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Issue 6 2007 / 23 November 2007 /
In order to meet the challenges demanded by the requirements of Process Analytical Technology (PAT), the modern microbiological laboratory needs to become more innovative in microbial detection, identification and enumeration. Technology is becoming available that will speed up microbiological analysis, potentially allowing pharmaceutical microbiology tests to get as close as is possible to the concepts of PAT. Following on from the article by Bob Johnson1, this article explores the future technologies in greater detail.
The technical requirements for any rapid microbiology method (RMM) include a combination of the following: significantly reduced time-to-result when compared with conventional microbiological methods; automated, miniaturised and high-throughput technology platforms; increased sensitivity, accuracy, precision and reproducibility; detection of a single, viable micro-organism without the requirement for cellular growth; capable of testing for total counts and specified objectionable simultaneously; enhanced detection of stressed organisms. Business requirements include: significant reduction of testing time to release products more rapidly; lower inventories (raw material, in-process material and finished product); reduction of repeat testing, deviations, OOS investigations and product rejection. Furthermore, the system should be portable and user-friendly. (more…)
Issue 1 2007, Past issues / 25 January 2007 / Dr Andrew M. Middleton, GlaxoSmithKline
Subsequent to the publication of the PDA technical Report Number 33 in 20001 there has been a multitude of articles published in pharmaceutical reviews and commentaries with regard to rapid microbial methods (RMM). The majority of these articles cover, to a greater or lesser degree, the technologies available and summaries of the requirements for validation, implementation and regulatory acceptance. There have also been some articles that have explored the potential reasons for the relatively slow uptake of alternative microbiological testing methods. While these articles address valid issues, few explore in detail the further possibility for the slow uptake; the appropriateness of the currently available RMM technologies.
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Issue 5 2006, Past issues / 28 September 2006 / Tony Cundell, Director, Pharmaceutical Sciences – Microbiology, Schering Plough Research Institute
Following on from our latest report in Issue 4 in which we outlined independent views on ‘solutions for the next stage’ in Rapid Microbiological Methods (RMM) from some of the industry’s leading names, Tony Cundell follows up with his own thoughts on this exciting field.
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Issue 4 2006, Past issues / 20 July 2006 / Tim Lloyd, Editor, European Pharmaceutical Review
Rapid microbiology is an exciting field for the development of new technologies and applications. There are significant challenges to be overcome and in doing so, great prospects for microbiologists and the companies that provide cutting-edge equipment.
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Issue 1 2006, Past issues / 2 February 2006 / Anthony M. Cundell, Ph.D. Consulting Microbiologist
Since the 2000 publication of the PDA Technical Report Number 33 Testing Methods, rapid microbial methods (RMM) have not lived up to their promise for changing routine Quality Control microbiological testing in the pharmaceutical industry. With the next generation of rapid microbial methods emerging from the R&D laboratories of instrument manufacturers, this article will discuss the obstacles to the successful implementation of the currently marketed technologies and strategies to overcome these obstacles.
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Issue 4 2005, Past issues / 11 November 2005 / Amy McDaniel, Ph.D., QC Manager, Microbial Science & Technology, Wyeth Biotech
Timely results for microbial bioburden monitoring of in-process cell culture samples are critical to the production process for recombinant proteins and other biopharmaceutical products.
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Issue 2 2005, Past issues / 20 May 2005 / Paul J Newby PhD, GlaxoSmithKline R&D
In the last decade interest in Rapid Microbiological Methods (RMMs) has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a lot of confusion and considerable hesitancy associated with the introduction of these methods into the pharmaceutical sector.
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