2023年3月13日星期一

Will Gamma sterilization of COP vials change color

 When choosing pharmaceutical packaging, the compatibility with the drug and the overall quality of the product are important considerations for pharmaceutical companies. For some high value-added drugs, whether the COP vial will change color after Gamma sterilization is also a key issue. one of the factors to consider.


Requirements for COP vials for cell-based drugs

RTU(ready to use) 2ml COP vial


Sterilization is a necessary link for packaging to be put into use. Irradiation sterilization is a commonly used method. It is an effective method to kill microorganisms on most substances by using electromagnetic waves generated by ionizing radiation. The rays used for sterilization include electron beams, X-rays and gamma rays, etc., which can control the growth of microorganisms or kill microorganisms in a specific way. X-rays and γ-rays can oxidize other substances or generate free radicals (OH·H) to act on biomolecules, or directly act on biomolecules, breaking hydrogen bonds, oxidizing double bonds, destroying ring structures or making certain Molecular aggregation and other methods destroy and change the structure of biological macromolecules, thereby inhibiting or killing microorganisms.


Application of COP vial in high pH value drug

5ml COP vial


Application of COP vial in high pH value drug

100ml COP injection vial


COP vial is a kind of high-transparency pharmaceutical packaging, which is mostly used for the packaging of biological drugs, high-end chemical drugs and protein drugs. If the color changes after sterilization, it will affect the overall image of the drug and make the drug greatly discounted. Thanks to the good stability of cyclic olefin polymers, this product will basically not change color when sterilized with a radiation dose of less than 15kgy. There will be a slight greening phenomenon if it is above 20kgy, but it will recover part of it after a week. Guaranteed To ensure overall transparency.


In addition, COP vials also have good chemical stability and can tolerate drugs with a pH value greater than 10; low protein adsorption ensures the accuracy of drugs. These characteristics also make the application range of this packaging more extensive.


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