Freeze-Pak™ Bio-Containers

• Robust performance down to –196°C

• Remains flexible in frozen state

• Designed to fit a variety of freezing cassettes

Overview

Freeze-Pak™ bio-containers are designed for use in cryogenic temperature applications under liquid nitrogen conditions.  This Single Web Film is a 12 mil thick polyolefin mono-layer.

Typical Applications:

• Cellular Therapy

• Cell Storage

• Regenerative Medicine

• Configurations available to fit your custom specifications

Product Catalog Freeze-Pak™ Bio-Containers

Validation

• The Freeze-Pak™ bio-container film and the bio-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

Mechanical & Optical Tests:

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, 51mm [2in.]/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 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 Rate 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.

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

ISO 10993-4
Biological evaluation of medical devices -- Part 4: Tests for interactions with blood.

ISO 10993-5
Biological evaluation of medical devices -- Part 5: Tests for cytotoxicity.

ISO 10993-6
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation

SO 10993-10
Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed type hypersensitivity.

ISO 10993-11
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.