Best Practice LDO

Best Practice LDO

Best Practice LDO

Product catalog summary
Introduction
LABORATORI DERIVATI ORGANICI (LDO) is an Italian company specializing in the extraction of active pharmaceutical ingredients (API) from animal origins. The company has expanded across Europe, Asia, and South America and is now aiming to enter the US market by achieving FDA compliance for its API production.

Project Goal and Implementation
The goal of the project was to ensure that LDO's new production facility complies with FDA requirements, enabling entry into the US market. This involved implementing a weighing solution using Minebea Intec's load cells and weighing electronics, which are designed to meet Good Manufacturing Practices (GMP) regulations.

Products and Solutions
The solution included the use of load cells PR 6211, weight indicators PR 5410, and weight transmitters PR 5230. These components ensure precise measurement results and connectivity with superordinate systems. Their Hygienic Design reduces cleaning times and prevents cross-contamination, which is crucial for FDA compliance.

Customer Benefits
The selected weighing components guarantee exact measurement results and ideal connectivity, facilitating FDA compliance. The Hygienic Design of the equipment reduces cleaning times and ensures safe and hygienic installation.

Best Practices and Results
Minebea Intec's products have enabled LDO to achieve FDA compliance, allowing the company to enter the US market. The equipment's reliability and precision in weighing process vessels have been instrumental in meeting regulatory requirements.

Conclusion
Through collaboration with GEASS, a Minebea Intec partner, LDO successfully implemented a weighing solution that meets FDA standards. This strategic move has opened new market opportunities in the US for LDO.
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Catalog excerpts

Best Practice LDO-1

Best practice 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 LABORATORI DERIVATI ORGANIC! (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. Application 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. Products ■ Load cell PR 6211 Customer benefits 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. 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. US® LABORATORI DeRIVATI OrGANICI V*

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Best Practice LDO-2

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 Manufacturing...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.