Robotic And Automated Systems In The Pharmaceutical QC

摘要

Since the beginning of this decade the use of automated or robotic-systems for analytical purposes has decreased rapidely. Starting from the analysis of agriculturing products or medical samples, these instruments are now more and more common in the pharmaceutical industry. The systems are used for R&D purposes mainly in the area of combinatorial chemistry to analyze the huge amount of synthesis products in the biomedical labs and in chemical-physical laboratories of Quality Contol Units. Extensive stability studies, which have to be perfomed for new drug applications, and the release testing of medicinal products with a very high manufacturing batch-rate per year need highly effective analytical methods. Thus, Byk Gulden has introduced two automated systems based on Zymark products (TPWII and MultiDose), for the stability tests of an enteric-coated tablet. The number of batches, pack types and storage conditions (total number of samples: appr. 40 for the 3- and 6-months timepoints), for this stability st...