Robotic and Automated Systems in the Pharmaceutical QC

Abstract

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 study was required automation of the most time consuming test methods for purity, assay and dissolution of the tablets, because of the tight schedule for timepoints in the first year of storage (in general: two weeks). In order to have these automated systems in place for routine testing in a very short time, the method transfer from the manual procedure as well as the optimization and validation work (MTOV), were done completely by the supplier, Zymark. The other system, which is a customer designed robotic system built also by Zymark, is used for the release testing of an x-ray contrast medium with a very high batch-rate per year (approxmimately four batches per day that have to be analyzed). This enormous testing frequency is hardly to be realized by manual methods. Experiences with an already existent robotic systems has shown that the laboratory flow-through times are 30 to 50% decreased compared to manual testing.