Minneapolis, MN - June 28, 2011 -- http://www.testedandproven.com/ -- DDL is tapping into the fast growing sector of the life science industry commonly known as combination product testing. This type of testing includes combining the medical device and drug industries into one package. Code of Federal Regulations Title 21 states that, “a combination product comprises any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.”
“Combination products, such as pre-filled syringes, need to go through the same rigorous distribution simulation testing that medical device packaging goes through,” Pat Nolan, DDL President, said. “DDL is seeing a growing need for combination product testing and we’re using our years of testing experience on medical device packaging as a resource to also serve the combination product testing industry.”
DDL’s ability to perform the necessary ASTM, ISO and ISTA tests as well as follow the guidance principles provided by ICH and the PDA , make DDL uniquely equipped to handle the complex package requirements for combination packages.
“Whether the package validation requires integrity testing on drug containers or cold chain qualifications, DDL, can employ its 20 years of experience in package design and testing to ensure that the packaging system will meet all of the regulatory requirements of the agencies involved,” Nolan said.
