ASTM F3127-16
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

Standard No.

ASTM F3127-16

Release Date

2016

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F3127-22

Latest

ASTM F3127-22

Scope

5.1 This guide describes an approach to validate a cleaning system for a medical device. It is based on the manufacturer’s accurate and comprehensive understanding of their internal manufacturing and cleaning processes.

5.2 This guide is not intended to provide a detailed plan or road map, but will provide considerations that can be used by the device manufacturer to develop a detailed plan for performing cleaning validation.

5.3 In cleaning validation, as with other types of validations, there are multiple ways to achieve a compliant, scientifically sound and practical cleaning validation program.

5.4 There are several reference documents identified in Appendix X3 that describe cleaning validation approaches for non-medical devices (including cleaning for oxygen-enriched environments, pharmaceuticals, semiconductors). Any of these reference documents could provide guidance for a well defined process for establishing a manufacturer’s minimum expectation of a specific cleaning validation program.

5.5 This guidance specifically targets cleaning validation for medical devices, in-process and at terminal cleaning so that the result is a consistently clean medical device that meets the performance expectations for that device.

1.1 This 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.

1.2 Inclusions: 

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

1.3 Exclusions: 

1.3.1 Reusable medical devices.

1.3.1.1 Validation 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.

1.3.2 Cleaning of medical devices in health care facilities.

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

1.4x00a......

ASTM F3127-16 Referenced Document

• ASTM D543 Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
• ASTM E2857 Standard Guide for Validating Analytical Methods
• ASTM F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
• ASTM F2847 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments*， 2024-04-20 Update
• ASTM F619 Standard Practice for Extraction of Medical Plastics
• ASTM G121 Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
• ASTM G122 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents
• ASTM G131 Standard Practice for Cleaning of Materials and Components by Ultrasonic Techniques
• ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
• ISO 14971 Medical devices - Application of risk management to medical devices

ASTM F3127-16 history

• 2022 ASTM F3127-22 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• 2016 ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices