BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Use Notebook Studies to Ensure Successful Reusable Device Cleaning Validations, Recommends MicroTest Laboratories


8/15/2012 10:30:00 AM

AGAWAM, Mass., Aug. 14, 2012 /PRNewswire/ -- A new management brief from Microtest Laboratories recommends that medical device manufacturers use notebook studies to help ensure successful reusable device cleaning validations. The lab bases the advice on its performance of validations for various types of medical instruments over the years.

The brief discusses the document, "FDA Draft Guidance for Industry and Staff, Processing /Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," which was released in May 2011.

"Even though it's labeled as a draft, experience has shown that most reusable device cleaning validations are being evaluated based on this document," said Patrick Kenny, manager of analytical services at Microtest Laboratories and author of the new brief titled, "Notebook Studies to Ensure Successful Reusable Device Cleaning Validations."

Kenny's brief focuses on areas of the FDA guidance document that are causing difficulties in cleaning validations, and demonstrates how pre-validation laboratory work can help save time and money. It also identifies areas that can cause issues during validations if they are not thoroughly addressed prior to initiating the protocol. These include:

  • The use of worst-case conditions
  • The switch from microbial-based assays to chemical-based assays
  • The determination of an acceptable residual level
  • The validation of a reusable device's cleaning instructions

"The good news is that almost all of these issues can be eliminated with some up-front work," Kenny said. "And this preparatory work can best be performed by notebook studies prior to initiating GLP studies. The information obtained in these relatively quick studies often saves significant time later in the filing process."

"In short, we recommend the use of notebook studies prior to beginning the validation to eliminate as many unknowns as possible," he said.

To obtain a copy of the new management brief, "Notebook Studies to Ensure Successful Reusable Device Cleaning Validations," visit http://www.microtestlabs.com/notebook-studies-brief or call 1-413-786-1680, or toll-free 1-800-631-1680.

About Microtest Laboratories
Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that 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. Follow on Twitter at http://twitter.com/MicrotestLabs.

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 Laboratories



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES