Packaging components used in pharmaceutical drugs and medical devices are scrupulously cleaned before use to ensure patient safety. Regulators expect drug manufacturers to demonstrate compliance with federal requirements intended to assure clean, sterile and safe drug products enter the medical marketplace. Depyrogenation, the reduction of bacterial endotoxin, is critical in preparing packaging components for use in injectable drug products. Depyrogenation can be defined as the reduction of pyrogenic substances, including bacterial endotoxin, and is generally achieved by removal or inactivation. There are several techniques in which depyrogenation can be achieved. The more common techniques are shown in the table below. The two most utilized techniques for pharmaceutical packaging components are dry heat exposure via a depyrogenation oven and rinsing by USP and WFI water.
|Rinsing||Endotoxins are washed away by USP and WFI water.|
|Dry Heat||Endotoxins are destroyed by exposure to high temperature.|
|Moist Heat||Traditional autoclaving will not destroy endotoxins; however, the combination of hydrogen peroxide and pressure are effective.|
|Ethylene Oxide||Endotoxins are destroyed by nucleophilic substitution in the glucosomne of Lipid-A.|
|Ultrafiltration||Filters out endotoxins by molecular weight.|
In conclusion, depyrogenation is a critical process that, when validated, reduces bacterial endotoxins to an acceptable level. There are many factors to consider when depyrogenating pharmaceutical packing components such as the component’s material and intended application. With this said, if you have any questions on the subject, please feel free to come to WHEATON® for the answers!