Microbial ranking of porous packaging materials (exposure chamber method), ASTM method: collaborative study.
A collaborative study involving 11 laboratories was conducted to measure the microbial barrier effectiveness of porous medical packaging. Two randomly cut samples from each of 6 commercially available porous materials and one positive and one negative control were tested by one operator in each of 11 laboratories. Microbial barrier effectiveness was measured in terms of logarithm reduction value (LRV), which reflects the log10 microbial penetration of the material being tested. The logarithm of the final concentration is subtracted from that of the initial concentration to obtain the LRV. Thus the higher the LRV, the better the barrier. Repeatability standard deviations ranged from 6.42 to 16.40; reproducibility standard deviations ranged from 15.50 to 22.70. Materials B(53), C(50), D(CT), and E(45MF) differ significantly from the positive control. The microbial ranking of porous packaging materials (exposure chamber method), ASTM method, has been adopted First Action by AOAC INTERNATIONAL.
Placencia
A M
AM
U.S. Food and Drug Administration, Minneapolis, MN 55401, USA.
Peeler
J T
JT
D001419:Bacteria / Q000302:isolation & purification*; D001431:Bacteriological Techniques / Q000295:instrumentation; D004866:Equipment Contamination; D004864:Equipment and Supplies; D019064:Product Packaging; D012680:Sensitivity and Specificity