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Pharmaceutical companies, compounding pharmacists and physicians preparing estrogen and other hormone products need to be aware of the dangers of over exposure and provide properly engineered containment controls to protect themselves and their employees. Concentrated estrogen powder can be prepared for delivery by both capsule and tablet form, with a single dose containing amounts of estrogens that exceed the daily exposure limit.
Preparation of both capsules and tablets involves several steps in the manipulation, including weighing the active estrogen and other powders required in the formulation, mixing of these items in the proper proportions and then preparing the final dosage form, either capsules or tablets. These activities generate airborne “dust” containing the active estrogen, which can enter the breathing zone of personnel performing these activities. If dust or powder can be observed in the work place, it is likely that the exposure limit is being exceeded for employees who routinely work in this environment. During these operations, as small as a single prescription can create enough airborne estrogen to exceed the exposure limits. If this operation is performed several times daily, employees quickly exceed the safe levels of exposure.
In order to properly protect workers, engineered controls must have the ability to contain small quantities, and, for that reason, the preparation of these products should be in a closed system. Open systems, such as laminar flow hoods, require personnel to reach into the control zone thus creating the possibility that they may bring materials out of the control zone, by movement of hands and arms, as well as the materials that attach themselves to clothing. Even at quantities as small as one gram of active powder, barrier isolation technology should be implemented as the control device.
Pharmaceutical companies, which are preparing commercial batches, protect their employees throughout the entire manufacturing process of weighing, granulation, mixing, creating the final product form and packaging. Pharmacists and physicians who are preparing estrogen products should pay close attention to any activity where the concentrated estrogen is present-any dusty activity such as mixing, tableting or capsule filling-and implement proper containment controls. Packaging activities, unless being performed continually, are unlikely to exceed exposure guidelines.
Estrogens, hormones that can have far-reaching adverse effects, belong to the group of compounds with exposure limits in the low nanogram range. Overexposure to estrogen can cause serious side effects for both males and females. In males, the side effects can range from loss of facial and body hair, to enlarged breast tissue, while females experience significant changes in hormonal levels.
The safe handling of estrogen, or other types of hormone products, requires that personnel understand the amount of product being prepared, in terms of concentrated drug substance, the duration of activities and the capabilities of the engineering controls provided. The routine of daily manipulating concentrated drug substances greater than milligrams without engineered containment controls can result in over exposure causing long-term affects.
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He has over 30 years' experience in the healthcare industry, as well as four years in academia. He is an expert in the areas of conventional and advanced aseptic processing. He is the past chairman of the board of the International Society of Pharmaceutical Engineers, and is a member of the CleanRooms Editorial Advisory Board.