AseptiLink™ ST
MDI AseptiLink™ ST steam through connectors are 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™ ST, as part of the gamma irradiated single use disposable assembly is connected to stainless steel vessels/piping through its 25mm sanitary flange inlet connection. This connection is steam sterilized, along with SS component of the process flow, effecting a sterile connection between the two.
- No extraneous contamination: Completely closed, steam sterilizable connection
- Carefully selected materials of construction for minimum extractables
- Safe, secure and validated connection for transfer of sterile fluids
| Construction | |
| Seal Material | Platinum Cured Silicone |
| Body and Core | Polysulfone |
| Specifications | |
| Microbial Ingress | Exhibit absolute resistance to microbial ingress against a challenge of 10⁷ org/mL |
| Bioburden Levels | Bioburden level is < 1000 cfu/device as per ISO 11737-1: 2018 |
| Bacterial Endotoxin Levels |
Aqueous ex trac ts exhibit <0.25 E U /ml as established by Limulus Amoebocyte Lysate (LAL) test as per USP <85>
|
| Biosafety | Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP <88>. Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87>. |
| Operational | |
| Gamma Sterilization | Upto 50 kGy |
| Pressure Leak Test | Passes at 45psi |
| Steam Sterilization | 135 °C for 30 minutes, 1 cycle |
| Typical Water Flow Rates | 5lpm @ 2psi |
| Operating Temperature Range | 4 – 40 °C |
| Assurance | |
| 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 |
| Total Organic Carbon | Meets the WFI requirements of USP <643> for Total Organic Carbon |
| Conductivity | Meets the WFI requirements of USP <645> for Conductivity |
| Extractables | Passes NVR test as per USP <661> |
| File Type | Download |
|---|---|
| Datasheet | Download |
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