FDA Regulations and cGMP Guidelines
Hudson Valley Lyomac freeze dryers help companies meet FDA regulations and cGMP guidelines by offering advanced features such as validated processes, automated control systems, data logging capabilities, and strict adherence to temperature and pressure parameters. This ensures consistent and traceable production, product quality, and compliance with regulatory standards.
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Freeze Drying for API Production
Freeze drying is important for API (Active Pharmaceutical Ingredient) production because it allows for long-term stability, preservation of potency, and easier storage and transportation.
Lyophilizing API helps remove water without damaging the active compounds; this maintains the structural integrity of sensitive molecules, minimizing degradation and chemical reactions, and extending shelf life. 
Tailored API Solutions
Hudson Valley Lyomac customers rely on our expertise to deliver a tailored freeze drying solution for their API needs. By understanding their specific requirements, offering customization options, providing technical expertise, and delivering reliable equipment, we ensure a seamless integration of freeze drying processes into their API production workflows.
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Hudson Valley Lyomac maintains a staff of qualified Field Service Engineers that provide technical assistance for the installation, commissioning, repair, and maintenance of Hudson Valley Lyomac freeze-dryers. Our technical support centers are located in Europe and the US, as well as in key regional Customer Centers worldwide.