Bio-Pak® Small Volume Containers

• Convenient and cost-effective alternative to plastic bottles
• Perfect for fluid containment and processing of small volumes from 30mL to 25L
• Equipped with easy-to-use, needle-less sample port
• Light-weight, easy to fill

Overview

Our Bio-Pak® small volume containers come equipped with a needle-less sampling port. When used with the Charter Medical Syringe Access (SA), 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 sample port membrane in the same way as a needle.

Typical Applications:

• Bulk API Material
• Tissue culture media
• Buffer preparation
• Containment of sterile solutions used in laboratory or manufacturing
• Samples available to fit your custom specifications

Charter Medical's Bio-Pak® Small Volume Containers are non-cytotoxic, non-pyrogenic and meet the requirements of the USP Class VI tests for plastics.

Product Catalog Bio-Pak® 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

5 Liter Bio-Pak® Containers
Standard Bio-Pak® Bags, with 1/4", 3/8", MPC, or Mini-TC Fittings

Catalog No.	Description	Case Qty
BP514	5 Liter Bio-Pak Container, 1/4" HB Fittings	10
BP538	5 Liter Bio-Pak Container, 3/8" HB Fittings	10
BP5MP	5 Liter Bio-Pak Container, 3/8" MPC Fittings	10
BP5TC	5 Liter Bio-Pak Container, Mini-TC	10

Standard Bio-Pak^® Plus Bags, with Millipak-60 Filters, 6" silicone

Catalog No.	Description	Case Qty
BPF514	5 Liter Bio-Pak Container, Millipak-60 Filter 1/4" Tubing	4
BPF538	5 Liter Bio-Pak Container, Millipak-60 Filter 1/4" Tubing	4
BPF5MP	5 Liter Bio-Pak Container, Millipak-60 Filter 3/8" Tubing	4
BPF5TC	5 Liter Bio-Pak Container, Millipak-60 Filter 3/8" MPC	4

10 Liter Bio-Pak^® Containers
Standard Bio-Pak^® Bags, with 1/4", 3/8", MPC, or Mini-TC Fittings

Catalog No.	Description	Case Qty
BP1014	10 Liter Bio-Pak Container, 1/4" HB Fittings	10
BP1038	10 Liter Bio-Pak Container, 3/8" HB Fittings	10
BP10MP	10 Liter Bio-Pak Container, 3/8" MPC Fittings	10
BP10TC	10 Liter Bio-Pak Container, Mini-TC	10

Standard Bio-Pak^® Plus Bags, with Millipak-60 Filters, 6" silicone

Catalog No.	Description	Case Qty
BPF1014	10 Liter Bio-Pak Container, Millipak-60 Filter, 1/4" Tubing	4
BPF1038	10 Liter Bio-Pak Container, Millipak-60 Filter, 3/8" Tubing	4
BPF10MP	10 Liter Bio-Pak Container, Millipak-60 Filter, 3/8" MPC	4
BPF10TC	10 Liter Bio-Pak Container, Millipak-60 Filter, Mini-TC	4

20 Liter Bio-Pak^® Containers
Standard Bio-Pak^® Bags, with 1/4", 3/8", MPC, or mini-TC Fittings

Catalog No.	Description	Case Qty
BP2014	20 Liter Bio-Pak Container, 1/4" HB Fittings	10
BP2038	20 Liter Bio-Pak Container, 3/8" HB Fittings	10
BP20MP	20 Liter Bio-Pak Container, 3/8" MPC Fittings	10
BP20TC	20 Liter Bio-Pak Container, Mini-TC	10

Standard Bio-Pak^® Plus Bags, with Millipak-100 Filters, 6" Silicone

Catalog No.	Description	Case Qty
BPF2014	20 Liter Bio-Pak Container, Millipak-100 Filter 1/4" Tubing	4
BPF2038	20 Liter Bio-Pak Container, Millipak-100 Filter 3/8" Tubing	4
BPF20MP	20 Liter Bio-Pak Container, Millipak-100 Filter 3/8" MPC	4
BPF20TC	20 Liter Bio-Pak Container, Millipak-100 Filter, Mini-TC	4

25 Liter Bio-Pak^® Containers
Standard Bio-Pak^® Bags, with 1/4", 3/8", MPC, or mini-TC Fittings

Catalog No.	Description	Case Qty
BP2514	25 Liter Bio-Pak Container, 1/4" HB Fittings	4
BP2538	25 Liter Bio-Pak Container, 3/8" HB Fittings	4
BP25MP	25 Liter Bio-Pak Container, 3/8" MPC Fittings	4
BP25TC	25 Liter Bio-Pak Container, Mini-TC	4

Standard Bio-Pak^® Plus Bags, with Millipak-100 Filters, 6" Silicone

Catalog No.	Description	Case Qty
BPF2514	25 Liter Bio-Pak Container, Millipak-100 Filter 1/4" Tubing	10
BPF2538	25 Liter Bio-Pak Container, Millipak-100 Filter 3/8" Tubing	10
BPF25MP	25 Liter Bio-Pak Container, Millipak-100 Filter 3/8" MPC	10
BPF25TC	25 Liter Bio-Pak Container, Millipak-100 Filter, Mini-TC	10

Construction

BP Small Volume Bio-Containers highlights:

• Constructed of co-extruded three-layer composite film 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.
• 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 facility. 

Validation

• The Bio-Pak®-Small Container 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 is available to assist with regulatory requirements.

Specifications & Properties
Materials

Container: CPL-300 film, CPL-300/EVOH/ CPL-300. Ports: CPL-300, sample port CPL-300/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 0.05 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
Bio-Pak® containers are not designed for use in pressurized gas applications.

Environmental

Products can be disposed of as ordinary refuse by controlled dumping, landfill or incineration in a suitable furnace.