The customerwas a pharmaceutical company, that needed a comprehensive solution for its production process, where it would be possible to work safely and efficiently with a sticky and lumpy active substance. They needed to carry out several critical steps of the process in one clean room, including filtering and drying, crushing lumps, milling, micronization and final packaging. In addition, the client required high tightness throughout the manufacturing process, with an OEB rating of 5 and CPT of 0.1 µg/m^3.
Solution provided:
Aware of the complexity of the client's requirements, a team of technical experts and engineers designed and implemented a customized solution that fully integrated all stages of the process while maintaining the highest level of protection. The solution provided allowed the client to not only comply with the strictest safety standards and pharmaceutical regulations, but also enabled the industrial processing of drugs and minimized downtime due to maintenance and cleaning.
Achieved results:
- By implementing customized isolator and milling system solutions, the client significantly improved their pharmaceutical manufacturing process;
- Increased efficiency: The integrated system allowed for seamless transitions between process steps, minimizing downtime and maximizing productivity.
- Improved safety: FPS's OEB5 containment solutions has provided a safe working environment for operators, minimizing the risk of exposure to hazardous API.
- Regulatory compliance: The client's company met strict regulatory requirements, demonstrating a commitment to quality and safety in pharmaceutical manufacturing.
Using experience in custom isolator design, milling technology and high containment solutions, FPS was able to meet the client's requirements and provide a comprehensive solution that exceeded their expectations.
