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COBETTER Pharmaceutical ECM Connectors Polysulfone PSU 10/pk

In stock
Part No. ECMSMH1N
$67.20 USD
$96.00 USD $67.20 USD
Size
*Ships within 3 Business Days
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Brand Name COBETTER
Material Polysulfone
Package 10/pk


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

· Polysulfone material, Can be sterilized by gamma irradiation at 25-45 kGy or autoclaved 60 minutes at 132 °C.

· At room temperature, Maximum operating pressure is 0.41 MPa.

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

    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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