| Bio-Pak® 3D Gusset Bio-Container Systems |
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| Bio-Pak® 3D Gusset bio-containers are designed for bioprocessing applications, storage, and transport of sterile fluids. |
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- Excellent gas barrier properties
- Animal derivative free construction
- Superior Film Clarity
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Typical Applications |
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- Bulk API Material
- Media & Buffer Preparation
- Containment of sterile solutions used in laboratory or manufacturing settings
- Custom designs available in 2D configurations
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Bio-Pak® 3D Gusset Bio-Containers |
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| Catalog No. |
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 |
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Validation |
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- 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.
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| Materials |
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| 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. |
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Production Control & Qualification Tests: |
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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. |
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| Biocompatibility Tests: |
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- 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.
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| Mechanical & Optical Tests: |
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- ASTM D882—Tensile Properties
- ASTM D1004 - Tear Resistance
- ASTM D1003—Transmittance
- ASTM F88 - Seal Strength
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| Gas Transmission Tests: |
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- ASTM D3985- Gas Transmission Rate
- ASTM F2476 - Carbon Dioxide Gas Transmission Rate (CO2TR)
- ASTM F1249 - Water Vapor Transmission Rate
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| Transportation Tests: |
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- ASTM D4169 - 05 - Performance Testing of Shipping Containers and Systems.
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