The Microbial Ranking test evaluates porous materials intended for use in packaging sterile medical devices. This test employs a low flow rate, extended exposure time and increased challenge level, which allows testing of materials with high differential pressure values. This test method is not intended to predict the performance of a given material in a specific sterile packaging application.
This procedure is designed to comply with ASTM F1608 test method. Nelson Laboratories is an active member of the ASTM committees.
|PKG350 - Packaging: Microbial ranking, ASTM F1608
PKG350 - Packaging: Microbial ranking, ASTM F1608
Turn Around Time
Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.
||Packaging: Microbial ranking, ASTM F1608
PKG350: 4 replicates of one material type per chamber run; each replicate must be 47 mm
The Microbial Ranking test procedure consists of subjecting samples to an aerosol of Bacillus atrophaeus spores at a concentration of about 1 x 106 for 15 minutes within an exposure chamber. Spores passing through the porous material are collected on membrane filters and enumerated.
Please see our Packaging Validation matrix for more information.