JOHN P. FARRIS¹, J. JUSTIN MASON-HOME²
1. President & CEO, SafeBridge Consultants, Inc., Mountain View, California, USA
2. Managing Director, SafeBridge Europe, Ltd., Liverpool, UK

Abstract

Pharmaceutical compounds that can elicit health effects at low levels have been known for many years and include materials such as steroid hormones, opioids, peptide hormones, anti-cancer compounds, and prostaglandins. As pharmacological selectivity has increased within the pharmaceutical industry, therapeutic compounds have become more potent over time. Accordingly, there has been a corresponding increase in the occupational health risk associated with research and development of these increasingly potent drug entities. This article is intended to assist in providing a summary description of safe work practices, facility and process design, exposure controls, and associated equipment considerations when working with potent pharmaceutical compounds in the laboratory.

INTRODUCTION
Some pharmaceutical compounds are among the most potent and toxic compounds encountered in the laboratory. These molecules, specifically designed to exert a pharmacological effect on human beings, have been known to elicit health effects at low airborne levels occupationally in both manufacturing and laboratory environments. Pharmaceutical substances reported to have caused effects to workers include materials such as steroid hormones, opioids, peptide hormones, anti-cancer compounds, prostaglandins, and can also include new chemical entities (NCEs). As pharmacological selectivity has increased within the pharmaceutical industry, therapeutic compounds have become more potent over time. Serious health effects have even occurred in workers handling very small quantities of pharmaceutical substances in pharmaceutical research laboratories, scale-up environments (Kilo Lab and Pilot Plant) as well as in larger scale operations.
Accordingly, there has been a corresponding increase in the occupational health risk associated with research and development of these increasingly potent drug entities. This could not be starker than in the relat ...