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
Ordering Information
| Catalog # | Description | Case Qty. |
|---|---|---|
| SV50ML444 | 50 mL Bio-Pak® Small Volume Bag 444 | 30 |
| SV50ML44 | 50 mL Bio-Pak® Small Volume Bag 44 | 30 |
| SV500ML444 | 500 mL Bio-Pak® Small Volume Bag 444 | 20 |
| SV500ML44 | 500 mL Bio-Pak® Small Volume Bag 44 | 20 |
| SV500ML44C | 500 mL Bio-Pak® Small Volume Bag with C-Flex® Tubing | 20 |
| SV1L444 | 1 L Bio-Pak® Small Volume Bag 444 | 20 |
| SV1L44 | 1 L Bio-Pak® Small Volume Bag 44 | 20 |
| SV2L444 | 2 L Bio-Pak® Small Volume Bag 444 | 20 |
| SV2L44 | 2 L Bio-Pak® Small Volume Bag 44 | 20 |
| SV5L8844P | 5 L Bio-Pak® Small Volume Bag 8844P | 15 |
| SV5L8844N | 5 L Bio-Pak® Small Volume Bag 8844N | 15 |
| SV5L6644P | 5 L Bio-Pak® Small Volume Bag 6644P | 15 |
| SV5L6644N | 5 L Bio-Pak® Small Volume Bag 6644N | 15 |
| SV5L844P | 5 L Bio-Pak® Small Volume Bag 844P | 15 |
| SV10L8844P | 10 L Bio-Pak® Small Volume Bag 8844P | 15 |
| SV10L8844N | 10 L Bio-Pak® Small Volume Bag 8844N | 15 |
| SV10L6644P | 10 L Bio-Pak® Small Volume Bag 6644P | 15 |
| SV10L6644N | 10 L Bio-Pak® Small Volume Bag 6644N | 15 |
| SV10L844P | 10 L Bio-Pak® Small Volume Bag 844P | 15 |
| SV10L844N | 10 L Bio-Pak® Small Volume Bag 844N | 15 |
| SV20L8844P | 20 L Bio-Pak® Small Volume Bag 8844P | 15 |
| SV20L8844N | 20 L Bio-Pak® Small Volume Bag 8844N | 15 |
| SV20L6644P | 20 L Bio-Pak® Small Volume Bag 6644P | 15 |
| SV20L6644N | 20 L Bio-Pak® Small Volume Bag 6644N | 15 |
| SV20L844P | 20 L Bio-Pak® Small Volume Bag 844P | 15 |
| SV20L844N | 20 L Bio-Pak® Small Volume Bag 844N | 15 |