Can Your Medicine Packaging Withstand-196°C?

In the New Age of Advanced Therapies, Packaging Matters More Than Ever. As the pharmaceutical industry moves rapidly into the era of cell and gene therapies, mRNA-based vaccines, and advanced biologics, the demands on packaging have never been greater. One critical challenge? Ensuring medicine packaging can withstand cryogenic temperatures as low as –196°C—the boiling point of liquid nitrogen.

sterile vial in tray

What Is an RTU COP Vial?

RTU stands for Ready-To-Use, and COP refers to Cyclic Olefin Polymer, a cutting-edge plastic used in pharmaceutical packaging.

Unlike traditional glass vials, RTU COP vials offer:

High break resistance

Lightweight and shatter-proof design

Exceptional barrier properties against moisture and oxygen

No risk of delamination or extractables

They come pre-sterilized and are ready for immediate filling—saving time and reducing contamination risk.

The –196°C Low Temperature Challenge

For drugs and therapies that require cryopreservation, such as:

CAR-T cell therapies

Stem cell treatments

mRNA vaccines

DNA plasmids

Maintaining integrity at –196°C is non-negotiable.

RTU(ready to use) 2ml COP vial

This is known as the cryogenic or low temperature challenge. RTU COP vials are engineered to pass this test by maintaining:

✅ Container Closure Integrity (CCI)

✅ Structural integrity (no cracks or breaks)

✅ Label and print stability

✅ Compatibility with automated cold chain systems

Why COP Outperforms Glass at Cryogenic Temperatures

While glass has been a traditional packaging material for decades, it struggles at ultra-low temperatures:

Risk of breakage during handling or drop tests

Delamination and particle contamination

Higher weight and fragility in logistics

COP offers a superior alternative by combining durability, transparency, and flexibility, even in extreme cold.

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

Applications in Advanced Therapies

Cryogenic-ready RTU COP vials are already being used in the packaging and distribution of:

CAR-T therapies

iPSC and MSC stem cells

Gene editing tools (CRISPR/Cas9 components)

Novel RNA and DNA therapeutics

As demand for cold chain logistics and cryopreservation grows, more pharmaceutical manufacturers are transitioning to RTU COP vial systems.

Key Challenges & Considerations for -196°C COP Vials

Even with COP's advantages, the -196°C environment demands careful attention:

Thermal Shock During Freezing/Thawing:

Risk: Rapid immersion in LN2 or rapid warming can cause differential contraction/expansion, stressing the vial or seal.

Mitigation: Controlled-rate freezing/thawing protocols are ESSENTIAL. Vial design (wall thickness uniformity, base geometry) plays a role. Validated processes are non-negotiable.

Seal Integrity Under Extreme Stress:

Risk: Stoppers (elastomers) also contract significantly. The COP-stopper interface experiences massive stress cycles. Potential for loss of seal integrity, leading to LN2 ingress (contamination) or sterility breach.

Mitigation: Selection of cryo-optimized stoppers (special formulations designed for extreme low-T flexibility and minimal shrinkage). Precise stopper placement and validated crimping/capping processes. Use of secondary packaging (e.g., cryo-bags) as a safety measure.

Material Qualification & Long-Term Data:

Risk: Long-term (years/decades) stability data at -196°C is still evolving. Potential for very slow, unforeseen material changes.

Mitigation: Rigorous vendor qualification. Accelerated aging studies (though true extrapolation is complex). Real-time monitoring programs for critical products.

Industry Standards and Testing

To qualify for use at –196°C, RTU COP vials are tested under strict regulatory and performance standards:

USP <1207>: Container Closure Integrity Testing

ISO 21973: Guidelines for the transport of cell-based medicinal products

ASTM D4169: Distribution testing for cold chain packaging

Final Thoughts

The future of medicine depends not just on scientific breakthroughs, but also on smart packaging solutions. RTU COP vials are at the forefront of that innovation—proving that it's possible to protect life-saving therapies even at –196°C.