AseptiDlink™ Sterile Disconnector
Single Use Systems (SUS) are increasingly being used in biopharmaceutical, and cell and gene therapy manufacturing processes. Aseptically disconnecting single use components such as bags from a single use assembly being used is a critical process requirement.
MDI AseptiDlink™ sterile disconnectors are designed to provide a fast and smooth, leak free aseptic disconnection of single use systems. This allows the user to maintain sterility during disconnection while doing away with pinch clamps and tube welders.
Sterile disconnection from processing equipment and components such as:
- Single use bioreactors
- Filter capsules
- Single use bags
- Sampling systems
- Transfer lines
| Materials of Construction | |
| Fluid Contact Parts | Polycarbonate |
| Flow Path Springs | 316 Stainless Steel |
| O-ring Seal | Platinum Cured Silicone |
| Specifications | |
| Microbial Ingress | Exhibit absolute resistance to microbial ingress against a challenge of 107 org/mL |
| Sizes Available |
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| Bacterial Endotoxin Levels | Aqueous extracts exhibit <0.25 EU/ml as established by Limulus Amoebocyte Lysate (LAL) test as per USP <85> |
| Operational | |
| Operating Temperature | 4 - 40 °C |
| Burst Pressure | > 4 bar (60 psi) |
| Assurance | |
| Fiber Release | Passes test as per USP and comply with USFDA Title 21 CFR Part 210.3(b)(6) for fiber release |
| Sterilization by Gamma Irradiation | Sterilizable upto 50 kGy |
| Particle Release | The filtrate complies with USP <788> test for particulate matter in injections |
| Bioburden Levels | Bioburden level is < 1000 cfu/device as per ANSI/AAMI/ISO 11737-1 |
| Extractables | Passes NVR test as per USP <661> |
| Biosafety | Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP <88> |
| Datasheet | Download |
- Reliable aseptic disconnection even in non sterile areas
- Fast and easy single step disconnection
- Carefully selected materials of construction for minimum extractables