The Microbial Aerosol Fallout Challenge Test method is a qualitative test designed to evaluate a sterile-barrier system when subjected to an extreme microbial load. This test simulates fallout a package may be subjected to over its intended shelf life. Afterwards, the inner contents or inner surfaces of the packaging system are evaluated to determine if penetration of the indictor organism occurred. This test is intended only for sterile-barrier systems that are not appropriate for testing under consensus standards, such as the following:
- ASTM F1608 Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
- ASTM F2981 Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
- ASTM F3287 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
The Microbial Aerosol Fallout Challenge test method can satisfy the requirement for porous materials, as outlined in ISO 11607 for microbial barrier testing when other consensus standards are not appropriate. This test is not intended to detect artificially created defects to establish sensitivity detection levels in packaging materials. In cases where artificially created defects and sensitivity are required, established integrity tests would be more appropriate.
Applicable Standards
- ISO 11607
- AAMI TIR17
- PDA Technical Report 27
