Our single-use fluid path integrity testing instrument for pre-use post-sterilization (PUPSIT) delivers automated, non-destructive online integrity verification engineered to meet stringent contamination control requirements defined by EU GMP Annex 1 and global biopharmaceutical regulatory standards. Purpose-built for sterilizing-grade filter assemblies, this instrument performs in-situ integrity testing of reusable or single-use sterilizing filters immediately after sterilisation cycles and prior to product contact, to identify latent filter media damage, seal defects or fitting discontinuities introduced during SIP, autoclaving, handling and installation. Unlike conventional post-batch integrity testing that can only confirm filter performance after processing, this platform enables PUPSIT as a formal, auditable unit operation within aseptic workflows, supporting biologic, vaccine, cell therapy and parenteral drug manufacturers to strengthen contamination control strategies for critical sterile filtration steps.
The instrument incorporates high-precision pressure transducers, real-time temperature compensation modules, automated gas regulation circuits and recipe-driven embedded software to execute standardised bubble point, diffusion flow and pressure hold test sequences for sterilizing-grade filters. It enables fully online, closed-line testing without breaking the sterile boundary of the downstream process circuit, with configurable test parameters calibrated to filter pore size, housing geometry and process fluid characteristics. The digital control architecture enforces role-based user access, electronic signature functionality and immutable audit trail logging compliant with 21 CFR Part 11 and Annex 1 data integrity requirements. Our supporting deliverables include factory acceptance testing, IQ/OQ/PQ protocol packages, test method development guidance and validation documentation tailored to client filter trains and aseptic process design.
Automated temperature-compensated measurement eliminates manual variability in PUPSIT execution, delivering high-sensitivity detection of filter integrity failure across the installed sterilizing filter train. Closed online testing preserves system sterility throughout the verification process, avoiding secondary contamination risks associated with open handling or offline filter sampling. Predefined test libraries and programmable workflow recipes reduce operator training burden and compress batch cycle durations, while objective pass/fail decision logic removes subjective interpretation of test results. Its compact cleanroom-suitable footprint supports seamless integration into existing bioprocess skids, isolator filling lines and upstream/downstream process trains without extensive facility retrofitting.
This integrity testing platform serves biopharma manufacturers, advanced therapy CDMOs and vaccine producers operating critical sterile filtration steps for buffer preparation, bioburden reduction and final fill-finish operations. Beyond instrument supply, we provide end-to-end technical services including filter test method optimisation, regulatory gap assessment, data integrity consultancy and on-site commissioning support. Deploying this PUPSIT-capable tester strengthens the site contamination control strategy, mitigates the risk of costly batch losses from undetected sterilizing filter defects, and generates robust, inspection-ready evidence for global regulatory audits, accelerating product registration and commercial launch of sterile biopharmaceutical products.
