The use of real-time polymerase chain reaction (rT-PCR) technologies to screen for the presence of total bacteria in a liquid sample

5^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs

August 03-05, 2015 Orlando, USA

Andy Moreno

HSG/AME Certified Laboratories, USA

Posters-Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Microbiological data collected by traditional methods are inherently variable. The â�?�?plate countâ�? is at best an interpretation of an approximation of the number of cells present. Colony Forming Units (CFU) method analysis is only an estimate of the number of cells present. It is a skewed estimate at best as the only cells able to form colonies are those that can grow under the conditions of the test (e.g., incubation media, temperature, time, oxygen conditions). Traditional methods require days before the results can be interpreted and reported to decision-makers in a production setting. The use of real-time polymerase chain reaction (RT-PCR) technologies with a total bacteria screen (TBS) assay permits the detection of the DNA of all bacteria within 35 minutes. The use of RT-PCR TBS assays allows process control/quality control managers precious time and additional specificity and sensitivity prior to decision-making.

Biography :

Email: andy.moreno@ame-qpcr.com