Method for controlling amount of residual oxygen in packages for medicine filling

Abstract

The invention belongs to the field of medicine packages, and discloses a method for controlling the amount of residual oxygen at the top of an ampoule or a vial filled with pharmaceutical preparationand a production method of a filled finished product obtained by filling the ampoule or vial with the pharmaceutical preparation and sealing the ampoule or vial. According to the method, high fillingspeed and low after-nitrogen-filling amount are adopted, and the amount of the residual oxygen at the top of the ampoule or vial and the defective product occurrence rate are effectively controlled.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical packaging, and in particular relates to a process for reducing residual oxygen in packaging when filling pharmaceuticals. Background technique [0002] Most pharmaceutical products are sensitive to oxygen and are easily oxidized and deteriorated, causing discoloration and odor, etc., which not only affect the efficacy of the product, but also produce toxic and harmful substances that may even endanger life. Drugs containing hydroxides, calcium salts and other ingredients are easy to absorb Carbon dioxide forms carbonates. In order to reduce the amount of oxygen and carbon dioxide that the medicines are exposed to, the oxygen and carbon dioxide sensitive medicines are usually packaged in packaging forms such as vacuuming and filling with inert gas (usually nitrogen). Therefore, controlling the amount of residual oxygen in the packaging during the production process is one of the important c...

AI Technical Summary

Problems solved by technology

When using ampoules or vials to package medicines, nitrogen-filled packaging is mostly used. However, due to the limitation of the gas-filling process, the content of nitrogen and oxygen in the finished product packaging of ampoules or vials will be different from the expected ones. Influenced by airtightness, the above-mentioned gas content will change with the prolongation of storage time

In addition, the content control of nitrogen and oxygen in the finished product packaging will be affected by the volume of the packaging bottle. Those skilled in the art can understand that for large-packed vials or infusion bottles, such as 10-200ml, the control of residual oxygen It is relatively easy, and usually can be controlled below 2% or even 1%. For ampoules or vials with a capacity of 1-5ml, due to limited operation, it is better to reach below 5%, or about 3%. Therefore, in practice In industrial production, the nitrogen filling process and residual oxygen control of small-capacity packaging are much more difficult than large-capacity packaging, and the two are incomparable

Images