Using Liquid Chromatography-Mass Spectrometry (LC-MS) detergent residues, such as carboxylates and sulphates can be identified, both qualitatively and quantitatively. Ceram’s team of materials experts can then advise on how to establish a cleaning procedure to limit them to acceptable levels.
Steve Newman, Product Manager for Testing at Ceram, says:
“Adding detergent analysis to our portfolio means that we can offer a comprehensive cleaning validation service to medical device manufacturers, whether that be implementing a cleaning procedure to gain regulatory approval, quality control to ensure that limits are not being exceeded or identifying contaminants, should they occur. With medical devices under the spotlight at the moment, achieving and maintaining cleanliness throughout the manufacturing process is critical.”
Ceram provides a complete validation service for the medical device manufacturer, VALIDATA, to determine the effectiveness of the cleaning process and environment on an ongoing basis. The service includes a unique cleanliness index to quantify product/process changes, troubleshooting facilities to help pinpoint and solve cleanliness issues and the availability of specially-designed test coupons (either ‘off-the-shelf’ or bespoke).
For more information visit www.ceram.com/cleanliness