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.
Продукты и технологии
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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.
Continuous Granulation Lines
Continuous Processing is becoming more and more important in the pharmaceutical industry. GEA takes the lead in introducing this innovative technology with ConsiGma® - continuous high-shear granulation and drying lines.
Continuous Processing Lines for Pharma
At GEA, we believe that continuous processing improves the quality of pharmaceutical end products: by focusing on quality during the whole product lifecycle, not just “tested in” quality; and by understanding the capability of your processes, managing sources of variability and decreasing any associated risks.
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Аналитика GEA
The breakthrough that changed spray drying
In 1976, NIRO engineers responded to a competitive challenge by rethinking what spray drying could do. Their idea became the multi-stage dryer MSD. Fifty years later, the same fundamental principle helps turn liquids into the powders used in essential nutrition products and important medicines around the world. Refined through decades of engineering expertise, customer insight and continuous development, MSD is a story of innovation with lasting impact.
Не только оборудование: повышение эффективности работы предприятия
Эффективное оборудование не является автоматической гарантией эффективности всего предприятия. Реальные улучшения часто начинаются с того, что мы перестаем ограничиваться рассмотрением отдельных единиц оборудования и начинаем вникать в то, как технологические процессы, энергетические системы и эксплуатационные решения влияют друг на друга. Этот комплексный подход позволяет выявить возможности, которые в противном случае могли бы остаться незамеченными.
Как клапан меняет подход к производству продуктов питания и напитков
На предприятиях по производству продуктов питания и напитков клапаны, как правило, приводятся в действие с помощью сжатого воздуха. GEA Hydract® Actuation Technology обеспечивает привод клапанов с помощью воды в замкнутом контуре с цифровым управлением. Результатом стал клапан, который можно точно зафиксировать в нужном положении и регулировать с высокой точностью. Это обеспечивает снижение энергопотребления и повышение уровня контроля.
