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ASTM E2097-00

Historical Revision

Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products (Withdrawn 2022)

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1.1 This 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.

1.2 The values stated in SI units are to be regarded as the standard.

1.3 There is no companion guide available.

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

1.5 This guide 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.


SDO ASTM: ASTM International
Document Number E2097
Publication Date June 10, 2000
Language en - English
Page Count 5
Revision Level 00
Supercedes
Committee E48.03
Publish Date Document Id Type View
Dec. 1, 2014 E2097-00R14 Revision
June 10, 2000 E2097-00 Revision
Nov. 1, 2006 E2097-00R06 Reaffirmation