Originally Published PMPN May 2005
NEWS
ISO 11607 Clause 6 Certification Program UnveiledDDL Testing Service (Eden Prairie, MN) has announced the introduction of a new testing certification program called PackReview, designed to verify package compliance with clause 6 of the ISO 11607 Packaging for Terminally Sterilized Medical Devices standard.
PackReview will be presented to companies that demonstrate successful deployment of a protocol and successful completion of the intense clause 6 testing process, according to the company. ISO 11607 was created to provide device companies with a framework of laboratory tests and evaluations that can be used to qualify performance of a package during handling, distribution, and storage.
“Our intention is for PackReview to become recognized industrywide as a respected certification that verifies a package’s compliance with ISO 11607 clause 6,” says Patrick Nolan, COO of DDL. The company recently showcased the PackReview program at HealthPack 2005, an industry conference held in San Antonio, TX in late March.
Through the PackReview process, the company urges package engineers to ask the following questions prior to validation:
- What types of packages are we validating?
- What type of expiration date do we want?
- What is the overall package configuration?
- Which strength and integrity methods do I utilize?
- What are the glass transition rate and the melt and heat distortion temperatures of the package and product?
With PackReview, a DDL package engineer works directly with a company to help determine and document the definition of a specific testing project. A protocol is then developed, including purpose, scope, references, materials and equipment, sample description and preparation, test procedure, acceptance criteria, and documentation. A test procedure consists of sterilization, poststerilization package analysis, distribution simulation tests, posttransportation simulation package analysis, accelerated-aging test protocol, post-accelerated-aging package analysis, sample inspection and evaluation, and summary of accelerated-aging pouch sample size.
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