Hormones & Steroids
Steroids, endogenous hormones such as the sex hormones estrogen and testosterone or the hormones of the adrenal cortex, cortisol and aldosterone, play a key role in metabolic processes and have a number of pharmaceutical applications, including hormone therapy, anti-rheumatic, anti-arthritic and bodybuilding preparations.
Predominantly used in the global hormone replacement therapy, currently worth about $3.6 billion, the three major segments comprise estrogen, growth and thyroid hormone, and testosterone replacement therapy. A major market driver is the increased awareness of postmenopausal hazards amongst women; others include an ageing population, innovative drug delivery systems and the pharmerging economies.
Ensuring Operator Health and Safety
Occupational steroid exposure can occur when the active ingredients are inhaled, ingested or absorbed through exposed skin. Although exposure can occur at any point in the production process, the greatest potential for worker steroid exposure during steroid/hormonal manufacture occurs during weighing, material transfer, equipment loading or milling.
Because of the different manufacturing procedures used and the strict environmental control requirements necessary for aseptic production, the risk of exposure is greatest during blending granulation, drying, tablet compression and coating. It can also occur in the packaging area, during sampling and quality control, the testing of raw materials, intermediates and finished products, and during maintenance and cleaning.
Manufacturers have the responsibility to protect their operators, particularly those working with potent and toxic compounds, and set defined areas or controls necessary to eliminate the risk of product cross-contamination on a case-by-case basis.
GEA can help you to achieve these goals. From facility design and layout, manufacturing process controls (including adherence to standard operating procedures) and environmental control systems (HVAC) to extraction systems, industrial hygiene solutions and fully integrated, end-to-end containment solutions. We can advise and assist you to determine what level of containment is required where and when, optimizing the manufacturing process and making it efficient, safe and cost-effective.