By Dean Calhoun

Each year, pharmaceutical manufacturers spend millions of dollars on engineering controls to prevent employee exposure to highly potent active pharmaceutical ingredients (HPAPIs). These engineering controls can include isolators, local exhaust ventilation, high containment split butterfly valves, downflow booths, and more. But in many cases, after review of industrial hygiene monitoring results, these engineering controls fail to deliver the desired results. Is it because of a poor design? Did the manufacturer of the engineering controls overstate the containment capabilities? Or is it something more elusive, like employee work practices?

Based upon years of experience in the pharmaceutical industry, we often observe a variety of human factors and poor work practices that defeat the containment capabilities of even the most sophisticated engineering controls. These practices can include

1. open container transfers of active pharmaceutical ingredients,
2. use of dry methods to “clean-up” spills,
3. failure to thoroughly clean the outside of containers and equipment prior to removal from containment,
4. unapproved modifications to engineering controls,
5. breaching of containment by personnel or materials, and
6. a serious misunderstanding that just because the equipment stops, that the potential for exposure also stops.

Employees must understand that, beyond the potential for adverse health effects, product outside of containment, product in the air, and product on the floor means loss revenue and a decrease in yield. Also, in a multi-product facility it increases the potential for cross-contamination of products.

Fortunately, the majority of these practices can be remedied by applying a few basic principles:

• Written procedures for the use and maintenance of engineering controls must be established.
• Operators and supervisors must be thoroughly trained in these procedures, as well as trained in the potential occupational hazards of the materials they will process. Consistent with occupational safety and health regulatory requirements, training on the hazards of the materials that they will work with must occur prior to handling. Employees must respect the potential hazards of highly potent compounds.
• Containment validation studies must be performed. While, containment studies from the engineering control manufacturers may be available, these studies are generally performed under ideal conditions. In addition, once installed at a given facility, a number of important factors can affect the performance of the engineering controls.
• Routine observation and auditing of work practices must occur to ensure consistency over time. If deviations from procedures are noted, corrective actions must occur.Finally, it should never be assumed that once controls are installed that your containment project is complete. Containment of potent compounds is an ongoing effort and requires a team effort on the part of operations, engineering, maintenance, quality, and industrial hygiene.

Dean M. Calhoun is the President and CEO of Affygility Solutions. He is an American Board of Industrial Hygiene Certified Industrial Hygienist (CIH). Dean can be reached at dcalhoun@affygility.com.