Manufacturing Hormone and Steroid Drugs: Ensuring Operator Health and Safety
Steroids, endogenous hormones such as estrogen and testosterone and the adrenal cortex hormones, cortisol and aldosterone, play a key role in metabolic processes and have a number of pharmaceutical applications, including contraception, hormone therapy, antirheumatic, antiarthritic and bodybuilding preparations.
Predominantly used in global hormone replacement therapy, 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 aging population, innovative drug delivery systems and the pharmerging economies.
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 exposure during steroid/hormonal drug production occurs during weighing, material transfer, equipment loading or milling.
Nevertheless, unit operations such as blending, granulation, drying, tablet compression and coating can also present hazards. It can even 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.
Products & Technologies
Showing 4 of 26
Analytical, in-line control & measurement devices
Combining process monitoring using online analyzers, together with solid process engineering principles and advanced process modelling techniques will enable processes to be actively controlled in order to compensate for input variations.
CIP/SIP Solutions
Innovative CIP concepts of GEA meet comprehensive high standards. Our experts guarantee product safety at every point of the process. Every upgrade is adapted to individual local conditions and customer requirements and leads to noticeable savings.
Contained Materials Handling Systems
Contained Materials Handling solutions for Primary and Secondary Pharmaceuticals and Healthcare. With extensive experience within the generics sector, supply a wide range of technologies and equipment that improve and enhance the efficiency and performance of Oral Solid Dosage production.
Continuous Direct Compression Line
The ConsiGma® DC for direct compression is the latest expansion of GEA's continuous portfolio for cost effective, compact, high yield manufacturing systems. It offers a robust and flexible manufacturing method for a wide range of products.
Downloads
GEA Insights
Innovating for impact: shaping better solutions for customers
Industrial production is being asked to use fewer resources, become smarter and keep equipment productive for longer. At GEA, that is changing how innovation happens: engineering, customer insight, digital expertise and service come together earlier – when a solution can still be shaped at its core.
