by Hank Rahe
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The term “communication” suggests that there's an exchange of information taking place. Communication concerning workplace safety should come from a variety of sources, including government agencies, both federal and state, employers as well as companies that provide materials and tools used to accomplish our jobs.
Safety from exposure to airborne materials, such as pharmaceutical compounds, is expressed as a concentration of the materials in the air we breathe and is usually described in terms of a unit weight per volume of air. Determination of the concentration comes from data accumulated in the development and testing process, which is defined and reviewed by the FDA.
Pharmaceutical companies follow standard practices in gathering data concerning the amount of the pharmaceutical compound required to cause an effect in a person. This data comes from established test methods and is used to determine a range of concentrations for humans. The dose range is then used to conduct clinical trials on volunteer human subjects. Information gathered during this closely monitored clinical testing establishes a therapeutic dose and helps to establish the level at which the compound first creates an effect in humans. This helps to establish the basis for a no-effect level that is a key element in determining a safe level of exposure in the workplace.
Using the no-effect level of the compound and established criteria, a team representing a number of areas within the pharmaceutical company establishes an exposure guideline for employees based on quantity, effects of the exposure and any other pertinent information about the compound.
To ensure that the exposure level is met during the handling of compounds, engineering controls, along with proper work practices, are developed. They are supported by personal protective equipment for non-routine operations. These safeguards supported by monitoring assure a safe work place.
Major pharmaceutical companies follow these practices, however, some manufacturers do not. Distributors, repackagers and the health care workers who deliver these drugs may not have the knowledge or technical resources to put the safeguards into their workplace.
The first step in helping to bridge the gap in worker safety is to communicate the need. This should be followed by information on the proper engineering controls and work practices.
The gap seems to be in the technical resources available to define what needs to be done. Contamination-control specialists, along with additional data from the pharmaceutical companies that develop the drug, can go a long way to fill this gap. However, pharmaceutical companies seem to be reluctant to provide exposure limits perhaps because of potential liability.
A solution to this problem may lie in a current practice used by companies in defining the contamination-control level. Companies tend to develop categories rather than a specific exposure limit to communicate internally.
Based on the recommended containment category, appropriate engineering controls could be established based on recommendations of contamination-control experts who would identify the proper technologies. Work practices to match the containment category could be developed by professionals involved in engineering and industrial hygiene. The combination of engineering controls and work practices could be matched to the category of protection required and turned into a implementation plan.
This approach reduces the cost and creates a means of providing a safe workplace for all workers involved in the industry.
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He is a member of the CleanRooms Editorial Advisory Board.