Greater flexibility for chemical active pharmaceutical ingredient (chem API) production
Incoming goods the correct solution at hand
Whether raw materials or packing materials, the cornerstones of your successful chemical active ingredient production can be found in the incoming goods department. This department must be optimally managed, comprehensively protected, and thoroughly documented.
We support you with a broad portfolio of components and systems to efficiently meet all the requirements of the incoming goods sector. This includes our proven and flexible solutions for storage and material flow logistics; bar-code reader and radio-frequency identification (RFID) systems for the automatic recording of goods; and fire protection, safety, and building automation systems. The optimum interaction of all components and systems enables Good Manufacturing Practice-compliant documentation of all environmental conditions that a raw material has been exposed to. You benefit from more efficient commodity flows, maximum transparency, and improved safety.
Laboratory optimally controlled
The requirements for modern laboratory management include the highest laboratory safety, greater process efficiency, and reduced effort in ensuring compliance with requirements such as 21 CFR Part 11. It is crucial to maintain the consistent high quality of the products manufactured. For this purpose, we offer proven solutions for access control, building automation, and hazard management that ensure constant and safe environmental conditions. You can also optimize your entire laboratory workflow with our SIMATIC IT Unilab laboratory information management system, from sampling to performance that complies with US Food and Drug Administration (FDA) and EU regulations, and from documentation of tests to the supported release of batches. And with Totally Integrated Automation, we enable the seamless integration of your laboratory into all existing control systems up to the levels of the enterprise resource planning (ERP) system, manufacturing execution system (MES), and distributed control system (DCS).
Preparation foundation of successful production
The better the preparation, the more efficient the process. This includes not only the preparation of the qualitatively inspected raw materials by weighing, crushing, or mixing but also the documented supply of all subprocesses with the correct ingredients at the right time and in the correct quantity and quality.
Our products and solutions for preparation make it possible to design the entire material flow from the raw material to the finished product in a transparent and efficient manner. This includes, for example, the integrated SIMATIC IT manufacturing execution system (MES). With the material management module, it offers a solution for the seamless recording and control of material flows. And SIMATIC Route Control ensures the availability of the precursors with maximum precision and traceability.
Reaction from the process to the product
In the core process of chemical active ingredient production, the extremely different reactions, reactor types, and reaction speeds require maximum flexibility in process automation. This is the only way to optimally coordinate parallel and sequential synthesis reactions and safely meet the high demands on safety, reaction kinetics, heat, and mass transfer. With our integrated and scalable automation solutions, you achieve this degree of flexibility. We provide the optimum foundation for your process with proven products and solutions in the areas of energy supply, process instrumentation, building safety, and network technology. And we can offer you a unique package with our SIMATIC PCS 7 distributed control system (DCS), our SIMATIC Batch recipe system, and our SIMATIC IT manufacturing execution system (MES), for optimum control of all processes within and outside the reaction. In tangible terms, this means seamless recording of all process variables, safe influencing of all process parameters, and innovative quality optimization with our SIMATIC SIPAT Process Analytical Technology (PAT) software.
Separation and purification step by step to the pure active ingredient
Whether via filtration, crystallization, grinding, sifting, drying, or centrifuging or via the combination of individual processes, the last impurities must be removed from chemical active ingredients during preparation and purification.
Whichever process you use, we ensure consistent environmental conditions with sophisticated energy supply solutions and proven building technology systems. We provide scalable network solutions for the seamless integration of your components in the separation and purification processes. And we allow for customizable automation, as needed, via local Supervisory Control and Data Acquisition (SCADA) solutions with customized control and operating systems or via our cross-system SIMATIC PCS 7 distributed control system (DCS), which ensures maximum process efficiency in combination with our SIMATIC Batch recipe automation system. All this enables increased productivity.
Conditioning the perfect finish
Due to increasing process optimization demands, the automation of active ingredient production and the automation of medicinal product production are growing closer together. Required material properties such as particle size, bulk densities, and flow properties as well as optimum packaging for the next processing step must be achieved in a consistent and reliable manner, from the first to the last batch.
From clean-room technology to energy supply, our solutions ensure constant and reliable environmental conditions. In addition, highly precise process instrumentation and analytics are ready to deliver all the relevant material proprieties and quantities at any time. Totally Integrated Automation ensures perfect coordination between the process control technology, manufacturing execution system (MES), and enterprise resource planning (ERP) system. The seamless information flow makes it possible, for example, to store all relevant process and production data directly on the packaging unit optionally via bar code, data matrix, or radio-frequency identification (RFID). You benefit from transparent and efficient processes.