Match Your Process Needs: Design and Selection of Cobetter Single-use Assemblies for Filtration

Single-use filtration assemblies serve as self-contained fluid transfer units and are now widely adopted across a range of biopharmaceutical filtration processes. 

Cobetter Lifecube™ single-use assemblies offer exceptional system flexibility, enabling rapid membrane material screening, dynamic binding capacity determination, and critical process parameter optimization at small-scale, while integrating seamlessly into diverse single-use processing platforms. 

 

These assemblies can be flexibly combined with a broad portfolio of complementary consumables—including single-use tubing, aseptic connectors, and storage bags—to fully address key applications such as media and buffer filtration, bioburden control, final sterilizing filtration for drug product, and pre-filling filtration. Furthermore, Lifecube™ supports deep customization, delivering end-to-end solutions from configuration through validation, tailored to customers' specific process needs. 

Quality Assurance 

• ISO 9001:2015 Quality Management System 
• Manufactured in ISO Class 5 or ISO Class 7/8 cleanroom area. 
• 100% integrity testing. 
• ADCF-grade raw materials, compliant with FDA 21 CFR 177–182 indirect food additive requirements. 
• Compliant with USP <87> in vitro biological safety test requirements for non-toxicity. 
• Compliant with USP <88> Class VI in vivo biological safety requirements for plastics. 
• Compliant with bacterial endotoxins limits (<0.25 EU/mL) for WFI. 
• Compliant with USP <788> large-volume infusion requirements for particulate matter. 
• Compliant with ISO 11137 gamma irradiation dose requirements 

Features 

• Available in adapter assemblies for commonly used connectors 
• Available in double sterile packaging, gamma-irradiated at 25–45 kGy 
• Available in non-sterile packaging compatible with autoclaving 
• Locally supplied with extensive and flexible customization services 

Applications 

• Bioreactor bag exhaust gas filtration 
• Media and buffer filtration 
• Bioburden reduction / sterile filtration of intermediates 
• Final sterilizing filtration 

Customized Assembly Design 

Cobetter single-use assemblies can be configured with a variety of tubing types and connector formats to suit multiple process applications. With deep customization capabilities for specific process requirements, they help reduce cleaning and validation overhead, and are broadly applicable to fluid handling across all stages of biopharmaceutical manufacturing.

Typical Applications 

Bioreactor Bag Exhaust Gas Filtration

Media and Buffer Filtration

Bioburden Reduction / Sterile Filtration of Intermediates 

Single-Stage Filtration

Two-Stage Filtration

Three-Stage Filtration

Cobetter provides customizable single-use filtration assembly solutions that cover the entire biopharmaceutical process workflow, from upstream and downstream process filtration, through media and buffer filtration, to final sterilizing filtration. Leveraging modular design and broad connector compatibility, we flexibly combine membrane materials, assembly configurations, and connection types to meet specific customer process requirements. The result is a tailored filtration solution that delivers enhanced performance, greater operational ease, and precise process alignment, effectively accelerating process development and supporting the robust scale-up to commercial manufacturing.