Background: The following case study involves a company with operations in pharmaceutical manufacturing.  To control IH risk, the company uses a control banding process that specifies what employee protection measures are appropriate based on where a specific compound falls within a predetermined airborne exposure range.  The control band is ranked from 1-5 with range 1 being the most potent and 5 being the least potent.

Hazard Identification

The hazard identified within this particular chemical manufacturing operation involved exposure to highly potent active pharmaceutical powders. Pharmaceutical powders at varying exposure levels can be extremely hazardous to workers who handle or work near them. These powders have many exposure routes including inhalation, skin contact, skin absorption, or ingestion.

Hazard Intervention

The company identified the hazard as a chemical exposure to employees. The abatement approach involved a change in the engineering controls to eliminate the need for operator use of powered air purifying respirators (PAPRs) in the hazard ranges from 2-5.  The capability of containment bags to prevent release of powder into the work environment was augmented. 

Impacts of the IH Activity

Many positive health, business, and risk management benefits resulted from the implementation of the engineering control and containment modifications. Health improvements resulted from the intervention because employees were not directly exposed to the pharmaceutical powders. Operator exposure rates were significantly reduced. The business process was improved because savings in the amount of $172,800 per year resulted from reduced PPE usage; employee time to put on PPE was also reduced resulting in a savings of $78,000 per year. The intervention allowed for a 40% reduction in non-hazardous waste generation. Since less waste was generated, less waste required disposal. Less IH sampling was needed to verify an adequate level of employee protection. Savings from reduced IH sampling were $30,000 per year. Positive risk management changes included assurance of regulatory compliance, potential FDA/EMEA benefits for contained processing, and less processing area to be cleaned.

Financial Metrics

After entering the data into the ROHSEI software the intervention resulted in a positive net present value (NPV) of $76,668.  The internal rate of return (IRR) was 16% while the return on investment (ROI) was 7%. The discounted payback period (DPP) was 4.2 years.

Lessons Learned

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