COBETTER Pharmaceutical Silicone Gasket Single-use Accessory 10/pk

In stock
Part No. TCGST1N
Regular price $12.00 USD
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Brand Accessory Brand Lifemeta™ Tri-Clamp Sets
Physical Properties Material Silicone
Biological Safety Bacterial Endotoxin <0.25 EU/ml
Bio-compatibility

Meet the requirement of USP<87> In Vitro Biological Test;

Meet the requirement of the USP<88> Biological Reactivity Test for Class VI plastics.

Sterilization Option Gamma-irradiation 25-45 kGy
Autoclave(126°C) 1 cycle, 30 mins
Package Delivery Condition Non-sterile
Pack Size 10/pk


Cobetter Lifemeta™ tri-clamp sets include TC clamps, silicone gaskets, and blind caps, catering to the frequent disconnection or connection needs in the biopharmaceutical process. It is mainly used for bag powder port sealing, flange connections, as well as tubing and filter product connections. This series of clamps is made of reinforced nylon material, which exhibits minimal distortion compared to other high polymer materials, making it lightweight, flexible, and easy to operate.

Features

• Silicone Gasket

• Can maintain long-term sealing

• Prevent leakage caused by twisting of the inner gasket

• Good wear resistance

• Good elasticity and small deformation

• Double-layer PE bag packaging

Applications

• Realize powder port sealing

• Sealing with TC clamp

• Single-use assemblies application

Quality Assurance

• ISO 9001:2015 quality management system

• ADCF raw materials, ISO 7 cleanroom production

• Raw material meet the requirement of USP <87> Class VI, Biological Reactivity Test, In Vitro (2020)

• Raw material meet the criteria of USP <88> Class VI, Biological Reactivity Test, In Vivo (2020)

• Endotoxin limit of WFI System <0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>

• Particulate matter in injections meet the requirements in USP <788> for large volume parenterals

Q: The material of the film-coated tee pressure gauge?

The film-coated tee pressure gauge does not require a gasket and is made of HDPE+KA film. It cannot withstand steam sterilization.

Q: Will a single-use system that has been irradiated have any impact on the product? Can irradiation residues be detected in the irradiated items?

No. The irradiation dose is validated to ensure sterilization effectiveness. Moreover, the irradiation process only involves energy absorption and does not involve direct contact with the radiation source. Therefore, there are no issues of irradiation residues in the disposable system.

Q: The clamp does not tighten or fit. What should I do?

This may be due to the thickness of the TC connector. It is recommended to use Cobetter's clamp with Cobetter's TC flange.

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