Single-Use Accessories

Single-Use Accessories

Overview

ECM & ECS Connectors

· Easy to operate for connect-disconnect

· Fit 1/8'', 1/4'', 3/8'' and 1/2'' tubing

· Main material: Polysulfone

· Can be sterilized by gamma irradiation at 25-45 kGy or autoclavable

· Validation and extractables data available

 

PP Luer Fittings

· A common choice in laboratory of pharmaceutical industries

· Disposable applications

· Connections between a male luer fitting and its mating female part

· Luersdimensions have been tested according to ISO standards

· Fit 1/8''and 1/4'' tubing

· Main material: Polypropylene

 

Y & Cross & Straght Fittings

· Available inEqual & Reducer straight fittings, Tee fittings, Y and Cross Fittings

· Straight fittings barb sizes range from 1/8″ to1/2″

· Tee fittings with barb sizes 1/4″ and3/8″, are widely used for laboratory

· Y fittings are available in a variety of standard sizes from 1/16″ to 1/2″

· Cross fittings are available in sizes from 1/8″ to 1/2″

· Used for wide applications including the food&beverage, medical and industrial areas

· Main material: Polypropylene

 

Sanitary Fittings, Gaskets & Clamps

· Use in single-use container fluid transport systems, manifolds 

· Available in two flange sizes, 3/4" (Mini) and 1-1/2" (Maxi)

· Sanitary fittings can be sterilized by autoclaving or gamma irradiation

· Silicone gaskets fit the 3/4" mini flange, 1-1/2" maxi flange, 2" flange, 4" flange, and 8" flange

· Clamps work with sanitary fitting, caps and gaskets, providing for quick and convenient assembly

 

Bag Ports

· Available in a wide range of sizes, 2 ports, 3 ports and 4/6/8/10/12 ports

· Port disc are available in a variety of barb sizes ranging from 1/8″ to1″

· Made for ultrasonic or thermal welding to materials used in the pharmaceutical industries

· Main material: Polyolefins, with low density can reduce the weight of end products

· Durable and flexible

 

Quality Assurance

· Manufactured in ISO Class 7 clean room

· ISO 9001:2015 Quality Management System

· Meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182

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

· Meet the criteria of the USP <88> Biological Reactivity Test for Class VI plastics

· Aqueous extraction contains < 0.25 EU/mL as determined by LAL, USP <85>

· Particulate matter in the product eluent meets the requirements in USP <788> for large volume parenteral

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FAQ

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.