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ASTM E 2097 : 2000 : R2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

01-11-2006

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 11.06, 2016 Defines procedures and test methods for process component qualification by the end user.

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.

Committee
E 55
DocumentType
Guide
Pages
5
ProductNote
Reconfirmed 2006
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM D 4951 : 2014 : REDLINE Standard Test Method for Determination of Additive Elements in Lubricating Oils by Inductively Coupled Plasma Atomic Emission Spectrometry
ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics

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Hardcopy - English
PDF - English
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