Global industry-leading manufacturer of high-performance, innovative solutions and components across a wide range of industries.
Serving Biopharm and Cell Therapy
Industry-leading provider of material science-based solutions in the biopharmaceutical and cell therapy markets for single-use fluid management.
Medical Components and Custom Solutions
We provide custom components and engineered systems for the medical device industry, including critical parts where precision enables superior performance.
Electronics and Semiconductor Industry Solutions
Design and manufacture a complete line of ultra-high purity, fluoropolymer-based fluid handling components and solutions for the electronics and semiconductor markets.
Industrial & Consumer Solutions (ICS)
Superior engineering and customer support to achieve safety, performance, and regulatory compliance across a broad range of capabilities. Offerings include Tygon® Tubing and Accessories, Hoses and Fittings, Heat Shrink Tubing, and High-Performance Seals.
Sensors Flow Measurement Solutions
Playing an essential role in preventing cross-contamination, validating essential processes, and driving cost savings, we specialize in the development and production of high-quality single-use flow sensors and corresponding equipment.
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Pre-Use Post-Sterilization Integrity Testing (PUPSIT) is a non-destructive integrity test performed on a sterilized filter and its associated components before they are used to filter a product. This testing method, which includes procedures such as bubble point and diffusion tests, is crucial in confirming that the filter is integral after sterilization and prior to use.
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Why Implement PUPSIT?
The primary purpose of PUPSIT is to ensure that a sterilizing filter remains integral after the sterilization process, thereby preventing microbial contamination. It addresses the issue of "filter flaw masking," where a flaw in the filter could be blocked by fluid contaminants during use, potentially remaining undetected in post-use integrity tests.
The most recent Annex 1 regulatory changes emphasize the critical role of PUPSIT in maintaining filter integrity and product sterility. This shift drives the need for robust procedures and advanced technologies to enhance compliance, efficiency, and contamination control strategies.
PUPSIT is a connected process step prior to the Fill Finish operation. Learn more about our Fill Finish custom assembly capabilities here.
Design considerations for a PUPSIT assembly using Saint-Gobain Life Sciences components and technologies. Example of a redundant filter PUPSIT configuration:
1
Design Customization
Design will be adjusted depending on the customer specificities, for example:
Additional Wetting fluid source to get a separate flow channel for wetting fluid (if not using product for integrity testing)
Backup line to redirect the fluid flow out of the assembly (safety option in case of integrity failure)
2
Overmolding
Overmolding connections to reduce leakage risk and system complexity.
Sterilizing grade filter with hydrophobic membrane to permit sterile gas flow (Nitrogen) from integrity tester through the assembly during integrity testing.
Saint-Gobain Life Sciences PUPSIT designs facilitate easy handling, assembly, and operation by end-users, minimizing the risk of operator error. They include ports or connectors that allow for straightforward integrity testing post-sterilization without compromising sterility. Additionally, the designs are scalable to different sizes and capacities to accommodate various production needs.
The flow path is designed to minimize dead legs and areas where the product could stagnate, maintaining sterility and ease of cleaning. Selected connectors are robust, easy to use, and compatible with existing systems, with quick connect/disconnect features to enhance usability. Filters are strategically placed to allow easy pre-use integrity testing and ensure that post-sterilization integrity can be verified without compromising sterility.
Saint-Gobain Life Sciences PUPSIT Assemblies Provide:
RELIABILITY: Our seamless flow path overmolding technology and tubing range meet critical fluid path requirements for high pressures and significantly reduce connection leakage. As a result, this minimizes the number of components in assemblies.
EXPERTISE: Saint-Gobain Life Sciences' deep expertise in materials science, our own products, and single-use technologies enables our team of engineers to discuss, propose, and design the most suitable PUPSIT assemblies that meet your requirements and constraints.
REGULATORY: Testing to regulatory standards is provided to ensure the cleanliness, biocompatibility, and sterility of assemblies. We have dedicated assembly sites in NA, Europe, and Asia. Request access to the Validation & Technical section of our website for more details on our assembly sites and sterility programs.
FLEXIBILITY IN DESIGN: Our open-architecture approach gives our customers the ability to customize assemblies using our vast library of components. Vertically integrated components such as Pure-Fit® SIB connectors, BarbLock® ultra-secure retainers, and single-use bioprocess bags, coupled with our industry-proven tubing, Sani-Tech® STHT®-80, Sani-Tech® STHT®-R, and C-Flex® Braided, can help to achieve your PUPSIT process requirements.
