ASTM F3127 Standard Guide for Validation of Cleaning Processes Used in the Manufacture of Medical Devices

EUROLAB laboratory provides testing and compliance services within the scope of ASTM F3127 standard. This guide provides considerations for validating cleaning processes for medical devices during initial manufacture and assembly prior to first use.

Validated cleaning processes are important to achieve consistency in function and consistency in biocompatibility. Considerations include, but are not limited to, the verification approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues.

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

Validation of cleaning processes for reusable medical devices is not within the scope of this standard guideline. While cleaning reusable medical devices is beyond the scope of this guide, many of the principles outlined in this guide may apply to the validation of cleaning procedures for reusable devices.

This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory restrictions prior to use.

EUROLAB assists manufacturers with ASTM F3127 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.