| |
BP Small Volume Containers
A convenient alternative to small plastic bottles for biopharmaceutical processing
- Perfect for fluid containment and processing for small volumes ranging in sizes from 30mL to 3L
- With easy-to-use sample port
Overview
The Charter Bio BP Small Volume containers are a cost-effective alternative to rigid glass and plastic bottles. The single use BP eliminates the issues surrounding cleaning validation, storage and sterilizing of traditional containers. They are lightweight, easy to fill, and more convenient to handle than conventional rigid bottles.
BP Small Volume containers come equipped with a needle-less sampling port. When used with the Charter Bio Syringe Access Device, the sampling port prevents accidental needle sticks, protecting both the user and the product inside the bag. The Syringe Access Device uses a unique plastic probe that is inserted through the sampling port membrane in the same way as a needle.
Typical applications include:
- Final product bulking
- Tissue culture media
- Buffer preparation
- Containment of sterile solutions used in laboratory or manufacturing
BP Small Volume containers are non-cytotoxic, non-pyrogenic, and meet the requirements of the USP Class VI tests for plastics.
Product Catalog
BP Small Volume Containers
| Catalog No. |
Description |
Case Qty |
| BP30 |
30ml CPL-300 Bag, 4" PVC Tube w/ Clamp |
48 |
| BP2X30 |
2X30ml CPL-300 Bag, 4" PVC Tubes w/ Clamp |
24 |
| BP250 |
250ml CPL-300 Bag, 4" PVC Tube, SA Port |
24 |
| BP-50A |
500ml CPL-300 Bag, 4" PVC Tube, SA Port |
24 |
| BP500 |
500ml CPL-300 Bag, (2) 4" PVC Tube - Luer & Cannula |
24 |
| BP530 |
30ml & 500ml CPL-300 Bag, 4" PVC Tube - Luer & Cannula |
24 |
| BP1000 |
1000ml CPL-300 Bag, 4" PVC Tube, SA Port, Spike Port |
24 |
| BP2000 |
2000ml CPL-300 Bag, 4" PVC Tube, SA Port, Spike Port |
24 |
| BP3000 |
3000ml CPL-300 Bag, 4" PVC Tube, SA Port, Spike Port |
24 |
Construction
BP Small Volume Biopharmaceutical Containers are manufactured from a co-extruded three-layer composite film called CPL-300. Two layers of pure ethylene vinyl acetate copolymer (EVA) surround a center layer of ethylene vinyl alcohol (EVOH). The EVOH layer is a barrier film that prevents transmission of gas into or out of the container. By maintaining an inner solution contact layer of pure EVA, extractables are minimized. The film extrusion process for BP Small Volume containers is unique among containers of this style. Bio-Pak® film starts out as a continuous tube which is immediately laid flat. This ensures that the interior of the tubular film is isolated from the possibility of contamination by the outside environment. Such containment provides for a fluid contact pathway that is virtually free from particulate. The containers are radio-frequency welded in a validated process. Final assembly of the Bio-Pak® product (i.e. attachment of tubing, fittings, integrity testing, etc.) is performed under cGMP's in a cleanroom environment.
Validation
The BP Small Volume Containers film and the container itself undergo extensive physical, chemical, and microbial tests before release. Each container is shipped with a Certificate of Conformance that guarantees adherence to specifications and provides lot traceability. A detailed Validation Guide (BPD-VG1) is available to assist with regulatory requirements.
Specifications & Properties
Materials
Container: CPL-300 film, EVA/EVOH/EVA. Ports: EVA, sample port EVA/PVC co-extrusion Clamps: Polyester Sample Port: Polycarbonate, latex membrane, silicone oil lubricant Adapters: Male luer adapters: Polycarbonate
USP <88>, Toxicity
All Bio-Pak® component materials meet the USP In-vivo Biological Reactivity Test for Plastics.
USP <87>, Cytotoxicity
Gamma-irradiated Bio-Pak® containers are qualified as non-cytotoxic per the USP Elution Test (In-vitro Biological Reactivity Tests).
USP <661>, Physico-chemical Tests for Plastic Containers
Gamma pre-sterilized Bio-Pak® containers pass the USP test for Non-Volatile Residue (NVR), Residue on Ignition, Heavy Metals, and Buffering Capacity.
Gamma Irradiation
Bio-Pak® containers are gamma-irradiated. Dosimetric measurement confirms that all portions of the packaging environment have received 25 - 40 kGy.
USP Bacterial Endotoxins
Concentration of endotoxin in aqueous extracts contains less than .05 EU/mL as determined by the Limulus Amebocyte Lysate Test (LAL). The test does not include filters or other miscellaneous equipment that could be included with customized Bio-Pak® containers.
Hemolytic Effects
Representative samples passed the test for Hemolytic Effects in Buffered Systems as described in the European Pharmacopoeia.
Maximum Pressure Rating
BP Small Volume containers are not designed for use in pressurized gas applications.
Environmental
Products can be disposed of as ordinary refuse by controlled dumping, landfill or Waste to energy (in a suitable furnace).
|
