Navigation Links
"Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers" - New White Paper from Microtest Laboratories
Date:8/10/2011

AGAWAM, Mass., Aug. 10, 2011 /PRNewswire/ -- Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.

In attempting to meet regulatory demands from sources such as the U.S. FDA and the European Pharmacopoeia, the greatest challenge for medical device and pharmaceutical manufacturers may be determining what exactly is required for compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs?

Unfortunately, there is no single reference document that U.S. manufacturers may rely upon to help them design, validate, and demonstrate room class compliance. Nor, given the monumental scope of the task, is it likely that one will be drafted anytime soon.

But a new, free white paper titled "Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers," available for free download at http://www.microtestlabs.com/environmentpaper, may help.

The white paper reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. Topics include: What Is Required; Viable vs. Nonviable Particulates; Sampling Plans; Validation Management; Sterilization Programs; Cost/Product Savings; Critical Factors; and The Benefits of Experience. The paper also discusses how these challenges may be met w ith the assistance of an update-to-date testing laboratory.

The white paper is authored by Steven Wieczorek, Supervisor, Environmental Sciences, who leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services based in Agawam, Mass.

Download the new, free white paper, "Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers," at http://www.microtestlabs.com/environmentpaper.

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. Follow Microtest Labs on Twitter @MicrotestLabs 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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Patient Self-Monitoring: Devices, Markets, Players and Prospects
2. New Microbiological and Environmental Monitoring System Cuts Risk for Batch Rejection
3. UK Cardiovascular Monitoring Systems - Market Trends Till 2016
4. Intelsius Forms Strategic Partnership With American Thermal Instruments to Launch Industrys First Fully Integrated Temperature-Controlled Packaging and Monitoring Solution
5. iHealth Labs Blood Pressure Self-Monitoring System Gets Nationwide Distribution
6. With Launch of New ActiveHome Monitoring System, ActiveCare Announces New Head of Sales and Marketing
7. Reportlinker Adds US Cardiovascular Monitoring Systems - Market Trend Till 2016
8. Mindray Medical Receives the 2011 Medical Device Excellence Award for its V Series Patient Monitoring System
9. Reportlinker Adds Asia-Pacific Markets for Patient Monitoring Devices 2011
10. Masimo Initiates Limited Market Release of E1, Single-Patient-Use Ear Sensor for Pulse Oximetry Monitoring
11. Reportlinker Adds Cardiovascular Monitoring and Diagnostic Devices - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2017)... 2017 To mark the end of Save Your ... leader in digital imaging solutions, will showcase Canon eye care ... New York,s Jacob Javits Center from ... sponsored by the American Optometric Association, is observed annually in ... comprehensive eye exams. In recognition of this observance, Canon ...
(Date:3/27/2017)... -- A new survey from the American Association ... Program (CBP) significantly reduced beneficiary choice and access to ... forces beneficiaries to switch to unfamiliar or unsuitable testing ... AADE,s survey is the latest in a continuous ... the inherent problems with the CBP. Last year, a ...
(Date:3/27/2017)... YORK , March 27, 2017 FinancialBuzz.com ... Based ... adult use in states where cannabis is legal will generate $655 ... million will be from cannabis specific taxes, such as ... $96 million will be earned from state sales taxes that are ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... 2017 , ... Bacteria and fungi are probably not the first ingredients that come to mind ... right microorganisms in your diet can actually improve health outcomes. And the good news is ... topic of a new peer-reviewed paper led by Maria Marco, Ph.D. , ...
(Date:3/27/2017)... ... March 27, 2017 , ... The respected dental ... want straight teeth without the extensive time commitment and aesthetic disadvantages of traditional ... a referral. A custom-designed series of virtually invisible aligners are created for each ...
(Date:3/27/2017)... Ohio (PRWEB) , ... March 27, 2017 , ... New ... OH to replace their missing teeth can now have them placed by Dr. Manju ... the latest i-CAT® Cone Beam technology to increase the accuracy of each dental implant ...
(Date:3/27/2017)... ... March 27, 2017 , ... ... gain site attention and engagement over the household brands of Top-20 pharma by ... will discuss how partnering with the right outsourcing payments provider can provide the ...
(Date:3/27/2017)... ... March 27, 2017 , ... A study by the founder of the ... Sudeep Roy, MD, was recently published in the American Journal of Cosmetic Surgery. ... Drs. Buckingham and Roy’s study on the use of Electro Lube during the facelift ...
Breaking Medicine News(10 mins):