COBETTER 250mL Sampling Bag with 1/4''ID x 7/16''OD Tubing Sterile by Gamma Irradiation

In stock
Part No. KAS0251TLF
Regular price $30.00 USD
Tubing
Inlet
Outlet
*Ships within 3 Weeks
*Read our Shipping Policy and Refund Policy
Bag Brand Lifecube® AS Sampling Bag
Tubing

20cm 1/4''ID x 7/16''OD Lifemeta® STT Pt-cured Silicone,

40cm 1/4''ID x 7/16'' OD C-Flex® 374 TPE,

40cm 1/4''ID x 7/16'' OD Lifemeta® STF Thermoplastic Elastomer

Material KA membrane
Sterilization Option(S) Gamma Irradiation
Package 1/pk

 

Quality Assurance

· ISO® 9001:2015 quality management system

· ISO Class 7 clean zones

· Leak testing

· ADCF raw materials

· 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 Limulus Amebocyte Lysate (LAL), USP <85>

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

· Verify gamma irradiation dose according to ISO® 11137

Features

· Good physical strength and excellent biological safety

· Integrated bag body and less residual liquid

· Double-layer sterile packaging sterilized by 25-45 kGy gamma irradiation

· Various choices for sampling application

· Variable and flexible customized services

Applications

· Sampling with single-use bags

· Secondary sampling from sampling bag

· Store samples after sampling

Q: Sampling and product sterility assurance

If you require to ensure that the main pipeline and the front-end feed liquid are sterile, the sampling can be non-sterile.

The design can use a needle-free sampling connector at the end of the branch pipeline. When sampling, use the Luer male connector on the sampling bag, and take the sample after docking. If the sample to be taken out is also required to be sterile, then you can only use one of the three options: a metal disconnect ring, a sterile disconnect device, or thermoplastic tubing.

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: What's the ISO class level of Cobetter bag manufacturing cleanroom?

We have one ISO 5 production line for manufacturing stock solutions and filling-related products. We also have eleven ISO 7+ISO 8 production lines for manufacturing storage bags, mixing bags, and customized tubing assemblies, etc. The cleanliness of our production workshop is consistent with the requirements of the products.

Q: Do storage bags have been integrity tested?

Yes, except for the 50ml sampling bags, all our bags undergo integrity testing. We do not perform integrity testing on the 50ml sampling bags because the integrity test is conducted using a pressure hold test method, and even a small amount of gas escaping can cause a significant decrease in pressure, making it difficult to accurately measure. Unlike other brands that perform sampling inspections, Cobetter tests the integrity of every bag.

Q: What tests do you perform on the bags before they leave the factory?

Each product comes with a COQ, which includes the bag testing items and reference standards. We conduct tests for bag integrity, endotoxins, sterility, and insoluble particles, etc.

Q: Can you provide irradiation certificates for the bags?

Yes, we can provide irradiation certificate upon request. By default, it is not included with the shipment, but if needed, please contact us, and we will promptly provide it to you.

Q: Can the bags be made in the form of cylindrical containers?

We recommend using square-shaped bags (four-films welding) as they are easier to fold, package, and prevent damage during transportation due to excessive creasing. Additionally, the corners of square-shaped bags can create turbulence in the solution, facilitating better mixing. However, circular containers can also be used in conjunction with square-shaped bags without any limitations.