By Vilma Bonilla, MMC, President-BPTS Learning Center
Much has been published about the limitations of traditional microbiological culture-plate methods and the need of rapid methods to solve these limitations.
Traditional methods tend to be labor-intensive and take several days to obtain results. As per FDA, Rapid Methods are methods designed to provide performance equivalent to the traditional testing methods while providing results in significantly less time. Manufacturers should show that an alternative method will provide assurances of the safety, purity, potency and effectiveness of the product equal to or greater than the assurances provided by the method specified in 21 CFR Parts.
RMM include identification, qualitative and quantitative methods. Identification methods provide the name or species of the microorganism in a sample. Qualitative methods provide a presence or absence result in a sample. Quantitative methods provide a numerical result (number of microbes present in the sample.) Common technologies used in RMM include nucleic-acid-based detection, which uses DNA or RNA targets; antibody-based detection; biochemical and enzymatic detection methods, among others. Some of the benefits of RMM are shorter production cycles and shorter release time of finished products to market; also, reduction of inventory requirements, among others.
Comparison of both methods:
|TRADITIONAL METHODS||RAPID MICROBIOLOGY METHODS (PAT-PROCESS ANALYTICAL TECHNOLOGY)|
|Microorganisms growth in media.Cultures are visually check for microorganisms.Microbes can only been seen when growth reaches a high number of colony-forming unit.||Use markers that can be detected by an instrument.Many instruments detect those markers even at a low number of colony-forming units which reduces time for detection|
|It is slow, labor-intensive, and subjective||It is easier to use and provide a much faster time to result. Are sensitive and objective in detecting bacteria and fungi compared with the traditional methods|
BPTS Learning Center will be providing one-hour conference and demonstration on “Advanced Methods for Detection and Identification of Microorganisms in Controlled Environments?
Traditional and RMM methods will be compared using Genotypic Identification Method-Micro SEQ Microbial Identification System for detection and identification of a fungi. It will be held Th (4:30pm-5:30pm); Fr (3:30pm-4:30pm) @ Booth 1231. Spaces are limited.
Learn more about the single source for complete biopharmaceutical manufacturing solutions that gathers 12,000 industry professionals each year.