Revised Standard for Validation of In Process Cleaning of Medical Devices.
Cleaning Validation and Verification of Residual Removal
Standard ASTM F3127 - 16. Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices has been revised for 2016.
Removal of residual processing materials from production and of any cleaning chemicals is important in the production of many devices. This document gives a logical approach to cleaning and assessment of its effectiveness, leading to a validated system proven by chemical analysis. It also seeks to ensure that information is accurate and that there is a good understanding of what is happening through the use of Q and As, flow charts and risk analyses. It will help medical device manufacturers collect sufficient data to demonstrate that they consistently clean their products to a safe and effective level.
METs laboratories can assist with all parts of this requirement: risk analysis, process development, material selection, equipment qualification (IQ, OQ, PQ), and laboratory analysis of residuals. We can also apply toxicological risk analyses. ASTM F 3217 refers to ISO 10993-17 for calculation of tolerable intakes and other factors relating to the safety of leachates and residues.
A wide variety of analytical methods are also mentioned in the standard. MET can advise which one are most appropriate to your application.