MDI AseptiLink SV Connector is designed to provide safer, secure and validated connection for transfer of sterile fluids. This connector enables integration of steamable hard piped processing systems to gamma sterilized disposable flow paths in single use assemblies.
MDI AseptiLink SV, as part of the gamma irradiated single use disposable assembly is connected to stainless steel vessels/piping through its 50 mm sanitary flange inlet connection. This connection is steam sterilized, along with SS component of the process flow, effecting a sterile connection between the two.
- It enables integration of steamable hard piped processing systems to gamma sterilized disposable flow paths in single use assemblies.
|Body and Core||Polysulfone|
|Typical Water Flow Rate||5lpm @ 2psi|
|Operational Radius (with Vent/ Drain)||66 mm|
|Pressure Leak Test||Passes at 2.5 bar (40psi)|
|Steam Sterilization||135 °C for 30 minutes, 3 cycles|
|Number of actuations||5 times|
|Operating Temperature Range||4 – 40 °C|
|Toxicity||Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics|
|Cytotoxicity||Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity|
|Fiber Release||Passes test as per USP and comply with USFDA Title 21 CFR Part 210.3(b)(6) for fiber release|
|Particle Release||The filtrate complies with USP <788> test for particulate matter in injections|
|Extractables||Passes NVR test as per USP <661>|
- No extraneous contamination: Completely closed, steam sterilizable connection
- No steam through into the environment
- No requirement of condensate drain tubing