The partnership will combine GEA’s ConsiGma tablet press with Siemens’ Simatic Sipat quality control software.
GEA cited US Food and Drug Administration (FDA) support for continuous manufacturing and quality by design as the driver for the agreement.
Spokesman Harald Stahl told us “Traditionally in pharmaceutical production batch processing is used. Here the quality control is simple end product testing resulting in a very limited set of data which can be simply stored on paper.
“In the early 2000s the authorities demanded for improvement of the situation. PAT tools were introduced resulting in a massive increase of data which needed to be handled. This was the beginning of the GEA Siemens partnership.”
A request from UK drug manufacturer GSK for a continuous production system prompted the firms to develop the first ConsiGma platforms.
Data processing
Integrating Simatic Sipat into the platform offers improved data processing according to Stahl, citing the ability to monitor “trending over many batches as well as the more seamless integration of complex PAT tools such as spectrometers” as examples.
Drug companies that already own ConsiGma will be able to upgrade to Simatic Sipat Stahl added, reiterating that a continuous approach calls for technologies capable of handling large amounts of complex information.
“The amount of data generated by a properly equipped continuous process requires in almost any case some intelligent software solution for intelligent storage as well as for further processing.”