ASTM E 3106 : 2018 : EDT 1
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
Hardcopy , PDF
17-08-2023
English
02-11-2018
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This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes.
| Committee |
E 55
|
| DocumentType |
Guide
|
| Pages |
9
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
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| 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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