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GEA’s ConsiGma continuous tableting line combined with Siemens’ automation and Sipat data management systems enables continuous manufacturing.
On Jan. 9, 2017, GEA and Siemens AG announced a partnership to bring continuous manufacturing to the pharmaceutical and life-sciences industries by offering an integrated continuous tablet manufacturing line. The collaboration will deliver both production benefits, in terms of reduced project execution risk, higher quality, and cost-effective manufacturing, and customer benefits in the form of seamlessly integrated technologies, expertise, and support. Comprising GEA’s ConsiGma continuous manufacturing platform equipped with a Siemens Automation & Industrial IT solution, including Sipat for PAT Data Management, the combined technologies offer both wet granulation and direct compression for continuous tablet production in the pharmaceutical and life-sciences industries.
“Amalgamating our state-of-the-art continuous processing technology with Siemens’ automation systems allows us to further support the US Food and Drug Administration’s Pharmaceutical Quality for the 21st Century program and help pharmaceutical companies to adopt continuous manufacturing (CM) technologies and modernize their production infrastructure,” said Frans Maas, vice-president, APC Pharma Solids, GEA, in a press release. “Together, our combined experience and expertise will provide significant industry benefits as pharmaceutical manufacturers transition towards continuous manufacturing.”
The ConsiGma continuous tableting line is a multipurpose platform that has been designed to transfer powder into coated tablets in development, pilot, clinical, and production volumes in a single compact unit. The system can perform dosing and mixing of raw materials, wet or dry granulation, drying, tableting, coating, and quality control, all in one line. From powder to coated tablet, ConsiGma allows pharmaceutical companies to continuously process and manufacture oral solid-dosage forms. Offering significant reductions in development time and raw material (API) use, process and energy costs can be considerably decreased while maintaining quality and increasing manufacturing efficiency.
Simatic Sipat is a scalable and modular software solution that enables companies to extend their process analytical technology (PAT)-based quality control strategies on a step-by-step basis within the scope of a quality-by-design approach. With PAT, product development and production processes can be monitored, controlled, and optimized by measuring and calculating the critical-to-quality attributes (CQAs) of the end product in real time. This continuous monitoring of product quality can prevent deviations from specifications and therefore reduce production costs. It allows for real-time release testing so that final quality inspections can be reduced or eliminated.