ASTM D4196-05(2011) - 1.6.2011
 
Significance and Use

This test method may be employed to check the sterility of commercially procured sterile membrane filters. The test also confirms that sterilized filters have not been contaminated. Additionally, this test may be used to monitor the efficacy of in-house sterilization procedures. Filter packages that have obvious packaging defects should not be tested because sterility may have been compromised.

 
1. Scope

1.1 This test method describes a test to confirm the sterility of either manufacturer presterilized or user-sterilized analytical membrane filters.

1.2 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. ^

 
2. Referenced Documents

The United States Pharmacopeia, Current Edition Mack Publishing Co., Easton, PA 18042. (Sections on Sterilization and Sterility Testing)

D1129-24

Standard Terminology Relating to Water

D1193-24

Standard Specification for Reagent Water