Qualification
Opta® SFT Sterile Connector has been qualified applying the most stringent and innovative test regimes. Biological, chemical and physical tests combined with extensive extractable testing provide users of Opta® SFT sterile connectors with data representing a variety of processing conditions. Full compliance with ISO11137 allows for a validated claim of sterility on all Sartorius Stedim Biotech single-use products with a sterility assurance level of 10-6 over the shelf life.
Opta® SFT Sterile Connectors are tested for compliance to:
- USP <85>: Bacterial Endotoxin testing
- USP <87>: Biological reactivity tests, in Vitro
- USP <88>: Biological reactivity tests, in Vivo
- USP <661>: Tests for plastic
- USP <645>: pH and conductivity
- USP <788> and E.P. 2.9.19: Particulate
- ISO 11737: Bioburden
- ISO 11137: Sterilization of Medical Devices
Details on methodologies and equipment used as well as further tests performed are available in the Validation Guide.
