How do I select materials for my medical device?
Selecting a material depends on many factors. These factors include: marketing appeal, sterilization methods, quality inspection requirements, shelf life, and distribution requirements.
What type of equipment do I need to invest in?
Equipment selection is vital to sealing your packaging and will effect project lead times. Depending on your requirements, you may need to purchase sealing machines such as hermetic sealers, trays sealers, and shrink wrappers. However, contract manufacturers may provide them, helping you avoid some excess expenses other than tooling costs.
What type of testing must the packaging undergo and what industry standard is appropriate?
All sterile packaging is subject to a series of integrity and conditioning tests under ISO 11607. This testing includes shelf life testing (accelerated & real time), distribution testing (performance & dynamic), and strength/integrity testing.
What type of environmental conditioning should my product undergo?
It depends on your requirements for shipping. If your product is temperature sensitive, then testing will have to include temperature profiles that best suit your shipping requirements.
How do I determine the bioburden associated with my product and packaging?
Bioburden is normally defined as the number of bacteria living on a surface that has been sterilized and it is quantified in terms of colony forming units (CFU). Your product and packaging are all taken into consideration when determining bioburden. Pre-sterilizing materials prior to packaging can help reduce your bioburden. However, if you plan on using high dose gamma radiation, pre-sterilization may not be necessary.
How is my product deemed sterile?
Testing is dependent on the method of sterilization. For instance, gamma radiation falls under ISO 11137 and requires bacteriostasis and fungistasis (B/F), bioburden, and sterility testing. B/F testing ensures that your product does not contain any agents that can invalidate sterility testing. Bioburden testing quantifies the amount of bacteria on your product (Bioburden Test). Lastly, sterility testing involves sterilizing your product based on the bioburden results and testing for any bacterial growth (Sterility Test).