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ASTM-E3106:2022 Edition(Redline)

ASTM-E3106:2022 Edition(Redline)

$44.96

E3106-22 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation (Redline)

Published By Publication Date Number of Pages
ASTM 2022 28
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ASTM E3106-22

Redline Standard: Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

ASTM E3106

Scope

1.1 This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals (including active pharmaceutical ingredients (APIs)); all dosage forms; over-the-counter medicinal and neutraceutical products, veterinary products, biologics, clinical supplies, advanced therapy medicinal products (ATPM), medical device manufacturing; and is also applicable to other health, cosmetics, and consumer products.

1.2 This guide is focused only on the cleaning of equipment product contact surfaces and medical device surfaces and does not cover disinfection, sterilization, or non-product contact surfaces (which are covered under other existing guides: Ref (1),2 USP <1072>, Guide E2614, ISO 14698, and ISO 14937).

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

1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords

acceptance limits; CIP; cleaning development; cleaning validation; HBEL; PAT; QRM; risk-based; science-based; Shirokizawa;

ICS Code

ICS Number Code 13.020.60 (Product life-cycles)

DOI: 10.1520/E3106-22

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