Filter Integrity Tester Manufacturer & Supplier

Sterilizing Filter Integrity Testing

A sterilizing filter, when appropriately validated, removes all microorganisms from a fluid stream, producing a sterile effluent. Integrity testing verifies the filter before and after use — the basis of your contamination control strategy for aseptic manufacturing.

PUPSIT & EU GMP Annex 1

EU GMP Annex 1 (2022 revision) requires the integrity of the sterilised filter to be verified by integrity testing before use, and a non-destructive integrity test post-use where process constraints allow. Pre-use, post-sterilization integrity testing (PUPSIT) is now central to the requirement. The Integtest series is built around that sequence: pre-use, post-sterilization, and post-use checks on the same instrument, with the record that proves each one happened.

Methods

Bubble point, diffusive flow, dry-bubble, pressure hold and vacuum decay — the method set defined by USP <43> and EP 11.0 for liquid and gas sterilizing-grade filters. The method set matters because a single number does not describe filter integrity: the largest pore, the small-pore distribution and the seal each answer a different question, and a complete program tests each one where the process needs it.

HEPA & ULPA Air Filter Integrity

HEPA and ULPA filters are the barrier between a cleanroom and its supply air, and the test for them is the dry bubble point method — raise the pressure across the dry membrane until the first bubble, which pins the largest pore and classifies the filter against the limits set in ISO 21502 and EN 1822. That dry-bubble test is already in the Integtest method set, so a HEPA filter integrity test runs on the same instrument, reads the largest pore and keeps the electronic record. When the HEPA integrity test sits inside your cleanroom qualification, what has to hold is that the instrument keeps the pressure steady, logs the result and keeps the trail the auditor will read.

Choosing V6.5 or V8.0

Both the Integtest V6.5 and V8.0 run the full method set with electronic records; the difference is configuration — the range of filter sizes, ports and accessories your line needs. Tell us your filter housings and the methods your procedure calls for, and we will size the configuration rather than make you fit a standard one.

The record is part of the result

Integrity testing that cannot be documented is not defensible. Every test cycle on the Integtest series is an electronic record: method, parameters, result, operator and time, stored for trend analysis and retrieval. When an auditor asks whether the filter held, the answer comes from the instrument, not from a log sheet.