Navigation Links
New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes

AGAWAM, Mass., June 2 /PRNewswire/ --  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:

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

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.

Follow Microtest Labs on Twitter @MicrotestLabs at

About Microtest

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 or call 1-413-786-1680 or toll-free 1-800-631-1680.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

Steve Richter, Ph.D.:

SOURCE Microtest
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Make Meth Ingredients Prescription-Only Says Former White House Drug Spokesman Bob Weiner; Oregon Did and Cut Crisis by Half
2. Abbott Chairman and CEO Miles D. White to Present at Sanford Bernstein Strategic Decisions Conference
3. Dr. Robert B. Arnot Releases White Paper on the Silent Threat of H1N1 and Other Infectious Diseases
4. New White Paper Examines Advanced Mycoplasma Tests - How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers
5. Whitepaper From Mirial Explains how Visual Communication Technology can Improve Healthcare Services
6. BIA Publishes White Paper: ISO 9000 Role in Document Review, Emphasizes Quality Equals Defensibility
7. Society of Gynecologic Oncologists Issues White Paper on HPV Vaccines Impact on Cervical Cancer Prevention
8. ALP Life Sciences, LLC Announces Nanoveson(TM) Patent Filing and Whitepaper Availability on Proposed Therapy for Non-Alcoholic Fatty Liver Disease (NAFLD) and Comorbid Diseases
9. White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
10. White Nose Syndrome: Is Pennsylvania Next?
11. AHF Seeks White House Clarification After Press Room Flap Over CDCs HIV Numbers
Post Your Comments:
(Date:11/24/2015)... -- Avery Biomedical Devices (ABD), manufacturer of the Avery ... of Anders Jonzon , MD; Ph.D. as clinical ... Dr. Jonzon is a Physiologist and consultant in ... Uppsala and Children,s Hospital, Karolinska, Stockholm, Sweden ... the Cardiovascular Institute (UCSF). His research has covered circulation, ...
(Date:11/24/2015)... , November 24, 2015 ... of the University of Bern ... Nutrition of the Bern University Hospital "Inselspital" are proud ... develop a novel generation artificial pancreas. Combining a fully ... for diabetic patients with the unequalled accuracy of an ...
(Date:11/24/2015)... 2015 Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today ... Services, Education and Human Resources will be presenting in the ... Health Plan Strategies for a Dynamic Market" on Dec. 1, ... a consultant with the Cambridge Advisory Group, where she leads ... The webinar will discuss the rapid growth of oral ...
Breaking Medicine Technology:
(Date:11/24/2015)... N.J. (PRWEB) , ... November 25, 2015 , ... ... delivery technologies and development solutions for drugs, biologics, consumer health and global clinical ... will present at the upcoming Clinical Trial Supply East Asia Conference, to be ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Preparing for ... p.m. – 3:00 p.m. EST, , FDA has long asserted that ... regulations apply to performing the tests and do not meet the device regulations. , ...
(Date:11/24/2015)... ... November 24, 2015 , ... Brillouin Energy Corp. Congress ... the developer of renewable energy technologies capable of producing commercially useful amounts of ... that its WET™ and HHT™ Boiler System reactor core modules were presented to ...
(Date:11/24/2015)... PLAINSBORO, N.J. (PRWEB) , ... November 24, 2015 ... ... experts will gather to share their knowledge and experiences at a live taping ... during the Ruesch Center for the Cure of Gastrointestinal Cancers 2015 Symposium at ...
(Date:11/24/2015)... Marne, MI (PRWEB) , ... November 24, 2015 , ... ... has released a series of recent video interviews with some of the staff members ... life at the residential treatment facility, as well as some of the things that ...
Breaking Medicine News(10 mins):