UA-44035381-1
  • AseptiLink SV

AseptiLink SV

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.

Patent Pending

  • It enables integration of steamable hard piped processing systems to gamma sterilized disposable flow paths in single use assemblies.
Construction
Body and Core Polysulfone
Typical Water Flow Rate 5lpm @ 2psi
Size
Operational Radius (with Vent/ Drain) 66 mm
Operational
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
Assurance
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>

AseptiLink SV is available only as a part of Single Use System. It is not available separately

Datasheet Download

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  • No extraneous contamination: Completely closed, steam sterilizable connection
  • No steam through into the environment
  • No requirement of condensate drain tubing