article
The implementation of Rapid Microbiological Methods (Article 1)
This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010.
List view / Grid view
Microbiology
article
Novel and emerging sterilisation technologies
9 October 2009 | By Dr Edward Tidswell, Senior Director of Sterility Assurance, Baxter Healthcare; Ash Khorzad, Sterile Manufacturing Support Group Manager and Mike Sadowski, Director of Sterile Product Manufacturing Support, Baxter Healthcare Corporation
The increasing number and diversity of traditional patient therapies, medical devices, and combinatorial products has created an increasing world-wide interest in the innovation of novel sterilisation technologies. In contrast to traditional moist heat sterilisation processes, emerging technologies are diverse, predominantly reliant on physical processes, involve multiple mechanisms of microbial inactivation…
article
Real-time environmental monitoring: PAT solutions using rapid microbiological methods
In these economic times the pharmaceutical industry has expressed a renewed interest to explore ways in which to enhance the efficiency and agility of existing and future manufacturing processes. This is also true for laboratory-based operations that support forward processing and product release decisions. One function that can greatly benefit…
article
Concurrent Evaluation of both Compendial and Rapid Methods (ATP Bioluminescence) for Monitoring Water Quality in Pharmaceutical Manufacturing
29 May 2009 | By
Much has been published elsewhere about the limitations of the compendial microbiological methods and the needs of current Pharmaceutical manufacturing, in particular related to the adoption of PAT as a quality tool1-4. Rapid Microbiology is seen by many as a tool for addressing a number of these limitations5,6. Rather less…
article
Quality risk management and the economics of implementing rapid microbiological methods
Quality risk management (QRM) is an important part of science-based decision making which is essential for the quality management of pharmaceutical manufacturing1. The ICH Q9 guideline, Quality Risk Management2 defines QRM as a systematic process for the assessment, control, communication and review of risk to the quality of drug product…
article
A practical approach to microbial testing to support non-sterile product stability
3 December 2008 | By
During stability, product testing is performed to ensure the product will continue to meet specified criteria of quality and strength through its expiration or shelf-life at the temperature and humidity required by specific markets. This article will not address the other stability requirement of continued efficacy during consumer use which…
article
Recent development in Rapid Microbiology Methods
29 September 2008 | By
Microbiology is the scientific study of micro-organisms and includes many sub disciplines like bacteriology, virology, mycology, and parasitology: all characterized by the study of organisms too small to be seen by the naked eye. This defining aspect has determined the focus of microbial research over the last century: the need…
article
Implementation, validation and registration of rapid microbiological methods
19 June 2008 | By
Over the last decade, interest in rapid microbiological methods (RMMs) in the pharmaceutical sector 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…
article
Microbiology / Microbiologists – Where next?
23 January 2008 | By Stewart Green Director of Quality, Wyeth, UK and Chair, Pharmig
Arguably microbiology is the oldest of the applied sciences, although early exponents doubtless had no understanding of how the fruits of their labour in fermentation for example, came about. The true forerunners of microbiology as it is recognised today would be Koch, Pasteur, Petri et al, who developed much of…
article
Cutting edge technologies and their potential role in pharmaceutical microbiology
23 November 2007 | By
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…
article
Are the needs of the pharmaceutical industry being met?
25 January 2007 | By 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…
article
The current market and future trends for RMM
28 September 2006 | By 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.
article
Rapid microbiology: Solutions for the next stage
20 July 2006 | By 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.
article
Opportunities for Rapid Microbial Methods
2 February 2006 | By 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…
article
Microbial detection in mammalian cell culture systems
11 November 2005 | By 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.
