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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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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Labels: combinatory products testing, concomitant sterility, medical device testing, package validation, transportation simulation, Validation requirements
posted by Microtest Laboratories at
10:00 AM
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