In recent years, the application of disposable bioreactors has increased gradually. Due to their relatively simple structure and operation, they reduce the workload of reactor cleaning and disinfection, which decreases the risk of cross-infection and production costs. Serving as a sterile environment to reduce the risk of contamination, the matching disposable bioreactor bags should be capable of ensuring stability between batches and the integrity of the body.
CytoLinX® BR disposable bioreactor bags are made with Renolit 9101 film, with a total thickness of 325μm and a liquid contact layer of ultra-low-density polyethylene (ULDPE), which provides good biocompatibility and chemical compatibility. This film material has high transparency, making it easy to observe the cultivation inside the bag.
Vent pore sizes of 20μm, 0.3mm, 0.5mm, 1mm are available. The average pore size is uniformed. Sizes for micro-bubbles, mid-sized bubbles, and large bubbles can be combined freely, which is suitable for different processings.
The large-volume agitators adopt engineering-grade Peek material and have high intensity.
Imported filters are equipped to ensure the integrity of the bags.
All pipelines can be flexibly customized.
Comprehensive supervision and control of manufacturing processings and quality to ensure stable supply.
Complete validation reports are provided.
Raw material control and management
Direct fluid contact: Materials in direct contact or potential contact with the inner surface of disposable products, such as co-extrusion film; circular/boat-shaped interfaces; hoses; impellers; connectors, etc.
Indirect fluid contact: Materials that do not come into contact with the inner surface of disposable products, such as tube clamps/covers, ties, bag components, packaging bags, etc.
Production control and management
First sample inspection of film material to confirm accurate cutting sizes.
Light inspection of welded edges after welding, light inspection of bag film and pipelines before sealing, and re-light inspection after integrity testing.
100% integrity testing.
Sampling inspection of inner packaging before QA release.
Conduct daily production of 2L quality control bags to test for insoluble particles and endotoxins.
Conduct quarterly inspection for sterilant dosage, selecting representative products for testing biological loads.
Test Results of Comparison of CHO-ZN cell culture
The electrode sleeve series components for the BR bioreactor bags
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