Packaging Pharmaceuticals With Low Humidity And/Or Low Oxygen Requirements

By Fred DiPasquale, PE, Validation Manager, Steve Hamaday, Director, Engineering, Rebecca Jones, Quality Supervisor, Frank S. Santillo, Ph.D., Sr. Director Research Services, Sharp

The pharmaceutical industry must live by the rules of the regulatory bodies such as the FDA, EMEA, and other organizations. In the US Code of Federal Regulations, Title 21 – Food and Drugs – Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs, states:

“…the regulations…contain the minimum correct good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirement of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.”

In short, the onus is on manufacturers and their contract partners to meet patient expectations and deliver a safe, pure, effectively packaged drug. To this end, key considerations are to identify protective packaging materials/components and to ensure that drug products are packaged in an environment with the appropriate humidity and oxygen levels.