Physical Operations are crucial steps in API Manufacturing which have to be understood and controlled. We at Siegfried understand the importance of physical operation steps like e.g. extraction, distillation, crystallization, filtration or centrifugation and drying technologies. We have implemented dedicated tools, equipment and experimental protocols to investigate and optimize physical operations whenever needed.
The physical properties of an Active Pharmaceutical Ingredient (API), such as flow properties and particle size distribution, are crucial for the success of a drug formulation and its bioavailability. Therefore, we continually invest in the necessary physical operations (from crystallization, filtration and drying technologies to milling, micronization and spray drying) which best tailor an API’s properties to the needs of a formulation. By bridging the gap between bulk API manufacture and drug product formulation, Siegfried provides you with the physical processing capabilities you need and can expect.
We offer you more through a range of equipment and technical expertise for crystallization, drying and milling, and we further can manipulate an API’s physical properties through spray drying and micronization.
Large-scale cGMP spray drying requires both the infrastructure and operational excellence of a chemical plant and the mindset and environment of pharmaceutical manufacturing. Siegfried’s longstanding background in drug substance and drug product manufacturing brings together the capability, experience and services your project needs. Please contact us to openly discuss how we can assist you.
- Capacity: Pilot Spray Dryer 125 m³ N2/h; Plant Spray dryer 400 kg N2/h
- Operating under full GMP in clean rooms (> 100’000 and 10’000 particles/ft³)
- Closed loop with Nitrogen; suitable for flammable solvents; infrastructure and license to operate with HAP (Hazardous Air Pollutant) solvents like Dichloromethane
Milling and Micronization
The last operations in the manufacturing of a bulk API are milling and micronization. Here the physical properties are finalized and c-GMP requirements for manufacturing are high. The requirements for defined and robust Particle Size Distribution of APIs have increased with the years. Siegfried provides milling and micronization services and expertise from lab to manufacturing scale.
Certain prevailing trends in pharmaceutical development are driving the increasing need for micronized API with mean particle sizes below 10 µm. One factor is that APIs are becoming more potent such that a fine and narrow particle size distribution is needed to guarantee e.g. content uniformity of the formulation. Secondly, APIs increasingly have lower solubility, and micronization is needed to increase the surface to volume ratio to increase bioavailability.
To meet this growing market need for micronized API, Siegfried is expanding its Jet Mill capabilities. By using Design of Experiment and Quality by Design approaches, we evaluate robust parameters for micronization and milling to ensure reliable particle size distribution, working with our customers to achieve the desired specification.