Vacuum Test Chamber For Integrity Testing

Integrity testing of pharmaceutical packages, e.g. plastic containers, has always been an important phase of the manufacturing process.

Current FDA guidelines require validation for container closure integrity tests. EU GMP guidelines stipulate "Plastic ampoules should be subject to 100% integrity testing".

For smaller quantities, rommelag® offers a simple vacuum test chamber for integrity testing. Once the vacuum chamber has been loaded manually, a two-step vacuum cycle is performed. Subsequent to unloading, the ampoules are inspected visually by personnel.