AGAWAM, MASS. – June 2, 2010 – A new free, white paper that guides medical device manufacturers in the validation of their cleaning processes is now available from Microtest Laboratories.
As many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various agents to aid in the manufacturing process, or produce contaminants that need to be removed. Thus, these products must be cleaned to ensure both patient safety and the continuing functionality of the device.
In a new white paper titled, “Five Steps to Validating the Cleaning Process of Medical Devices,” Patrick Kenny, Manager of Analytical Services at Microtest Laboratories, reviews medical device regulation under 21 CFR Part 820 – Quality System Regulation. (Download from: http://www.microtestlabs.com/cleaning-validation-paper.)
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
• #2: Determine the Limits
• #3: Identify the Analytical Test
• #4: Validate the Method for Use
• #5: Validate the Cleaning Process
Download a free copy of “Five Steps to Validating the Cleaning Process of Medical Devices,” from http://www.microtestlabs.com/cleaning-validation-paper.
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.
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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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