A closed, low-risk Post-Use Post-Sterilization Integrity Testing (PUPSIT) module designed to verify filter integrity immediately after in-line sterilization without introducing contamination risk into the fluid path.
PUPSIT - testing a sterilizing filter's integrity immediately after sterilization but before product is passed through it - remains one of the most operationally debated requirements in aseptic processing. Manufacturers must demonstrate that a filter was not damaged during sterilization or installation, but the test itself, if poorly engineered, can introduce the very contamination risk it is meant to rule out. Sites are now expected to justify their PUPSIT approach, or its omission, within a formal contamination control strategy rather than by default practice.
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Regulatory Basis
EU GMP Annex 1 (2022) requires that where PUPSIT is not performed, the decision must be justified through risk assessment and documented in the site's contamination control strategy; where it is performed, the test system must not compromise sterility. PDA Technical Report No. 26 provides engineering guidance on closed PUPSIT system design, including approaches that avoid opening the fluid path to non-sterile conditions during testing.
Our Solutions
Our PUPSIT module integrates with existing filtration skids to perform post-sterilization integrity testing through a closed, pre-validated flow path, using diffusion flow and water intrusion testing via hygienic tri-clamp bypass sterile connections. The system is designed for retrofit onto standard stainless steel and single-use filtration skids with universal tri-clamp and industrial bus interfaces, minimizing capital disruption for sites that already have filtration infrastructure in place. As a factory-direct supplier we can offer fast 15-day custom configuration, competitive factory pricing and round-the-clock global technical support, and every test cycle produces the same Part 11-ready, lot-traceable record set as our standalone filter integrity testers.
Product Center
PUPSIT Inline Module ： Retrofit closed-loop test unit for existing sterilizing filter skids, supports diffusion flow & water intrusion test via hygienic tri-clamp bypass pipeline, fully GMP Annex 1 compliant.
V8.0 Filter Integrity Tester： Flagship standalone tester with full audit trail, electronic signature, lot traceable test reports, identical data output as PUPSIT module.
V6.5 Filter Integrity Tester ：Cost-effective bench-top model for laboratory & small-scale production line integrity verification.
Sanitary Filter Housings & Aseptic Connectors：316L stainless steel filter housings + custom sterile bypass manifolds, universal 1.5"/2" tri-clamp interface for seamless PUPSIT module integration.
FAQ
★Q1: Is PUPSIT mandatory under EU GMP Annex 1?
A1: Annex 1 does not mandate PUPSIT unconditionally; it requires that its use or non-use be justified by a documented, science- and risk-based rationale within the contamination control strategy.
★Q2: Why is PUPSIT considered a contamination risk in itself?
A2: Testing after sterilization but before product exposure can require opening or manipulating the fluid path, which - if not engineered as a closed system - can introduce the same microbial ingress risk the test is meant to detect.
★Q3: Can PUPSIT be retrofitted onto an existing filtration skid?
A3: In many cases yes, depending on the existing housing and tubing configuration; a site-specific engineering assessment is typically required before retrofit.
★Q4: What data should a PUPSIT system record for audit purposes?
A4: Test method, pressure/flow values, pass/fail result, filter lot and batch identifiers, operator ID, and timestamp, ideally in an exportable, tamper-evident format.