Pyrogens destruction

In the case of injectables and ophthalmic preparations which are manufactured aseptically but do not receive a sterilization treatment in their final container the packaging has to be sterilized. Dry heat at 170°C is often used for vials and ampoules. Containers and closures may also be sterilized by moist heat, chemicals and irradiation, but consideration for the destruction or removal of bacterial pyrogens may be necessary. 

In general, all parenteral products must be manufactured under strict, current good manufacturing processes (cGMP) to ensure the final product is sterile and pyrogen-free. Sterilization is defined as the complete destruction of all living organisms or their spores or the complete removal from the product. 

Dry-heat processes have two main targets microorganisms and their by-products, pyrogens or endotoxins. Depyrogenation is the process that destroys the chemical activity of these by-products. Destruction of microorganisms and endotoxins by dry heat is considered an oxidative process, which is almost a combustion. Depyrogenation requires a higher temperature than sterilization and can be summarized as follows ... 

For most practical purposes the term endotoxin can be regarded as synonymous with pyrogen, depyrogenation with endotoxin destruction, and pyrogen-free with endoioxin-free. 

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