New White Paper: Having a Solid Package Validation Program Can Prevent Failure of Combination Products

AGAWAM, MASS. – November 16, 2010 – A new white paper urges medical device and combination product manufacturers to employ a solid package validation program as a means of preventing the failure of combination products.

“FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs,” said Steven Richter, Ph.D., founder, president and chief scientific officer of Microtest Laboratories in Agawam, Mass.

Richter is author of the new white paper that provides insight into the general requirements in a microbiological and physical testing program. In it, he discusses how combination products pose a unique set of challenges to package validation engineers.

Titled, “Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products,” the paper is available for download from: http://www.microtestlabs.com/packaging-validation-paper.

In the white paper, Richter discusses the challenges of packaging validation and some of the options for testing. He provides a summary of the standardized test methods commonly used in the U.S. for satisfying ANSI/AAMI/ISO 11607 requirements, and outlines the steps in the packaging validation process. He also focuses on the points to consider during packaging validation studies for cell therapy products.

“All device and combination product manufacturers are required to have a robust package validation program, and medical device stability package validation programs should be designed to encompass the overt product storage and shipment conditions,” Richter said. “The necessity to develop a robust packaging validation regimen cannot be overstated. A comprehensive regulatory approach to validation during early product development can save many weeks of redevelopment and testing activities.

“This white paper is presented to give medical device and combination product manufacturers a starting point for package validation programs,” he said.

Download the new, free white paper, “Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products,” from: http://www.microtestlabs.com/packaging-validation-paper.

Steven Richter, Ph.D., is founder, president, and chief scientific officer of Microtest Laboratories, Inc., in Agawam, Mass. Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest has provided the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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.

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Get with the Program: Having a solid package validation program can prevent failure of combination products

FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs.

Read the new bylined article by Steven Richter, "Get with the Program: Having a solid package validation program can prevent failure of combination products," for insight into the general requirements in a microbiological and physical testing program. It also discusses how combination products pose a unique set of challenges to package validation engineers.

Published May 2010 in MD&DI, at http://ht.ly/1P7lO

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