Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-10-2022

Publisher

American Society for Testing and Materials

1.1This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for achieving consistency in function and consistency in biocompatibility. The considerations include but are not limited to: validation approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues.

1.2Inclusions:

1.2.1This guide describes the validation of critical cleaning processes for medical devices to reduce contaminants to acceptable levels prior to packaging.

1.3Exclusions—The following items / medical devices / processes are excluded from the scope of this document:

1.3.1Reusable medical devices.

1.3.1.1Validation of cleaning operations for reusable medical devices is not within the scope of this standard guide. Although cleaning of reusable medical devices is beyond the scope of this guide, many of the principles outlined in this guide may be applicable to the validation of cleaning operations for reusable devices.

1.3.2Cleaning of medical devices in health care facilities.

1.3.2.1Validation of cleaning processes in patient/health care facilities is not within the scope of this standard guide.

1.4This standard does not purport to be a replacement for biological safety testing.

1.5This 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.

1.6This 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	F 04
DocumentType	Guide
Pages	17
PublisherName	American Society for Testing and Materials
Status	Current
Supersedes	ASTM F 3127 : 2016

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ASTM E 3106 : 2018 : EDT 1	Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
ASTM G 131 : 1996 : R2023 : EDT 1	Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
ASTM E 3263 : 2022 : EDT 1	Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
ASTM E 3219 : 2020	Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
ASTM E 1766 : 2015	Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices (Withdrawn 2023)
ASTM E 3263 : 2022	Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
ASTM E 3106 : 2022	Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
ASTM G 131 : 1996 : R2016 : EDT 1	Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques