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.
- Reliable aseptic disconnection even in non sterile areas
- Fast and easy single step disconnection
- Carefully selected materials of construction for minimum extractables
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 |
|
| 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> |
| File Type | Download |
|---|---|
| Datasheet | Download |
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