
Group: MinebeaMitsumi

Catalog excerpts

Best practice A weighing solution opens door for FDA compliance The producer of active pharmaceutical ingredients LDO chooses a Minebea Intec weighing solution, enabling it the option of FDA compliance for API production and thus entering the US market. Key facts Customer benefits LABORATORI DERIVATI ORGANICI (LDO) specialises in the extraction of active pharmaceutical ingredients (API) from animal origins. Over the last decades, the company headquartered in Italy has continuously expanded across Europe, Asia and South America. For a new production facility and to enter the US market, LDO required API production compliance from the FDA. On account of the strict requirements GEASS, a Certified Minebea Intec Partner, brought in a weighing solution of load cells and different weighing electronics with Hygienic Design. The selected components for vessel weighing guarantee exact measurement results and ideal connectivity with superordinate systems. Their Hygienic Design reduces cleaning times and also enables LDO the option of FDA compliance for API production. Products Load cell PR 6211 Weight indicators PR 5410 Weight transmitters PR 5230 Customer LABORATORI DERIVATI ORGANICI (LDO) was founded in 1960 in Italy and has since become a specialist for producing the glycosaminoglycans Heparin sodium, Heparin calcium and Heparinoids. These are used as medication to prevent clotting in blood and to treat, e.g., thrombosis and heart attacks.
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Project goal and implementation In the recent past, LDO has invested a lot of resources to implement new production divisions. Its projection building comprises an area of approx. 2,000 square metres, a space used for injectable, oral and topical use active pharmaceutical ingredients products. The plant is fitted with equipment, instrumentation and devices that need to comply with FDA requirements so as to be able to obtain the approval of North American authorities. To obtain the FDA approval it is important that drugs are manufactured under conditions and practices required by the Good...
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