Impact of vial quality on frozen drug storage

29 januari 2025

Storing biopharmaceuticals in a frozen state presents new challenges for packaging materials. Standard Type I glass vials are commonly used, but they have some drawbacks, such as breakage due to extreme temperatures. In response, new types of vials have been developed for injectable drug products to improve safety and performance. In a study different vial materials were examined to determine their suitability for frozen drug storage.

When vials are frozen and thawed, they expand and contract. These changes put stress on the material, which may affect how the vial interacts with the drug or impact its overall integrity. The researchers examined how different vial types interact with frozen drug formulations and their response to mechanical stress. The surface characteristics, including hydrophobicity, surface free energy, and roughness, were evaluated. The results showed that these properties remained stable after undergoing freeze-thaw cycles and did not influence the interaction between the vial and the drug product.

Particles

Furthermore, the formation of particles originating from the vial material was investigated using light and electron microscopy. It was found that coated glass vials exhibited only minimal particle release, even under extreme stress conditions. However, in severe drop tests, a small number of particles were observed in coated polymer vials.

In terms of container closure integrity and gas permeability, all vials maintained a secure seal, preventing any leakage. However, it was noted that uncoated and coated polymer vials had slightly higher oxygen permeability compared to glass vials.

Conclusion

Different vial materials can be suitable for frozen drug storage. The choice of vial should depend on the specific drug formulation and product requirements. While some vials may allow more oxygen transfer, they still maintain integrity and prevent contamination. Understanding these factors helps in selecting the best packaging for biopharmaceuticals to ensure their safety and effectiveness.

Read the research article 

Bron: ScienceDirect

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