OEL Values for Potent Compounds and Workplace Monitoring by a Pharmaceutical Company

W.M. Grath Corporate Quality Environment, Health and Safety, Bristol-Myers Squibb Company

Summary :
Controlling exposure to potent compounds in the manufacturing setting is an important part of an overall strategy to provide a safe and healthy workplace. A number of classes of medicines produced by the pharmaceutical industry are considered to be highly potent and may require a number of workplace controls in order to limit the potential for employee exposure. The presentation will include a general discussion of the process by which Occupational Exposure Levels (EOLs) are set for those compounds that may have a cytotoxic mechanism. A review of the parameters to be considered during the OEL setting process will be described.

When an OEL has been established, a review of the manufacturing environment is then conducted in order to determine the appropriate level of control for the production processes. In order to verify the effectiveness of control systems, a workplace monitoring program is developed and implemented. This presentation will include : a description of those issues to be considered during the development of a workplace monitoring program, program implementation steps, and actions that may be required to be taken after a review of the monitoring results.

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