GORE® STA-PURE™ Flexible Freeze Container

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

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Pharmaceutical & Biopharmaceutical

Gore’s solutions for pharmaceutical and biopharmaceutical manufacturers are based on our technologies, capabilities and competencies in fluoropolymer science and include a suite of efficient, technology-driven products for single- and multi-use applications. 

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Overview

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
Image shows array of available sizes of GORE® STA-PURE™ Flexible Freeze Container

GORE STA-PURE Flexible Freeze Containers in medium, large and sample sizes.

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.

Technology

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

  • Proven strength and durability at frozen temperatures
  • Frozen film integrity maintained after impact and flex cycles
  • Frozen Container integrity maintained after multiple freeze/thaw cycles
  • High purity, biocompatible fluoropolymer film
  • Low extractables profile ideal for bioprocess applications

This distinctive material is combined with a patent-pending bag design to create robust containers able to withstand the rigors of frozen handling.

Product Performance

Gore takes the responsibility of providing products that perform the way we say they will perform seriously. Our comprehensive approach to product testing includes evaluation of performance at the material level and in final product form.

Froze GORE® STA-PURE™ Flexible Freeze Container

We put our filled containers through a battery of durability tests, including impact testing and multiple freeze thaw cycles, to prove that they will be able to withstand the rigors of frozen transport, handling and storage.

Containers filled with a phosphate-buffered saline solution were frozen in a blast freezer for a minimum of 24 hours with a set point of -86°C (-123°F), or in a plate freezer for a minimum of 4 hours at a set point of -70°C (-94°F). After freezing, the containers were tested for frozen impact durability, performance after five freeze/thaw cycles and after long-term storage.

Frozen Impact Durability Frozen and dropped from height of 3 feet (91.4  cm) onto concrete floor
Freeze/Thaw Stored in a freezer and thawed in water bath for 5 cycles
Long-Term Frozen Storage Stored for 2 months (testing up to 12 mos. in process)

 

After testing, the containers were integrity tested by vacuum decay and visual inspection. All samples passed.

High Purity and Low Extractables
Red text box reads 'High purity & low extractables profile ideal for single-use applications"

The materials used in the GORE STA-PURE Freeze Container are durable and, above all, highly pure and suitable to bioprocessing applications. All fluid contact surfaces of the containers (container and port) are made of 100% fluoropolymer composite. The container film is chemically inert and has high degree of compatibility with a variety of fluids.

We compared the material in our containers with commonly-used films in traditional single-use bags. Results show that the film material in the GORE STA-PURE Freeze Containers (container and port) have a lower extractables profile compared to other commonly-used films.

Graph comparing extractables profiles between GORE STA-PURE Flexible Freeze Container, two commercial films, and 100% IPA blank

Test Details: Following the recommended sterilization protocols for each, a 6cm2/mL sample of Gore film and commonly-used films were tested in 100% IPA at 50°C for 3 days. The impurities were measured using GC/MS.

The extractables data shown is based on Gore’s internal test protocol. In line with industry standards, Gore is also undertaking an extractables study based on guidelines put forth by the BioPhorum Operations Group (BPOG) as stated in their User Requirements Pack. This study involves testing representative material sets after sterilization from the GORE STA-PURE Flexible Freeze Container’s product portfolio. Please contact us for more information about the test protocol and availability of results.

Configurations

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

Size Dimensions (W x L) Freezing Method Maximum Fill Volume
Sample 5 x 6 in (12.7 x 15.2 cm) Suitable for plate or blast freezers 50 milliliter (mL)
Medium 12 x 18 in (30.5 x 45.2 cm) plate
blast
4.25 Liter (L)
5.0 Liter (L)
Large 25 x 18 in (63.5 x 45.2 cm) plate
blast
10 Liter (L)
12 Liter (L)

 

GORE® STA-PURE™ Flexible Freeze Container with optional hard-shell carrier and barrier wrap

Optional hard-shell carriers and barrier wraps are available.

Gore also offers single-use hard-shell carriers made of durable high-density polyethylene (HDPE), configured for use in either blast or plate freezers, as an optional accessories to the Container. They are designed to maximize freezer space, make handling easier and further protect tubing in the Container Assembly. See our Use Guidelines for more information about our carriers.

If carbon dioxide (CO2) or oxygen (O2) permeation are a concern in the application, an optional vacuum-sealable secondary Barrier Wrap is available to minimize ingress. The Wrap fully encloses the Container Assembly, including tubing. For more information about our Wraps, see our Use Guidelines.

Sterilization

The Freeze Container Assemblies are packaged sterilized and ready to use inside two TYVEK® pouches prior to shipment. Contact us for more information about sterilization.

Compliance & Quality Control

GORE STA-PURE Flexible Freeze Containers (container and port) are 100% integrity tested by vacuum decay and visually inspected before quality control release.  The raw materials and/or components of the fluid contact surfaces meet standards for biocompatibility, bacterial endotoxin, and particulates as shown in the table. 

Biocompatibility USP ‹87› Biological Reactivity Tests in Vitro
USP ‹88› Biological Reactivity Tests in Vivo Class VI
Bacterial Endotoxin USP ‹85› Bacterial Endotoxin limits
 Particulates USP ‹788› Particulate Matter in Injections

 

Gore is committed to providing our customers with rigorously compliant products that deliver high-quality performance over time. GORE STA-PURE Flexible Freeze Containers are manufactured and assembled in a manner that adheres to relevant current Good Manufacturing Practices (cGMP) as defined in the Gore PharmBIO Products' quality system, which is certified to ISO 13485 and ISO 15378. These products are manufactured following the appropriate material and regulatory requirements. Please Contact us for current compliance statements.

Resources

Recent News

Press Release

Gore to Launch GORE® STA-PURE™ Flexible Freeze Containers at BioProcess International

Posted August 24, 2018

Gore will debut its new GORE® STA-PURE™ Flexible Freeze Containers at the 2018 BioProcess International Conference and Exhibition (BPI).

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