Pharmaceutical Industry

The abundant, hazardous Active Pharmaceutical Ingredients can become suspended in air and become a significant hazard. There are thousands of different APIs and their limits differ based on the chemicals within them. Here are some examples of the chemicals associated with APIs and their PELs:

  • Acetone: 2400 mg/m³
  • Arsenic: 0.5 mg/m³
  • Ethylene glycol: (C) 1 mg/m³
  • Nicotine: 0.5 mg/m³
  • Warfarin: 0.1 mg/m³

(C) - Ceiling limit

These hazardous materials can also contaminate surfaces without human detection, so it's important to have a limit for visible residue of APIs. The general limit is:

  • Visible Residue for APIs: 1-5 μg/cm²

OSHA gives you a formula to calculate personalized limits. "A common rule of thumb is to use the maximum allowable dose (based on the chemical's airborne exposure limit in units of μg/m³) and the approximate area of a worker's hand (100 cm²) to arrive at an acceptable value for surface contamination in work areas (i.e., a housekeeping standard)."

It's also important to keep the dusts from manufacturing controlled. OSHA has issued many standards for air quality which include very clear limits for nuisance dust to minimize combustion hazards.

  • Nuisance Dust
    • Respirable Fraction: 5 mg/m³
    • Total: 15 mg/m³


Another organization that is governs and influences the pharmaceutical industry is the FDA. Their regulations concern product quality.

The FDA's Current Good Manufacturing Practice (CGMP) rules “provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.” 

In other words, the CGMP rules say that pharmaceutical manufacturers must maintain a clean facility. Here are some common Q&A's regarding CGMPs that illustrate the rules better. 


Failure to comply with OSHA limits or the CGMP rules has its downsides including serious fines. 


To view more regulations and recommendations for this industry, visit the following websites.

OSHA - Occupational Safety and Health Administration of the U.S. Department of Labor

ACGIH - American Conference of Governmental Industrial Hygienists

NIOSH - National Institute for Occupational Safety and Health

NFPA - National Fire Protection Association

EPA - United States Environmental Protection Agency

CSB - U.S. Chemical Safety and Hazard Investigation Board


Please note, this is a list of common applicable regulations, not a comprehensive list of all regulations applicable to this industry and may not reflect the latest publications.