Thermal stability testing requirements for vaccine bottles

Apr. 02, 2021

Vaccine bottles are of great significance in ensuring the stability and safety of drugs, and are an important factor in ensuring the immune effect of animals. Therefore, the quality of vaccine bottles has always been the focus of the industry.

Thermal stability testing requirements for vaccine bottles

plastic injection vial

Thermal stability refers to the heat resistance of the package, which aims to test the deformation ability of an object under the influence of temperature. The smaller the deformation, the higher the stability. Thermal stability testing is suitable for steam sterilized products in the filling area. Steam sterilization is a common method of sterilization through pressurization and heating. Because the heating temperature is too high, it is tested whether the product is deformed under high temperature. It is a key test index to ensure its stability.

In response to the quality requirements of vaccine bottles, the industry has the relevant standard T/CVDA 3-2019 "Veterinary Liquid Vaccine Polypropylene Bottles". Among many testing items, thermal stability is the key to ensuring the quality of medicines. The detection method is as follows: Take an appropriate amount of this product, place it in a high-pressure steam sterilizer, and evenly rise from room temperature to 110°C within 15-20 minutes, keep it for 30 minutes or 121°C, and keep it for 15 minutes. Naturally cool until the pressure inside the autoclave is the same as outside. Open the cover of the autoclave and take out the sample for observation. There should be no cracks or obvious deformation.

The thermal stability test of vaccine vials is only one of its many testing items. Qualified vaccine vials should meet the requirements of industry standards. This is the basic requirement for veterinary drug packaging and the key to ensuring the stable quality of veterinary drugs.

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