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Lifecube MS Single-use Mixing Bag Sterile by Gamma Irradiation

In stock
Part No. BMS50LT41Y1K
$594.00 USD
Volume
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*Ships within 3 Weeks
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*Not for medical use

Cobetter Lifecube Single-use Mixing Bags offer no-clean, many specifications, pre-sterilization, easy to install and flexibility of use, etc. The Lifecube Single-use Mixing bags are made of multi-layer co-extrusion film, feature good physical and chemical properties and extremely low gas permeability. Lifecube Single-use Mixing bags are suitable for a wide range of mixing steps in upstream and downstream processes.

Specifications

Materials Mixing Type
 Cobetter Lifecube MS Single-use Mixing Bags
Material Cobetter Topene RB Film

Impeller

(MS)

 Materials of Construction

Main part/ Welding pad: HDPE
Volume 50L - 3000L
Total Fluid Contact Area 1316 cm²
Main Height* 4 cm
Speed** ≤ 750 rpm
Sampling and Port Sampling 20cm 1/4''ID Lifemeta™ STT Pt-cured Silicone+Needle-free site
Powder Port 4'' TC
Package Pack Size 1/pack

Note:

*Height from the welding plate to the top of the impeller; 

**For reference only. The mixing speed is different from bag specifications, stirring volumes, solutions and brand of mixers. Please confirm the mixing speed and efficiency according to the actual situation.

Features

  • Magnetic suction/magnetic suspension mixing, integrated/split system, compatible with other brands
  • Fast installation, well mixing run and easy setup
  • Double-layer packaging, sterilized by 25~45 kGy gamma irradiation
  • Many specifications, meeting a variety of preparation applications
  • Customized bag sizes, flexibly match different specification of containers
  • Customized Tubings, connectors and filters
  • Sensors can be customized to allow on-line monitoring during the process
  • Hardware with audit trail and automatic management functions available

Applications

  • Buffer and culture medium preparation
  • Semi-finished products preparation
  • Batch mixing

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 addictives)
  • Meet the requirement of current USP <87> Class VI, Biological Reactivity Test, In Vitro
  • Meet the criteria of the current USP <88> Class VI, Biological Reactivity Test In Vitro
  • 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

Configuration Options

*Contact us for other configuration options.

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.
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