High-Performance Lifecube FT Frozen Storage Container--Validated from Film to Function

With the rapid development of the biopharmaceutical industry, the freeze-thaw process has become an indispensable step in key operations such as bulk storage and intermediate filling. During this process, products undergo drastic temperature gradient changes, repeated freeze-thaw cycles, and the risk of brittleness from extreme low temperatures, imposing higher demands on the material stability, mechanical strength, and biocompatibility of single-use systems, particularly freeze-thaw bags.

Traditional liquid storage and transport systems face numerous challenges when dealing with ultra-low temperature storage at -80℃, such as frequent issues like film embrittlement, weld seam cracking, and port leakage, posing potential quality and safety hazards.

Therefore, to ensure the safety and stability of the freeze-thaw process, the design of freeze-thaw bags must undergo systematic optimization across multiple dimensions, including film structure, welding processes, compatibility with protective systems, and validation strategies, comprehensively enhancing their performance under harsh conditions. Based on a deep understanding of industry needs and accumulated technical expertise, 

Cobetter introduces the high-performance freeze-thaw solution - Lifecube FT Freeze-Thaw Bag, committed to providing biopharmaceutical customers with safe, reliable, and scenario-comprehensive single-use freeze-thaw bag products and supporting services, helping to enhance the efficiency and compliance levels of freeze-thaw processes.

Blown Co-extrusion, Bi-directional Strength: Leading the New Trend in High-Purity Bioprocessing Applications

As single-use systems become widely adopted in the biopharmaceutical field, the film, acting as the core structural component, directly impacts the safety, compatibility, and process stability of the entire system through its physical properties, chemical stability, and cleanliness level.

Currently, the mainstream multilayer film production processes in the industry primarily include cast co-extrusion and blown co-extrusion.

Comparatively, the blown process, leveraging its unique stretch orientation and cooling formation mechanisms, demonstrates superior performance in terms of the film's mechanical strength, uniformity, and low-temperature flexibility, making it particularly suitable for freeze-thaw application scenarios demanding higher structural stability and low-temperature resistance.

Cobetter Lifecube FT Freeze-Thaw Bag utilizes Cobetter's self-developed TOPEVA multilayer co-extrusion film, manufactured using a high-purity blown process, ensuring excellent performance during freeze-thaw operations.

Table 1. Comparison of Different Co-extrusion Film Processes

Welding Process and Structural Design

In single-use bioprocessing systems, common single-use bag welding methods predominantly employ heat-seal welding. However, this process is highly sensitive to temperature control; uneven heating or excessive temperatures can easily cause a phenomenon known as "hot melt edge" at the weld seam periphery. This leads to localized melting of the film material, reduced mechanical properties, and even the risk of brittle fracture extending from the weld, thereby compromising the bag's overall sealing integrity and low-temperature reliability.

To overcome these challenges, Lifecube FT Freeze-Thaw Bag body employs high-frequency welding technology. This process utilizes a high-frequency electromagnetic field to cause internal molecular vibration within the film material, generating heat through mutual friction.

This enables rapid and precise localized heating of the welding zone without relying on direct high-temperature heating, enhancing mechanical integrity and crack resistance at -80℃.

Table 2. Comparison of Different Welding Processes for Single-Use Bags

Regarding shell design, the shells commonly used on the market typically comprise two completely separated chambers: one chamber accommodates the bioprocess fluid bag section, and the other houses the tubing section connected externally to the bioprocess fluid bag, thereby separating the bag from the tubing. Lifecube FT Single-Use Freeze-Thaw Bag adopts a "sandwich" design.

The freeze-thaw bag and tubing are placed within a single chamber, in designated freeze-thaw bag and tubing zones. This promotes heat exchange and circulation between the two zones while providing full protection to both the bag body and tubing, preventing damage during freeze-thaw cycles and handling. [2]

Simulating Handling Procedures: Comprehensive Validation Safeguards Freeze-Thaw

Freeze-thaw bags in practical bioprocessing often endure multiple physical challenges, including freezing, thawing, transportation, and manual handling. Material brittleness increases significantly at low temperatures, making structures vulnerable to damage. To ensure product safety and integrity under demanding application environments, we have designed and implemented a systematic drop and freeze-thaw validation protocol:

-80℃ Freezing Treatment

Bags are statically frozen at -80℃for 48 hours, simulating typical deep-cold storage and transport scenarios to evaluate material toughness and weld seam integrity at low temperatures.

Multi-Angle Drop Testing

Referencing ISTA 3A and potential collisions during actual operations, 9 typical drop angles and multiple orientations (face/corner/edge) are tested. This simulates impacts the bag might suffer during handling, loading/unloading, or accidental slips while in a frozen state.

Multi-Cycle Freeze-Thaw Testing

Bags undergo no fewer than 3 freeze-thaw cycles (freezing at -80℃) to assess structural tolerance under repeated freezing or multi-batch operations.

Microbial Barrier

Simulating extreme conditions where the freeze-thaw bag might contact contaminants in actual use, this verifies structural integrity and sealing post-sterilization and post-freezing are sufficient to block the penetration of exogenous microorganisms.

Wide Range of Sizes and Configuration Options

Available Capacities: 30mL / 100mL / 2L / 6L / 12L;
Optional Configurations: Thermoplastic Tubing / Silicone Tubing; Single-use Connectors / Aseptic Connectors;

Note: The 2L/6L/12L units are integrated freeze-thaw bags, each comprising a bag body and protective shell.