Solid pharma process development and manufacturing tablets
At this year’s Achema in Frankfurt, Syntegon is presenting new solutions for the production of solid pharmaceutical dosage forms. With the fluid bed laboratory unit Solidlab 2 Plus and the tablet press TPR 200 Plus, the company will display upgraded versions of two proven systems at stand C71 in hall 3.1. Both the Solidlab 2 Plus and TPR 200 Plus enable time-saving product transfers from laboratory to production scale, also supporting continuous manufacturing processes. In addition, both systems ensure easy cleanability as well as optimal operator protection thanks to containment features.
The fluid bed Solidlab 2 Plus allows manufacturers to flexibly develop granulation, drying, and coating processes, as it covers all steps in a single product vessel. With the Solidlab 2 Plus, Syntegon also offers the only solution available on the market for the development of both batch and continuous manufacturing processes. “The Solidlab 2 Plus can be configured according to customer requirements, thus offering maximum flexibility in terms of both process development and the subsequent transfer to production scale,” says Fritz-Martin Scholz, product manager at Syntegon. The fluid bed, equipped with a powerful Hüttlin bottom spray system, can process batch sizes ranging from 0.25 to 12 kg.
The Solidlab 2 Plus provides a basis for the development of batch processes and the subsequent transfer to production equipment, as the laboratory unit and the production platforms from Syntegon use the same technology. “Solidlab 2 Plus helps manufacturers determine the optimal process parameters for batch operation and transfer them to the batch production plant using scale-up software. Companies thus save valuable development time and cost,” Scholz adds.
In addition to batch processes, the Solidlab 2 Plus can facilitate the development of continuous manufacturing processes. When combined with a feeder-blender-unit, the Solidlab 2 Plus becomes the Xelum R&D, Syntegon’s development platform for continuous manufacturing. In this configuration, the Solidlab 2 Plus covers the central granulation steps of the continuous production platform Xelum. Process parameters from the Xelum R&D can be transferred directly to the Xelum production unit, eliminating the need for scale-up. This applies to fluid bed granulation as well as direct compression without granulation.
Thanks to software-supported automatic Design of Experiments (DoE), the Xelum R&D can automatically run several pre-defined parameter sets thus efficiently developing the design space of the formulation.
For handling highly potent active ingredients, the system can be equipped with containment features such as ‘safe change’ filters and split valves, as well as a recipe-controlled automatic cleaning system for both batch and continuous manufacturing processes.
The TPR 200 Plus tablet press offers processing for various granules and pellets. It also features a light containment concept with dust-tight machine protection up to OEB 3. Besides the production of small and medium-sized batches, the compact system supports the development of continuous tablet production. When combined with the Solidlab 2 Plus, the TPR 200 Plus is particularly suitable for laboratory-scale test runs and subsequent scale-up. “The TPR 200 Plus is essential to process development,” emphasizes Andreas Nüssle, product manager at Syntegon. “Our new solution helps pharmaceutical companies to achieve the best possible tableting.”
Among other features, the APD Feeder (Automated Process Development) helps make that possible – thanks to the new, automatically adjustable powder feeder with APD software, companies can define the optimum parameters for the formulation feed into the die. The new system also allows them to improve existing processes and increase product yield and quality in tablet production. Process efficiency benefits from an integrated Data Acquisition System (DAQ), which allows assessment of tablet quality and process stability on the basis of up to 600 measuring points per compression process. “In this way, the TPR 200 Plus provides crucial information on where to further improve tableting,” Nüssle continues. The press’ light containment concept includes an optionally integrable dry cleaning function with glove ports and specially designed suction nozzles for extracting dry powder residue. Rotors with removable segments help to avoid the need to remove individual sealing rings, improving the cleanability of the rings on the press plungers.
In addition to the equipment on display, the Syntegon portfolio includes further solutions for the production of solid pharmaceuticals. These include stand-alone machines and complete solutions, both for laboratory-scale and high-performance applications. In addition to tablet presses, the company offers capsule filling machines, tablet coaters, high-shear mixers, and continuous manufacturing systems such as the Xelum platform.
A comprehensive consulting and service offering spanning the entire machine lifecycle rounds out the portfolio. Whether spare parts service or remote maintenance, modernization, or preventive maintenance, Syntegon covers a wide range of new and customized services, including new digital solutions for holistic machine data collection, processing, and analysis.
Learn more about Syntegon technologies and services and meet the experts from August 22 to 26 at the Achema 2022 in Frankfurt. Visit Syntegon at C71 on stand 3.1.
The Covid-19 pandemic led to the country-wide lockdown on 25 March 2020. It will be two years tomorrow as I write this. What have we learned in this time? Maybe the meaning of resilience since small companies like us have had to rely on our resources and the forbearance of our employees as we have struggled to produce our trade platforms.
The print and packaging industries have been fortunate, although the commercial printing industry is still to recover. We have learned more about the digital transformation that affects commercial printing and packaging. Ultimately digital will help print grow in a country where we are still far behind in our paper and print consumption and where digital is a leapfrog technology that will only increase the demand for print in the foreseeable future.
Web analytics show that we now have readership in North America and Europe amongst the 90 countries where our five platforms reach. Our traffic which more than doubled in 2020, has at times gone up by another 50% in 2021. And advertising which had fallen to pieces in 2020 and 2021, has started its return since January 2022.
As the economy approaches real growth with unevenness and shortages a given, we are looking forward to the PrintPack India exhibition in Greater Noida. We are again appointed to produce the Show Daily on all five days of the show from 26 to 30 May 2022.
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