Global industry-leading manufacturer of high-performance, innovative solutions and components across a wide range of industries.
Serving Biopharm and Cell Therapy
Industry-leading provider of material science-based solutions in the biopharmaceutical and cell therapy markets for single-use fluid management.
Medical Components and Custom Solutions
We provide custom components and engineered systems for the medical device industry, including critical parts where precision enables superior performance.
Electronics and Semiconductor Industry Solutions
Design and manufacture a complete line of ultra-high purity, fluoropolymer-based fluid handling components and solutions for the electronics and semiconductor markets.
Industrial & Consumer Solutions (ICS)
Superior engineering and customer support to achieve safety, performance, and regulatory compliance across a broad range of capabilities. Offerings include Tygon® Tubing and Accessories, Hoses and Fittings, Heat Shrink Tubing, and High-Performance Seals.
Sensors Flow Measurement Solutions
Playing an essential role in preventing cross-contamination, validating essential processes, and driving cost savings, we specialize in the development and production of high-quality single-use flow sensors and corresponding equipment.
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Saint-Gobain Bioprocess Solutions' bioprocess bags offer a robust, single-use cold storage solution for biopharmaceuticals, including Bulk Drug Substance (BDS) and Bulk Drug Product (BDP). Their dual-film design ensures durability at ultra-low temperatures (down to -80°C), and integration with the RoSS® Shell enhances protection during transport. Available with C-Flex® 374 or Sani-Tech® STHT®-LT tubing, they’re optimized for safe, flexible, and contamination-free storage.
Cold storage is a critical step of the biopharmaceutical manufacturing process. It ensures the safe handling, storage, and transport of sensitive materials like Bulk Drug Substance (BDS) and Bulk Drug Product (BDP), which are highly vulnerable to temperature fluctuations. Implementing a cold storage solution helps:
Preserve product integrity by maintaining ultra-low temperatures.
Improve operational flexibility across decentralized manufacturing sites.
Reduce risk of costly failures during shipping and handling.
Comply with regulatory standards for temperature-sensitive biologics.
Saint-Gobain Life Sciences' cold storage bags, with their dual-film structure and compatibility with RoSS® Shells, offer a robust, validated solution for ultra-low temperature applications.
#the-importance-of-raw-material-230901
The Importance of Raw Material
Material Brittleness at Ultra-Low Temperatures:
Many plastics become brittle or lose flexibility at -80°C.
This increases the risk of cracking, leakage, or mechanical failure, especially during handling or transport.
Provides outstanding impact and tear resistance, optimizing overall toughness of the bag.
Gas Barrier Layer
Ethylene Vinyl Alcohol (EVOH)
Provides excellent barrier to the transmission of oxygen and carbon dioxide.
Biocompatibility Layer
Linear Low Density Polyethylene (LLDPE)
Good biological compatibility (low extractables and good resistance to product-related stress: pH, broad chemical compatibility).
Low-Temperature and Fluid Contact Film
Low-Temperature Linear Low Density Polyethylene (LT-LLDPE)
Good biological compatibility (low extractables and good resistance to product-related stress: pH, broad chemical compatibility). Provides outstanding flexibility to bags at -80°C, which is the key protective element in case of shock.
The LT-LLDPE film retains the excellent biocompatibility performance of our multilayer bioprocessing film and further reinforces the ultra-low temperature performance of our bags. The unique mechanical properties of this film allow it to absorb more energy before breaking which allows it to better resist accidental mechanical shocks that may be experienced during frozen transportation. Together with our multilayer bioprocessing film, the LT-LLDPE film performs comparably to competition at room temperature and far exceeds the performance of comparable non-fluoropolymer films in the market at ultra-low temperature.
Pull Test Details of Films:
Test based on ASTM D638
Conditioning temperature: -70°C
Strain rate = 500 mm/min
Strain energy at break = energy absorbed by the film before breaking/energy required to break the film
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Robustness Evaluation
To simulate real-world conditions, bags were subjected to three freeze-thaw cycles and evaluated for chamber integrity using pressure decay methods. Weld peel tests and tensile strength assessments confirmed the durability of the seams and film layers. Additionally, the bags were gamma-sterilized and tested post-sterilization to ensure no compromise in structural integrity.
The tubing options - C-Flex® TPE and Sani-Tech® STHT®-LT silicone - were validated through crush and bend tests at –80°C, with all samples passing under simulated operational stress. Connectors and sampling ports were tested for flow stoppage, coupling fatigue, and leak resistance under full load conditions, confirming their reliability after repeated thermal cycling.
Finally, the complete bag and RoSS® Shell assembly was validated through instrumented drop tests based on ASTM D4169 standards. Bags of 1L, 5L, and, 10L volumes were frozen and dropped from heights up to 610 mm (24 inches), with all samples passing visual inspections and integrity tests post-thaw.
These results confirm that Saint-Gobain Life Sciences' cold storage bags meet the highest standards of robustness and reliability, ensuring safe handling, transport, and storage of high-value biopharmaceutical products.
Instructions for Use: Saint-Gobain Cold Storage Bag with RoSS® Shell
How to Load Cold Storage Bags into RoSS® Shell
This video provides step-by-step instructions on how to properly place Saint-Gobain Bioprocess Solutions' cold storage bags into the Single-Use Support (SUS) RoSS® Shell.
Saint-Gobain Life Sciences Cold Storage Assemblies Provide
RELIABILITY: Our cold storage bags are engineered with advanced film technology and tested at 100% by pressure decay to ensure maximum integrity during frozen storage. This significantly reduces the risk of leaks and product loss, even under extreme temperature conditions.
EXPERTISE: With decades of experience in material science and single-use systems, Saint-Gobain Life Sciences designs cold storage solutions tailored to your process needs. Our engineers collaborate closely with you to deliver robust, application-specific bags & assemblies.
REGULATORY: All cold storage bags are tested to meet stringent regulatory standards for cleanliness, sterility, biocompatibility, and extractables.
FLEXIBILITY IN DESIGN: Our cold storage bags are designed to fit within a protective shell, which defines the available volume and ensures optimal safety during frozen storage and transportation. While this format offers robust protection, we remain open to exploring alternative protection systems. In such cases, we offer full customization to meet your specific requirements in terms of volume, ports, and integration.
