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For Kuhner, the quality and long service life of its shakers and bioreactor systems are top priorities. For this reason, Kuhner products have proven themselves internationally, even in GMP environments. Documentation, development, and production are continuously optimized throughout the entire product lifecycle to ensure they meet the ever-increasing requirements of the GMP world. The GMP version of our in-house software (Kuhner Insight) enables control of the shakers and bioreactors, digital and analog communication with the customer-specific infrastructure, and the storage, evaluation, and display of recipes and process data—all in compliance with the requirements of 21CFR Part 11 and EU GMP Annex 11.
The development, production, and qualification of Kuhner machines are carried out in accordance with the V-model recommended in the GAMP 5 Guide. By applying the GAMP 5 V-model to the development, production, and qualification of our machines, Kuhner fully meets the pharmaceutical industry’s increased requirements for GMP-compliant qualification of our machines. Our international GMP customers therefore particularly value Kühner as a reliable partner.
Kuhner's GMP Support includes a comprehensive portfolio of qualification documents (FAT/SAT/IQ/OQ) for its shakers, bioreactor systems, software, and communication interfaces. All documents are available in a standard Kuhner version or can be customized according to customer requirements in terms of format, layout, or scope. Based on feedback from our customers, we are continuously working to improve and expand our qualification documents to ensure they continue to meet our customers’ requirements and comply with new regulations in the future.
With the new MPS-Z Automated, Kuhner is expanding its portfolio with a forward-looking solution for continuous, automated cell culture operations in microtiter plates. Thanks to modern interfaces and high process reliability, the MPS-Z Automated can be seamlessly integrated into existing automated platforms and into GMP and clinical development processes.
Upon request, our certified technicians can also perform equipment qualification on-site at the customer's location.
