Part 1
By Wendy Mach, Packaging Section Leader BS, ASQ(CQA), RM(NRCM)
Package validation testing has always been an important aspect of any medical device development process. What’s interesting today is it isn’t just new packaging manufacturers need to worry about; economic and environmental conditions are also driving manufacturers to re-validate their packaging.
The green movement is causing many companies to look at providing functional, yet environmentally friendly packaging for their devices—not always an easy task. In this scenario, green friendly packaging must still meet the rigors necessary to protect the device.
Economic conditions are causing not only the device manufacturers to look for ways to save costs, but the packaging materials makers as well. A manufacturer may have been using validated packaging system for years, but if the materials provider changes a resin or other key material then the packaging needs to be re-validated. The same is true if the manufacturer has been using expensive materials and are looking to use less expensive packaging or packaging with fewer materials.
Whatever the reason—new packaging or changes due to economic or environmental conditions—Nelson Labs can help manufacturers see what is required to make and keep their packaging validated. Some aspects to consider when looking into a new packaging system include: the method of sterilization, material compatibility, and the process of how it will be packaged and shipped.
There are basically three tests/categories (USP 11607) to validate packaging, only one test is required from each category:
- Strength. There are two options for demonstrating the strength of seals. The seal peel test identifies the amount of force it takes to open a package seal, whereas the burst test will provide information regarding the weakest seal and the amount of pressure it takes to fail that seal.
- Integrity. Package integrity can be demonstrated using one of the following methods. Each test allows the
manufacture to evaluate holes, abrasion, channels, cuts, etc in the packaging. Dye migration involves injecting blue dye into the package. The weight of the dye then sits on the seals for a predetermined time. Failures are identified by dye passing through the seal. The second option is a bubble emission test. The package is immersed in fluid and inflated to a validated pressure. Package failure is represented by bubbles originating from a single point.
- Microbial Barrier. The microbial barrier test ensures the packaging can prevent microorganisms from penetrating to the medical device. The test samples comprise of four 47mm disks cut from the porous portion of the packaging (the packaging width needs to be able to provide exactly 47mm diameter disks). The disks are placed in the chamber cups and exposed to a known concentration of organisms for 15 minutes. A filter below each disk is plated to see how many, if any, organisms were able to penetrate the test samples.
These are just some of the important packaging validation elements manufacturers need to think about with new packaging or changes in their existing packaging due to evolving conditions. There are many other important items to consider that will be discussed in the second part on packaging.