MICROBIOLOGY SERIES
MALDI-TOF mass spectrometry is then performed, and the DNA or RNA fragments reach the detector according to their nucleotide composition and length. The resulting mass spectra can be used for the detection of a specific microorganism or for microbial identification using a mass spectral database. In the second system, a set of 12 broad-range bacterial PCR primers are used to generate PCR products which are then transferred to an electrospray ionisation-TOF mass spectro - meter. The resulting spectral data are compared with an internal database for bacterial or viral identification.
Summary The number of available nucleic acid and gene amplification-based rapid microbiological methods has literally exploded over the last few years, and for good reason. They provide an accurate and reliable means for detecting specific microorganisms of interest, especially in pharmaceutical dosage forms that are required to be free of objectionable or specified pharmacopeial organisms. Furthermore, genetic-based rapid methods are now the preferred choice for microbial identification when a contamination event has occurred, due to their enhanced accuracy and reproducibility.
I will leave you with two final notes.
First, I have added two excellent publications that provide additional insight into rapid nucleic-acid-based systems and their applications (you will find these at the end of this article). Second, there are novel genetic-based Lab-on-a-Chip and microarray technologies have been introduced that make use of PCR amplification methods in a miniaturised detection format for a wide range of microorganisms, including Mycoplasma. This is where the future of rapid microbiology is heading, and this is where we will be heading as we close out the year with my final article in this series: the fascinating world of Micro-Electro-Mechanical (MEMS) and nano - technology methods of tomorrow.
REFERENCES
2011. Jimenez, L. Molecular Applications to Pharmaceutical Processes and Cleanroom Environments. PDA Journal of Pharmaceutical Science and Technology. Volume 65, Issue 3.
2009. Denoya, C.D. Nucleic acid amplification- based rapid microbiological methods: Are these technologies ready for deployment in the pharmaceutical industry? American Pharmaceutical Review. Volume 12, Issue 4.
For additional references on these and other types of RMMs, please visit the Reference Page on my educational website,
http://rapidmicromethods.com
BIOGRAPHY
Dr. Michael J. Miller is an inter - nationally recognised micro biologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC
(
http://microbiologyconsultants.com). For more than 23 years, he has held numerous R&D, manufacturing, quality, and consulting and business development leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc. In his current role, Dr. Miller consults with multinational companies in providing technical, quality and regulatory solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control, isolator technology, validation and microbiological PAT. He also provides comprehensive training for his clients in the areas of rapid method validation and implementation.
Dr. Miller has authored over 100 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilisation, is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods, and is the owner of
http://rapidmicromethods.com, a website dedicated to the advancement of rapid methods. He currently serves on a number of PDA’s program and publication committees and advisory boards, is co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods, and routinely provides RMM training programs for the industry and professional organisations worldwide.
Dr. Miller holds a PhD in Microbiology and Biochemistry from Georgia State University (GSU), a BA in Anthropology and Sociology from Hobart College, and is currently an adjunct professor at GSU. He was appointed the John Henry Hobart Fellow in Residence for Ethics and Social Justice, awarded PDA’s Distinguished Service Award and was named Microbiologist of the Year by the Institute of Validation Technology (IVT).
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