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

Importancia y uso:

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, and 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.

Subcomité:

F04.15

Referida por:

D8219-19, F3321-19, E3106-22, F3438-24, D8270-23B, D8270-23B, F3335-20, G0121-18, E3219-20, E3418-23E01

Volúmen:

13.02

Número ICS:

11.080.01 (Sterilization and disinfection in general)