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ASTM E 3106 : 2018 : EDT 1

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Science-Based and Risk-Based Cleaning Process Development and Validation
Available format(s)

Hardcopy , PDF

Superseded date

17-08-2023

Language(s)

English

Published date

02-11-2018

Publisher

American Society for Testing and Materials

This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes.

1.1This 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); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and is also applicable to other health, cosmetics, and consumer products.

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

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

1.4This 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.

1.5This 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.

Committee
E 55
DocumentType
Guide
Pages
9
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM G 122 : 2020 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes
ASTM E 3263 : 2022 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
ASTM F 3127 : 2022 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
ASTM G 121 : 2018 Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
ASTM D 8219 : 2019 Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center

ASTM E 1325 : 2002 : R2008 Standard Terminology Relating to Design of Experiments
ASTM E 1325 : 2016 Standard Terminology Relating to Design of Experiments
ASTM E 1325 : 1991 : R1997 Standard Terminology Relating to Design of Experiments
ASTM E 2476 : 2009 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ASTM E 2476 : 2016 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ASTM E 1325 : 2015 Standard Terminology Relating to Design of Experiments
ASTM E 1325 : 2021 Standard Terminology Relating to Design of Experiments
ASTM E 1325 : 2002 Standard Terminology Relating to Design of Experiments
ASTM E 2614 : 2015 : R2020 : EDT 1 Standard Guide for Evaluation of Cleanroom Disinfectants
ASTM E 2614 : 2015 Standard Guide for Evaluation of Cleanroom Disinfectants
ASTM E 2476 : 2022 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ASTM E 2614 : 2008 Standard Guide for Evaluation of Cleanroom Disinfectants

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Hardcopy - English
PDF - English
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