Avantor® PUPSIT Assemblies

Avantor's PUPSIT (Pre-Use Post-Sterilization Integrity Testing) assemblies are designed to simplify pre-use integrity testing while maintaining product sterility.

• Configurable designs that easily integrate into your filtration and filling process

• Reduced risks associated with designing and implementation of PUPSIT
• Open architecture for greater flexibility in configuration and enhanced supply chain securityFaster lead times compared to fully customized assembly solutions

We offer a range of pre-designed PUPSIT assemblies with configurable elements. By leveraging our extensive library of validated components and a supplier-agnostic approach, we enable flexible design adaptation while maintaining compliance with EU GMP Annex 1. Choose from a large validated component library that includes:

• Filters - air filter, liquid filter, barrier filter

• Connectors - quick connectors/disconnectors, aseptic connectors and disconnectors, steam-to and steam-through connectors

• Tubing - thermoplastic elastomers, platinum-cured silicone, reinforced tubing

• Sensors - sensors or single-use guage tees

• Fittings - straight, reducing, elbow, T-style, X-style, and cross-style

• Sample ports - septum-style, EVSS, Omnitop, other needle-based and needle-free ports

Certifications: PUPSIT assemblies are assembled in an ISO Class 7 cleanroom and are manufactured from USP Class VI materials. All product contact materials are animal-free or processed in accordance to EMEA/410/01. These assemblies are gamma irradiated to Sterility Assurance Level (SAL) 10-6. Each assembly is individually triple bagged and is accompanied with a certificate of quality and certificate of processing.

Bestillingsoplysninger: PUPSIT assemblies are available in a wide variety of configurable designs, as well as custom engineered designs, to suit specific applications.   Few options are presented below. For more information, please contact a local Avantor sales representative.