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Why Depyrogenate Pharmaceutical Packaging Components?

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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.

 

Depyrogenation Technique  Description 
 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!

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About the Author : Jeffrey Reid

A member of the scientific community for 10 years, Jeffrey Reid earned his chemistry degree from the University of Delaware. Jeff has also worked on the development of sub-micron particles for HPLC columns, and earned an M.B.A. in Marketing from Goldey-Beacom College. Jeff worked as a Product Manager at BUCHI Corporation, specializing in laboratory technologies and techniques, such as pressurized solvent extraction (PSE), automated solvent extraction and solid phase extraction (SPE). Currently Jeff works at WHEATON Industries as a Global Market Manager, where his main focus is finding solutions for customers in the pharmaceutical market.

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