Iso 11607 2 packaging for terminally sterilised medical devices validation requirements for forming sealing and assembly processes.
Medical device packaging materials.
Packaging material is the first key factor that you should not avoid to create efficient packaging for your medical devices.
Each turnkey medical device and pharmaceutical packaging solution is designed to fit delicate instrument and implants form fit and functionality.
Iso ts 16775 guidance for use of.
Iso 11607 1 packaging for terminally sterilised medical devices requirements for materials sterile barrier systems and packaging systems.
Medical devices packaging market growth trends and forecasts 2020 2025 the medical devices packaging market is segmented by material plastic paper paper board product pouches bags trays boxes clam shells application sterile packaging non sterile packaging and geography.
Medical device packaging standards.
The most common sterilization methods for medical devices are gamma electron beam e beam ethylene oxide eto and autoclave.
Packaging strength is important to show that the package protecting the product is strong enough to contain the product system after distribution or aging.
Raw materials used in sterile medical device packaging must be traceable safe and effective in creating a microbial barrier.
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Medical device packaging must allow its contents to be sterilized and then must maintain that sterility until the time of use all while optimally balancing the multitude of considerations that are part of the package development process.
These devices need proper packaging material that will allow your product to work correctly.
Moreover if a medical device has sharp features thicker materials may be needed or additional protective packaging materials may be required such as protective sleeves or retaining lids.
We know how important speed to market is for our medical customer which is why we staff our sample and prototyping lab 24 hours per day 7 days per week.
Package manufacturing machinery must be set up and maintained in a validated state and produce a result that can be measured and monitored over time for performance to specification.
Packaging materials and systems for medical devices which are to be sterilized part 5.
Seal strength also allows the medical device manufacturer to confirm the reproducibility of their sealing process and adherence to design specifications.
Our packaging is used in all major healthcare segments throughout the globe providing clients with the highest quality packaging in the industry.
Heat and self sealable pouches and reels of paper and plastic film construction requirements and test methods.