Pre-Use Post Sterilisation Integrity Testing (PUPSIT) | Parker
Biopharmaceutical Final Fill Vials

Parker's innovative pre-use post sterilisation integrity testing (PUPSIT) solutions combine single-use consumables and advanced filtration technology to ensure sterility and integrity in biopharmaceutical applications. 

BRINGING BIOPROCESSING TO LIFE

Our systems are designed for seamless integration into your existing processes, helping you meet regulatory standards while improving operational efficiency. By choosing our reliable single-use products, you can significantly reduce contamination risks and enhance product safety. Our dedicated team is here to assist you in implementing effective PUPSIT strategies, empowering you to deliver safe, life-enhancing therapies with confidence. 

SciLog® NFF+

Simplifying PUPSIT with Automation

The SciLog® NFF+ is a multipurpose normal flow filtration (NFF) system with on-board pre-use post sterilisation integrity testing (PUPSIT) in a compact footprint for GMP operating environments.

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PureTain® PUPSIT Assemblies

Ensuring Downstream Sterility

Combining the benefits of both filtration and single-use tube sets, PureTain® PUPSIT Assemblies provide a pre-assembled fully enclosed, sterile plug-and-play PUPSIT solution. 

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White Paper

Application of Pre-Use Post Sterilisation Integrity Testing

Considerations for implemenation

The latest revision of EU GMP Annex 1: Manufacture of Sterile Medicinal Products (August 2023) included PUPSIT as a default requirement for manufacturers using filtration to sterilise their final product. This white paper discusses the considerations and challenges for the incorporation of PUPSIT into both single-use and hard piped processes including filter selection and integrity test method, and system design, location and operation.

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