GEA and Siemens AG announce a partnership to bring continuous manufacturing to the pharmaceutical and life sciences industry 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.
As an important supplier of process technology and operational systems, GEA has established itself as a leading solution provider in the pharmaceutical industry. The collaboration with Siemens reinforces this global position and now offers life sciences companies — from large multinational organizations to regional specialists and CMOs — an experienced partner to help them implement continuous manufacturing platforms. 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 in a standard-setting solution for continuous tablet production in the pharmaceutical and life sciences industry.
“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. “Together, our combined experience and expertise will provide significant industry benefits as pharmaceutical manufacturers transition towards continuous manufacturing,” he added.
“The use of CM technologies and inline PAT monitoring is a key driver of building quality by design (QbD) into the complete product lifecycle, from R&D through to manufacturing, with the ultimate aim of getting safer medicines to market in a more efficient and cost-effective way,” added Hartmut Klocker, Vice President Market Development Board Pharma.
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 using this groundbreaking technology while maintaining quality and increasing manufacturing efficiency.
Simatic Sipat is a scalable and modular software solution that enables companies to extend their PAT-based quality control strategies on a step-by-step basis within the scope of a Quality by Design based approach. With PAT, product development and production processes can be monitored, controlled and optimized by measuring and calculating the Critical-to-Quality Attributes (CQA’s) of the end product in real-time.
This continuous monitoring of product quality can prevent deviations from specifications and therefore reduce production costs. Also, it allows for Real Time Release Testing so that final quality inspections can be reduced or eliminated. Simatic Sipat is Siemens’ PAT Data Management solution that integrates PAT activities of an entire line — hence shortening time-to-market significantly.