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