Millipore Lynx® CDR Connector
| Brand | Millipore |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | Lynx® CDR |
| Pricing | Upon Request |
Overview
The Millipore Lynx® CDR (Connect, Disconnect, Reconnect) Connector is an engineered aseptic fluid pathway interface designed for single-use bioprocessing applications. It operates on a mechanical latching and sealing principle—utilizing precision-machined polymer components and elastomeric seals—to enable repeated, validated sterile connections without compromising system integrity. Unlike traditional single-use connectors requiring permanent fusion or heat sealing, the Lynx® CDR supports up to six full connect/disconnect/reconnect cycles under controlled process conditions while maintaining sterility assurance per ISO 13408-1 and USP . Its deployment is optimized for upstream and downstream unit operations including buffer transfer, harvest clarification, tangential flow filtration (TFF), and final fill preparation—where dynamic reconfiguration of single-use assemblies is critical for campaign flexibility and facility utilization.
Key Features
- Validated aseptic performance across up to six complete connection cycles, with microbial ingress testing conducted per ASTM F1608 and simulated use under ISO Class 5 environments.
- Robust mechanical architecture featuring a three-component assembly: female valve body, sterile protective housing, and male valve with rotatable hose barb—enabling torsion-free tubing alignment during connection.
- Operational pressure rating: 10 psi (0.69 bar) during active liquid transfer; maximum holding pressure of 60 psi (4.1 bar) when fully engaged and static.
- Bidirectional fluid compatibility—supports flow in either direction without seal degradation or leakage risk.
- Modular tube interface accommodating multiple standard tubing outer diameters (e.g., 1/4″, 3/8″, 1/2″ ID), enabling interoperability across Mobius® and third-party single-use systems.
- Ergonomic actuation design reduces operator fatigue and minimizes misalignment risk—validated through human factors testing per IEC 62366-1.
Sample Compatibility & Compliance
The Lynx® CDR is constructed from USP Class VI-certified thermoplastics (including polypropylene and medical-grade polycarbonate) and platinum-cured silicone elastomers compliant with FDA 21 CFR 177.2600. All wetted materials are extractables- and leachables-tested per ICH Q5C and aligned with BioPhorum Operations Group (BPOG) guidelines. The device meets requirements for GMP-compliant manufacturing environments and supports audit readiness for FDA, EMA, and PMDA inspections. Sterilization is performed via gamma irradiation (25–40 kGy), with full validation documentation available—including bioburden limits, sterility test reports (ISO 11737-2), and endotoxin levels (<0.25 EU/device).
Software & Data Management
As a passive mechanical component, the Lynx® CDR does not incorporate embedded electronics or firmware. However, its integration into digitally enabled single-use systems is supported via traceability protocols: each unit carries a unique alphanumeric lot code and 2D Data Matrix barcode compatible with MES and LIMS platforms (e.g., Siemens Opcenter, Thermo Fisher SampleManager). Batch records, sterilization certificates, and QC release documentation are accessible through Millipore’s online portal and comply with 21 CFR Part 11 requirements for electronic record retention and signature attribution. Full material declarations and regulatory dossiers (including REACH and RoHS compliance statements) are provided upon order fulfillment.
Applications
- Buffer and media transfer between single-use bags and bioreactors or chromatography skids.
- Aseptic sampling line connections for real-time process monitoring (e.g., pH, conductivity, viability probes).
- Modular TFF system reconfiguration during multi-step purification campaigns.
- Closed-system connections for viral clearance filtration trains.
- Flexible scale-down models in process development labs requiring rapid setup changes.
- Integration into automated fill–finish lines where tubing re-routing must occur without breaking sterility.
FAQ
How many times can the Lynx® CDR be connected and disconnected while maintaining sterility?
It is validated for up to six complete connect/disconnect/reconnect cycles under nominal operating conditions and documented aseptic technique.
Is the Lynx® CDR compatible with aggressive solvents or high-concentration surfactants?
Material compatibility must be verified against specific process fluids using Millipore’s chemical resistance guide; standard configurations are intended for aqueous buffers, cell culture media, and low-concentration cleaning agents (e.g., NaOH ≤ 0.5 M).
Does the device require special tools for actuation?
No—connection and disconnection are performed manually using finger-torque only; no wrenches, clamps, or auxiliary equipment are needed.
Can Lynx® CDRs be autoclaved or EtO sterilized post-manufacture?
No—units are supplied pre-sterilized via gamma irradiation and are not designed for terminal sterilization by end users.
What documentation is supplied with each order?
Each shipment includes a Certificate of Conformance, Sterilization Certificate, Material Declaration, and full regulatory dossier access credentials.
