Bio-Pak® XL Bioprocess Container
Flexible single-use biopharmaceutical process containers for large-scale applications
- Flexible single-use containers for processing sterile solutions up to 1000L and beyond for custom applications.
- Ideal for buffer, media and bulk product storage
- Eliminate the cleaning, sterilizing, and validation headaches of rigid containers
- Available in an unlimited array of custom designs in 2D and 3D styles
- Multiple port configurations, internal tubing, and sophisticated fluid sampling devices for enhanced quality.
Overview
The Charter Bio-Pak® XL series containers are an efficient and cost-effective alternative to large tanks and carboys for sterile fluid containment and processing. The single use Bio-Pak® XL bags eliminate the issues surrounding cleaning validation, storage and sterilizing of traditional containers. In addition, they are lightweight, easy to fill, and easier to handle than large glass or steel tanks. The Bio-Pak® XL Plus containers include built-in 0.22um hydrophilic filters. Bio-Pak® XL containers can be custom-configured with the right combination of inlets, tubing, filters and sampling outlets to suit a specific process. Compared to steel tanks, which require custom assembly and sterilization before each use, these pre-assembled bags present tremendous time savings.
All Bio-Pak® XL containers can be customized to match your application. Our automated manufacturing equipment and Integraflex™ port system allow a nearly unlimited variety of bag designs. The computer-controlled XL manufacturing equipment can maneuver the film, cut any number of desired port holes and then quickly weld any style of port into the film, all without a tooling change. Each custom bag design is archived in a database so that repeat orders of the same product are simply a matter of retrieval. The proprietary Integraflex port system enhances the ruggedness of Bio-Pak® XL containers by providing a single, integral port structure that is welded directly to the bag film. Although this method is difficult to automate, it is clearly superior to the threaded or snap-on adapters used by other manufacturers. By automating processes and eliminating many manual steps, Charter can manufacture a higher quality, customized product at a lower cost. Go to www.custombiobags.com to use our online design tool.
The Integraflex Port System includes: 1/4" Dip Tube 3/4" Port 1/2" Dip Tube Anchor 1/4" with Luer Adapter Dual 1/4" Port Unique process applications require innovative container design. Quick Disconnects Sterile Filter Dip Tube Anchor Fluid Samples
Typical applications include:
- Tissue culture media
- Buffer preparation
- Cell harvest supernatant
- Waste collection
- Containment of processing intermediates
- Sterile solutions
All Bio-Pak® XL containers are non-cytotoxic, non-pyrogenic, and meet the requirements of the USP Class VI tests for plastics.
Construction
Charter Bio-Pak® XL Biopharmaceutical Containers are manufactured from a two-layer film called CPL-612. The fluid contact layer is linear low-density polyethylene (LLDPE). The exterior layer consists of a multi-layer composite film bonded to an additional layer of LLDPE. The resulting laminate provides increased strength and enhanced oxygen and moisture vapor barrier properties. CPL-612 provides the fluid inside Bio-Pak® XL with the highest level of protection available in the industry. The containers are fabricated by heat-impulse welding in a validated process. Final assembly of the Bio-Pak® XL product is performed under cGMP's in ISO Class 7 clean room. All production occurs in a FDA registered manufacturing facility.
Bio-Pak® small volume containers are manufactured from a coextruded 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 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 fabricated by radio-frequency welding 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 an ISO Class 7 cleanroom environment.
Validation
The Bio-Pak® XL film and the container itself undergo extensive physical and chemical testing before release. Each container is shipped with a Certificate of Conformance that ensures conformance to specifications and lot traceability. A detailed Validation Guide (BPD-VG2) is available to assist with regulatory requirements. The Validation Guide contains test reports and other information supporting each of the claims referenced in the Certificate of Conformance.
Specifications & Properties
Materials
Container: CPL-612 Film, LLDPE+(LLDPE+Barrier) Tubing: Silicone, Synthetic Rubber, C-Flex, PVC - per specifications Ports: Polyethylene Hose barb adapters: polypropylene TC adapters: PVDF MPC adapters: polycarbonate
USP <88>, Toxicity
All Bio-Pak® XL component materials meet the USP In-vivo Biological Reactivity Test for Plastics.
USP <87>, Cytotoxicity
Gamma-irradiated Bio-Pak® XL 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® XL containers pass the USP test for Non-Volatile Residue (NVR), Residue on Ignition, Heavy Metals, and Buffering Capacity.
Gamma Irradiation
Bio-Pak® XL 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 0.05EU/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® XL containers.
Hemolytic Effects
Representative samples of gamma-irradiated film have been tested for Hemolytic effects.
Maximum Pressure Rating
Bio-Pak® XL containers are not designed for use in pressurized gas applications.
Packaging
The product is supplied sealed in a double-poly pouch and individually labled. Each unit is provided with a gamma-irradiation indicator that provides a visual means for verifying gamma processing.
STANDARD Bio-Pak® XL CONTAINERS
A variety of Bio-Pak® XL container products are available off-the-shelf for immediate delivery.
Components
Fluid Sampling
Our Syringe Access Sampling Devices and BP-Mini Sampling Bags are the perfect tools for obtaining fluid samples from inside a Bio-Pak® XL container. The SA Device (purchased separately) is available in sizes ranging from 20 - 60 mL. The needle-less cannula is designed to penetrate the septum provided on every Bio-Pak® XL bag. The system is re-enterable and provides an excellent method for obtaining fluid samples. Alternatively, the SA Device can be used to inject additives into the container as well. Each device is gamma irradiated and pyrogen tested, and intended for a single use.
Dip Tube Anchor
Charter's Dip-Tube Anchor provides uniquely effective bottom draw-off. Since it's anchored, there are no more worries about free-floating tubing suctioning to the side. Fluid is removed from bottom of tank, minimizing holdup volume and eliminating the chance of pulling air.
Tote
Charter offers purpose-designed, mobile container handling units mounted on durable, non-marking wheels. These tough HDPE totes hold the flexible bags plus outlet tubing in a self-contained, wheeled unit that can even be fork lifted. A uniquely designed bottom outlet system allows fast flow rates and minimal container holdup volume.
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