• ASTM E2097-00(2014)

ASTM E2097-00(2014)

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Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products (Withdrawn 2022)

ASTM International, 12/01/2014

Publisher: ASTM

File Format: PDF

$32.00$64.00


Published:01/12/2014

Pages:5

File Size:1 file , 76 KB

Note:This product is unavailable in Russia, Ukraine, Belarus

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.

More ASTM standard pdf

ASTM A333-67

ASTM A333-67

Standard Specifications For Seamless And Welded Steel Pipe For Low-Temperature Service

$24.00 $49.20

ASTM D1588-60(1967)e1

ASTM D1588-60(1967)e1

Methods of Test for Dissolved and Gaseous Hydrogen in Water (Withdrawn 1983)

$28.00 $56.00

ASTM E29-67

ASTM E29-67

Recommended Practice For Indicating Which Places Of Figures Are To Be Considered Significant In Specified Limiting Values

$21.00 $43.20

ASTM E168-67(1977)

ASTM E168-67(1977)

Standard Recommended Practices for General Techniques Of Infrared Quantitative Analysis

$24.00 $49.20