Description

1.1 This test method is designed for use in product development and for the generation of product potency data. The loading of each carrier with a known volume of the test organism suspension is possible. The incorporation of control carriers also allows for an assessment of the load of viable test organism on the test carriers.

1.2 This test method is designed to have survivors and also to be used with a performance standard. The surviving microorganisms on each test carrier are compared to the mean of no less than three control carriers to determine if the performance standard has been met. To allow proper statistical evaluation of results, the size of the test inoculum should be sufficiently large to take into account both the performance standard and the experimental variation in the results. For example, if an arbitrary performance standard of 6-log₁₀ reduction in the viability titer of the test organism is used, and an inoculum size of 10⁷ CFU, then theoretically a maximum of ten survivors per carrier is permitted; however, because of experimental variability the exact target may need to be higher than 10⁶ CFU/carrier, thus fewer survivors would be permitted.

1.3 This test method should be performed by persons with training in microbiology and in facilities designed and equipped for work with infectious agents at the appropriate biosafety level (3).

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

1.5 In this test method, metric units are used for all applications, except for distance in which case inches are used and metric units follow.

1.6 It is the responsibility of the investigator to determine whether Good Laboratory Practice Regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions).