Microtest Offers Comprehensive Accelerated Aging Studies for Medical Device Manufacturers

AGAWAM, MASS. – June 16, 2009 –Microtest Laboratories is an industry leader in providing validation studies is now offering accelerated aging studies as part of Microtest’s portfolio of package validation services.

Microtest uses accelerated aging studies to aid medical device manufacturers in predicting what will occur to the packaging or product during normal storage conditions. Studies are used to set preliminary shelf life dates, the period during which the product remains stable for its intended use.

Available accelerated aging studies from Microtest include:

• Standard chamber temperature studies (-70C, -20C, 25C 60% RH), (30C 65%RH), (35C 75% RH), (40C 75%RH), (50C 10-50% RH),( 55C 10-50%RH), (60C 10-50%RH)
• Post-stability/aging testing
• Custom studies
  

Backup storage is guaranteed. All chambers are monitored by SCADA, a 24-hour temperature monitoring system that alerts Microtest personnel to out of tolerance conditions, and feature back-up power.

“Unlike some other labs, at Microtest advanced SCADA systems monitor test chambers 24 hours a day, 7 days a week. So customers and regulators can be sure humidity and temperature remain within prescribed ranges,” said Steven Richter, Ph. D., President and Scientific Founder of Microtest Laboratories (http://www.microtestlabs.com/). “And since we offer a full range of drug testing at a single source, products aren’t exposed to temperature or humidity hazards in transit between tests.”

Microtest is widely recognized for its problem-solving expertise in medical device contract manufacturing. Services include single-source production and testing, plus dedicated product management.

For more information on Microtest’s complete portfolio of services, visit Microtest Laboratories on the Web at www.microtestlabs.com/medical-device-testing/package-validation-testing.html, or call 1-800-631-1680.

Or, visit Microtest at the 2009 MD&M East, June 9th-11st, in Booth 1442 in the Jacob K. Javitz Convention Center New York, NY.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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.

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Public Relations contact: Tiziani Whitmyre Inc., www.tizinc.com

White Paper Explains Package Validation Requirements For Medical Devices & Combinatory Products

AGAWAM, MASS. – June 9, 2009 – Validation requirements and combination products pose a unique set of challenges to the medical device engineer. A new whitepaper from Microtest Laboratories discusses how an engineer can best to utilize packaging validation programs and discusses options when testing medical device packaging.

The white paper, ““Package Validation Requirements For Medical Devices and Combinatory Products” provides an insight into the general requirements in microbiological and physical testing programs. It is available for download at: www.microtestlabs.com/package-validation-paper/

Specifically, the white paper discusses that medical device stability package validation programs should be designed to encompass the overt product storage and shipment conditions and that performing accelerated aging studies does little to address liability during shipment and storage.

The white paper discusses:
· The necessity to develop a robust packaging validation regimen
· That a packaging validation program should include transportation simulation testing with concomitant sterility testing.
· A comprehensive regulatory approach to validation during early product development can save many weeks of redevelopment and testing activities.

The white paper is authored by Steven Richter, Ph.D, is President and Chief Scientific Officer of Microtest Laboratories, (www.microtestlabs.com/), a contract manufacturer and provider of contract manufacturing testing.

To download the white paper, “Package Validation Requirements For Medical Devices and Combinatory Products“ visit: www.microtestlabs.com/package-validation-paper/

Or, visit Microtest at the 2009 MD&M East, June 9th-11st, in Booth 1442 in the Jacob K. Javitz Convention Center New York, NY.

About Microtest
Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, 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.

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Public Relations contact: Tiziani Whitmyre Inc., www.tizinc.com