Free white paper details compliance requirements for pharma, medical device manufacturers

July 9, 2007 — /PRNewswire/ — AGAWAM, MA — A new, free white paper, detailing critical industrial sterilization and contamination control programs and compliance challenges in the pharmaceutical and medical device manufacturing industries, is now available for download at

One of the biggest challenges faced by medical device manufacturers is determining exactly what is required for compliance. For parenteral manufacturers, the environmental control parameters are highly stringent and pose significant compliance challenges.

In the white paper, titled “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” Microtest project manager Scott Mackin reviews key elements of a best practice environmental testing program, including sterilization standards, FDA compliance requirements, and vital factors in maintaining controlled environments.

At Microtest, Mackin has assisted a number of medical device manufacturers in designing, implementing, and maintaining both sterilization and environmental monitoring programs.

Microtest, a full service testing services and contract manufacturer, offers a complete range of onsite and remote monitoring programs for specialized environmental testing services. Microtest experts utilize cutting edge technology and processes to determine viable microbial and nonviable particulate levels of any area used for medical device and pharmaceutical cleanroom or manufacturing purposes.

Download the free white paper, “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” at: Or, for more information, visit Microtest on the Web at or call toll-free 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, MA, the company’s expertise and flexible processes enhance product safety and security, accelerate time-to-market, and minimize supply chain disruption.

Source: Microtest

Don Goncalves
Tel: 781-793-9380
E-mail: [email protected]

Brandie Gerrish
Tel: 781-793-9380
E-mail: [email protected], both of Tiziani Whitmyre, Inc. for Microtest


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