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Why pharmaceuticals choose COP Vials for Liquid Nitrogen Storage

Nov 06 , 2024

Pharmaceutical companies and researchers choose COP (Cyclo Olefin Polymer) vials for liquid nitrogen storage due to the unique material properties that make them well-suited for the stringent demands of cryopreservation. Here's why COP vials are often the preferred option:

What is Gene Therapy

Polymer Vial 2ml 5ml 10ml for cell and gene therapies

1. Exceptional Low-Temperature Performance

COP vialsare highly resistant to brittle fracture at ultra-low temperatures. Many materials, such as polypropylene, can become brittle or crack at temperatures below freezing, but COP remains flexible and maintains its strength in cryogenic environments, such as those involving liquid nitrogen (-196°C).

This makes COP vials more reliable for cryogenic storage, especially when the samples are exposed to sudden temperature fluctuations or rapid temperature changes during handling.

2. Superior Chemical Resistance

COP has a very high chemical resistance, meaning it can withstand exposure to various solvents, acids, bases, and other chemicals without degrading. This is important for pharmaceutical applications, where precise chemical integrity must be maintained for both biological samples and pharmaceutical products.

This is especially critical when storing biologics such as vaccines, monoclonal antibodies, or cell-based therapies, which may be sensitive to chemical interactions or contamination.

3. Low Moisture Absorption





Requirements for COP vials for cell-based drugs

RTU(ready to use) 2ml COP vial


COP vials have low moisture absorption compared to other plastics. When storing biological samples or drug formulations in cryogenic conditions, it is important that the vial doesn't absorb moisture, as that could alter the sample's properties or integrity over time.

In cryogenic storage, moisture trapped within or around a vial can cause frost or ice formation, potentially damaging sensitive biological material. COP's low moisture uptake ensures that the sample's quality remains stable during storage.

4. Enhanced Clarity and Transparency

COP vials are crystal clear, which allows for easy visual inspection of the sample without needing to open the vial or thaw the contents. This is essential for quality control in pharmaceutical and biotechnology applications where it is critical to monitor the condition of the samples while keeping them at low temperatures.

The transparency helps technicians monitor the fill level and avoid contamination or mishandling, thus maintaining the quality of the sample for longer periods.

5. Consistency in Sample Integrity

Pharmaceutical products, especially those involved in biopharmaceutical manufacturing (e.g., gene therapies, cell therapies, or biologics), often require long-term storage at extremely low temperatures to maintain their potency and viability.

COP vials provide a consistent environment by preventing leakage, evaporation, or changes in temperature that could compromise the integrity of the stored material.

With excellent sealing options (e.g., crimp caps or screw-threaded caps), COP vials ensure that the stored samples remain safe from environmental exposure, contamination, and temperature fluctuations.

6. Compatibility with Automation Systems

Many pharmaceutical companies rely on automated storage systems for managing large quantities of samples. COP vials are compatible with high-throughput storage systems, which often require uniform size and structure for efficient handling.

The durable and standardized design of COP vials ensures compatibility with cryogenic storage units such as liquid nitrogen tanks, vapor-phase storage units, or cryogenic freezers, minimizing the risk of human error and improving workflow efficiency.

7. Regulatory and Quality Assurance

Regulatory bodies such as the FDA and EMA have stringent guidelines for the storage of pharmaceutical products, especially biologics. Using COP vials allows pharmaceutical companies to meet these stringent requirements because the material ensures:


Key Benefits of COP Cryogenic Vials in Biological Storage

100ml polymer vial

    

Sample stability in extreme conditions

Minimal leaching or interaction with the stored material

No contamination risks, as COP is free from plasticizers or other additives that may leach into the sample.

COP vials are considered a trusted material that helps manufacturers comply with Good Manufacturing Practices (GMP) and other industry standards.


8. Long-Term Stability

COP vials are designed to retain the properties of the sample over time, ensuring long-term stability during cryogenic storage. This is particularly crucial for biologics and pharmaceuticals, where even minor changes in composition can impact the efficacy of the drug or the biological sample.

Since COP has minimal leachability and is free from contaminants, pharmaceutical companies can be confident that their samples will not degrade or lose efficacy during long-term storage.

9. Cost-Effectiveness for High-Quality Storage

While COP vials may be more expensive than other standard plastics, their long-term performance and reliability justify the investment for high-value pharmaceutical products that require cryogenic preservation.

In the long run, they help companies reduce the risk of product loss, contamination, or degradation, thereby preventing more costly failures or the need for product recalls.

10. Versatility in Sample Types

COP vials are versatile and can store a variety of sample types, including biological samples, biologics, vaccine formulations, cell lines, DNA/RNA samples, and pharmaceutical preparations. Their compatibility with a wide range of applications makes them suitable for multiple stages of the pharmaceutical production process, from research to distribution.




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