One of the skills of SBA members is in matching the packaging types and materials to the medical device and to the sterilisation process.In selecting materials for sterile barrier systems for medical devices many aspects need to be considered including the following:
- Microbial barrier properties
- Compatibility with the device *Biocompatibility/toxicological
- Barrier properties – Moisture, Gases, Light etc.
- Physical/chemical properties e.g. porosity
- Method of packing e.g. sealed, folded, taped, need for aseptic opening
- Material limitations e.g. max.sterilisation T for non-woven materials of polyolefin is 1270C
- Compatibility with printing and labelling systems
- Bioburden control
- Compliance to standards
- Storage limitations
- Transport conditions
- Disposal/Recycling requirements
Sterile barrier system packs need to resist the demands of the sterilisation process such as gamma and e-beam radiation, ETO gas, steam autoclave and others. Some packaging materials are not compatible with certain types of sterilisation process for e.g. PVC changes colour and weakens during gamma radiation. Click here to see a table giving a broad overview of material compatibility with the various sterilisation processes or click here for a complete overview of sterilisation processes and material compatibility.
Excellent barrier properties are a consequence of carefully selected materials, packaging formats and equipment to suit your product and continuous quality assurance.
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