Potent Compound Safety - Why is it important?

Categorization and placement of active pharmaceutical ingredients into control bands is an important step in the drug development process and a necessary part of any potent compound safety program. In most cases a preliminary assignment of a potent compound should occur shortly after the decision to pursue development has been determined. Affygility Solutions' experienced industrial hygiene and toxicology professionals can determine the proper control band assignment for your APIs. Our prices are very competitive and turn around is rapid. We can assign your potent compound to either your own internal control banding scheme or to the 4- or 5-band systems common to many potent compound safety programs. Contact us today for a no-obilgation quote.

Control Banding - Background and History

Since 1942, occupational health professionals in the pharmaceutical industry have recognized the potential for occupational disease caused by overexposure to active pharmaceutical ingredients (APIs), potent compounds and hazardous drugs. In their article, Health effects of exposure to active pharmaceutical ingredients (APIs), Heron and Pickering (2003) provided an in-depth review of adverse health effects within the industry.

More recently, the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) have had limited involvement regarding this issue. However, in cases where employees have experienced adverse health effects due to overexposures to potent compounds, OSHA has applied the general duty clause. Application of the general duty clause in cases where a hazardous substance does not have a permissible exposure limit is provided in their policy letter: Enforcement Policy for Respiratory Hazards Not Covered by OSHA Permissible Exposure Limits. In addition, in 2004, NIOSH released its alert titled Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs. Biotechnology and pharmaceutical companies should establish a potent compound safety program.

Preventing and controlling exposures

As the trend towards more potent pharmaceuticals continues, environmental health and safety professionals (EH&S) in the industry must respond by taking measures to prevent and control exposures. These measures include:

• Risks assessments for compounds early in development
• Placement of compounds into potent compound categorization or control banding schemes
• Occupational exposure limits (OELs) for active pharmaceutical ingredients
• Industrial hygiene monitoring for APIs
• Engineering controls to provide containment and prevent overexposures
• Potent compound handling and exposure control practices
• Potent compound safety training

The EH&S and toxicology professionals at Affygility Solutions have performed 100s of potent compound categorizations and development of occupational exposure limits for active pharmaceutical ingredients. Contact us now to discuss how we can assist you in your potent compound safety program.