Containment of Potent and Toxic Compounds

Determining and controlling hazards

The discovery, development, manufacture, and testing of pharmaceuticals requires the use of many potentially toxic and hazardous chemicals. That's why Eli Lilly and Company is committed to ensuring that employees receive consistent and accurate hazard information about chemicals they may be exposed to. This commitment is reflected in our global hazard communication program.

Currently, more than 100,000 Material Safety Data Sheets are available to Lilly employees worldwide on both a computer network and CD-ROM.
Approximately 3,000 of the MSDSs are for Lilly-manufactured materials
Six thousand caution/warning statements have been developed for use in container labels and in manufacturing protocols, which contain both compound-specific hazard information, and the specific required personal protective equipment.

In 1994, the 6,000 caution/warning statements were provided in six languages: English, Spanish, Portuguese, French, Italian, and German.
In 1994, a supplemental hazard communication training program was rolled out at the Global Health and Safety conference that included specific hazard information on the new development compound raloxifene.

Once hazards have been accurately defined and described, they must be controlled using engineering and administrative control strategies. To guide us in this effort, specific Lilly Exposure Guidelines (LEG) have been established to provide an airborne concentration of a substance to which unprotected workers may be exposed day after day during a 12-hour work shift. In 1994, final LEGs or interim LEGs were established for 10 Lilly compounds. To date, LEGs have been established for 129 compounds.

GEMZAR

The development of Gemzar, a new anti-cancer drug, is an example of Lilly's commitment to the hazards containment program. The Lilly Exposure Guidelines for gemcitabine hydrochloride, the active material, is 0.2 microg/m3, averaged over a 12-hour shift. Gemcitabine hydrochloride is handled at our Tippecanoe, Indianapolis, and Fegersheim, France manufacturing facilities. Special engineering controls have been applied and verified with industrial hygiene monitoring to contain dust levels to the LEG where personal protective equipment is no longer required.

Gemzar^® (gemcitabine hydrochloride, Lilly)

The Glove Box

Custom designed for Lilly, the glove box is the newest technology for containing potent compounds used in pharmaceutical manufacturing.