Recommendation for an OEL for an Active Pharmaceutical Ingredient (API)

Client

A global contract developer and manufacturer of pharmaceutical products

Background

The use of Occupational Exposure Limits (OELs) to protect workers from potential adverse health effects arising through their handling of chemicals in the workplace is a long-established tool for industrial hygienists. Working in the pharmaceutical sector presents a particular challenge in that many of the chemicals that are being handled are designed to be biologically active, and increasingly pharmaceuticals are being developed with greater and greater potency. Whilst the effects of such agents may be beneficial to the patient under medical supervision they would not be considered acceptable if they were to arise as a result of exposure at work.

Project Goals

To recommend an acceptable Occupational Exposure Limit (OEL) as a time-weighted average (TWA) airborne concentration for an API based on a normal 8-hour work day and 40-hour work week. Assess need additionally for any Short-term (15-minute) exposure limit (STEL) and requirement for warning against dermal exposure.

Approach

The client provided detailed reports on the toxicological and pharmacological characteristics of the active pharmaceutical agent, including a large number of both completed and on-going non-clinical and clinical studies. Bibra evaluated the whole toxicological profile to identify potential endpoints that may give rise to concern in the context of occupational exposure. Using the effective therapeutic dose as the key point of departure, together with appropriate assessment factors, recommendations for an Occupational Exposure Limit could be made.

Project Outcome

We provided the client with a recommendation for an 8-hour TWA Occupational Exposure Limit (OEL) and were able to provide re-assurance that a Short-term exposure limit (STEL) or warning against dermal exposure were not required. This will enable the client to implement appropriate industrial hygiene control measures to protect their workers in the most cost-effective way.

Project Leaders

Philip Copestake

Pharmaceutical Product Toxicological Support

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