By running high humidity levels at your elevated temperature, you're over saturating the materials/product to a point where it is unrealistic in the real world. - basically you're over testing
Minneapolis, MN (PRWEB) October 19, 2009
DDL, leader in medical device package, product and material testing, announced that via findings from their 3rd quarter "Packaging Quizzler" nearly half of medical device packaging professionals that answered this quarter's quizzler question understand that the humidity should mimic the equivalent water content.
"Essentially what you are trying to achieve is the same absolute humidity derived from your real time storage conditions. You are basically trying to mimic the same amount of moisture content (PPM) as you real time aging conditions." Scott Levy, Packaging Engineer at DDL said.
Common real time aging conditions equate to 23 degrees Celsius at 50 percent relative humidity. Often time's people will choose a relative humidity based upon conditions that are unrealistic, for example, running 1 year of aging at 55 degrees Celsius at a 60 percent relative humidity.
"By running high humidity levels at your elevated temperature, you're over saturating the materials/product to a point where it is unrealistic in the real world. - basically you're over testing," Levy said.
Accelerated Aging is performed to ensure that the sterility maintenance is maintained over the specified period of time (expiration date). Accelerated Aging entails subjecting the package and or product to time and temperature and then subjecting the package and or product to further testing procedures to prove either sterility maintenance or product performance.
About The TCP Family of Companies
DDL is a third party testing facility specializing in medical device package, product and material testing. We have three full service labs located throughout the country offering testing services that include shock testing, vibration testing, tensile testing, leak testing and validation services. DDL maintains full service testing labs in Minnesota, Southern California and New Jersey. (http://www.testedandproven.com)]
The TCP Family of Companies is a complete packaging integrity solutions provider servicing life science industries. The TCP Family consists of Cryopak, the leading manufacturer of cold chain related products and DDL, the leader in package, product and material testing validation for the medical device and biopharmaceutical industries. The TCP family handles your packaging projects with one paramount goal: help get your product to market faster while maintaining the integrity of your products.