using process automation
- Practical examples of commonly used operations to illustrate the impact of automation
- How the automated facility will look like in the future
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
Advantages of Developing Processes and Manufacturing API with Single-Use Tech...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3jMIsr4
When biopharma companies move towards commercial manufacturing their focus shifts towards demand forecast, capacity constraints, and lifecycle management. Whether you chose a CDMO partner as a second-source manufacturer or to fully outsource your commercial manufacturing, quality, flexibility and cost-effectiveness are top priorities.
In this webinar, our experts will shed light on how we are currently designing our new biologic GMP commercial manufacturing facility in France that will go live in one year from now.
Flexibility is at the heart of our facility planning and set-up. We will showcase the advantages of single-use technology and its impact on the plant’s running costs, flexibility and capabilities e.g. for perfusion.
In 2012, we converted our GMP clinical manufacturing facility into 100% single-use technology. Today, our process development capabilities and our GMP clinical drug substance supply are based on single-use technology. Being a CDMO and a product provider, we are leveraging our industry leading single-use technologies to help our customers minimize risk and optimize speed for scale up and tech transfer. Using and sharing our first-hand experience combined with modern facility conceptual design, we will walk you through our facility planning, the ballroom concept and showcase what we mean by flexibility.
In this webinar, you will learn about:
• Designing a GMP biologic commercial manufacturing facility – a CDMO’s perspective
• Single-use technology and its impact on the facility’s flexibility and capabilities
• Customers’ advantages using single-use equipment for process development, clinical and commercial production
Presented by:
Laetitia Botrel, Head of Business Planning and Operation, End-to-End Solutions part of the BioReliance® portfolio
Jérôme Pionchon, Global Facility Engineering Expert, End-to-End Solutions part of the BioReliance® portfolio
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3bJypPv
Tablet coating simplified. Finding the perfect coating for your formulation can be challenging. A particle engineered polyvinyl alcohol helps you to optimize your process while maintaining full flexibility in designing the right coating formulation at the right time.
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy.
The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality.
In this webinar, you will learn:
• How to create your coating formulation by utilizing a broad excipient toolbox
• Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances
• Creating the perfect surface finishing
• How to utilize novel analytical technologies to boost your formulation development
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
Extractables profiles for chromatography resins - adapted approach of upcomin...MilliporeSigma
Watch the webinar here: https://bit.ly/36JaZpx
In biopharmaceutical industry there is a trend towards comprehensive risk assessments of drug manufacturing processes. Extractables studies for chromatography resins based on the adapted requirements of the upcoming USP <665> support risk evaluation for your specific chromatography steps.
In this webinar, you will learn about:
- Study design for extractables profiles of chromatography resins
- The new category Emprove® Chromatography
- Communication of extractables data as part of Emprove® Dossiers
Description:
Detailed information on any component or material in contact with the drug substance/ product is required to conduct a compreshensive risk assessment of a biopharmaceutical manufacturing process. No explicit guidelines providing required testing procedures for chromatography steps are in place yet. In the upcoming USP <665> chapter chromatography steps are in focus as well as any other plastic or polymeric component and can as such assessed as to the described criteria. To support our chromatography resin users an adapted extractables study approach was developed. The webinar will demonstrate our study design and the communication of the extractables profiles within our Emprove® Program.
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
The Viscosity Reduction Platform: Enabling subcutaneous (subQ) deliveryMerck Life Sciences
We will introduce an excipient platform that makes it possible to combine excipients in ways that can reduce protein viscosity to a greater extent.
*About challenges arising from high concentrated protein formulations
*The Viscosity reduction Platform: A portfolio of excipients to manage protein viscosity
*Impact of viscosity reducing excipient use on protein stability
*Impact of protein viscosity on syringeability
Aseptic Process Sampling to address Risk of Contamination & Containment in co...Merck Life Sciences
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Aseptic Process Sampling to address Risk of Contamination & Containment in co...MilliporeSigma
Watch this webinar here: bit.ly/asepticwebinar2020
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...MilliporeSigma
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process.
In this webinar, you will learn:
- Risk assessment of extractables
- Single-use component evaluation
- Complexity when evaluating multiple assemblies
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
Potential Impact of Draft Annex 1 on Sterilizing FiltrationMilliporeSigma
Access the interactive recording here: https://bit.ly/2mvFxs7
Abstract:
The support for EMA GMPs related to sterile medicinal products is Annex 1. EMA, PICS and WHO have collaborated on the largest and most comprehensive revision of Annex 1 since it was first written in 1997.
There are a number of proposed changes to the sections in Annex 1 dealing with filtration, integrity testing and single-use.
This presentation will compare the current version with the proposed changes and highlight areas of specific interest to companies who either manufacture in or export to EMA countries, PICS member countries, and WHO compliant countries.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
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.
In this webinar, you will learn:
How Single-Use helps to simplify ADC manufacturing
Safety and Integrity of the complete process
Flexibility and adaptability to changing needs
How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC
Detailed description:
The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
Using Single-use Technology to Overcome the Challenges of ADC ProcessingMerck Life Sciences
Participate in the interactive webinar: http://bit.ly/SU-ADCWebinar
Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship.
Explore our webinar library: www.merckmillipore.com/webinars
USP <665> draft standard : A rational risk-based approach to characterization...MilliporeSigma
This webinar will cover risk-based characterization of filters and single-use systems used in biopharmaceutical manufacturing according to USP <665>.
Novel innovative biomanufacturing systems such as single-use assemblies often comprise of polymeric materials. There is a lack of standards for characterization of these polymeric systems. USP <665> draft standard is the first standard in development addressing this topic. This chapter recommends risk assessment with respect to patient safety, risk level assignment and risk level appropriate characterization of components.
In this webinar we will discuss:
● Risk assessment to assign a risk level
● Risk level based testing
● Our approach for compliance
● Emprove™ Dossiers for Filters and Single-use systems
PVA for sustained release: theory and practiceMilliporeSigma
Watch this webinar here: https://bit.ly/32cbiHt
This webinar will introduce PVA as an optimized excipient for sustained release formulations. Combining direct-compression compatibility with a robust and reliable matrix formation, PVA has the potential to enhance sustained release formulations.
By modifying the drug release characteristics, significant therapeutic benefits can be achieved, such as improved efficacy of the therapeutic agent, reduced adverse effects, optimization of the dosing scheme and overall improvement in patient compliance. There are numerous approaches for modified release, each with its own benefits and drawbacks. This webinar will present PVA, a fully-synthetic polymer, for optimized sustained release matrix formulations. Combining robust and reliable gel-forming behavior with optimized tableting properties, PVA provides solutions for the most challenging sustained release formulations.
In this webinar, you will learn:
• How the gel-formation properties of PVA introduce sustained release
• Why compatibility with direct compression leads to simplified formulations
• That PVA can provide flexibility in sustained release formulation development
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
Next-Generation Bioprocessing Monitoring to Enable Smart Data Management and ...MilliporeSigma
Watch this webinar here: https://bit.ly/2ZpV3GU
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and unpredictable process outcomes. To manage complexity and better understand causes of variability, in-depth knowledge and thorough understanding of the process is critical. Bio4C™ ProcessPad provides the data integration, analysis and sharing across the manufacturing network and end-to-end data management throughout the process lifecycle required for continued process verification, reporting, and analytics.
Bio4C™ ProcessPad is a data visualization, analytics, and process monitoring platform that enables bioprocess lifecycle management, reporting, investigations, and continued process verification (CPV). Intelligently combining process data from batches, Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Historian, process equipment, and manual sources into a single, validated data source, Bio4C™ ProcessPad ensures data is current, complete, and contextual throughout the product lifecycle.
In this webinar, you will learn:
• Introduction to Next Generation BioContinuum™ Digital Platform and Bio4C™ Software Suite
• Overview of Bioprocess lifecycle and present biomanufacturing data management challenges
• Introduction to the Bio4C™ ProcessPad digital platform and its modules and features
• Benefits of Bio4C™ ProcessPad in investigations, process monitoring, continued process verification (CPV) and CDMO operations
Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technolog...Merck Life Sciences
Watch the interactive on-demand webinar here: https://bit.ly/2G8KSMu
The cost to develop and manufacture monoclonal antibodies has been highlighted as a substantial hurdle towards the widespread availability of these effective therapies for patients. Facility costs, utilization and labor are key contributing factors to the overall cost of these critical medicines. A proven method to increase utilization of a facility, increase process and quality robustness and lower overall costs of manufacturing is through the automation of a manufacturing process. The transformative impact that digital technologies have had on other industries’ manufacturing operations through IT and OT can be applied to the evolution happening in biopharma today. Examples of commonly used unit operations such as bioreactor, mixing and chromatography will be presented to illustrate incremental improvements that can be achieved today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.
In this webinar, you will learn:
- Incremental improvements that can be achieved today using process automation
- Practical examples of commonly used operations to illustrate the impact of automation
- How the automated facility will look like in the future
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
Advantages of Developing Processes and Manufacturing API with Single-Use Tech...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3jMIsr4
When biopharma companies move towards commercial manufacturing their focus shifts towards demand forecast, capacity constraints, and lifecycle management. Whether you chose a CDMO partner as a second-source manufacturer or to fully outsource your commercial manufacturing, quality, flexibility and cost-effectiveness are top priorities.
In this webinar, our experts will shed light on how we are currently designing our new biologic GMP commercial manufacturing facility in France that will go live in one year from now.
Flexibility is at the heart of our facility planning and set-up. We will showcase the advantages of single-use technology and its impact on the plant’s running costs, flexibility and capabilities e.g. for perfusion.
In 2012, we converted our GMP clinical manufacturing facility into 100% single-use technology. Today, our process development capabilities and our GMP clinical drug substance supply are based on single-use technology. Being a CDMO and a product provider, we are leveraging our industry leading single-use technologies to help our customers minimize risk and optimize speed for scale up and tech transfer. Using and sharing our first-hand experience combined with modern facility conceptual design, we will walk you through our facility planning, the ballroom concept and showcase what we mean by flexibility.
In this webinar, you will learn about:
• Designing a GMP biologic commercial manufacturing facility – a CDMO’s perspective
• Single-use technology and its impact on the facility’s flexibility and capabilities
• Customers’ advantages using single-use equipment for process development, clinical and commercial production
Presented by:
Laetitia Botrel, Head of Business Planning and Operation, End-to-End Solutions part of the BioReliance® portfolio
Jérôme Pionchon, Global Facility Engineering Expert, End-to-End Solutions part of the BioReliance® portfolio
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3bJypPv
Tablet coating simplified. Finding the perfect coating for your formulation can be challenging. A particle engineered polyvinyl alcohol helps you to optimize your process while maintaining full flexibility in designing the right coating formulation at the right time.
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy.
The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality.
In this webinar, you will learn:
• How to create your coating formulation by utilizing a broad excipient toolbox
• Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances
• Creating the perfect surface finishing
• How to utilize novel analytical technologies to boost your formulation development
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
Extractables profiles for chromatography resins - adapted approach of upcomin...MilliporeSigma
Watch the webinar here: https://bit.ly/36JaZpx
In biopharmaceutical industry there is a trend towards comprehensive risk assessments of drug manufacturing processes. Extractables studies for chromatography resins based on the adapted requirements of the upcoming USP <665> support risk evaluation for your specific chromatography steps.
In this webinar, you will learn about:
- Study design for extractables profiles of chromatography resins
- The new category Emprove® Chromatography
- Communication of extractables data as part of Emprove® Dossiers
Description:
Detailed information on any component or material in contact with the drug substance/ product is required to conduct a compreshensive risk assessment of a biopharmaceutical manufacturing process. No explicit guidelines providing required testing procedures for chromatography steps are in place yet. In the upcoming USP <665> chapter chromatography steps are in focus as well as any other plastic or polymeric component and can as such assessed as to the described criteria. To support our chromatography resin users an adapted extractables study approach was developed. The webinar will demonstrate our study design and the communication of the extractables profiles within our Emprove® Program.
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
The Viscosity Reduction Platform: Enabling subcutaneous (subQ) deliveryMerck Life Sciences
We will introduce an excipient platform that makes it possible to combine excipients in ways that can reduce protein viscosity to a greater extent.
*About challenges arising from high concentrated protein formulations
*The Viscosity reduction Platform: A portfolio of excipients to manage protein viscosity
*Impact of viscosity reducing excipient use on protein stability
*Impact of protein viscosity on syringeability
Aseptic Process Sampling to address Risk of Contamination & Containment in co...Merck Life Sciences
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Aseptic Process Sampling to address Risk of Contamination & Containment in co...MilliporeSigma
Watch this webinar here: bit.ly/asepticwebinar2020
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...MilliporeSigma
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process.
In this webinar, you will learn:
- Risk assessment of extractables
- Single-use component evaluation
- Complexity when evaluating multiple assemblies
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...Merck Life Sciences
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...Merck Life Sciences
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
USP <665> draft standard : A rational risk-based approach to characterization...Merck Life Sciences
This webinar will cover risk-based characterization of filters and single-use systems used in biopharmaceutical manufacturing according to USP <665>.
Novel innovative biomanufacturing systems such as single-use assemblies often comprise of polymeric materials. There is a lack of standards for characterization of these polymeric systems. USP <665> draft standard is the first standard in development addressing this topic. This chapter recommends risk assessment with respect to patient safety, risk level assignment and risk level appropriate characterization of components.
In this webinar we will discuss:
● Risk assessment to assign a risk level
● Risk level based testing
● Our approach for compliance
● Emprove™ Dossiers for Filters and Single-use systems
pilot plant is a small system which is operated to find out about the behavior of a process before using it on a large industrial scale. so, this presentation tries to illustrate its objective and significance to understand the methodologies of various pharmaceutical dosage forms.
Considerations to Extractables and Leachables Testing SGS
How to organize Extractables Assessments? FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, and Process Validation, and recently to include failures of manufacturers in Risk Management. The evaluation of extractables and leachables has become an increasingly important aspect in the Quality by Design (QbD) initiative of the FDA in the area of drug product design, including materials used in the drug product production process and container and closure systems used for product packaging. This presentation provides general approaches and practical aspects in E&L testing.
Visual Inspection of Parentetal Drug Products in Pharmaceutical Quality testingKarishmaRK
This presentation aims to elaborate the regulatory & compendial requirements of Visual inspection in Pharmaceutical parenteral manufacturing and the methodology of carrying out the testing.
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.
Process equipment characterization – how standardized extractables data suppo...MilliporeSigma
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Process equipment characterization – how standardized extractables data suppo...Merck Life Sciences
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Similar to Redacted bpsa particulate paper bpog 150115 (1) (20)
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
2. Bio-Process Systems Alliance
Trade association of suppliers and users: 46 Members
Facilitates implementation of single-use via:
Networking opportunities
Safe harbor for dialogue
among industry business leaders
End-user / supplier forums
Best practice guides/projects
Extractables; Particulates; Integrity; Change
7. The Team
Csilla Kollar, Dow Corning Corp.
Mark A. Petrich, Merck & Co., Inc.
Eric Isberg, Entegris
Ernie Jenness, EMD Millipore
Helene Pora, Pall Life Sciences
James D. Vogel, The BioProcess
Institute
John Stover, AdvantaPure/New Age
Industries
Ken Davis, Value Plastics, Inc.
Kirsten Strahlendorf, Sanofi Pasteur
Mike Johnson, Entegris
Patrick Evrard, GSK Vaccines
Maureen Eustis, The BioProcess Institute
8. Discussion
How BPSA got here?
Some History
The Effort…The Team and Methods.
Details of the Paper
Recommended Next Steps
BPSA Recommendations
Panel Discussion
Efforts in Standards Organizations.
9. Recognized a Need
Concerns for particulate contamination
discussed at 2011, 2012 and 2013 BPSA Int’l
Single-Use Summits (ISUS).
2013 formed working group of SMEs from SUT
supplier and end user companies to discuss
and recommend best practices.
Dozens of meetings held over 9-months to
balance all considerations from both sides.
10. Document Overview
Educational document for suppliers and end
users in the Single-Use Technology (SUT)
Industry
Guide to characterization and determination
of levels and types of particles in SUTs
Recommends procedures to achieve
minimal levels of particles in SUTs.
11. The Intent
Help the BPSA members navigate this
complex topic throughout the lifecycle of
the SUT.
New to--and familiar with--SUT
End Users and Suppliers
12. Common Understanding
End users to convey their specific
particulate requirements.
Suppliers can demonstrate their
capabilities.
13. Common Goal
“The goal of end users, regulators, and
standards-setting organizations should be to
minimize particulates in drug products, without
placing unnecessary expectations on suppliers
for minimal safety gains. Improving the
manufacturing quality will reduce the risk of
harm to patients from particle contamination.”
--Langille, Stephen E., Particulate Matter in Injectable Drug Products, PDA J Pharm Sci Tech 2013
14. Table of Contents
Part I: Introduction
Part II: Particle Risk
Part III: Particle Characteristics & Quantification
Part IV: Particle Measurement Methods
Part V: Single-Use Technology Lifecycle
Part VI: Methods of Control for Suppliers
Part VII: Particulate Evaluation as Part of End User
Manufacturing
Part VIII: Deviation Response/Mitigation Plans
Part IX: Summary and Conclusion
Part X: BPSA-recommended Next Steps
Part XI: Terms and Definitions
Part XII: References
16. Common Goal
“The goal of end users, regulators, and
standards-setting organizations should be to
minimize particulates in drug products, without
placing unnecessary expectations on suppliers
for minimal safety gains. Improving the
manufacturing quality will reduce the risk of
harm to patients from particle contamination.”
--Langille, Stephen E., Particulate Matter in Injectable Drug Products, PDA J Pharm Sci Tech 2013
18. Definition of “Particle”
“A particle is loose mobile matter or
embedded matter that is unintentionally
present in/on the single-use
component/assembly and potentially
may contact or may end up in the
process/product fluid.”
19. Comparison
Multi-use Equipment
o Usually cleaned and rinsed before sterilization
o Rinse removes particles; soil, cleaners,
environmental contaminants
Single-Use Equipment
o Received as Ready-To-Use
What’s in the SUT may end up in the process
media
o Usually not rinsed prior to sterilization
o Particles may be generated during the products
lifecycle
20. Risk
Fewer is Better!
Well documented in the regulations.
o “Surfaces…shall not be reactive, additive or
absorptive”
(CFR 211.65)
o “All surfaces…free of surface solids”
(CFR 600.11)
21. What are the Risks of Particles?
for the Patients
for the Product
for the Process
22. Patients
o Obstruction of blood vessels
o Over-taxation of immune system
o Incompatibility with arterial system
o Level of risk is based on factors such as the route
of drug delivery (IV, SC, IM), age/health of patient,
frequency of dosage, characterization of the
particle
What are the Risks of Particles?
23. Product
o Safety
o Effectiveness
o Chemical structure
o Top cause of recalls in 2012
o Level of risk can be based on the product;
Vaccines, mAbs, Cell Therapies, Intermediate
What are the Risks of Particles?
24. Process
o Media/Buffer Prep
o Upstream: Fermentation, Separation
o Downstream: Purification, Drug Substance Storage
o Final Fill
o Is there a filter downstream of the process?
o Is it storage or transfer of process media?
o What is the exposure time?
What are the Risks of Particles?
25. • Location of Particle
o External surface
o Embedded
o Process Contact Surface
What are the Risks of Particles?
27. • Particle Definition
• Type of Particle
• Particle Characteristics
Particle Characterization
28. Type of Particles
Intrinsic (native to the SUT)
Extrinsic (foreign to the SUT)
Known
Unknown - MOST CONCERNING
29. Particle Characteristics
Size
o Visible or sub-visible
Shape
o Spherical or angular
Hardness
o Soft/deformable or hard/brittle
Texture
o Smooth or rough
Chemical Composition
o Inert or toxic
o Intrinsic or extrinsic
Quantity
30. Particle Size
Visible (>50-100 microns)
o USP <1>
o USP <790> (<1790>)
o EP 2.9.20
o JP 6.06
Sub-visible
o USP <788>
10 and 25 micron
31. Particle Size
Visible Gray Zone
1µm 50µm 150µm
Sub-visible
visible
gray zone
Visible
100µm
33. Particle Size
The BPSA suggests the 100-micron size be the
benchmark for differentiating between visible and
sub-visible particles.
The draft USP monographs have clearly defined
visible particles as being >100 microns.
36. Visual Inspection
Typical attributes inspected for are:
Component arrangements are verified;
Connections are verified to be secure;
Embedded particles/gels;
Film creases;
Exterior particles are observed and removed;
Finished goods are inspected for internal particles
where possible, e.g. clear and translucent
components; and
Actions are taken based on inspections and may
include discarding the single-use assembly.
39. Single-Use Lifecycle
Each step of the SUT’s lifecycle can
contribute to the potential for additional
particulates.
A proper Particulate Management Program
will minimize these contributions and keep
the levels as low as possible.
Process steps can be added, e.g. filtration,
to reduce SUT’s particulate levels.
40. Particulate Management Program
Fishbone of potential sources
Each sub component
Each Process Step
people
methods
machine
environment
measurements
42. SUPPLIER
Raw materials of the components (resins,
compounds);
Preparation of equipment (cleaning and/or
sanitization) for manufacturing components
or assemblies;
Fabrication of each individual component.
(bag film, tubing, connectors, O-ring, filter
membrane);
Assembly of the sub-assembly (bag with
ports, filter capsule, connector);
Assembly of the final assembly (bag
assembly, transfer assembly, filling
assembly);
Packaging;
Transportation and handling; and
Sterilization (irradiation).
END USER
Receipt;
Quality inspection;
Storage;
Transfer to the production area;
Removal of packaging (may
occur at various stages);
Preparation (e.g., rinsing,
autoclaving);
Use; and
Disposal.
SUT Lifecycle
49. Methods of Control for Suppliers
• Raw Components
• Clean Room Operation
• Clean Room Performance
• Manufacture of the SUT
50. Requirements
Manufacturing processes designed to minimize the risk of particle
generation, introduction or inclusion into the finished assembly;
Maintaining proper preventative maintenance of manufacturing
equipment;
Ensuring cleanliness of materials and people entering the
cleanroom;
Controlling flow of materials and personnel within the
manufacturing environment;
Providing operator training;
Demanding cleanroom gowning;
Ensuring cleanroom maintenance and control;
Inspecting product, including up to 100% in-process surveillance
and lot release testing;
Recording performance trending for both the cleanroom operation
and the manufactured SUT; and
Documenting non-conformance, root cause analysis and
corrective/preventative actions.
52. Recommendations
Apply risk-adjusted and science-based approach
Particulate control is everyone’s responsibility –
not just the final integrator’s
ISO Class 8 or better for component providers unless
thorough risk analysis concludes this is not needed (post-
production cleaning possible)
ISO Class 7 or lower for assembly integration unless
thorough risk analysis concludes this is not needed (pre-
use flush possible or end-use doesn’t require low
particulate claims)
53. Conclusions
Quality has to be built in – can’t rely of final test
Particulate control – both visible and sub-visible – in single-use
assemblies is feasible
Awareness regarding particulate contamination has increased
tremendously – requirements for critical applications will get even
more stringent
Instituting the following…
Appropriate incoming material controls
Material /personnel workflow in/out of clean rooms
Environmental monitoring
Appropriate gowning/de-gowning processes
In-process inspection
Robust OOS investigation and CA/PA procedures
… will result in meeting/exceeding user expectations for particulate
contamination
56. Potential Sources
Source type Manufacturing-induced source
Processing materials and raw
material ingredients/ product
Particulates from the single-use component can interact with components of a protein
solution to form precipitates.6 These can be further exacerbated by process conditions
and/or type of single-use component
Manufacturing activities Connecting and disconnecting assemblies
Using fiber-shedding filters with zero-to-minimal flushing
Limited use of rinsing/washing/flushing steps
Valve use
Pump use
Onsite or site-to-site transportation conditions and containers
Mismatched components, non-optimal component-equipment integration
Mixing components chafing inside of container or impeller parts/bearings
Rough handling
Regular equipment/processing aid wear
Abrasive product (e.g. undissolved aluminum salts)
Manufacturing environment Open system applications of single-use
Personnel Handling of SUT assembly or part(s)
57. Processing Considerations
Mixing speed;
Number of connections made during the
process;
Storage times and temperatures;
Line clamping or valve use;
Pumping/spallation;
Rinsing/flushing/washing steps; and
General handling practices
58. Best Practices for Handling Single-
Use Components
1. Cover sharp parts. Do not remove
supplier’s protective coverings until
necessary.
2. During storage, bags should be
contained in a hard-shelled container
or, at minimum, covered with a sealed
outer bag. Lines should be secured
as appropriate, especially when
freezing.
3. Flush the systems, especially those
that contain filters or fiber-shedding
components, where possible.
4. Avoid over-processing: over-mixing,
or over-handling of
components/assembly.
5. Avoid pulling, flattening, rubbing,
squeezing, flexing, or twisting of
components/assembly.
6. Optimize the welding and sealing
conditions to avoid “flashing” or
inadequate welds.
7. Keep product fluid contact path as short
and with as few components as possible.
8. Do not lift items by their tubing
connections.
9. Minimize the stress on tubing junctions.
Avoid sharp bend radii.
10.Do not allow sharp objects to be used in
the same area as single-use components.
11.Match peristaltic pump tubing type and
dimensions to pump heads, process
duration, and process fluids. Do not
exceed anticipated tubing life.
12.Minimize surfaces that can rub together
during shipping, storage, or use.
60. • When in the lifecycle is the particle
observed?
• Where is the particle observed?
• Particle Investigation Steps
Deviation Response/Mitigation
61. WHEN in the Life Cycle a
Particle is Observed?
Supplier
Subcomponent manufacturing
QC prior to packaging
After packaging and before shipment
End User
Incoming receiving
Point of use
Before use
During Use
After Processing is complete
62. WHERE is the particle Observed?
On or In the SUT?
Outer Package
Inner Package
Exterior of the SUT
Within the Product/Process Contact
Surface
63. Particle Investigation Steps
Detect Report Hold the Lot
Compare to
Catalog
Capture &
Characterize
Quarantine
Determine
Root Cause
Assess
Impact
Prepare
Investigative
Report
Review and
CAPA
64. Summary & Conclusion
There are four primary areas that must be managed
in order to ensure robust control of particulates in
single-use systems:
1. Cleanliness of the incoming materials;
2. Cleanliness of the manufacturing steps and assembly
processes;
3. Cleanliness of the operators and associated gowning;
and
4. Cleanroom facility and equipment maintenance and
controls.
66. Summary
Particle Control is everyone’s responsibility.
Quality must be built-in.
Proper systems to minimize particulates
Continuous Improvement for the full SUT lifecycle
Track Results
Show the particle control process is improving.
67. What We Did
Listened to concerns of BPSA Members
(suppliers and end users)
Formed working group of SMEs (suppliers and
end users)
Held weekly phone meetings for 9 months often
involving very spirited “debates”
Developed best practices and recommendations
Resulted in BPSA Paper.
68. But a lot did not make it into the
particulate paper…
69. …because of…
Some lack of consensus
Very In-depth discussions
Attempts to keep the paper
a manageable length.
Deadlines!
We’re making progress, but a lot of
content still needs to be addressed!
71. Next Steps
1. Need SUT Particulate Measurement Method.
2. Better defined application-specific requirements.
3. Create industry-wide catalog of particles.
4. Conduct particulate generation studies.
5. Create a formal SUT Best Practices Guide.
6. Establish supplier/end-user Quality Agreements
of SUT Acceptance Criteria.
73. How Can You Buy the Paper?
Contact Jeanette McCool
or Kevin Ott at
mccoolj@socma.com
ottk@socma.com
or visit:
www.bpsalliance.org
Cost: $295
74. Other Happenings…
In addition to the BPSA project:
USP-787, 790, 1787, 1790
ASME-BPE added particulate content to the
Non-Mandatory Appendix portion of the ASME-
BPE 2014 Standard resulting from discussion by
their Particulate Task Group…More to come
ASTM has two work streams creating a draft of a
standard related to particulate currently under
review.
75. If You Build It…
BPSA has made a big contribution.
What is next?
Who can help?
How can you help?
76. Discussion
More is needed.
Do we do it? Or do we hand it off to
someone else?
Did we miss anything?
Your thoughts?