Bio-Pak® 3D Gusset Bio-Container Systems

Bio-Pak® 3D Gusset single-use disposable bags are ideal for large scale bioprocessing manufacturers and are available in 50L to 3500L sizes.  Bio-Pak® 3D Gussett bags are constructed with Clear-Pak® film which has excellent gas barrier properties.  Clear-Pak® film has a Polyethylene Outer Layer, EVOH Gas Barrier Layer and Ultra Low Density Polyethylene Contact Layer and is animal derivative component free.

  • Scalable configurations from 50L to 3500L
  • Superior bag Integrity for high value drug substances
  • Complete Validation Package

Typical Applications

  • Bulk API Material
  • Media & Buffer Preparation
  • Containment of sterile solutions used in laboratory or manufacturing settings
  • Custom designs available in 2D configurations
Download the BioPak® 3D Gusset Data Sheet

Ordering Information – Bio-Pak® 3D Gusset Bio-Container Systems

Product Number Bag Volume (L) Description
CPGFMPT 50 Port 1: 36″ L, 1/2″ ID Silicone to Colder MPX Coupler and Cap
Port 2: 36″ L, 1/2″ ID Silicone to Colder MPX Coupler and Cap
CPG1MPT 100 Port 1: 36″ L, 1/2″ ID Silicone to Colder MPX Coupler and Cap
Port 2: 36″ L, 1/2″ ID Silicone to Colder MPX Coupler and Cap
CPG2MPT 200 Port 1: 36″ L, 1/2″ ID Silicone to Colder MPX Coupler and Cap
Port 2: 36″ L, 1/2″ ID Silicone to Colder MPX Coupler and Cap

Validation

  • The Clear-Pak® bio-container film and the container itself undergo extensive testing before release
  • Each bio-container is shipped with a Certificate of Conformance that guarantees adherence to specifications and provides lot traceability.
  • A validation guide is available to assist with regulatory requirements.
  • Shelf life for  Bio-Pak® 3D Gusset bio-containers has been validated for a two-year shelf life from the date of manufacture.

Materials

Container:  Clear-Pak®: Film Polyethylene (PE) Outer Layer, EVOH Gas Barrier Layer, Ultra Low Density Polyethylene (ULDPE) Contact Layer, Tubing: Silicone, C-FLEX®, Ports: Polyethylene hose barb adapters, Cap: Polycarbonate.

Production Control & Qualification Tests: 

All Bio-Pak® 3D Gusset bio-containers are manufactured and assembled in a Charter Medical, Ltd facility compliant with 21 CFR 820, Quality System Regulation for Medical Devices.  The following studies were conducted during the qualification of our bio-containers manufactured from Clear-Pak® Film.

Biocompatibility Tests:

  • USP Class VI <88>– Biological Reactivity Tests, in Vivo
  • USP <661>–Physicochemical Tests of Plastic Containers
  • USP <87>–Biological Reactivity Testing, in Vitro
  • Oxidizable Substances—USP XXIII Supplement VIII
  • USP <85>–Bacterial Endotoxin Testing
  • EP <3.1.5> European Pharmacopoeia Conformity Analysis
  • Protein Adsorption.

Mechanical & Optical Tests:

  • ASTM D882—Tensile Properties
  • ASTM D1004 – Tear Resistance
  • ASTM D1003—Transmittance
  • ASTM F88 – Seal Strength

Gas Transmission Tests:

  • ASTM D3985- Gas Transmission Rate
  • ASTM F2476 – Carbon Dioxide Gas Transmission Rate (CO2TR)
  • ASTM F1249 – Water Vapor Transmission Rate

Transportation Tests:

  • ASTM D4169 – 05 – Performance Testing of Shipping Containers and Systems.