1.1 This practice presents the principles, state-of-the-art concepts and generally accepted methods for aseptic sampling of materials involved with or produced by biotechnical processes where contamination of either the sample or the source of the sample cannot be accepted. These processes could involve living organisms such as virus, bacteria, yeasts, and mammalian cells or biologically active constituents, such as enzymes and biochemicals that must exist in a noncontaminated state.
1.2 This practice also applies to the products from these bioprocesses that can be for human consumption, sterile or parental drug applications, which also require aseptic sampling to meet regulatory, current good manufacturing practices, or other quality control requirements.
1.3 Warning--Since some biotechnical processes could produce flammable products, this sampling practice should be applied only after taking into account all of the factors that are pertinent to an assessment of the fire hazard of a particular end use.
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.