Cobetter, BAS0101FLV-3, 100mL Lifecube™ AS Single-Use Sampling Bag Sterile by Gamma Irradiation, 3/10/pk

Check this product with a package size of 40cm 1/8" ID x 1/4" OD STF TPE / Male Luer Lock with Plug + Sampling Plug / 3/pk on Iright. Specifications

Brand
COBETTER
Material
Cobetter Topene RB film
Volume
100 mL
Tubing
20cm 1/8" ID x 1/4" OD Lifemeta™ STT Platinum-Cured Silicone tubing,
40cm 1/8" ID x 1/4" OD Lifemeta™ STF TPE tubing,
40cm 1/8" ID x 1/4" OD C-Flex® 374 TPE tubing
Inlet Connector
Male Luer Lock with Plug
Outlet Connector
Needlefree Swabable Valve / Sampling Plug
Number of Ports
2 ports
Sterilization
Sterile by Gamma Irradiation
Package
3/pk or 10/pk
 
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 bags
Store samples
Regulatory Compliance
ISO 9001:2015 quality management system
ISO Class 4.8/ ISO 7/ ISO 8 cleanroom production
100% leak testing
ADCF raw materials, complies with FDA 21 CFR Part 177-182 (Indirect food additives)
Meet the requirement of USP <87> Class VI, Biological Reactivity Test, In Vitro (2020)
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
The use of Gamma sterilization dose (kGy) complies with ISO 11137
Configuration Options
*Contact us for other configuration options. 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.