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Performance-based exposure control limits for pharmaceutical active ingredients

B D Naumann¹, E V Sargent, B S Starkman

¹Merck & Co., Inc., Whitehouse Station, NJ 08889-0100, USA.

American Industrial Hygiene Association Journal

|January 1, 1996

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Pharmaceutical companies now use a performance-based approach to set employee exposure limits for potent drugs. This method categorizes compounds by hazard, guiding containment strategies for worker safety.

Area of Science:

Occupational Health
Pharmaceutical Science
Toxicology

Background:

Traditional risk assessment methods for setting employee exposure limits are becoming insufficient for increasingly potent pharmaceutical compounds.
Difficulty in establishing no-effect levels for certain drugs necessitates a new approach.

Purpose of the Study:

To introduce a novel performance-based approach for establishing employee exposure limits.
To categorize pharmaceutical compounds based on toxicological and pharmacological properties to guide containment strategies.

Main Methods:

Developed a performance-based approach assigning materials into five hazard categories (PB-ECL Categories 1-5).
Criteria for categorization focus on the impact of exposure on human health.
Created matrices to guide engineering controls and safe handling practices for laboratory and manufacturing operations.

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Main Results:

The performance-based exposure control limit (PB-ECL) system categorizes compounds from low potency (Category 1) to extremely potent (Category 5).
Containment strategies range from conventional handling to advanced closed systems with robotics.
Assignments dictate necessary engineering controls and safe handling practices to ensure employee safety.

Conclusions:

The performance-based approach provides a structured method for setting exposure limits for diverse pharmaceutical compounds.
This system ensures appropriate containment measures are implemented based on inherent material hazards.
It supports the safe development and manufacturing of increasingly potent pharmaceutical agents.