What are the quality inspection items of COP vial

COP vial is a packaging container processed from a new type of material, which is mainly used for the storage of proteins, anti-tumor, high pH value and other drugs. The quality of packaging is closely related to the safety and stability of drugs, so what are the quality inspection items for this packaging?

RTU(ready to use) 2ml COP vial

COP vials are widely used in biopharmaceuticals. Compared with ordinary drugs, biopharmaceuticals have stricter requirements on packaging quality. Appearance is the first impression. First of all, the appearance of COP vials should have a uniform transparent color. The surface of the bottle should be smooth and flat, without deformation and obvious scratches. There shall be no trachoma, oil stains, air bubbles, and the mouth of the bottle shall be flat and smooth. Secondly, it also includes visible foreign matter, sterilization test, identification, sealing, absorbance, acidity and alkalinity, total organic carbon, extractable metals, residue on ignition, etc.

5ml COP vial

100ml COP injection vial

In addition, if the precipitate or other toxicity on the packaging material will also affect the safety of the drug. Therefore, the quality inspection items of this packaging also include dissolution tests (solution clarity, color), biological tests (cytotoxicity, skin sensitization, intradermal irritation, acute systemic toxicity, hemolysis).

The above are the quality inspection items of COP packaging materials. These items are indispensable and together constitute the quality system of this packaging, and are also the key to ensuring the final quality of the product and ensuring the stability and safety of the drug within the validity period.