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Lifecube™ AF Single-Use Filling Bags

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*Not for medical use

Cobetter Lifecube AF™ single-use filling bag is designed for a wide range of filling processes in biopharmaceutical applications, such as antibodies, vaccines and gene therapies, etc. It is a pre-assembled, pre-tested, pre-validated, pre-sterilized transfer unit that can be configured with various tubing options and connectors. Looking for a complete solution? Explore our Single-Use Assemblies, with custom configurations available to match your process requirements.

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.

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • ISO 4.8 cleanroom production
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • COA/COQ provided with shipment
  • Validation documents are available upon request
  • TSE/BSE certificate 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.
Physical Properties Product Name Lifecube™ AF Filling Bag
Bag Volume 3 L or 5 L (fully customizable)
Standard Hanging Hole Size 200 mm (hole pitch can be customized)
Vent Filter Optional
Filling Needle Cobetter Lifemeta™ FCS (compatible with main-brand filling machines, and can be customized)
Materials Film Material Topene™ RB film
Pump Tubing Material Lifemeta™ ST5P (excellent wall thickness control)
Connections Inlet Connector Lifemeta™ AC Aseptic Connector
AseptiQuik® G
Outlet Connector Tubing Ports
Boat Ports
Dispenser
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Sterility Delivery Condition Sterile
Sterilization Method Gamma irradiation at 25–45 kGy
Package Pack Size Pack of 1
Packaging Individually packed in double PE bag

 

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.

 
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What is the ISO level of Cobetter filling bag manufacturing cleanroom?

The whole process including film cutting, welding, assembly is undergone in ISO class 4.8 workshop (equivalent to GMP Class A). And the accessories will be pre-washed, ensuring a high level of cleanliness.

What are the applications of Cobetter filling bags in bio-pharmaceutical processes?

Typical applications:
1. Biological products: monoclonal antibodies (mAb), recombinant proteins, mRNA vaccine filling
2. Freeze-dried preparations: Pre-filling before freeze-dried after
3. Blood products filling

What are the specifications and filling range of Cobetter filling needles?

Filling needles with inner diameters ranging from 0.6 mm to 5.5 mm can be selected according to actual requirements, and the corresponding filling volumes range from 0.1 mL to 500 mL. When used with Cobetter Lifemeta ST5P platinum-cured silicone pump tubing, it enables long-duration, high-precision filling.

What quality inspections are carried out on filling bags prior to shipment?

Each filling bag undergoes 100% air integrity testing to ensure it is free from leaks and damage. Quality control bags are tested daily for endotoxins and insoluble particulates, and monthly for bioburden and sterility. Quality Assurance Certificates (QAC) are provided.

How are Cobetter filling bags packaged？

Cobetter filling bags are sterilized by gamma irradiation after being packaged in three layer PE bags. When customers require VHP (Vaporized Hydrogen Peroxide) fumigation, we will offer customized solutions for innermost layer — using RB film with an integrated barrier layer to prevent hydrogen peroxide penetration and customizing hanging holes to ensure efficient deployment.