COBETTER Lifecube® ML Single-use Mixing Bag Sterile by Gamma Irradiation

In stock
Part No. KML50LT41Y1K
Regular price $439.00 USD
Volume
Inlet
Outlet
*Ships within 3 Weeks
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Brand Name COBETTER
Material KA
Volume 50L/100L/200L/500L/1000L
Sampling 20cm 1/4''ID Lifemeta® STT Pt-cured Silicone+Needle-free site
Powder Port 4''TC
Package 1/pk

Quality Assurance

· ISO® 9001:2015 quality management system

· ISO Class 7 clean zones

· 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

· Magnetic coupling drive, split system

· The bag body is easy to install, mix evenly, and easy to control

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

· There are many specifications to meet most of the applications of liquid preparation technology

· The size of the bag body can be customized to match various specifications of containers

· Tubing, connector and filter can all be customized on the mixing bag

· Various sensors can be customized to meet in-line monitoring in the process

Applications

· Buffer and Media Preparation

· Intermediates Preparation

· Batch Mixing

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

1. Liquid-liquid mixing, solid-liquid mixing, such as media preparation, buffer preparation, intermediate product preparation, mixing of liquid collections from different batches, and so on.

2. The recommended temperature range is usually 0-40°C, pH range is 2.5-11.

3. Common specifications for mixing bags are 50L, 100L, 200L, 500L, 1000L, 1500L, 2000L, with a minimum nominal stirring volume of 20%.

Q: What is the minimum volume specification for the mixing bag?

Currently, we can provide mixing bags in a 20L specification, and the minimum mixing volume can be achieved at 4L. We also offer matching hardware systems (MG series).

All MP bags have the same specifications for the impeller.

The MG impellers come in three sizes: 100/50/20.

The MK impellers are available in different sizes for volumes below 100, 100-200, and 500-1000.

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 is the minimum mixing volume for mixing bags?

Generally, the minimum mixing volume for mixing bags is 20% of the nominal volume of the bag, assuming complete mixing. However, if the aim is to achieve mixing effects, then a liquid level that reaches the height of the paddle blades is generally sufficient.

Q: What is the maximum mixing volume for mixing bags?

Typically, the maximum filling volume for mixing bags is 110% of the nominal volume. However, due to gas entering during the liquid filling process, the actual volume may be slightly smaller. If the liquid level is close to the maximum filling volume, it is recommended to add a vent filter.

Q: What is the installation process for single-use storage bags and mixing bags?

When customers receive the bags, they need to remove the two layers of outer packaging. The films are attached together.

First, position the bag right and stretch the drainage tube out of the drainage hole of the container. If there is a mixing paddle, align it with the magnetic head position, adjust the bag.

Then fill the liquid while adjusting the position and angle of the bag to fit the container. If it is a square container, the weld position of the bag is different, so it is necessary to confirm the top and bottom first, and then operate. If it is a round container, it is necessary to adjust the bag to ensure that it is vertically placed and the bag body is in contact with the wall of the drum.

All adjustments must be made as quickly as possible during the liquid filling process. After the liquid filling is completed, the bag is too heavy to adjust (do not pull the film, tube, etc.). If the final fit is poor, If the final fit is poor, it increases the risk of damage. (Paper instructions are included with the shipment.)

Q: What is the difference between magnetic stirring and magnetic levitation stirring?

Magnetic stirring: MP/MG series, with sufficient power and strong shear force, good mixing effect, and a rotation speed of usually ≤250rpm; Magnetic levitation stirring: ML/MK/MKP/MS series, with gentle stirring, low shear force, a rotation speed of 250rpm-1000rpm, zero friction, but high cost. There is no absolute good or bad, and the choice should be made based on the application.

Q: Can single-use products be irradiated again after expiration?

No, the validation test of single-use products is based on one-time irradiation, and the strength of the material and risks such as E&L have not been systematically validated for multiple irradiations.