Validacija na metod za opredeluvanje mikrobioloska cistota na Kafetin® tableti

Izvrsena e validacija na metodot za opredeluvawe mikrobioloska cistota na Kafetin® tableti. Za taa cel koristeni se test-mikroorganizmi: Escherichia coli, Pseudomonas aeruginosa ,Staphylococcus aureus, Candida albicans i Aspergillus niger, od kolekcijata ATCC. Upotreben e nespecificen hranliv medium za aerobni mikroorganizmi i specificni hranlivi mediumi za soodvetni test mikroorganizmi: ENDO, Cetrimid, Baird-Parker i Sabouraud hranliv agaren medium. Koristeni se dva nacina na izveduvawe na metodot: direktna inokulacija vo hranliv medium i membranska filtracija. Pritoa e koristen testot na predizvik (Challenge test) i testot na broenje na porasnati kolonii (CFU/ml). Vrsena e presmetka na faktorot sto pretstavuva odnos pome|u porasnati mikroorganizmi na inokuliran hranliv medium, bez i so dodavawe na ispituvaniot preparat, kako kriterium za prifatlivost na dobienite analiticki rezultati. Dobienite vrednosti za faktorot kako kriterium za prifatlivost pokzaa zadovolitelni vrednosti. Toa ukazuva deka metodot so koj se raboti moze da se upotrebuva za opredeluvanje na mikrobioloska cistota kaj Kafetin® tableti

Optimized genotyping method for identification of bacterial contaminants in pharmaceutical industry

Microbiological control has crucial importance in the pharmaceutical industry regarding the possible bacterial contamination of the environment, water, raw materials and finished products. Molecular identification of bacterial contaminants based on DNA sequencing of the hypervariable 16S rRNA gene has been introduced recently. The aim of this study is to investigate the suitability of gene sequencing using our selection of PCR primers and conditions for rapid and accurate bacterial identification in the pharmaceutical industry quality control. DNA was extracted from overnight incubated colonies from 10 bacterial ATCC strains, which are common contaminants in the pharmaceutical industry. A region of bacterial 16S rRNA gene was analyzed by bidirectional DNA sequencing. Bacterial identification based on partial sequencing of the 16S rRNA gene is the appropriate method that could be used in the pharmaceutical industry after adequate validations. We have successfully identified all tested bacteria with more than 99 % similarity to the already published sequences

Optimized genotyping method for identification of bacterial contaminants in pharmaceutical industry

Microbiological control is of crucial importance in the pharmaceutical industry regarding the possible bacterial contamination of the environment, water, raw materials and finished products. Molecular identification of bacterial contaminants based on DNA sequencing of the hypervariable 16SrRNA gene has been introduced recently. The aim of this study is to investigate the suitability of gene sequencing using our selection of PCR primers and conditions for rapid and accurate bacterial identification in pharmaceutical industry quality control