Bio-Pak® Small Volume Bio-Container Systems

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

Typical Applications

  • Scale up Preparation
  • Fill & Finish Applications
  • Containment of sterile solutions used in laboratory or manufacturing settings
  • Configurations available to fit your custom specifications
Download the Bio-Pak® Small Volume Data Sheet

Ordering Information – Bio-Pak® Small Volume Bio-Containers

Product Number Bag Volume Description Case Qty
SV50ML444 50mL 50mL, 1/4″ ports (3); 20″ x 1/4″ C-Flex® Tubing with clave connector and 20″ x 1/8″ C-Flex® tubing with clave connectors (2) 30
SV50ML44 50 mL 50mL, 1/4″ ports (2); 4″ Pt-silicone tubing with male and female luer connectors (2) 30
SV500ML444 500mL 500mL, 1/4″ ports (3); 20″ x 1/4″ C-Flex® tubing with clave connector and 20″ x 1/8″ C-Flex® tubing with clave connectors (2) 20
SV500ML44 500mL 500mL, 1/4″ ports (2); 4″ Pt-silicone tubing with male and female luer connectors (2) 20
SV500ML44C 500mL 500mL, 1/4″ ports (2); 4″ C-Flex® tubing with male and female luer connectors (2) 20
SV1L444 1L 1L, 1/4″ ports (3); 20″ x 1/8″ C-Flex® tubing with clave connector and 20″ x 1/4″ C-Flex® tubing with MPC connector 20
SV1L44 1L 1L, 1/4″ ports (2); 4″ Pt-silicone tubing with male and female luer connectors (2) 20
SV2L444 2L 2L, 1/4″ ports (3); 4″ Pt-silicone tubing with male and female luer connectors (2) and 2″ Pt-silicone tubing with clave connector 20
SV2L44 2L 2L, 1/4″ ports (2); 4″ Pt-silicone tubing with male and female luer connectors (2) 20
SV5L8844P 5L 5L, 4 bottom ports: 1/2″ ports (2), 5″ Pt-silicone tubing with male MPX connectors; 1/4″ ports (2), 5″ Pt-silicone tubing with female luer, 2″ Pt-silicone tubing with clave connector; 1 top port: 1/2″ port, 5″ Pt-silicone tubing with female MPX connector 15
SV5L8844N 5L 5L, 4 bottom ports: 1/2″ ports (2), 5″ Pt-silicone tubing with male MPX connectors; 1/4″ ports (2), 5″ Pt-silicone tubing with female luer, 2″ Pt-silicone tubing with clave connector 15
SV5L6644P 5L 5L, 4 bottom ports: 3/8″ ports (2), silicone tubing with male MPC connectors; 1/4″ ports (2), 2″ silicone with clave connector, 5″ x 1/4″ silicone tubing with female luer; 1 top port: 1/2″ port, 5″ Pt-silicone tubing with female MPX connector 15
SV5L6644N 5L 5L, 4 bottom ports: 3/8″ ports (2), 20″ C-Flex® tubing with male MPC connectors; 1/4″ ports (2), 2″ Pt-silicone tubing with plug, 20″ x 1/8″ C-Flex® tubing with clave connector 15
SV5L844P 5L 5L, 3 bottom ports: 1/2″ port, 5″ Pt-silicone tubing with male MPX connector; 1/4″ ports (2), 5″ Pt-silicone tubing with male MPC connector, 2″ Pt-silicone tubing with clave connector, 1 top port: 1/2″ port, 5″ Pt-silicone tubing with female MPX connector 15
SV5L844N 5L 5L, 3 bottom ports: 1/2″ port, 5″ Pt-silicone tubing with male MPX connector; 1/4″ ports (2), 5″ Pt-silicone tubing with male MPC connector, 2″ Pt-silicone tubing with clave connector 15
SV10L8844P 10L 10L, 4 bottom ports: 1/2″ ports (2), 5″ Pt-silicone tubing with male MPX connectors; 1/4″ ports (2), 5″ Pt-silicone tubing with female luer, 2″ Pt-silicone tubing with clave connector; 1 top port: 1/2″ port, 5″ Pt-silicone tubing with female MPX connector 15
SV10L8844N 10L 10L, 4 bottom ports: 1/2″ ports (2), 5″ Pt-silicone tubing with male MPX connector; 1/4″ ports (2), 5″ Pt-silicone tubing with female luer, 2″ Pt-silicone tubing with clave connector 15
SV10L6644P 10L 10L, 4 bottom ports: 3/8″ ports (2), silicone tubing with male MPC connectors; 1/4″ ports (2), 2″ silicone with clave connector, 5″ x 1/4″ silicone tubing with female luer; 1 top port: 1/2″ port, 5″ Pt-silicone tubing with female MPX connector 15
SV10L6644N 10L 10L, 4 bottom ports: 3/8″ ports (2), 20″ C-Flex® tubing with male MPC connectors; 1/4″ ports (2), 2″ C-Flex® tubing with plug, 20″ x 1/8″ C-Flex® tubing with clave connector 15
SV10L844P 10L 10L, 3 bottom ports: 1/2″ port, 5″ Pt-silicone tubing with male MPX connector; 1/4″ ports (2), 5″ Pt-silicone tubing with male MPC connector, 2″ Pt-silicone tubing with clave connector; 1 top port: 1/2″ port, 5″ Pt-silicone tubing with female MPX connector 15
SV10L844N 10L 10L, 3 bottom ports: 1/2″ port, 5″ Pt-silicone tubing with male MPX connector; 1/4″ ports (2), 5″ Pt-silicone tubing with male MPC connector, 2″ Pt-silicone tubing with clave connector 15
SV20L8844P 20L 20L, 4 bottom ports: 1/2″ ports (2), 5″ Pt-silicone tubing with male MPX connectors; 1/4″ ports (2), 5″ Pt-silicone tubing with female luer, 2″ Pt-silicone tubing with clave connector; 1 top port: 1/2″ port, 5″ Pt-silicone tubing with female MPX connector 15
SV20L8844N 20L 20L, 4 bottom ports: 1/2″ ports (2), 5″ Pt-silicone tubing with male MPX connectors; 1/4″ ports (2), 5″ Pt-silicone tubing with female luer, 2″ Pt-silicone tubing with clave connector 15
SV20L6644P 20L 20L, 4 bottom ports: 3/8″ ports (2), silicone tubing with male MPC connectors; 1/4″ ports (2), 2″ silicone with clave connector, 5″ x 1/4″ silicone tubing with female luer; 1 top port: 1/2″ port, 5″ Pt-silicone tubing with female MPX connector 15
SV20L6644N 20L 20L, 4 bottom ports: 3/8″ ports (2), 20″ C-Flex® tubing with male MPC connectors; 1/4″ ports (2), 2″ C-Flex® tubing with plug, 20″ x 1/8″ C-Flex® tubing with clave connector 15
SV20L844P 20L 20L, 3 bottom ports: 1/2″ port, 5″ Pt-silicone tubing with male MPX connector; 1/4″ ports (2), 5″ Pt-silicone tubing with male MPC connector, 2″ Pt-silicone tubing with clave connector; 1 top port: 1/2″ port, 5″ Pt-silicone tubing with female MPX connector 15
SV20L844N 20L 20L, 3 bottom ports: 1/2″ port, 5″ Pt-silicone tubing with male MPX connector; 1/4″ ports (2), 5″ Pt-silicone tubing with male MPC connector, 2″ Pt-silicone tubing with clave connector 15

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, 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.