Material Qualification Dossier
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|Lynx® S2S Connector Application Note (EMD)|
|Lynx® S2S Connector Capability and Integrity after Three Autoclave Sterilization Cycles|
|Lynx® S2S and Lynx® ST Connector Tubing Assembly Autoclave Sterilization|
|Lynx® S2S Connector|
|Lynx®S2S Connector User Guide|
Lynx® ST ConnectorsEnables integration of steamable hard piped process equipment with disposable sterile fluid paths
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Lynx® CDR ConnectorsMultiple, sterile connections, disconnections and reconnections of single-use assemblies
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|Biopharmaceutical Manufacturing > Downstream Processing > Single-use Manufacturing > Connectors, Crimping and Tubing|
The uniquely designed Lynx S2S connector is a single-use, single actuation, gamma- and autoclave-compatible disposable device for connecting sterilized fluid paths in biopharmaceutical processes.
The Lynx S2S connector is constructed of a female coupling and a male coupling. Once these two components are assembled together, the sterile fluid path is enabled. Once assembled, the two components cannot be disassembled, reducing the risk of sterility breach.
Safe, Disposable Connectors
The Lynx S2S connector is disposable and intended for single-use, one-time actuation. There are no parts to clean-in-place, and the risk of contamination is reduced.
Sterility Assurance During Actuation
The Lynx S2S connector is 100% air-integrity tested in manufacturing. Connector sets were tested utilizing an aerosolized bacterial challenge method with 106 B. diminuta and direct bacterial soiling method with B. diminuta, assuring a sterile connection can be made in non-classified areas.
Quick and Easy Connectivity
A series of simple steps connects the two independently sealed fluid paths by joining the female coupling and the male coupling. Then by way of a slide, the sealing caps are moved out of the way. At this point, the female coupling and male coupling are connected and the two fluid paths are aligned, creating one continuous path that has not been exposed to outside contamination. This path is sterile when the female coupling and male coupling are assembled as part of a sealed assembly that has been properly sterilized by either gamma irradiation or autoclave.
No Special Capital Equipment Required
Once gamma-irradiated or autoclaved, the Lynx S2S can be connected in either a classified or non-classified environment. The unique design of the Lynx S2S connector does not require a specialized clean room or equipment to ensure a sterile connection.
Ideally suited to a broad range of applications including sterile liquid transfer and microbiological sampling, the Lynx S2S connector provides the optimum solution for making secure, safe connections between two sterilized single-use disposable assemblies.
Sterile Liquid Transfer
The Lynx S2S connector can be integrated with assemblies that include single-use capsules, tubing, and flexible containers. Pre-sterilized by gamma irradiation or autoclave and ready to use, these assemblies are ideal for a wide range of liquid transfer applications and can be easily integrated into both the bulk production and final fill processes, ensuring the secure transfer of your valuable product. Best of all, the entire assembly is disposable.
Replace your current rubber septum or valve and bottle sampling techniques with a pre-sterilized disposable sampling system. A number of flexible sampling containers can be linked to each other via a Lynx S2S connector, and the entire assembly can be sterilized by gamma irradiation. This sterile connection to the sample point minimizes the risk of false positives. For instance, bioreactor sampling at multiple sites requires a large investment in capital equipment, is labor intensive and open to the risk of contamination. By utilizing the Lynx S2S connector for bioreactor sampling at multiple sites, the process is now secured, aseptic connections are eliminated and capital equipment costs and overhead labor are significantly reduced.
The Emprove® Program
The Emprove® Program complements the product portfolio through
- Comprehensive documentation to support qualification, risk assessment and process optimization needs.
- Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
- Convenient 24/7 access to up-to-date product information.
|Length||Typical Flow Rate|
|0.64 cm (0.25 in.)||9.5 L/min @ 1.38 bar (20 psid) @ 25 °C (bi-directional)|
|0.95 cm (0.375 in.)||27.3 L/min @ 1.38 bar (20 psid) @ 25 °C (bi-directional)|
|1.27 cm (0.5 in.)||71.9 L/min @ 1.38 bar (20 psid) @ 25 °C (bi-directional)|
|Maximum Differential Pressure, bar (psig)
|4.1 bar (60 psid) @ 25 °C (bi-directional)|
|Materials of Construction|
|Connector||Polysulfone, USP Class VI, 21 CFR|
|Gasket||Silicone, USP Class VI, 21 CFR|
|Operating Temperature Range||4 to 40 °C|
|Fittings - Inlet/Outlet Couplings|
|1/4 in Hose Barb to fit 0.19 in (4.8 mm) ID|
|3/8 in Hose Barb to fit 0.25 in (7.1 mm) ID|
|1/2 in Hose Barb to fit 0.43 in (10.9 mm) ID|
|Sterilization||Gamma compatible up to 45 kGy; Autoclave once for 30 minutes @ 130 °C. Do not steam in place.|
|Male Coupling, mm||Female Coupling, mm|
|Classification of Plastics||Meets USP Class VI Biological Test for Plastics In-vivo <88> (wetted surfaces only)|
|Endotoxin||(LAL) pre- and post-gamma irradiation: ≤ 0.25 EU/mL|
|Particle Releasing||This product has been tested per USP <788> to ensure particulates >10 μm are <20/mL and particulates >25 μm are <2/mL.|
|Non-Fiber Releasing||Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).|
|Indirect Food Additive||All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.|