In a highly regulated industry marked by economic pressures and drug development and processing challenges, Gore provides technology-driven products and process components designed for efficiency, reliability and contamination control.

Single-use GORE® STA-PURE™ Flexible Freeze Containers are intended for storing and transporting bulk drug substances after freezing at -86°C (-123°F).

Single-use storage containers have many advantages to biopharmaceutical manufacturers and are commonly used throughout drug production. However, there are vulnerabilities associated with traditional polymer-film-based disposable bags:

• They can become brittle and fragile at cold temperatures, increasing the risk of loss during cold chain handling, transport or storage.
• Extractables and leachables from materials commonly used in disposable packaging are a concern.

NOW, GORE MATERIALS SCIENCE DELIVERS A SOLUTION TO BOTH ISSUES
Single-use GORE STA-PURE Flexible Freeze Containers are intended for storing and transporting bulk drug substances, after freezing at -86°C (-123°F).

The strength, durability and high purity of the materials of construction make GORE STA-PURE Flexible Freeze Containers ideal for high-value biopharmaceutical bulk drug substances such as:

• vaccines
• monoclonal antibodies
• antibody drug conjugates (ADCs)
• And a robust validation package and available technical support are offered to make initial evaluation easier

Utilizing our advanced materials understanding, we’ve engineered a highly durable proprietary fluropolymer (PTFE) composite film designed specifically for bulk biopharmaceutical cold chain applications.

GORE STA-PURE Flexible Freeze Containers are sold as an assembly and are suitable for both plate and blast freezers in sample, small, medium and large sizes. Maximum fill volumes vary by freezing method. Contact us for tubing and connector options.

Introducing the GORE® STA-PURE® Flexible Freeze Container Stability Bag

W.L. Gore & Associates, Inc.’s PharmBIO division is excited to announce the launch of the GORE® STA-PURE® Flexible Freeze Container Stability Bag.  The stability bag is a product line extension to the GORE STA-PURE Flexible Freeze Container intended for handling, transport and storage of biopharmaceutical intermediates after freezing at temperatures as low as -86 C.  The 50 mL container can be supplied with Luer Lock connectors for easy under hood filling. Colder AseptiQuik® S connectors for aseptic filling of small volumes are also available to support stability testing, phase 1-3 clinical testing or sampling during GMP production.  The stability bag is constructed using the same proprietary 100% fluoropolymer PTFE film as our GORE STA-PURE Flexible Freeze Container product line. Supplied inside two Tyvek® pouches, the stability bag is sterile certified and ready to use. For more information, visit our website to review the GORE STA-PURE Flexible Freeze Container datasheet.

GORE STA-PURE Flexible Freeze Containers have proven strength and durability at frozen temperatures and maintain integrity after multiple freeze/thaw cycles.  If the risk of product loss due to container breakages or leaks are a concern throughout your cold chain, you can contact a Gore associate today for more information or samples of the GORE STA-PURE Flexible Freeze Container product line.