Lifecask™ RW Single-Use Bioreactor Bags
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Cobetter Lifecask™ RW Single-Use Bioreactor Bags are specially designed for a rocking mode bioreactor. It is sterilized by gamma irradiation and packaged in double PE bag to avoid cross-contamination. The bioreactor bags are manufactured with our self-produced Lifemeta™ KA film to ensure a good mechanical performance as well as biocompatibility.
Lifecask™ RW Single-Use Bioreactor bags can be widely applied to multiple upstream process of bio-pharmaceuticals such as antibody, vaccine and CGT. Apart from the basic bag configuration, we launched RW PRO features integrated pH and DO optical sensors, and RW Perfusion with an integrated retention membrane to satisfy multiple culture modes such as seed train expansion, fed-batch or perfusion processes. What’s more, fabric carriers or microcarriers can also be applied to the bags for adherent cell culture.
Quality Assurance
- ISO 9001:2015 quality management system
- ISO7 class 7 manufacturing site
- 100% bag integrity test
- ADCF raw material，meets the requirement of FDA 21CFR177-182 indirect food additives
- Meets the requirement of ISO 11137 sterilization validation
- Meets the requirement of USP <87> in Vitro Biological Reactivity Test
- Meets the requirement of USP <88> Biological Reactivity Test, in Vivo 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 requirement in USP <788> for large volume parenterals
- Product validation guide and COA available
Applications
- Suspension Cell Culture: CHO, HEK293, BHK21, Hybridoma, SF9
- Suspension cell perfusion culture (Cell Retention Membrane/ Hollow Fiber)
- Adherent cell culture: HEK 293, Vero, etc.
Cobetter Lifecask™ RW Single-use Bioreactor bags use our self-produced LifemetaTM KA film for the bag body. Lifemeta™ KA film is a five layer co-extruded film manufactured to meet the high mechanical strength required by a rocking mode bioreactor. Lifemeta™ KA film is manufactured by a blowing film technology and has a clean inner layer made by ULDPE. The outer layer is made by HDPE, which allows the film to have good environmental stress resistance, tensile strength and chemical tolerance.
Lifemeta™ KA film has been tested and validated to have the features of a low E&L profile and good biocompatibility. It has no potential risk of introduction of impurities and could be applied throughout the whole process of bio-pharmaceuticals. Till now, it has been used for media or buffer preparation and storage bags, cell culture bioreactor bags and filling bags.
Specifications of Lifemeta™ KA
| item | Results (After Gamma irradiation>25kGy) | Procedure |
| Haze | 21.20% | ASTM D1003 |
| Specular Gloss | 118 GU | ASTM D2457 |
| Color | SCI: L 94.06, a -0.27, b 2.89 SCE: L 90.50, a -0.43, b 2.33 |
ASTM D6290 |
| Transmittance | 90.20% | ASTM D1003 |
| Tensile Strength at Break | Transverse 219 Lengthways 267, bar | ASTM D882 |
| Elongation at Break | Transverse 380 Lengthways, 420% | ASTM D882 |
| Elastic Modulus | Transverse 2770 Lengthways 2890，bar | ASTM D882 |
| Brittleness Temperature by impact | Below -70°C | ASTM D1790 |
| Density | 0.941 g/cm³ | ASTM D792 |
| Dart Impact | 1398 g | ASTM D1709 Method B |
| Peak load | 178 N | ASTM D3763 |
| Deflection at peak load | 13.6 mm | ASTM D3763 |
| Tear Strength | Transverse 37.5 Lengthways 34.7, N | ASTM D1004 |
| Puncture Resistance | 52.2 N | ASTM F1306 |
| Water Vapor Transmission Rate | 0.593 g/(m²·day) (23°C，100% RH) |
ASTM F1249 |
| Oxygen Permeability | 1.024 cm³/(m²·day·bar) | ASTM D1434 |
| Carbon Dioxide Permeability | 1.455 cm³/(m²·day·bar) | ASTM D1434 |
| Particulate Matter | Particulate matter in the product eluent meets the requirements in USO<788> for larger volume parenterals. | |
| USP<87> Cytotoxicity | Meet the requirement of USP<87> in Vitro Biological Reactivity Test. | |
| USP<88>Biological Reactivity | Meet the criteria of USP<88>Biological Reactivity Test for Class VI plastics. | |
| Indirect Food Addictive | The fluid contact component materials meet the FDA Indirect Food Addictive requirements cited in 21 CFR 177-182. | |
| Animal Derivative Content | Products do not contain animal derived components and are free from TSE risk. | |
| Quality Assurance | These products are manufactured in a facility which adheres to ISO®9001:2015 Practices. | |
Over 90% Self-Produced Components & Corollary Equipment
Over 90% of components of LifecaskTM RW single-use bioreactor bag are self-produced by Cobetter including bag body, bag ports, tubings and tubing connectors. Cobetter can also provide relevant devices and equipment such as pH and DO optical cables, tubing welder or sealer, and bag integrity tester.
pH, DO Sensor Parameter
| Module | Range of Control | Range of Measurement |
| pH | 6.0-8.0 | 4.5-8.5 |
| DO | 0-100% | 0-250% |
Systematic Product Validation
Cobetter Application & Validation Laboratory (AVL) center has been accredited by China National Accreditation Service for Conformity Assessment (CNAS). Cobetter LifecaskTM RW single-use bioreactor bag has been fully validated and well tested. The associated documents such as validation guide, E&L report and application notes are available.
Flexible Customization & Reliable Supply Chain
Cobetter offers custom solutions including customized bag dimensions or customized tubings & assemblies configuration according to customers’ bioreactor and up-stream cell culture process.
Cobetter takes full risk assessment on raw material including inventory management and key suppliers management. So far, Cobetter has 11 production lines for bags, tubings and assemblies in ISO Class 7 cleanroom, ensuring a stable product supply and a competitive lead time of our products.
| Bag Size(L) | 2 | 10 | 20 | 50 |
| Film | Lifemeta® KA | |||
| Length x Width | 296x570mm | 330x570mm | 660x570mm | 754x723mm |
| Optical pH Sensor (optional) | 1 | 1 | 1 | 1 |
| Optical DO Sensor (optional) | 1 | 1 | 1 | 1 |
| Max. working volume (L) | 1 | 5 | 10 | 25 |
| Min. working volume (L) | 0.2 | 1 | 2 | 5 |
| Perfusion membrane (optional) | 160x160mm | 160x160mm | 350x350mm | 350x350mm |