U.S. Manufacturer of Precision Testing Instruments for the Pharmaceutical Industry
MedIntegrity LLC is based in Santa Clarita, California, and builds the instruments that sit on regulated manufacturing lines and in QC labs: filter integrity, container-closure integrity, glove integrity, TOC, osmolality and packaging leak testing. The methods follow FDA, GMP, USP and EP, and the records they produce are built to be read at audit.
Testing Equipment by Category
Filter Integrity Tester
Bubble point to vacuum decay, from one instrument — the full method set for sterilizing-grade liquid filters.
2 models →
Glove Integrity Tester
Wireless decay testing for isolator and RABS gloves, down to 100 µm, with records kept for years.
2 models →
Container Closure Integrity (CCI)
Every-unit pressure-decay CCIT for vials and prefilled syringes, the deterministic side of USP <1207>.
systems →
Packaging Leak Tester
ASTM F2338 vacuum decay on blisters, pouches, sachets and rigid containers, down to 2 µm detection.
4 models →
RTP Integrity Tester
Integrity checks for rapid transfer ports on aseptic lines, with the IQ/OQ/PQ documentation included.
2 models →
Bag Integrity Tester
Pressure-decay leak detection for fluid bags and pouches, on the manufacturing floor or in QC.
3 models →
Total Organic Carbon (TOC) Analyzer
Under four minutes per result for pharmaceutical water, with an automatic sampler that runs unattended.
5 models →
Freezing Point Osmometer
Reference-method osmolality for injectables and reference standards, using only a small sample.
1 models →
Bubble Point Tester
The fast in-line check you run on every fill, fast enough to become a habit rather than a disruption.
method & instruments →Compliance You Can Audit
Our testing methods satisfy the requirements of FDA and GMP regulations, as well as USP and EP.
Selected Customer Cases
BeiGene USA, Inc. — 20× WGT-1200 Glove Integrity Testers
BeiGene USA purchased twenty WGT-1200 wireless glove integrity testers for isolator and RABS glove verification, continuing long-term cooperation.
See the WGT-1200 →
Sunny Pharmaceutical (Egypt) — WGT-1000 Online
Sunny Pharmaceutical deployed the WGT-1000 Online wireless glove integrity tester for routine aseptic-line glove inspection.
See the WGT-1000 →How We Work With You
Application review
Tell us your process, container format, pharmacopeia requirements and test volume. We map the right instrument, method set and acceptance criteria before you commit to anything.
Instrument & method selection
Filter integrity, glove integrity, CCIT, TOC or osmolality — we specify the model and the limits that fit your line, and help you set acceptance criteria you can defend at audit.
Installation & qualification
Installation coordination with an extensive qualification documentation package: guides for IQ, OQ and PQ, with 21 CFR Part 11 support. The paperwork and the hardware arrive as one package.
Training & after-sales
Operator training, responsive troubleshooting from our U.S. team, and long-term after-sales service with spares for every instrument we ship.
Frequently Asked Questions
Which standards do your instruments support?
Testing methods aligned with FDA and GMP requirements, plus USP and EP — including USP <43> and EP 11.0 for filter integrity, USP <1207> for container-closure integrity, and the TOC and osmolality methods behind pharmaceutical water and product testing. Development follows GAMP guidelines with 21 CFR Part 11 support.
Where is MedIntegrity based, and do you support customers internationally?
MedIntegrity LLC is U.S.-based in Santa Clarita, California, with a U.S. service team. Referenced customers include BeiGene USA (20× WGT-1200 glove integrity testers) and Sunny Pharmaceutical in Egypt, and we coordinate installation, training and after-sales across time zones.
Do instruments come with qualification documentation?
Yes. The delivery includes an extensive qualification documentation package with guides for installation qualification, operational qualification and performance qualification, so the instrument goes live inside your validation program, not after it.
How many product lines and models do you offer?
19 instrument models across seven product lines: filter integrity testers, glove integrity testers, container-closure integrity systems, packaging leak testers, RTP integrity testers, TOC analyzers and a freezing-point osmometer.
What happens after installation?
Operator training, responsive troubleshooting from our U.S. team, and long-term after-sales service with spares for every MedIntegrity instrument we ship. When something is off on a production night, someone who knows the machine answers the phone.
Need a quote or technical advice?
Tell us your application — our U.S. team responds with product selection, documentation and pricing.
Request a Quote