Biopharma Solutions
Aseptic biopharma production leans on barrier systems — isolators, RABs and closed filling. Each interface — the glove, the filter, the bag, the filled vial — is a point where sterility can be lost, and each one needs a defensible integrity program.
Glove & Barrier Integrity
Gloves are the thinnest interface in the barrier system and the one most exposed. The WGT series runs wireless pressure-decay glove integrity testing with 100 µm minimum detection and electronic records sized for five years or more — designed for isolator and RABS environments where a cabled instrument would be a penetration. Biopharma manufacturers such as BeiGene USA deploy the program at scale: 20 units of the WGT-1200 in operation.
Sterilizing Filter PUPSIT
EU GMP Annex 1 (2022) requires the integrity of a sterilizing-grade filter to be verified before use and, where process constraints allow, by a non-destructive test post-use. The Integtest V6.5 and V8.0 run that full sequence — pre-use, post-sterilization, post-use — with the method set defined by USP <43> and EP 11.0, and the record that proves each step happened.
Single-Use Bag Verification
A single-use bag that passed inspection at the manufacturer's plant can still be damaged in handling, before product goes into it. The BGT series puts a non-destructive pressure-decay check on that barrier at the critical stage of fluid filling — a pass/fail for each bag plus the quantitative leak reading for the record.
Filled-Product CCIT
Once the product is filled and sealed, the container-closure system is the last barrier. Pressure-decay CCIT for vials and prefilled syringes per USP <1207> gives you the deterministic, every-unit test that supports fill-finish release — the tested unit is the unit that ships.
The Instruments Behind It
Glove Integrity Testers →
Wireless pressure-decay, 100 µm detection, ≥5-year electronic records.
Filter Integrity Testers →
Full USP <43> / EP 11.0 method set for PUPSIT and routine checks.
Bag Integrity Testers →
Non-destructive pressure decay for single-use bags at the fill.
CCI Systems →
Pressure-decay CCIT for vials and prefilled syringes.
Frequently Asked Questions
Why does glove integrity testing have to be wireless?
A cable from an external instrument into an isolator or RABS is a penetration the contamination control strategy has to manage. Wireless, battery-powered testing removes that penetration from the test step entirely — the operator connects the glove, runs the decay test, and the result is recorded.
What detection size does glove testing need to reach?
100 µm on both WGT models. That sensitivity is what makes the test a meaningful integrity check for the glove as a barrier, rather than a coarse one that misses the small, early failures.
Can one instrument cover filter, glove and bag integrity?
They are separate instrument families — the methods differ — but they run as one documented set: same record format, same validation trail, one story to tell in the audit. That is the point of the program.
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