Navigation Links
New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes
Date:6/2/2010

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: 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.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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 http://www.microtestlabs.com 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.: https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... Corporation ("Unilife" or "Company") (NASDAQ: UNIS ; ASX: UNS), ... its financial results for the second quarter of fiscal 2016 (three ... Financial Results for the Second Quarter of ... Revenue for the second quarter of fiscal 2016 was $4.5 ... Cash receipts from customers for the second quarter of fiscal 2016 ...
(Date:2/9/2016)... February 9, 2016 ... heute den Abschluss eines Kooperationsvertrags mit 10x ... Lösungen in den Bereichen Next-Generation-Sequencing (NGS), Single-Cell-Biology ... ; Frankfurt Prime Standard: QIA) gab heute ... für die Entwicklung und Förderung umfassender Lösungen ...
(Date:2/9/2016)... February 9, 2016 QGEN ... collaboration with 10x Genomics to develop and promote ... and bioinformatics. --> QGEN ; Frankfurt ... 10x Genomics to develop and promote comprehensive solutions ... --> QIAGEN N.V. (NASDAQ: QGEN ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... AxoGen, Inc. (NASDAQ: AXGN), a leading ... the fourth quarter and full year ended December 31, 2015 on Monday, February 29, ... webcast for the investment community following the release at 4:30 PM ET. Investors interested ...
(Date:2/10/2016)... Carefree, AZ (PRWEB) , ... February 10, 2016 , ... ... coach in new book , Pioneering book "Better with Age: The Ultimate Guide to ... neuroplasticity can improve memory. The book’s publication date is March 16, 2016. ...
(Date:2/10/2016)... MA (PRWEB) , ... February 10, 2016 , ... ... their revolutionary, biocompatible columns and accessories. These PEEK-lined stainless steel (PLS) columns combine ... provide a solution that ensures the integrity of biological samples while operating at ...
(Date:2/10/2016)... ... February 10, 2016 , ... The recreational use of marijuana has been ... still face a lot of restrictions as to where they can smoke pot. ... use” and that cannabis “may not be consumed openly or publicly.” , Given the ...
(Date:2/10/2016)... ... February 09, 2016 , ... ... Face and Body Specialists are delighted to welcome a new addition to their ... Face and Body Specialists as a nurse practitioner performing cosmetic procedures ...
Breaking Medicine News(10 mins):