Vacuum Integrity Testing
Product specific tooling ensures maximum sensitivity. Vials, ampoules or other sealed products are placed into the close fitting tooling. A vacuum is then drawn and any leakage from the product into the vacuum is monitored. Very sensitive pass / fail levels can be set and individual leaking components identified. Additional equipment can be used to mark leaking product for easy identification.
Large leaks are detected by dilution of the vacuum. The vacuum is drawn remotely and then applied to the test chamber. Small leaks are detected by pressure decay. Validation and calibration is achieved using manufactured leaks of known size.
Testing can be carried out to ASTM F2338-05, Standard Test Method for non destructive Detection of Leaks in Packages by Vacuum Decay Method. (Sterility)
Hydrogen Testing
A variety of gases can be used for tracer gas testing of packaging. The essential requirement for the gas is that it should have low abundance in the atmosphere. Hydrogen fits the bill excellently, and has the added advantage of having extremely low viscosity. It is the most sensitive gas for detecting leaks. A non-explosive mixture of 5% hydrogen in nitrogen is used.
Product packages are sealed in an enriched atmosphere of the tracer gas. Gas detection equipment is then used further down the production line. This equipment can very accurately detect tiny leaks and provide a location.
Trace gas options from MET include: Carbon Dioxide, Helium and Hydrogen.
Validation and calibration is achieved using manufactured leaks of known size.
MET can provide equipment for testing to either of these standards:
ASTM F2227-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method.
ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
