Pharmaceutical Packaging White Paper
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.
Pharmaceutical packaging components such as ampoules, vials and stoppers require specific depyrogenation procedures appropriate for the component’s material. The main depyrogenation processes that will be referenced are dry heat and intense washing.
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