Sterile Medical Device Packaging Q&A
Asked November 21st, 2012
While biodegradable/compostable plastics are widely used in thermoforming, generally speaking, they are not suitable yet for pharmaceutical and medical device applications. Keep in mind, PLA and other biodegradable polymers have no practical infrastructure for recycling and can only be biodegraded in commercial composting facilities. Materials like PHB that will biodegrade in a typical landfill are generally cost prohibitive and have relatively poor mechanical properties when compared to petroleum derived materials.
With that said, advancements are being made very quickly in the area. I believe there will be a day when plant- and bacteria-derived polymers will have a place in pharmaceutical and medical device packaging, specifically in nonbarrier components such as clamshells and unsealed blisters. In fact today, if you can show a very controlled distribution cycle, especially temperature controlled, there may be a suitable use for these materials today. The question then becomes your business strategy as it relates to cost, environmental considerations, and market acceptance. We are successfully using up to 100% post consumer content recycled materials in many pharmaceutical and medical device packaging applications where the material is not a part of the sterile barrier and has no required MVTR/OVTR properties. Not long ago this would not have been accepted, but it is widely utilized in the industry.
Asked November 2nd, 2012
Tyvek is a breathable microbial barrier so pressure differences such as high altitude shipping will not affect the package. Foil, however, is not breathable, so you will want to test the package at low pressure. One key is to keep any head space inside the package to a minimum if you don’t have a breathable lid.
Shipping product bulk in a box is certainly a normal way to distribute your product. Regardless of how you decide to pack the product, simulating your distribution cycle is necessary.