Pharmaceutical Manufacturing Solutions

Sterile drug lines

The three integrity programs on a typical aseptic line were never designed to sit together. Filter testing lives with the fill line, glove testing with the barrier systems, CCIT somewhere in QC — each keeps its own record format and its own validation history, and when the auditor walks in you stitch all three together on the spot. We deliver them as one documented set covering the whole suite, so the record reads like a single program. The instruments qualify inside your GMP environment, and the IQ/OQ/PQ documentation arrives with the instrument rather than as a separate project a year down the road.

Packaging integrity

The moment the product is filled, the package is the barrier between it and the world, and a barrier has to prove itself. The MFT-series runs the ASTM F2338 vacuum decay method on vials, ampoules, syringes, blisters, pouches and sachets and hands back a quantified leak rate — a number you compare against a limit you set during validation, not a look at the seal. Depending on the package, detection reaches 2 µm, and every result is a traceable electronic record.

In-process and release

A lot of plants end up with two instruments — one for in-process checks, one for release — because they were told the two jobs needed two machines. With a deterministic, non-destructive method one instrument does both, and you run a single documented method set across the lot. The unit that passes on your bench is the unit that ships, and its number is already in the record your quality system reads.

What this looks like in the field

Sunny Pharmaceutical in Egypt runs the WGT-1000 Online for routine glove inspection on the aseptic line. One instrument, one documented routine, the same result every shift — without a person standing at it to make it happen. It is a small window into the pattern on pharma plant floors, and the rest of the line works the same way.