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LeKrius Single-use Bioreactor Bag

Short Description:

With the development of the bio-pharmaceutical industry, more and more customers choose single-use bioreactors for shortening the product preparation cycle, avoiding cross-contamination, cleaning validation, etc. The stability and consistency of single-use bioreactor bags are essential to ensure the safety of the culture process. Additionally, new challenges arise with the increasing use of single-use bioreactor bags in scale-up and commercial production of biopharmaceuticals. LePure Biotech aims to improve stability and consistency of product quality as well as supply assurance with a new polyethylene film-based bioreactor bag. The new bioreactor bag is produced in a local Grade C + A manufacturing plant, aiming to provide high-quality, single-use bioreactor bags that can be customized according to the actual needs of customers.


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Product Description

● Application
   ✓ For culture of mammalian and insect cells (antibody, vaccine, cell therapy/gene therapy, etc.)

● Advantages
   ✓ Independent formula, independent production, and controllable quality, ensuring sustainable supply chain of high-quality raw materials of film.
   ✓ Long-term contract and inventory of raw materials and related components, ensuring optimal supply and reliable delivery.
   ✓ The film recipe is optimized by the design of experiment. This ensures stable cell growth process control after short- and long-term storage of medium. Extractables data package is available.
   ✓ Biosafety of materials for single-use systems for pharmaceutical use, referenced and biologically evaluated by USP<87>, USP<88> and ISO10993, etc.
   ✓ The mechanical properties of the film are tested with reference to ASTM, ISO and other test standards, ensuring the operation safety and ease of use.

● Design Drawings
The main connection components of LeKrius single-use bioreactor bag can be customized according to the actual needs of the customer.

LeKrius Single-use Bioreaction Bag
Connection Components Luer taper, CPC sterile quick connector/Kleenpak
Capsule Air Filter Saint-Goban / Sartorius or other air filters
Ports Sampling port * 1; Feed port * 6; Harvest port * 1; Custom ATF connection port
Compatible pH/DO Electrodes Standard: Hamilton Non-disposable Conventional Analog pH Electrode
  Hamilton Non-disposable Optical DO Electrode
  Optional: Hamilton Disposable Conventional Analog pH Electrode / METTLER Non-disposable Conventional Analog pH Electrode
  Hamilton Disposable Optical DO Electrode / METTLER Non-disposable Optical DO Electrode
Bottom Ventilation 316L stainless steel
Impeller Material Polypropylene
Tubing Material TPE and platinum vulcanized silicone tubing
Film Information
Structure LDPE / EVOH / ULDPE (Liquid contact layer)
Thickness 0.400 mm

 

Product Data
Specification 50 L 200 L 500 L 1000 L 2000 L
Minimum Working Volume (L) 22 40 100 200 400
Maximum Working Volume (L) 50 200 500 1000 2000
Temperature during Use Temperature + 8°C to 40°C
Maximum Operation Pressure (max) 50 mbar
Maximum Stirring Speed (max) 240 rpm 200 rpm 160 rpm 140 rpm 95 rpm

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      Date-EN-LeKrius® Single-use Bioreactor Bag-20220804
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