Human Factors Leading to Occupational Exposure of APIs

In the past 17 years or so of experience within the pharmaceutical industry I’ve observed a number of human factors that have led to occupational exposure of active pharmaceutical ingredients (API)s. The majority of these factors could easily be resolved through effective training and education of operators and other employees. While I’m sure that this isn’t an all encompassing list, and I’m always amazed at the creative ways that employees can expose themselves, I will attempt to highlight the most common ones in no particular order:

  • Failure to understand that these compounds can have health effects. The failure to believe that these drugs and active pharmaceutical ingredients can and do have potential health effects is important. APIs need to be categorized and placed into appropriate control banding strategies.
  • Lack of any kind of a potent compound safety program.
  • Lack of, or improper use of engineering controls. It’s very common to visit facilities where dry powders of potent compounds are being handled out in the open with no attempt to contain or minimize the creation of dust. If there are engineering controls, the employees have a limited understanding of capture velocity and capture distance. Get yourself the latest copy of the ACGIH Ventilation Manual, and understand/communicate the basic concepts to employees and operators.
  • Use of air hoses to blow off dry powders – NO!!!! Based on the statistical charts prepared by Affygility Solutions, a single instant of using an air hose to blow dry powders off the top of an intermediate bulk container (IBC) can result in a 400% increase in the employee’s 8-hour time-weighted average.
  • Manual shaking/scraping/dry sweeping/etc. of dry powders. Again, creation of dust.
  • Failure to clean containers and equipment prior to removal from production suites. Prior to removing containers and equipment from isolated areas and containment, the materials should be either clean in place or bagged for thorough cleaning elsewhere. This holds true for production suites containing large equipment, as well as glove boxes, powders weighing hoods, and similar devices.
  • Unprotected employees entering production suites. Almost every facility I’ve been in, employees have entered production suites unprotected because they are “only going to be in there for a minute.” Watch out for support personnel such as maintenance, quality control, and the like.
  • Assuming exposure stops once the equipment stops. If the room hasn’t been thoroughly cleaned and air monitoring performed, don’t assume exposure stops.
  • Random selection of respiratory protection. Employees need to understand the concept of protection factors. Randomly selecting respiratory protection is unacceptable.
  • Failure to follow proper de-gowning procedures.

Other resources: There are a number of books that can be helpful in understanding containment and engineering controls. Here are a few links:

Containment in the Pharmaceutical Industry, J.P. Wood

Containment Systems: A Design Guide, Hirst, N., et la.

Help support this blog by using the above links to order. If you have any questions regarding potent compound safety, please contact me at 303-884-3028.


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About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

Affygility Solutions - provider of potent compound safety, webinars, and compliance management software