Clear-Pak^® Bio-Containers

• Superior Clarity
• Excellent gas barriers properties
• Animal derivative free construction

Overview

Clear-Pak^® bio-containers are designed for bioprocessing applications, storage, transport of sterile fluids. Clear-Pak^® is a single web film in a multi-layer, co-extruded format with a Ultra Low Density Polyethylene (ULDPE) contact layer, EVOH gas barrier layer, and Polyethylene (PE) outer layer. The thickness is 13 mil.

Typical Applications

• Bulk API Material
• Media & Buffer Preparation
• Containment of sterile solutions used in laboratory or manufacturing settings
• Configurations available to fit your custom specifications

Product Catalog Clear-Pak^® Bio-Containers

20L Clear-Pak^® 2D Bags

Standard Face Port CP Bags

50L Clear-Pak^® CP 2D Bags

100L Clear-Pak^® CP 2D Bags

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.
  

Specifications & Properties Materials

Biocompatibility Tests:

USP Class VI <88>-- Biological Reactivity Tests, in Vivo
The United States Pharmacoepia (USP) VI tests validate a plastic container or material’s fitness for use in the biopharmaceutical industry. Testing includes three sections, a muscle implantation study, a systemic toxicity study, and an intracutaneous toxicity study.

USP <661>--Physicochemical Tests of Plastic Containers
This is a battery of tests evaluating a plastic container’s leachable chemicals (chemicals that can easily leach from the plastic material under normal use, this differs from extractables in that extractables are extracted predominantly by the use of harsh chemicals and solvents).

USP <87>--Biological Reactivity Testing, in Vitro
This test evaluates the cytotoxicity of the film using elution.

Oxidizable Substances—USP XXIII Supplement VIII
The USP oxidizable substances test evaluates color changes in an extraction using purified water.

USP <85>--Bacterial Endotoxin Testing
Bacterial endotoxin testing is performed on each lot of Clear-Pak^® Bio-Containers. This test evaluates the amount of bacterial endotoxins in the sample product using kinetic LAL.

EP <3.1.5> European Pharmacopoeia Conformity Analysis
This battery of European Pharmacopoeia (EP) tests evaluates the film’s acidity and alkalinity, absorbance, reducing substances, appearance and extractables.

Protein Adsorption.
This study evaluates the amount of protein adsorbed to internal surfaces of the bio-container over 30 days when incubated at various temperatures.

Mechanical & Optical Tests:

ASTM D882—Standard Test Method for Tensile Properties of Thin Plastic Sheeting.
This test method covers the determination of tensile properties of plastics in the form of thin sheeting, including film (less than 1.0 mm (0.04 in.) in thickness).

ASTM F1306—Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates.
This test method permits flexible barrier films and laminates to be characterized for slow rate penetration resistance to a driven probe. The test is performed at room temperature, by applying a biaxial stress at a single test velocity on the material until perforation occurs. The force, energy, and elongation to perforation are determined.

ASTM D1004 - Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting.
This test method covers the determination of the tear resistance of flexible plastic film and sheeting at very low rates of loading, 51 mm [2 in.]/min. and is designed to measure the force to initiate tearing. The specimen geometry of this test method produces a stress concentration in a small area of the specimen. The maximum stress, usually found near the onset of tearing, is recorded as the tear resistance in newtons [or pounds-force].

ASTM D1003—Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics.
This test method covers the evaluation of specific light-transmitting and wide-angle-light-scattering properties of planar sections of materials such as essentially transparent plastic.

ASTM F88 - Standard Test Method for Seal Strength of Flexible Barrier Materials.
This test method covers the measurement of the strength of seals in flexible barrier materials.

ASTM D3418 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry.
This test method covers determination of transition temperatures and enthalpies of fusion and crystallization of polymers by differential scanning calorimetry. This was used to determine the glass transition temperature of the film.

Gas Transmission Tests:

ASTM D3985—Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor.
This test method covers a procedure for determination of the steady-state rate of transmission of oxygen gas through plastics in the form of film, sheeting, laminates, coextrusions, or plastic-coated papers or fabrics.

ASTM F2476—Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials Using An Infrared Detector.
This method covers a procedure for determination of the steady-state rate of transmission of carbon dioxide gas through plastics in the form of film, sheeting, laminates, coextrusions, or plastic-coated papers or fabrics.

ASTM F1249—Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
This test method covers a procedure for determining the rate of water vapor transmission through flexible barrier materials. The method is applicable to sheets and films up to 3 mm (0.1 in.) in thickness, consisting of single or multilayer synthetic or natural polymers and foils, including coated materials.

Transportation Tests:

ASTM D4169 - 05 Standard Practice for Performance Testing of Shipping Containers and Systems.
This practice provides a uniform basis of evaluating, in a laboratory, the ability of shipping units to withstand the distribution environment. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles.