The cost of corrosion of pharmaceutical equipment can be significant, and ways to mitigate these costs are important to the industry. A recent report, Corrosion Costs and Preventive Strategies in the United States (1), provides an estimate of the total economic impact of metallic corrosion and identifies national strategies to minimize the impact of corrosion.The study estimates the direct cost of corrosion in the United States at $276 billion, or roughly 3% of the US gross domestic product (GDP). Indirect costs of corrosion are conservatively estimated to be equal to the direct cost, resulting in a total direct and indirect impact of corrosion of approximately $551 billion annually, or 6.3% of the GDP.
Another incentive to use more corrosion-resistant materials is to ensure compliance to federal regulations. Title 21 CFR Parts 210 and 211, "Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; General and Current Good Manufacturing Practice For Finished Pharmaceuticals," Subpart D-211.65 states:Equipment shall be constructed so that surfaces that "contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (2)."
This regulation clearly implies corrosion of equipment or product contamination of any kind is not acceptable.