The Role of the Pre-use Post-sterilization Integrity Test (PUPSIT) in a Contamination Control Strategy

The recent revision of EU GMP Annex 1 positions the need for a pre-use post-sterilization integrity test (PUPSIT) in the context of Quality Risk Management and highlights that this is a natural component of the contamination control strategy (CCS). In this webinar, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing grade filtration in the control strategy, and talk about how this can change throughout the product life cycle. We review the risk assessment process as a precursor to developing an effective CCS and provide guidance on PUPSIT and other filtration-related contributions to the strategy. Throughout the webinar, we will share the perspectives from Cytiva’s experienced scientific and application teams and guidance for its successful implementation.

A medical laboratory from Spain, Reig Jofre, will also share their industry standpoint and showcase their journey of PUPSIT adoption and compliance, using both manual and automated solutions.

Presented by Mihir Kumar Patel, Senior Field Scientist at Cytiva

Mihir is a Senior Field Scientist for Cytiva, based in Philadelphia, USA. He has a Master’s degree in Biotechnology and over 15 years of experience in the life science industry. Mihir is a subject matter expert in downstream processing, separation sciences and single-use technologies, and he uses his expertise to provide scientific support for Cytiva customers and stakeholders throughout North America.

Sasha Nikolić, Manufacturing Process Development and Validation Expert at Reig Jofre

Sasha is a manufacturing process development and validation expert at Laboratory Reig Jofre (Barcelona, Spain), who specializes in the field of parenteral drug products (focused on freeze-dried injectables), including small molecules and complex biologics. He is responsible for the contamination control strategy definition/implementation, regarding the filtration and filling, using single-use assemblies.

Sponsored by Cytiva

At Cytiva, our mission is to advance and accelerate the development of therapeutics. With nearly 16 000 associates in more than 40 countries, we’re driven to use our expertise and talent to achieve better flexibility, capacity, and efficiency for our customers. Our broad and deep portfolio of tools and technologies, global scale, and best-in-class service provides critical support from discovery to delivery, for customers spanning researchers, emerging biotech, large-scale biopharma, and contract manufacturers. Learn more at cytiva.com.