Sterilization is a major part of the medical device manufacturing industry. Therefore, manufacturers take care to produce properly sealed medical packaging. Determining the method of sterilization early in the development of the product is critical. Two methods of medical device package sterilization include:
- EtO or Ethylene Oxide sterilization
- Gamma irradiation
EtO sterilization is common for sterilizing medical and pharmaceutical products that cannot withstand conventional high temperature steam sterilization. During this process, EtO gas penetrates the packages and kills off micro organisms. Gamma irradiation involves gamma rays disrupting living cells by damaging the DNA and other cellular structures.
Medical product designers and manufacturers not only need to develop a package that is sterile but manufacture something that is consistent. TestResources can aid in testing every step of the design and validation process. This can include:
- Design validation
- Process validation
- Production control
Design validation is a critical and experimental step in the development process. Design engineers must validate their product through a series of testing applications. The FDA requires that both the product and the packaging be validated formally. This includes rigorous testing of a statistically significant quantity of test specimens. Our engineers are experienced in the 510k process and can help guide designers through necessary steps to gain final design approval.
Process validation involves testing the manufacturing process to ensure that it consistently produces product that meets key specifications. This includes the medical device product, packaging, and the sterilization process. TestResources test equipment is often used in manufacturing processes for applications like sterile package seal testing and tensile proof tests. We can work with you to facilitate process validation of our test equipment.
Production control testing is a final yet reoccurring step to assure that packages are properly sealed now and in the future. It is common to use international testing standards for all three steps of design and medical device package validation. Following such standards is critical to ensuring that the production process consistently creates product and packaging that meets all specifications and therefore will perform well in the marketplace.
The two more popular testing standards for validating sterilized medical device packages are ASTM F88 and ISO 11607. ASTM F88 is a testing standard for measurement of seal strength for flexible barrier materials in medical packaging. Packaging should also comply with ISO 11607 to ensure that the enclosed medical devices are kept sterile throughout all the elements and hazards generated by the manufacturing, shipping and storage environments. This ISO test method can be used for sterile barriers for medical device packaging.
TestResources provides specially configured testing equipment to meet ASTM F88 and ISO 11607. Call today to directly speak with an applications engineer or view the links below to learn more about medical device package design and validation testing.
