The Polish pharmaceutical sector represents about 1.3% of the country’s gross domestic product and approximately 1.7% of its export trade. GEA is no stranger to this market. During the last 10 years or so, GEA Pharma & Healthcare has supplied a wide range of process technologies for development, pilot-scale and commercial production applications, including standalone (batch) granulation equipment, integrated oral solid dosage (OSD) lines and machinery for inhalable respiratory products.
The customer
Within this burgeoning environment, Aflofarm — one of the biggest generics and pharmaceutical product producers in Poland — manufactures more than 180 brands and boasts the number one sales position for over-the-counter products in the country. The company has previously established research and development facilities in which they’ve invested in process technology to enhance the quality and formulation of generic products.
Always wishing to remain current and ahead of the market, Aflofarm contacted GEA to discuss solutions that would enable them to increase their production capacity for multiple OSD products. Key requirements included an integrated batch granulation and drying line with top and tangential spray fluid bed granulation with a working capacity of 70–600 L.
High containment functionality was not an immediate requirement but needed to be considered for future applications. High productivity levels were, however, a prerequisite, as was ease of cleaning and, if possible, a wet-in-place system.
Other factors that needed to be addressed were speed — from start-up to first commercial batches — simple scale-up from an existing smaller capacity line, ease of product transfer from in-house equipment and yield optimisation (avoiding additional processes when possible). Being able to increase sub-lot batches within production shifts with design and functional efficiencies was also on the must-have list. No small task, but one that GEA was very able to tackle and complete.
The PMA 800 and MP6 were designed to provide similarities in terms of geometry; but, needless to say, local experts were available to provide support, offer advice regarding the conveyance of functional process parameters from the existing line and ensure risk-free product transfer and scale-up.
Primarily, GEA supplied an integrated large-scale high-shear mixer and a fluid bed processor. This included integrated control for the loading system, high shear granulation, wet milling, fluid bed drying, discharging and dry milling. The PMA 800 and MP6 were designed to provide similarities in terms of geometry compared with the existing line at Aflofarm. In addition, local experts were available to provide support, offer advice regarding the conveyance of functional process parameters from the current plant and ensure risk-free product transfer and scale-up.
The solution
A number of innovations that were part-and-parcel of GEA lines also helped with the sales process. The use of a vacuum-driven liquid ring pump in the granulator, for example, reduces the loading time for raw materials by more than half. The swept-back design of the impeller blade ensures that the energy required to achieve the granulation end point is delivered in a shorter timeframe.
And, perhaps most notably, the multi-head spray nozzle (multi-nozzle) liquid addition system both optimises liquid distribution and reduces the overall process time, which also means that less liquid is required in the granulation process. The upshot is that, with less liquid to be evaporated, shorter drying times were achieved.
Beyond the hardware
Interestingly, when Aflofarm bought the new, higher capacity equipment, they weren’t sure how the integrated software would work. It was quite a leap forward compared with previous versions and what was already onsite. However, it was found to be logical, user friendly, intuitive and delivered much higher levels of control — both from an operational and validation point of view. You can run many batches; you don’t have to stop the system; and it’s great for both batch and continuous manufacturing.
Similarly, having a hands-off production and cleaning regime in place offers a lot of time and cost benefits … and reduces the personnel count in the facility. Systems such as this help to validate both production and cleaning, which, particularly during the past few years, has become crucial for almost every customer.
Aflofarm was one of GEA’s first customers to implement the multi-nozzle system on a bottom-drive high shear processor … and this is significant. The multi-nozzle, which sits over the single spray lance system on the high-shear mixer, is reportedly working really well. The whole point of the innovation is to increase productivity and make the granulation process more efficient.
It provides an even spray throughout the powder bed, which, in turn, optimises granule formation. As a result, the wet milling process handles less oversized material and operates more efficiently. The upshot of this process optimisation was that Aflofarm not only minimised unnecessary batch losses, but they also saved money during the tableting stage by ensuring the right profile for the final product.
“We can confirm,” says an Aflofarm spokesperson, “that the spray ring liquid addition system is better. Because the ring uses several nozzles, the binder is uniformly distributed throughout a larger area. During the granulation process, small spheres of wet material are formed and the final granules are formed quicker compared with the existing single nozzle system.”
The GEA difference
There are many reasons why GEA won this project. First, beyond the technology that fully met the brief in terms of operational efficiency, throughput and quality, the company also supplied a much-improved and user-friendly process management system, which reduces the overall complexity and enhances batch control. Having such an intuitive system plays a significant role in manufacturing performance.
Furthermore, when a customer buys new machinery, they have a piece of equipment that needs to be commissioned and validated, etc. They then have to ramp up operations, go through tech transfer and jump a lot of hurdles to get their first (validated) commercial batch ready to sell. During that period of time, they can either do it on their own … or they can get support from experts like GEA. The company offers experienced and knowledgeable specialists who can make the process a lot smoother and quicker!
