Name: ASTM E 3106 : 2018
Brand: ASTM
Price: 75.00 USD

ASTM E 3106 : 2018

Superseded

View Superseded by

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

Available format(s)

Hardcopy , PDF

Superseded date

11-05-2018

Language(s)

English

Published date

09-01-2018

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
ProductNote	THIS STANDARD ALSO REFERS TO ISO 14698 Corrections were made editorially to 3.1.13 in October 2018.
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM E 3106 : 2018 : EDT 1
Supersedes	ASTM E 3106 : 2017

ASTM D 8219 : 2019	Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center
ASTM G 121 : 2018	Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents