Welding and Biotechnology

expanding biopharmaceutical industry in the USA has placed an increasing emphasis on quality standards and documentation to expedite the approval process for new therapeutic products by the FDA (United States Food and Drug Administration). This article discusses recent developments in quality standards used by mechanical contractors to assure conformance of pharmaceutical piping system installations to current good manufacturing practices (CGMPs).

The use of orbital welding technology has played a key role in improving piping system quality because of the smoothness of the inner weld bead and the repeatability of the process. These properties of orbital welds are essential for assuring the cleanability and sterilizability of critical pharmaceutical piping systems. The article describes the effective use of orbital welding systems and the increasing use of this technology in Latin America.

This paper was originally presented at the Latin American Pharmaceutical Show, Centro Costa Salguero, Buenos Aires, Argentina, March 29