The Whole Package test procedure involves aerosolizing a high number of Bacillus atrophaeus spores with a particle size of 4.5 microns or smaller and then testing the contents of the package for ingression of that organism. Occasionally, a product such as a syringe or bottle is filled with a broth medium prior to the challenge. Following the aerosol challenge, the product/simulated product is tested with soybean casein digest broth. The media is then incubated and scored for the presence of the challenge organism.
Please see our Packaging Validation matrix for more information.
Sample size required: Complete sterilized packages
Recommended replicates: We recommend 60 test samples plus controls based on an AOAC disinfection study to obtain a 95% confidence level. Sample size is at the discretion of the sponsor depending on your statistical analysis (risk, production, and cost). If a product is too expensive to permit 60+ samples, dummy parts can be used in place of the product.
The packages must come sterilized.
If you have additional questions about Whole Package Integrity testing services, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.