This test is intended to challenge the whole package in order to determine package integrity of a finished product package. Chamber size is 3 cubic feet with a single layer of product, configured for appropriate challenge flow. The test includes the whole package microbial challenge, subsequent sterility testing on the packaged product to determine penetration of the indicator organism used, test controls, and all protocol/report fees.
Study Outline
This 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. Nelson Labs recommends 60 test samples plus controls based on an AOAC disinfection study to obtain a 95% confidence level. Sponsors are responsible for sample size depending on their 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. Occasionally, a product such as a syringe or a 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.
Sample Requirements
The packages must come sterilized.
Nelson Experts:
- Wendy Mach 801-290-7810, 800-826-2088
- Erika Diaz 801-290-7841, 800-826-2088
