Quality
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Packaging and sterilisation – crucial for safe medical devices
In addition to production that meets all requirements, appropriate packaging is also indispensable. Samaplast meets all requirements here as well: We package medical devices in such a way that they meet the legal requirements until they are used and throughout their entire shelf-life.
Packaging
Packaging that does not alter the product
Packaging lies at the end of the production line for medical devices. We package them in such a way that their application characteristics and capabilities do not change during the entire life cycle.
We document the process of final packaging and produce proof that the specific requirements regarding sterility and functionality of the packaged medical device are fulfilled until the point of use. We are also happy to undertake safe packing in protective packaging.
Standard packaging
- Bag
- Blister
Technology
- Heat sealing process
- Validation of effectiveness and reproducibility (ISO 11607-2)
Methods
- Environment simulation/performance test according to ISTA 2A
- Accelerated ageing according to ASTM F 1980
- Visual tests according to ASTM F 1886
- PEEL test according to ASTM F 88
- Dye test according to ASTM F 1929
- Burst and creep test according to ASTM F 1140
- Bubble emission test according to ASTM F 2096
- Test for germ resistance in moist conditions according to DIN 58953 part 6 etc.
Parameters
- Sterilisation
- Ageing
Sterilisation methods
Sterilisation service
In addition to final packaging, we provide the sterilisation of the medical devices, including validation and final approval, in cooperation with our partners. This way we guarantee the Samaplast quality you are accustomed to.
Methods
- Gamma sterilisation according to ISO 11137 and X-Ray
- Ethylene oxide (ETO) sterilisation according to ISO 11135
- E-Beam
- Plasma sterilisation
- Autoclaving etc.
More of Samaplast
References
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