PDA Singapore Chapter - Webinar on PUPSIT
Join us for a webinar on PUPSIT where we focus on the need for PUPSIT, risk-based approach and design considerations for implementation
Recently, implementation of Pre-Use Post Sterilization Integrity Test (PUPSIT) to detect any filter flaw masking for the sterilized filters is a much talked about topic in the pharmaceutical industry. Debates are ongoing to assess the risk of implementing PUPSIT versus the benefits of detecting the filter flaw masking. There are differing opinions and views among both the industry and global regulators without clear consensus on either side. It is acknowledged that generation of additional scientific knowledge and data could be very valuable to determine the necessary controls for sterile filtration applications. PDA and the Biophorum Operations Group (BPOG) are working on a collaborative effort to address industry and regulatory concerns related to PUPSIT. This collaboration seeks to generate a series of integrated and interdependent workstreams that will provide industry and regulators alike with scientific data and information that can be used to make informed decisions on how best to control and prevent sterilizing grade filter failures or improve detection of failures. In this virtual webinar, we will discuss topics like the need for PUPSIT, updates from Annex 01 draft, risk based approach and design considerations for PUPSIT implementation.
Agenda
3.00 – 3.05 pm - Opening of the event, by Rama Tummala (GSK)
3.05 – 3.30 pm - Considerations for PUPSIT, by Sudhakar Nagaraj (Pall)Abstract:EU GMP Annex 1: Manufacture of Sterile Medicinal Products is currently under revision, and the current draft wording allows more flexibility on the requirement for performing Pre-Use, Post Sterilization Integrity Testing (PUPSIT) based on risk assessment. The driving force for performing PUPSIT is to detect the presence of a marginally non-integral filter after sterilization, where the process fluid, or impurities in the process fluid, could potentially mask a damage or a defect. Such masking would increase the risk of the marginal damage not being detected by the post-use integrity test. Sudhakar Nagaraj (Pall)
3.30 – 4.00 pm - An update on the scientific efforts to develop a Risk based position for implementing PUPSIT, by Vinh Thao Le (GSK)Abstract:The risk vs benefit analysis for implementing Pre-Use Post Sterilization Integrity Test (PUPSIT) is a hot topic in the industry. There is lack of availability of scientific data that can help to perform the risk assessment objectively. In December 2017, PDA and the Biophorum Operations Group (BPOG) began a collaborative effort to generate scientific evidences that can be used to make informed decisions on how best to control and prevent sterilizing grade filter failures or improve detection of failures. This task force group established the scientific evidence, plus looked at the risks and installation implications involved for PUPSIT. The data and information can be used as a basis to evaluate every terminal filtration application and run a risk assessment to determine whether PUPSIT would be of need or not. Vinh Thao Le (GSK)
4.00 – 4.30 pm - Filtration Assembly Design enabling implementation of PUPSIT, by Somasundaram G (Som) (Merck)Abstract:PUPSIT stands for pre-use post sterilization integrity testing. PUPSIT is performed once your sterilizing filter is installed to ensure that the sterilization and installation process has not damaged your sterilizing filter prior to filtration of your final drug product. When performing PUPSIT, you are working with a pre sterilized system and it needs to stay that way throughout the process of flushing/wetting, testing, drying & product filtration. When implementing PUPSIT, you need to focus on 3 design considerations (if not more) First-Number of filters in the system, Second - How are you going to flush the filter and finally, how you are going to recover your product held up in the system. Somasundaram G (Som) (Merck)
4.30 – 5.00 pm - Panel Discussion and Wrap up
About the Speakers
1. Sudhakar Nagaraj (Pall corporation): Sudhakar Nagaraj has been in Biopharmaceutical industry for over 21 years. He joined Pall during 2006 in Scientific Laboratory Services (SLS) organization as a technical leader in microbial contamination control and has extensive experience with sterile and virus filtration applications. Currently, he is part of SLS Global Regulatory and Validation consulting team, which is focused to provide streamlined technical guidance, scalable, customer-focused solutions to facilitate customer specification, qualification, validation and regulatory approval with Pall technologies. He is an active member of PDA & ISPE, representing Pall in Asia. He has completed post-graduation in Microbiology and based at Bangalore, India.
2. Vinh Thao LE (GSK): Thao has over 20 years of experience in Biological manufacturing industry with a strong background in Technical life cycle management and validation activities. Thao is leading the PUPSIT implementation for GSK Vaccines across various site and is an active member of the working team of PDA-Biophorum Operation Groups (BPOG) that is working on the Sterile Filtration Quality Risk Management (SF-QRM) including PUPSIT.
3. Somasundaram G (Som) (Merck Life Sciences): Somasundaram G (Som), is Senior Consultant for Asia Pacific in Merck Life Sciences under the Process Solutions division based in Singapore. He does consultation with customers in the areas of Aseptic Processing, Quality Risk Management and other BioPharmaceutical applications area. He is also a member of PDA and ISPE industry associations, and works closely with the team in APAC. Previously, Somasundaram was heading the Technology Management for South Asia & Oceania handling a team of Technology Managers who would work with customers in Product Adoption and training customers in best practices. Som has over 2 decades of experience working with Pharmaceutical customers in implementing best practices. Som holds a master’s degree in Food & Industrial Microbiology & with Business Management.
E-mail pda.sg.chapter@gmail.com for any questions.
Join us for a webinar on PUPSIT where we focus on the need for PUPSIT, risk-based approach and design considerations for implementation
Recently, implementation of Pre-Use Post Sterilization Integrity Test (PUPSIT) to detect any filter flaw masking for the sterilized filters is a much talked about topic in the pharmaceutical industry. Debates are ongoing to assess the risk of implementing PUPSIT versus the benefits of detecting the filter flaw masking. There are differing opinions and views among both the industry and global regulators without clear consensus on either side. It is acknowledged that generation of additional scientific knowledge and data could be very valuable to determine the necessary controls for sterile filtration applications. PDA and the Biophorum Operations Group (BPOG) are working on a collaborative effort to address industry and regulatory concerns related to PUPSIT. This collaboration seeks to generate a series of integrated and interdependent workstreams that will provide industry and regulators alike with scientific data and information that can be used to make informed decisions on how best to control and prevent sterilizing grade filter failures or improve detection of failures. In this virtual webinar, we will discuss topics like the need for PUPSIT, updates from Annex 01 draft, risk based approach and design considerations for PUPSIT implementation.
Agenda
3.00 – 3.05 pm - Opening of the event, by Rama Tummala (GSK)
3.05 – 3.30 pm - Considerations for PUPSIT, by Sudhakar Nagaraj (Pall)Abstract:EU GMP Annex 1: Manufacture of Sterile Medicinal Products is currently under revision, and the current draft wording allows more flexibility on the requirement for performing Pre-Use, Post Sterilization Integrity Testing (PUPSIT) based on risk assessment. The driving force for performing PUPSIT is to detect the presence of a marginally non-integral filter after sterilization, where the process fluid, or impurities in the process fluid, could potentially mask a damage or a defect. Such masking would increase the risk of the marginal damage not being detected by the post-use integrity test. Sudhakar Nagaraj (Pall)
3.30 – 4.00 pm - An update on the scientific efforts to develop a Risk based position for implementing PUPSIT, by Vinh Thao Le (GSK)Abstract:The risk vs benefit analysis for implementing Pre-Use Post Sterilization Integrity Test (PUPSIT) is a hot topic in the industry. There is lack of availability of scientific data that can help to perform the risk assessment objectively. In December 2017, PDA and the Biophorum Operations Group (BPOG) began a collaborative effort to generate scientific evidences that can be used to make informed decisions on how best to control and prevent sterilizing grade filter failures or improve detection of failures. This task force group established the scientific evidence, plus looked at the risks and installation implications involved for PUPSIT. The data and information can be used as a basis to evaluate every terminal filtration application and run a risk assessment to determine whether PUPSIT would be of need or not. Vinh Thao Le (GSK)
4.00 – 4.30 pm - Filtration Assembly Design enabling implementation of PUPSIT, by Somasundaram G (Som) (Merck)Abstract:PUPSIT stands for pre-use post sterilization integrity testing. PUPSIT is performed once your sterilizing filter is installed to ensure that the sterilization and installation process has not damaged your sterilizing filter prior to filtration of your final drug product. When performing PUPSIT, you are working with a pre sterilized system and it needs to stay that way throughout the process of flushing/wetting, testing, drying & product filtration. When implementing PUPSIT, you need to focus on 3 design considerations (if not more) First-Number of filters in the system, Second - How are you going to flush the filter and finally, how you are going to recover your product held up in the system. Somasundaram G (Som) (Merck)
4.30 – 5.00 pm - Panel Discussion and Wrap up
About the Speakers
1. Sudhakar Nagaraj (Pall corporation): Sudhakar Nagaraj has been in Biopharmaceutical industry for over 21 years. He joined Pall during 2006 in Scientific Laboratory Services (SLS) organization as a technical leader in microbial contamination control and has extensive experience with sterile and virus filtration applications. Currently, he is part of SLS Global Regulatory and Validation consulting team, which is focused to provide streamlined technical guidance, scalable, customer-focused solutions to facilitate customer specification, qualification, validation and regulatory approval with Pall technologies. He is an active member of PDA & ISPE, representing Pall in Asia. He has completed post-graduation in Microbiology and based at Bangalore, India.
2. Vinh Thao LE (GSK): Thao has over 20 years of experience in Biological manufacturing industry with a strong background in Technical life cycle management and validation activities. Thao is leading the PUPSIT implementation for GSK Vaccines across various site and is an active member of the working team of PDA-Biophorum Operation Groups (BPOG) that is working on the Sterile Filtration Quality Risk Management (SF-QRM) including PUPSIT.
3. Somasundaram G (Som) (Merck Life Sciences): Somasundaram G (Som), is Senior Consultant for Asia Pacific in Merck Life Sciences under the Process Solutions division based in Singapore. He does consultation with customers in the areas of Aseptic Processing, Quality Risk Management and other BioPharmaceutical applications area. He is also a member of PDA and ISPE industry associations, and works closely with the team in APAC. Previously, Somasundaram was heading the Technology Management for South Asia & Oceania handling a team of Technology Managers who would work with customers in Product Adoption and training customers in best practices. Som has over 2 decades of experience working with Pharmaceutical customers in implementing best practices. Som holds a master’s degree in Food & Industrial Microbiology & with Business Management.
E-mail pda.sg.chapter@gmail.com for any questions.