If you are in need of a single-use assembly that meets all requirements for Pre-Use-Post-Sterilization-Integrity-Testing (PUPSIT), Acuity can help. With extensive experience providing ready-to-use PUPSIT assemblies, we partner closely with our clients and vendors to specify and validate customized systems from start to finish. We also provide filters from most common manufacturers, so if you have already specified a filter for your application, we can likely provide it in a pre-sterilized assembly. In addition, Acuity’s T-LOC Tubing & Filter Management System is the perfect solution for managing your PUPSIT assemblies and adding integrity and repeatability to your process.
What is PUPSIT?
When filtering critical fluids in a bio-pharmaceutical process, one must ensure that the filter has not been compromised before the point of use. As such, filters are commonly tested before use to ensure the membrane performs as expected following any sterilization processes (e.g. gamma irradiation or autolcave). In essence, when using a sterilizing filter, one needs to ensure the pores have not grown in size or that the filter has not been damaged in a way that could allow unwanted particles to flow past the filter. To ensure filters are suitable for the intended purpose, PUPSIT is often employed in the bio-pharmaceutical industry and typically involves non-destructive testing methods, such as bubble point or diffusion tests. To implement best practices and comply with the current regulatory requirements, companies commonly refer to the cGMP guidance contained in EudraLex Annex 1.
Some of the drawbacks associated with PUPSIT requirements are the need for additional components adding potential failure points and the introduction of possible dead legs. Acuity is knowledgable about the common hurdles faced when designing and specifying a PUPSIT assembly. We also recommend this article from BioPhorum as a detailed introduction to PUPSIT, the related requirements under EudraLex Annex 1, and how to perform a risk assessment.
The Acuity Advantage
- Ready-to-Use Custom Assemblies
- Quick Turnaround Custom Designs
- ISO 11137 Sterility Validation Available
- Filters Available from Most Common Providers
- Full Extractables and Regulatory Support
- Innovative T-LOC Tubing & Filter Management System
Applications
- Pharmaceutical & BioProcessing
- Upstream
- Downstream
- Media
- Buffers
T-LOC Tubing & Filter Management System
Acuity’s proprietary T-LOC Tubing & Filter Management System is the perfect solution for managing your PUPSIT assemblies. Often with many branches, PUPSIT assemblies can be complex and heavy and can ultimately create challenges in terms of ergonomics and repeatability. To design the optimal PUPSIT process, it is often recommended to also design a system to manage the tubing and filter placement in a repeatable way. Acuity invented the T-LOC system to help our customers improve safety, process integrity, and ergonomics in critical bioprocessing applications. With comprehensive options such as floor stands, wall mounts, carts and a variety of filter and tubing clips, the modular T-LOC system can be configured to your specific needs.
Build Your Custom PUPSIT Assembly
Whether you are designing a new PUPSIT-related process or updating an existing process which must comply with PUSIT guidance per EudraLex Annex 1, Acuity can help. Contact us today for a personalized quote and tailored design drawing for your unique PUPSIT assembly.
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