Best practices for PUPSIT assembly design and operation

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This webinar explores the design and implementation of pre use post sterilisation integrity test assemblies (PUPSIT) in sterile filtration processes to ensure regulatory compliance while minimising operational risk.

As an important final step in drug manufacturing, sterile filtration ensures that liquid-based drug substances are free from microbial contaminants.

In this webinar, learn what Pre Use Post Sterilisation Integrity Test (PUPSIT) is used for, and which key design considerations are needed for its implementation in drug manufacturing. The session will cover different PUPSIT design proposals and their advantages and disadvantages.

Find out how to integrate PUPSIT into existing processes without compromising product quality or sterility assurance. Gain insight into systems configuration and equipment layout and receive recommendations and practical examples. Design challenges will also be explored.

The session provides an opportunity to understand the regulatory framework and overview regarding PUPSIT.

Additionally, our expert speaker will examine the following related to filter integrity testing:

  • Best practices of inline filter integrity testing of single use assemblies (eg, PUPSIT) without breaking sterile boundary
  • What needs to be avoided during filter integrity testing, with specific insight into considerations in a PUPSIT environment
  • Common devices for integrity testing.

Audience-specific questions will be addressed at the end of the webinar.

Key learning points:

  • Key considerations for PUPSIT assembly design
  • Best practices for integrity testing
  • Understand the regulatory framework of filter integrity testing following cGMP Annex 1.