ASTM E2097 - 00(2014) - Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products

ASTM E2097 - 00(2014)

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

Status : Current   Published : January 2014

Format
PDF

Format
HARDCOPY



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 standard. No other units of measurement are included in this 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 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.




Standard NumberASTM E2097 - 00(2014)
TitleStandard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products
StatusCurrent
Publication Date12 January 2014
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Biotechnology products, Components, Cytotoxicity, Extractables, Extraction, Raw materials
ICS07.080
PublisherASTM
FormatA4
DeliveryYes
Pages5
File Size76 KB
Price£40.00


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