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.
Productos y tecnologías
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Automatización del proceso
Como integradores de sistemas, unimos nuestro conocimiento sobre la tecnología de procesos y el diseño de plantas a los productos de software de los líderes del mercado.
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.
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GEA Insights
El avance que revolucionó el secado por atomización
En 1976, los ingenieros de NIRO respondieron a un reto competitivo replanteándose las posibilidades del secado por atomización. Su idea se materializó en la torre multietapa MSD. Cincuenta años después, ese mismo principio fundamental contribuye a transformar los líquidos en los productos en polvo que se utilizan en productos nutricionales esenciales y en medicamentos importantes en todo el mundo. Perfeccionada a lo largo de décadas de experiencia en ingeniería, conocimiento de las necesidades de los clientes y desarrollo continuo, la torre de atomización MSD es una historia de innovación con un impacto duradero.
Más allá de la máquina: cómo potenciar el rendimiento de la planta
El hecho de que una máquina sea eficiente no significa que la fábrica lo sea. La mejora real suele comenzar por ir más allá de los equipos individuales y comprender cómo los procesos, los sistemas energéticos y las decisiones operativas se influyen mutuamente. Se trata de un enfoque holístico diseñado para descubrir oportunidades que, de otro modo, podrían pasarse por alto.
Cómo una válvula transforma la manera de elaborar alimentos y bebidas
En las plantas de alimentación y bebidas, las válvulas suelen accionarse mediante aire comprimido. GEA Hydract® Actuation Technology mueve las válvulas mediante agua, en un circuito cerrado controlado digitalmente. El resultado es una válvula que puede mantenerse en su sitio con exactitud y regularse con precisión. Esto se traduce en un menor consumo energético y un mayor control.
