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Bio-Pak® Small Volume Bio-Containers

Bio-Pak Small Volume bio-containers are designed for bioprocessing applications, storage, and transport of sterile fluids. Bio-Pak Small Volume bio-containers are available in sizes ranging from 50mL to 20L. Custom boat port designs facilitate excellent recovery of vital fluids.

  • Excellent gas barrier properties
  • Superior film clarity
  • DEHP-free

Typical Applications

  • Scale-up preparation
  • Fill and finish applications
  • Containment of sterile solutions used in laboratory or manufacturing settings
  • Configurations available to fit your custom specifications

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.

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 Clear-Pak® Small Volume bio-containers are manufactured and assembled in a Charter Medical facility compliant with 21 CFR 820, Quality System Regulation for Medical Devices. These 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

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