A pharmaceutical company producing over-the-counter medicines for the global market conducted product trials with the new FE CPS (Continuous Processing System) dosing-mixing unit at an early stage. Now this manufacturer has opted for several Continuous Direct Compression lines from Fette Compacting.
“Our long-standing partner wants to continue to help people take responsibility for their own health and the well-being of their family members,” emphasizes Nicolas Walter, Group Lead Application Testing at Fette Compacting. “This includes medications that enable the treatment of minor illnesses as needed, such as colds or gastrointestinal complaints.”
In search of simplicity
To ensure the success of this division for the future, the company tested various new ways of producing tablets - with a clear favorite, as Nicolas Walter adds: "First and foremost, it was a matter of finding simplified formulation and processing techniques. Our partner had been convinced of the Continuous Manufacturing process for some time because of its numerous process- and quality-related advantages. Up to that point, the only thing missing was the right set-up for large-scale tablet production."
This is where the experts at Fette Compacting come in: they launched the compact and flexible FE CPS dosing-mixing unit in summer 2022. Together with a tablet press, this process unit forms a comprehensive Continuous Direct Compression line, thereby setting new standards in efficiency, quality and simplicity in continuous pharmaceutical production.
In combination with the FE55 and the operating terminal, the FE CPS forms a complete Continuous Direct Compression line. It processes a wide variety of powdered initial substances with throughputs ranging from about five to 200 kilograms per hour.
Flow regulating agent: not necessarily a must
The product trials were to demonstrate the extent to which the FE CPS is suitable for two important OTC medicines. “The goal was to get by as far as possible without interruptions as in batch-to-batch production,” explains Nicolas Walter, “as well as without upstream processes such as wet or dry granulation. It was decisive that we achieve a consistent product quality while simplifying the formulation. The Direct Compression line complied with this demand in several trials. It even proved its capability of simultaneously processing various initial substances without adding a flow regulating agent.” Regulating agents which change the flow properties of powders are not only an additional cost factor – they also pose a regulatory issue. The frequently used silicon dioxide in particular is increasingly coming under the scrutiny of health authorities, as it is based on nano particles and can have impacts on health under certain circumstances. It is therefore possible that such admixtures may no longer be used in the future. The FE CPS test runs confirmed that a flow regulating agent is no longer necessary at all if the process is appropriately arranged and gently processed.
Installation: suitable for existing production facilities
A decisive role was also played by the plant’s compactness, as Nicolas Walter adds: “The test scenarios for a location in Germany showed that the line can be well-integrated in existing production facilities. The dosing-mixing unit only requires minimum space beside the tablet press or, an as alternative, in an adjacent room. Conversions for two-level installation are completely eliminated.”
Furthermore, the combination with the FE55 rotary press was advantageous as this high-performance tablet press features three compression stations instead of two, for example. This enables a longer dwell time at lower pressure and thus gentler processing of formulations. Add to this the variable throughputs ranging from around five to 200 kilograms per hour, which means the plant can be used flexibly for a variety of different scenarios: from research and development through up-scaling to largevolume production.
Depending on the respective application, several near-infrared spectrometers ensure highly-efficient process analysis in real time, thereby guaranteeing consistent quality control. Easy operation of the line as a whole via a central HMI (Human Machine Interface) was also a key criterion. Many operators are well-versed in the intuitive control of the tablet press and can quickly familiarize themselves with the additional functions for dosing and mixing.
“All in all, the technology enabled us to present a turnkey overall solution for Continuous Manufacturing,” says Nicolas Walter with satisfaction. “Our partner has great confidence in the technology and the expertise behind it. This is ultimately the reason why they opted for several lines at once.”