Process analysers as inline and online measurement technologies provide real-time data for outstanding process control, which results in high-quality production. Thorough monitoring by process analysers with up to 100% coverage of process parameters and subsequent documentation ensures optimal compliance. Moreover, monitoring makes transactions verifiable and establishes a basis of trust between suppliers and customers.
Stable and robust processes require sophisticated control of critical process parameters (CPPs) based on reliable data acquisition, storage and evaluation capabilities. State-of the-art process control prevents or mitigates risks of producing faulty batches and represents a further step towards knowledge- and risk-based production of biopharmaceutical products.
Combined with process analyzers, process control & software tools provide an excellent approach for prospective quality assurance. Regarding the variability of input materials and production conditions, these software tools keep the CPPs within a proven operating range or design space, resulting in an overall increased process reproducibility and consistent high product quality.
Microbiology products for microbial enumeration, air monitoring and sterility testing: membranes, single use devices and instruments for microbial enumeration by the membrane filtration method, instruments and disposable plates for sampling of airborne microorganisms as well as disposable closed systems for the compendial sterility testing and PCR-based tests for Mycoplasma contamination control represent a broad range of advanced microbiology products.
Advanced chemometric methods as Design of Experiments (DoE) and Multivariate Data Analysis (MVDA) enable to look into cost savings besides ensuring process reliability and robustness. DoE is a standard technique to accelerate process development tasks and gain additional process understanding with a least amount of experiments. MVDA techniques are used for scale- and batch-to-batch comparison investigations, and are making inroads into continuous real-time quality control and assurance.