Full Description

1.1This guide covers procedures and test methods for process component qualification by the end user. The goal is to assess the safety impact of extractables from non-metallic process components used in contact with bioprocessing solutions. This encompasses the impact of extractables on the safety of the final product as it passes through the various stages of the manufacturing process. This guide is not designed for evaluation of metallic materials, final product container/closures or those components intentionally added to the product or production streams during the manufacturing process. Testing of solids and extracts is specified in other ASTM standards. Materials must be qualified by specific use.

1.2The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.3There is no companion guide available.

1.4Safety/Fire Hazards: Extractions with organic solvents will be infrequent under this guide, but, when used must be treated as potential fire/explosion hazards.

1.5This 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.