Bio-Pak® Cell Culture Container Systems

Bio-Pak® Cell Culture containers are designed for single-use bioprocessing applications promoting cell growth and viability. The Bio-Pak® Cell Culture containers are available in sizes from 2L to 100L. Bio-Pak® Cell Culture containers are manufactured using our Clear-Pak® film.

Download the Application Note

Featuring

  • Excellent gas barriers properties
  • Superior clarity
  • Scalable bag sizes
Download the Bio-Pak® Cell Culture Data Sheet

Ordering Information – Bio-Pak® Cell Culture Bio-Containers

Product Number

Bag Volume (L)

Description

CML-2L-CELLCP

1
Port 1: 2″ L, 3/16″ ID Silicone to Air Inlet Filter
Port 2:
2″ L, 3/16″ ID Silicone to Air Outlet Filter and Check Valve
Port 3:
42″ L, 1/4″ ID C-Flex(374) to Colder MPC Coupling Body and Plug
Port 4:
2″ L, 1/4″ ID Silicone to Sampling Site (Needleless)
2″ L, 1/4″ ID Silicone to Female Luer and Cap
CML-10L-CELLCP
5
Port 1:
2″ L, 3/16″ ID Silicone to Air Inlet Filter
Port 2:
2″ L, 3/16″ ID Silicone to Air Outlet Filter and Check Valve
Port 3:
42″ L, 1/4″ ID C-Flex(374) to Colder MPC Coupling Body and Plug
42″ L, 1/8″ ID C-Flex(374) to Female Luer and Cap
Port 4:
2″ L, 1/4″ ID Silicone to Sampling Site (Needleless)
2″ L, 1/4″ ID Silicone to Female Luer and Cap
CML-20L-CELLCP
10
Port 1:
2″ L, 3/16″ ID Silicone to Air Inlet Filter
Port 2:
2″ L, 3/16″ ID Silicone to Air Outlet Filter and Check Valve
Port 3:
42″ L, 3/8″ ID C-Flex(374) to Colder MPC Coupling Body and Plug
Port 4:
42″ L, 1/8″ ID C-Flex(374) to Female Luer and Cap
Port 5:
2″ L, 1/4″ ID Silicone to Sampling Site (Needleless)
2″ L, 1/4″ ID Silicone to Sampling Site (Needleless)
CML-22L-CELLCP
10
Port 1:
2″ L, 3/16″ ID Silicone to Air Inlet Filter
Port 2:
2″ L, 3/16″ ID Silicone to Air Outlet Filter and Check Valve
Port 3:
42″ L, 1/4″ ID C-Flex(374) to Colder MPC Coupling Body and Plug
Port 4:
42″ L, 1/4″ ID C-Flex(374) to Colder MPC Coupling Body and Plug
2″ L, 1/4″ ID Silicone to Sampling Site (Needleless)
CML-50L-CELLCP
25
Port 1:
2″ L, 3/16″ ID Silicone to Air Inlet Filter
Port 2:
2″ L, 3/16″ ID Silicone to Air Outlet Filter and Check Valve
Port 3:
42″ L, 3/8″ ID C-Flex(374) to Colder MPC Coupling Body and Plug
Port 4:
42″ L, 1/8″ ID C-Flex(374) to Female Luer and Cap
Port 5:
2″ L, 1/4″ ID Silicone to Sampling Site (Needleless)
2″ L, 1/4″ ID Silicone to Sampling Site (Needleless)
CML-100L-CELLCP
50
Port 1:
2″ L, 3/16″ ID Silicone to Air Inlet Filter
Port 2:
2″ L, 3/16″ ID Silicone to Air Outlet Filter and Check Valve
Port 3:
2″ L, 3/16″ ID Silicone to Air Inlet/Outlet Filter
Port 4:
42″ L, 3/8″ ID C-Flex(374) to Colder MPC Coupling Body and Plug
Port 5:
42″ L, 1/8″ ID C-Flex(374) to Female Luer and Cap
42″ L, 1/8″ ID C-Flex(374) to Female Luer and Cap
Port 6:
2″ L, 1/4″ ID Silicone to Sampling Site (Needleless)
2″ L, 1/4″ ID Silicone to Sampling Site (Needleless)

 

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 Bio-Pak® Cell Culture 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 tests or studies were conducted during the qualification of our bio-containers manufactured from Clear-Pak® Film.

Biocompatibility Tests

  • USP <661>–Physicochemical Tests of Plastic Containers
  • USP Class VI <88>– Biological Reactivity Tests, in Vivo
  • 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