Manufacturing APIs requires complex processes that must comply with stringent system and product quality requirements, vital safety considerations, and a demanding regulatory environment. At the same time, there is an ever-growing pressure to improve production efficiency and throughput times. The key to shorter time to market, higher yield and greater flexibility lies in smarter, more flexible processes that integrate quality control, documentation and process control - both for batch and for continuous processing. With our advanced digital solutions, you can reap the benefits of improved process transparency and understanding to achieve right-first-time production in your primary processes.
The production of APIs involves a variety of process steps that must be optimally coordinated. The systems must be flexible, but cross-contamination of the different APIs must be prevented at the same time. In addition, the effective utilization of production systems that are distributed around the world is becoming increasingly important. Process optimization is the key to meeting these challenges effectively. The integration of the entire process, from the raw materials through the respective production steps to the finished product, makes it possible to reduce costs and processing times; improve employee safety, including in explosion-hazardous areas; and prevent contamination of the active ingredients produced. Currently dominated by batch processes, the pharmaceutical industry is currently shifting to new processing options for both chemical and bio APIs, such as modular plants, single-use equipment or continuous manufacturing. With our proven digital solutions, you can make sure your production stays ahead of the race in primary processing - by networking process and quality data with business and laboratory systems.
Our solutions for laboratory management ensure highest safety levels, maximum process efficiency, and full compliance of procedures in your laboratory operations. Plus, you can also optimize your entire laboratory workflow and enable the seamless integration with your enterprise resource planning (ERP), manufacturing execution system (MES), and distributed control system (DCS).
Track all product and process data for raw materials, media and procedures for verification and documentation with a set of aligned solutions that make sure your fermentation or synthesis processes receive the correct ingredients at the right time and in the correct quantity and quality.
Our scalable, integrated solution for process control, process analytical technological and electronic batch records help you monitor and control your API process and automatically record all relevant data to achieve right-first-time quality - whether in biological batch processes, continuous production units or flexible, modular plants.
Ensure consistent product quality and purity through our solutions for monitoring and control of your clean-in-place/sterilize-in-place systems. Fully automatic routines with comprehensive recording of all relevant process data support process verification and increase process and equipment utilization.
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