AGAWAM, MASS. – Nov. 10, 2008 – A free morning-long seminar to help New England-based medical device manufacturers negotiate the increasingly important – and complex – challenges of sterile package validation is scheduled for November 12th in Agawam, Mass.
“FDA concerns regarding terminally sterilized medical products are based on years of data that implicates failures in primary packaging. The majority of failures occur because of inadequate package validation programs,” says Steven Richter, Ph. D., president and CEO of Microtest, a leader in medical device testing services, including medical device package stability and validation testing.
The seminar will detail the necessary sterilization processes and test methods that should be part of any reliable validation program to avoid such failures, Richter said.
Titled “Package Validation Requirements for Medical Devices and Combinatory Products,” the seminar will detail the general concepts and problems associated with medical device packaging testing as well as reviewing different testing methodologies. Specific topics will include:
- ISO 11607 Overview
- Physical Package tests vs Microbial
- Stability & Accelerated Aging
- Combinatory Products
- Flexible Packaging
- ISTA Shipping Testing
The seminar will be held Nov. 12, 2008, from 10 a.m. through Lunch at Microtest Laboratories, Inc., 104 Gold St., Agawam, Mass. The seminar is free and lunch will be provided.
The seminar is free, but prior registration is required. To register, visit www.microtestlabs.com/packagingseminar or call toll-free 1-800-631-1680.
For directions to Microtest, visit http://www.microtestlabs.com/contact-us/index.html.
Microtest is a leader in testing services and contract manufacturing 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.
# # #