Formulation Innovation in Generics Manufacturing
|A leading manufacturer of generic pharmaceuticals needed to improve control and efficiency of its formulation processes. A sophisticated formulation software solution helped the company achieve its goal.|
The U.S.-based company is a leading developer, manufacturer and distributor of generic pharmaceuticals. Operational excellence in quality and compliance is a key success driver for the company. That is why they always look for ways to improve their processes.
With regard to its formulation process, the customer saw several improvement options that could be realized with a sophisticated weighing solution. Full integration of the formulation process to the enterprise resource planning (ERP) system would significantly improve process control, helping prevent operator mistakes and ensuring complete tracking and tracing.
Improved process control
An innovative solution from METTLER TOLEDO combines weighing technology with the sophisticated formulation software FormWeigh.Net®. Three weighing stations were equipped with KCC300 floor scales, KA15 and PB303 bench scales, ID30 PC application weighing terminals as well as barcode readers and label printers.
FormWeigh.Net guides the operator through the formulation process. The system automatically makes potency adjustments at the weigh station, avoiding calculation mistakes that might be made by the operator. The software is fully integrated to the ERP system, ensuring complete tracking and tracing. The entire weigh-and-dispense operation is paperless because all data is transmitted electronically. Order data is downloaded and consumption data is uploaded, requiring no paper and no manual data entry by operators.
Full tracking and tracing
Orders scheduled in the ERP system are sent to the FormWeigh.Net system. FormWeigh.Net then calculates the required materials to process the order. Warehouse operators print picking lists to retrieve the materials and deliver them to the weigh stations. After operators weigh a material, consumption data is automatically sent back to the ERP system for full tracking and tracing. The FormWeigh.Net system is fully validated and provides 21 CFR Part 11 compliance.
In addition to the benefits delivered by the weighing solution, such as improved process control and efficiency, better accuracy of the formulation process and prevention of data-entry mistakes, METTLER TOLEDO's service helped convince the customer of whom to award the contract. A three-level software support ensures smooth operation of FormWeigh.Net, including local support near the customer site, second-level support at the METTLER TOLEDO site in Columbus, Ohio, and third-level support from the company's headquarters in Switzerland.
Find out how FormWeigh.Net can improve your formulation process.