Bio-Pak® XL Bio-Containers

Our flexible single-use Bio-Containers process containers for large-scale applications offer the following benefits:

• Multiple port configurations, internal tubing, and sophisticated fluid sampling devices for enhanced quality
• Ideal for buffer, media and bulk product storage
• Reduces cleaning validation of reusable containers
• Available in an unlimited array of custom designs in 2D and 3D styles
• Offers flexible single-use container solutions for processing sterile systems up to 1000L and beyond for custom applications

Overview

The Charter Bio-Pak® XL series bio-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 represent a tremendous time savings.

Typical applications:

• Tissue culture media
• Buffer preparation
• Cell harvest supernatant
• Waste collection
• Containment of processing intermediates
• Sterile solutions

All Bio-Pak® XL bio-containers are non-cytotoxic, non-pyrogenic, and meet the requirements of the USP Class VI tests for plastics.

Construction

Charter Medical's Bio-Pak XL Bio-Containers manufacturing highlights:

• Constructed from a dual web film of CPL-612
• Fluid contact layer is linear low-density polyethylene (LLDPE)
• Exterior layer is a multi-layer composite film bonded to an additional layer of LLDPE resulting in increased strength and enhanced oxygen and moisture vapor barrier properties.
• Containers are fabricated in a validated process
• Final assembly of the Bio-Pak® XL is performed under cGMP’s in an ISO Class 7 facility.
• All production occurs in an FDA registered manufacturing facility.

Validation

• Both the Bio-Pak® XL film and the container itself undergo extensive testing before release.
• Each container is shipped with a 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 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.

COMPONENTS

Fluid Sampling

Our Syringe Access (SA) sampling devices and BP 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 intended for a single use.

Dip Tube Anchor

Charter Medical's Dip Tube Anchor provides a uniquely effective bottom draw-off and eliminates problems with free-floating tubing suctioning to the side. Fluid is removed from bottom of tank, minimizing holdup volume and eliminating the chance of pulling air.