Medical Device Packaging Professionals at DDL Express the Urgency of Packaging Test Separation
Bundling accelerated aging and environmental conditioning testing leaves room for error and non-compliance
Minneapolis, MN, September 11, 2008 --(PR.com)-- http://www.testedandproven.com/ -- DDL, the leading product and package testing services firm specializing in medical device package testing, made a startling discovery in its August “Accelerated Aging and Environmental Conditioning Test Quizzler.”
Of the group of medical device professionals that responded to DDL’s Quizzler campaign, 17 percent indicated they are bundling accelerated aging and environmental conditioning tests together. The result is that their medical device packaging may not meet the requirements set forth by ISO 11607, because these tests should be considered separate inputs to package performance.
“If accelerated aging and environmental conditioning tests are conducted together, the product's packaging integrity may be compromised,” stated Patrick Nolan COO of DDL. “The risks associated with bundling testing and the loss of package integrity can be infection caused by bacteria and pathogens entering the package.”
“We ensure each custom medical device we develop that requires compliance to ISO 11607 is subjected to accelerated aging and environmental conditioning tests separately, said Tim Tipple, Product Engineer of Metrix Company and winner of the accelerated aging and environmental conditioning test Quizzler question. “These two testing methodologies are designed for completely different situations.”
Accelerated aging tests for shelf life survivability of a package, while environmental conditioning tests ensure the package is capable of surviving extremes in environmental conditions.
Take for instance a catheter’s packaging that has been modified and needs to be reintroduced into the medical marketplace. Before it is sent to market, it requires the assurance that the new packaging can be stored for an extended period without any decrease in performance that may affect the safety and efficacy of the catheter.
“Medical device professionals understand the importance in the integrity of a product and the need for products to be tested to ensure safety,” stated Nolan. “What they may be overlooking is the need for the packaging to be held to that same standard of integrity. This is why conducting accelerated aging and environmental conditioning tests separately is essential in the effectiveness of medical device packaging.”
To gain more insight in the importance of the need for accelerated aging and environmental conditioning testing, please visit http://www.testedandproven.com/aging/index.html.
About The DDL Packaging Quizzler
DDL’s Packaging Quizzler is a semi-monthly online challenge which poses real world packaging questions Medical Device Packaging Professionals encounter on a daily basis.
One randomly-selected winner who answers The Packaging Quizzler correctly will be awarded a prize, such as a custom iPod.
To participate in the next Quizzler, please visit our Packaging Quizzler at http://www.testedandproven.com/lp/quizzler2-2/.
About DDL
DDL offers expert package, product and material testing services, including shock testing, vibration testing, tensile testing, leak testing and validation services. DDL also recently implemented a package design, development and prototyping department. DDL maintains full service testing labs in Minnesota, Southern California and New Jersey. DDL's package design, development and prototyping services are offered to support national clients through staff and operations based in Southern California. (www.testedandproven.com)
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Of the group of medical device professionals that responded to DDL’s Quizzler campaign, 17 percent indicated they are bundling accelerated aging and environmental conditioning tests together. The result is that their medical device packaging may not meet the requirements set forth by ISO 11607, because these tests should be considered separate inputs to package performance.
“If accelerated aging and environmental conditioning tests are conducted together, the product's packaging integrity may be compromised,” stated Patrick Nolan COO of DDL. “The risks associated with bundling testing and the loss of package integrity can be infection caused by bacteria and pathogens entering the package.”
“We ensure each custom medical device we develop that requires compliance to ISO 11607 is subjected to accelerated aging and environmental conditioning tests separately, said Tim Tipple, Product Engineer of Metrix Company and winner of the accelerated aging and environmental conditioning test Quizzler question. “These two testing methodologies are designed for completely different situations.”
Accelerated aging tests for shelf life survivability of a package, while environmental conditioning tests ensure the package is capable of surviving extremes in environmental conditions.
Take for instance a catheter’s packaging that has been modified and needs to be reintroduced into the medical marketplace. Before it is sent to market, it requires the assurance that the new packaging can be stored for an extended period without any decrease in performance that may affect the safety and efficacy of the catheter.
“Medical device professionals understand the importance in the integrity of a product and the need for products to be tested to ensure safety,” stated Nolan. “What they may be overlooking is the need for the packaging to be held to that same standard of integrity. This is why conducting accelerated aging and environmental conditioning tests separately is essential in the effectiveness of medical device packaging.”
To gain more insight in the importance of the need for accelerated aging and environmental conditioning testing, please visit http://www.testedandproven.com/aging/index.html.
About The DDL Packaging Quizzler
DDL’s Packaging Quizzler is a semi-monthly online challenge which poses real world packaging questions Medical Device Packaging Professionals encounter on a daily basis.
One randomly-selected winner who answers The Packaging Quizzler correctly will be awarded a prize, such as a custom iPod.
To participate in the next Quizzler, please visit our Packaging Quizzler at http://www.testedandproven.com/lp/quizzler2-2/.
About DDL
DDL offers expert package, product and material testing services, including shock testing, vibration testing, tensile testing, leak testing and validation services. DDL also recently implemented a package design, development and prototyping department. DDL maintains full service testing labs in Minnesota, Southern California and New Jersey. DDL's package design, development and prototyping services are offered to support national clients through staff and operations based in Southern California. (www.testedandproven.com)
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Contact
DDL Inc.
Nicole Leach
952-400-0350
www.testedandproven.com
Nicole Leach
952-400-0350
www.testedandproven.com
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