Depyrogen and verification of chemical injection in direct contact with drug packaging materials
In order to ensure the safety of chemical injections,it is necessary to strengthen the effective control of pyrogen in direct contact with drug packaging materials.Based on the summary and comparison of domestic and foreign regulations and guidelines,combined with the review practice,the common process of pyrogen removal of packaging materials and related verification requirements are discussed in this paper.The process used to remove pyrogen from packaging materials mainly depends on the types and properties of materials.The process of depyrogenation should be studied and verified to prove that the ability of depyrogenation meets the requirements.The common depyrogenation process of glass packaging materials is dry heat treatment,the common rubber plug depyrogenation process is washing,and plastic packaging materials are usually controlled by granule endotoxin,high temperature blow molding process and production environment to ensure that the bacterial endotoxin meets the requirements.In the verification of depyrogenation,endotoxin indicators should be reasonably selected and the verification criteria for depyrogenation should be established.The usually acceptable standard is a decrease of at least 3 logarithmic units of endotoxin.
chemical injectionspackaging material in direct contact with the drugprocess of depyrogenationvalidation of depyrogenationability of depyrogenation
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