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:9/18/2017)... PROVIDENCE, R.I. , Sept. 18, 2017 ... in the fields of bioinformatics and immune ... to develop a protective avian influenza A (H7N9) vaccine. ... is distantly related to seasonal influenza and ... approaches, which rely on prior exposure to be ...
(Date:9/12/2017)... , Sept. 12, 2017  ValGenesis Inc., the ... (VLMS), is pleased to announce the appointment of ... of its Board of Directors and Chairman of ... enables life science companies to manage their entire ... of paper in this process. Furthermore, ValGenesis VLMS ...
(Date:9/7/2017)... 2017  Eli Lilly and Company (NYSE: ... operations to more efficiently focus resources on developing ... Global workforce reductions, including those from a U.S. ... approximately 3,500 positions. With the ... of approximately $500 million that will begin to ...
Breaking Medicine Technology:
(Date:9/25/2017)... ... September 25, 2017 , ... “Renew Refresh Restore Reward”: is a story ... is the creation of published author, Deborah Freeman, cofounded the Free Spirit Bible Church ... returned to our cars, my sister-in-law invited us to come over before the baby ...
(Date:9/25/2017)... ... September 25, 2017 , ... “The Majestic Unicorn”: a ... flood. “The Majestic Unicorn” is the creation of published author, Dayna Chantel, an artist ... from far and wide to march aboard the cypress ark-vessel. Male and female, no ...
(Date:9/25/2017)... New York, NY and Los Angeles, CA (PRWEB) , ... September ... ... City, has announced the opening of a full-time office in downtown Los Angeles, to ... Texas, Arizona, Nevada and the surrounding areas. , “We are seeing an ever-increasing amount ...
(Date:9/25/2017)... ... September 25, 2017 , ... ... September 28, 2017 to deliver a powerful message of teamwork, unity and collaboration ... Feature film writer/director Robert Adetuyi (Beat the World, Stomp the Yard) and Grammy-nominated ...
(Date:9/24/2017)... ... September 25, 2017 , ... The Venetian on Grace Bay in ... 1st. And, throughout the month of October, the resort will be offering 40% ... and Maria have passed and damage to the Venetian was very minimal and mostly ...
Breaking Medicine News(10 mins):