COBETTER 250L Lifecube® 3D Single-Use Liquid Storage & Shipping Bags

In stock
Part No. K3D250T21K
Regular price $252.00 USD
Tubing
Inlet & Outlet
Sampling
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Brand Name COBETTER
Material Five-layer KA Film
Volume 250L
Tubing Lifemeta®STT Pt-cured Silicone, C-Flex® 374 TPE
Inlet/Outlet Connector ECM Connector, TC50 Connector,  AseptiQuik® G Sterile Connector, Tubing Plug
Number of Ports 2 top, 1 bottom, 1 sampling
Sterilization By Gamma Irradiation
Package 1/pk


Cobetter 3D single-use storage and shipping bags are designed for the processing of large volumes of biopharmaceutical solutions from 50L to 3000L. Cobetter 3D Storage and Shipping Bags are available in standard bags with silicone tubing or TPE (thermoplastic elastomer) tubing, with or without sampling ports.

Features

· Robust five-layer KA film for a reliable and durable producty

· The single-use storage and shipping bags are 100% leak tested

· The single-use bags are sterilized by gamma irradiation and ready to use

· The single-use bags are assembled in ISO Class 7 clean rooms

· The manufacturing sites certified to ISO 9001 Quality management system

· Standard or custom designs available

Typical Applications

· Storage and shipping of large volume buffer and media

· Buffer preparation and storage

· Temporary storage of Intermediate products

· Collection of purified fractions

· Bulk product storage prior to filling

· Final product storage and transport

Quality Assurance

· 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

Q: What are the applicable conditions for the use of storage bags?

1. Liquid collection, liquid storage, liquid transport, sampling of liquids during the production process, such as media storage, buffer storage, collection of filtered liquids, buffer filling, and so on.

2. The recommended temperature range is -80°C to 60°C, pH range is 2.5-11.

3. Maximum filling capacity is 110%.

Q: What are the applications of storage bags?

Storage bags are commonly used in various industries such as pharmaceuticals, blood products, and medical aesthetics. They are used in processes involving liquid collection, storage, transfer, and sampling. Some examples include storage of culture media, buffering solutions during purification processes, collection of filtered liquids, and filling of buffers.

Q: What is the sterilization method for single-use storage bags? How can you determine if sterilization has been achieved? What’s the shelf life of the sterilized bags?

1. Cobetter Single-use products, including storage bags, mixing bags, custom assembly tubing, and single-use capsule filters, are all sterilized by gamma irradiation, typically with an irradiation intensity of 25-45 kGy.

2. Sterilization is identified by the color change of the irradiation label on the outer packaging box. The label is orange before irradiation and turns deep red after irradiation.

3. The shelf life of sterile bags is 2 years.

Q: How are Cobetter's single-use bags packaged and transported? For 2D & 3D storage bags and mixing bags of different volumes, how many are packed in each box?

1. The bags will be evacuated and folded, then packaged in double-layer PE bags and placed in different-sized cardboard boxes for gamma irradiation.

2. For 2D, 3D storage bags, mixing bags, custom tubing, and other products, the packaging size varies depending on the complexity of the product design, and there is no fixed quantity per box. It can range from one to several dozen bags per box.

Q: How to choose the material of the tubing on the storage bag? What are the applicable conditions?

1. Materials: Silicone and thermoplastic elastomer (TPE).

2. Silicone tubing: Used for fluid transfer, peristaltic pump applications, and filling processes.
Disadvantage: Not resistant to strong alkalis.

3. Thermoplastic elastomer (TPE) tubing: Used in combination with tube sealing machines/connector machines for aseptic disconnecting/aseptic connecting operations. Disadvantage: Not resistant to high temperatures and can be easily worn out when used with peristaltic pumps.

Q: How to install the storage bag?

Please refer to Cobetter "Instructions for Use of Single-use Products".

Q: Response regarding freezing and storage of storage bags.

1. The filling volume should be at about 50%; not too much.

2. Use suitable containers for storage.

3. Avoid stacking the bags.

4. The temperature should not be lower than -80°C. If it is at room temperature, there is no need to consider the problem of loading.

Q: If you already have a container and need to customize 3D storage bags, how should the container be measured?

Measure the internal dimensions of the container: length, width, and height.

Measure the size of any openings on the bottom or sides of the container, and accurately determine the position of these openings.

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: Customers have reported that the bags are too tight and difficult to allow liquid to enter or exit. What can be done?

This issue is commonly observed in 100mL and smaller 2D bags and is a common occurrence across manufacturers. It is not a quality issue but rather a result of minimal gas inside the bag.

We recommend manually squeezing the bag or adjusting the liquid level difference. If the issue persists, we suggest adding a vent filter.

Q: Can various special-shaped or designed storage bags be made?

The feasibility of processing, usage risks, and other factors need to be comprehensively evaluated. Please contact us for further evaluation.

Q: What is the lowest temperature tolerance for cryopreservation bags made from EVA film?

Cryopreservation bags made from EVA film can withstand low temperatures of liquid nitrogen, with a tolerance of up to -196 ℃. This product is currently under development.

Q: How should storage bags be transported?

Generally, bags with a capacity of 20L or less can be hung or carried by hand for transportation. However, for bags larger than 20L, it is recommended to place them on pallets or flatbed carts for transferring.

Q: Can 50L and 100L 3D storage bags be carried by hand without using a container for transportation?

No, 3D storage bags must be placed in storage containers for transportation, and the bags should be matched with the containers to reduce the risk of damage.

Q: Does the outer layer of KA film, with stronger hardness, become more brittle under low-temperature conditions?

Both our KA film and 9101 film have undergone freeze-thaw testing and accelerated aging testing. Our validation guidelines provide actual test results, and there is no difference in freeze-thaw performance between the two films under low-temperature conditions.

Q: What is the role of the adhesive layer in the film material?

Our inner fluid contact layer is ULDPE belongs to non-polar materials, gas barrier layer is EVOH belongs to polar materials, according to the principle of similarity and solubility, these two materials can not direct contact bonding. The bonding layer is used as a transition layer, the material is PE combined some ethylene groups.

Q: How is the chemical compatibility of the bags with certain solvents?

Please refer to the chemical compatibility section in the validation guidelines, where you can also find additional chemical compatibility tables for different applications.