The industry is headed to drug combination products containing two or more regulated components, said Hal Miller of PACE Solutions, LLC, at MD&M West.
• Combination product examples could be a drug-eluting stent, an antibiotic bone cement, or orthopedic implants with genetically engineered human protein. The difference between drugs and medical devices is that a device package protects the product, allows for sterilization and maintains sterility. Drugs and biologic products are focused on the safety and efficacy of the product until its expiration date. Also, drugs are very regulated, while devices have guidelines. Combination products can be shipped through the same distribution system.
• Medical device packaging materials must be nontoxic and biocompatible, with porous materials providing adequate microbial barrier. Sterilization should not affect materials or packages. Use aging or stability studies to demonstrate there are sufficient physical properties to protect the device from damage and maintain sterile package integrity until its expiry date.
• For drug packaging, refer to the FDA's Guideline for container closure systems for packaging human drugs and biologics, published in May, 1999. Drug packagers should be concerned with the proposed FDA guideline for container and closure systems, and ensure that components are suitable for use. Batch-to-batch uniformity of packaging components is also important.
--By Jim Butschli, Editor
