Several sections of Part 820 can be directly related to device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue (chemical and particulate) in order to ensure patients are safe.
In the paper, Kenny presents a five-step process that provides a framework to assist medical device manufacturers in their cleaning validation efforts:
#1: Evaluate the Process, Determine the Potential Contaminants
At Microtest Labs, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide. He holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories.
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.
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