Home » Fluid Management » Filling Assemblies » Lifecube™ AF Single-Use Filling Bags

Lifecube™ AF Single-Use Filling Bags

In stock
Volume
Filling Needles
Loading locations...
*Not for medical use

Cobetter Lifecube AF™ single-use filling bag is used to perform the various kinds of filling processes in the biopharmaceuticals such as antibody, vaccine and gene therapy, etc. It is a pre-assembled, pre-tested, pre-validated, pre-sterilized transfer unit that can be configured with a variety of tubings and connectors.

Configuration

Features

  • Made of Cobetter Topene™ RB blown film, reducing the contamination of particles.
  • Sterilized by 25-45 kGy gamma irradiation.
  • Designed with boat ports for ultra-low residual liquid.
  • Validation services are available for extractables & leachables, chemical compatibility.
  • Stable and reliable supply chain with over 90% conponents are self-produced.

 

Filling Accuracy and Needle Specification

Filling Volume Needle Inner Diameter Accuracy
>0.1 mL 0.6 mm ≤ 2%
>0.5 mL 1.2 mm ≤ 1% *
>1.5 mL 1.6 mm ≤ 1%
>3 mL 2.1 mm ≤ 1%
>5 mL 3.0 mm ≤ 1%
>10 mL 3.8 mm ≤ 1%
>30 mL 4.6 mm ≤ 1%
>50 mL 5.5 mm ≤ 1%

* Data source: laboratory filling system, tested using WFI

Check Cobetter Filling Needles here.


Quality Assurance

  • ISO 9001: 2015 quality management system
  • Filling bags are manufactured exclusively in a dedicated ISO 4.8 cleanroom. Fittings entering through transfer window. Personnel entering through air shower room.
  • 100% bag integrity test
  • ADCF raw material，meets the requirement of FDA 21 CFR 177-182 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 Product validation guide and CoA available

 

Lifecube™ AF single-use filling bags are suitable for multiple kinds of filling machines such as Syntegon, Groninger, Ima - Pharmasiena, Optima – Kugler, and other domestic ones.
  • Lifecube_AF_Single-Use_Filling_Bags_20250829 Download