All Package Integrity testing is aimed at determining the package integrity of a finished product package. This includes a whole package microbial challenge to determine the penetration of an indicator organism used and then sterility testing on the packaged product. Materials tested include bags, trays, syringes, IV bags, tube sets, vials, and containers.
All Package Integrity testing meets the requirements specified in ISO 11607 for microbial barrier testing.
The Whole Pack test procedure involves aerosolizing a large number of Bacillus atrophaeus spores with a particle size of 4,5 microns or less and then testing the contents of the pack for that organism to enter. Sometimes, a product such as a syringe or bottle is filled with a broth medium before tackling. Following the aerosol testing, the product / simulated product is tested with soybean casein digestion juice. The medium is then incubated and scored for the presence of the control organism.
Required sample size: Fully sterilized packages
Suggested replicates: Sample size is at the sponsor's discretion, depending on your statistical analysis (risk, production, and cost).
Packages must be sterilized.
EUROLAB, with its highly expert team and internationally accredited laboratories, Package Integrity Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
