Tablet compression is still one of the most challenging unit operations in solid dose manufacturing. With growing demand for contract manufacturing, CMOs need to be able to produce a huge variety of products at an economical speed, even when they comprise challenging formulations.
Flexibility and Productivity
As the need to process highly potent APIs becomes increasingly important, Haupt Pharma has cultivated a centre of excellence for this specific application. Tablet compression, from both a containment and processing perspective, is still one of the most challenging unit operations in solid dose manufacturing. With growing demand for contract manufacturing, CMOs need to be able to produce a huge variety of products at an economical speed, even when they comprise challenging formulations. Additionally, specific health and safety challenges arise when potent APIs are processed, requiring the use of equipment that combines very high flexibility with high productivity and an appropriate containment performance. GEA's MODUL™ rotary presses meet these criteria at Haupt Pharma’s Münster, Germany site.
Whereas most pieces of unit operation equipment (granulation, drying or blending) were assessed to be adequately contained, the transfer steps were a potential area of concern. Haupt Pharma opted for Müller drums in combination with GEA’s BUCK® MC split butterfly valves. Owing to its mechanical complexity, the tablet compression process demanded special attention, therefore Haupt Pharma decided to use GEA MODUL™ presses.
The Haupt Pharma Münster site has assessed the containment performance of its four MODUL™ S presses intensively by measuring particle load in the production environment under operating conditions. The two presses produce a huge number of tablets. When the turret of the single-sided press is equipped with BB tooling, it is able to produce up to one million tablets per hour, having been fitted for up to five-fold multi-tip tooling. Additionally, product changeover can be achieved in less than 2 hours, during which all product-contact parts are removed in a contained manner. A second ECM and second set of peripheral equipment are brought to the compression area and allow production to resume in less than 2 hours. The first set of parts is then cleaned off-line in a dedicated washing area, with no interference to manufacturing.
Health and Safety
After a successful placebo-based site acceptance test (SAT), the presses were taken into clinical production and air samples were assessment of their containment capability. Sampling heads were placed close to the most critical areas that had been identified by a risk analysis. Seven series of tests were done, comprising 26 individual measurements. The results were below the detection limit of 0.001 µg/m3.