Rapid Microbiology Methods (RMM): An Alternative for Traditional Microbiology?

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.


INTERPHEX

Learn more about the single source for complete biopharmaceutical manufacturing solutions that gathers 12,000 industry professionals each year.

About INTERPHEX

Official blog of: INTERPHEX New York - www.interphex.com
This entry was posted in Uncategorized. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s