Bag Integrity Tester Manufacturer & Supplier
Leak detection for fluid bags and pouches — pressure-decay method with electronic records for pharmaceutical bag manufacturing and QC.
Overview
Manufacturer & U.S. supplier. MedIntegrity designs and builds the bag integrity tester in its own factory — 28 patented products, 15 years in pharmaceutical testing equipment.
Where Bag Integrity Tester Is Used
Fluid filling
The check at the critical stage of fluid filling — catching damage that happened after the bag left the manufacturer, before product goes into the bag.
Bag manufacturing
Sealing validation, in-process checks and lot release at the bag supplier, with the quantitative reading connecting each lot to the sealing parameters of the run.
Incoming verification
The biopharma site's verification at receipt — closing the window no supplier's record covers, with the same method language the supplier's records were written in.
Going Deeper
Bag & Pouch Leak Detection
Single-use bags are the bulk fluid barrier in biopharmaceutical manufacturing — blending, storage, transfer, fill. A bag with an undetected leak fails quietly, and the product inside pays for it. The BGT series puts a measurable check on that barrier by the pressure decay method, with quantitative leak readings and electronic records for manufacturing and QC release.
Choosing Your BGT
The BGT-120 is the wireless, non-destructive inspection system for the critical stage of fluid filling — a definitive pass/fail for each bag plus quantitative data that correlates to a leak rate, with no tether through the area where sterility is being established. The BGT-200 adds operator independence: the instrument performs the measurement, the operator performs the connection, with sensitivity tuned to leaks of just a few microns. The BGT-5000 runs multiple channels in parallel for lot-scale work — sealing validation, in-process checks and lot release — so a lot of hundreds of bags is tested in one campaign.
Manufacturer side and use site
The same method language runs both sides of the bag's life. At the manufacturer: sealing validation, in-process checks and lot release. At the biopharma site: incoming verification and the check at the critical stage of fluid filling. Because every result is a number against the acceptance limit your validation defines, the lots, the suppliers and the trends are comparable from one record set.
Frequently Asked Questions
Which bags can the BGT series test?
Single-use fluid bags and pouches for pharmaceutical use — the bulk fluid barrier in blending, storage, transfer and fill. The BGT-120 and BGT-200 are single-bag inspection systems; the BGT-5000 runs multiple channels in parallel for lot-scale work.
Is the test destructive?
No. The BGT series uses the pressure decay method — non-destructive. The bag is dispositioned on the result rather than destroyed by the test, which matters when the bag is expensive and the lot is small.
What does a result look like?
A definitive pass or fail against the acceptance limit your validation defines, plus a quantitative reading that correlates to a leak rate — the number you trend across lots, suppliers and bag designs, stored as an electronic record with operator and timestamp.
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