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

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, 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

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. Follow Microtest Labs on Twitter @MicrotestLabs at

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

Steve Richter, Ph.D.:

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:
(Date:11/26/2015)... ) has ... Future Horizons and Growth Strategies in the ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> ) has announced the ... and Growth Strategies in the French Drugs ...
(Date:11/26/2015)... November 26, 2015 ... universitetssjukhus ser potential att använda SyMRI för ... för patienter med multipel skleros (MS) ... med SyntheticMR AB för att kunna använda ... sjukhuset. Med SyMRI kan man generera flera ...
(Date:11/26/2015)... India , November 26, 2015 ... --> adds ... Report" and "Investigation Report on China ... and 2021 forecasts data and information ... . ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, Vitalalert ... Organizations, One Beat ” campaign. The partnership between the two groups began in 2014 ... MAP International’s cause. , MAP International was founded in 1954 and is an international ...
(Date:11/25/2015)... ... November 25, 2015 , ... On November 25, 2015, officials of ... Narconon network, announced the release of a new cutting edge recovery program that has ... been working with drug- and alcohol-addicted individuals with the purpose to free addicts from ...
(Date:11/25/2015)... ... , ... Smiles by Stevens is pleased to announce the addition ... many patients are aware of the benefits of Botox® in the treatment of moderate ... with discomfort, soreness, and pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) ...
(Date:11/25/2015)... ... , ... In an ongoing Clinical Study conducted by an independent physician, Andrew ... is evaluating the efficacy of its product and its disinfection protocol. This study is ... May 2014 through October 2015 at a 360-bed, acute-care, academic medical center located in ...
(Date:11/25/2015)... Silver Spring, Md (PRWEB) , ... November 25, ... ... the Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups ... the history of this disease. The Periwinkle Pioneers, nominated by the public, will ...
Breaking Medicine News(10 mins):