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20 June 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. In my last article, I provided an overview of viability-based rapid microbiological methods (RMMs), such as flow and solid-phase cytometry. In this article, we will review some of…
19 April 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the second in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. In my last article, I provided an overview of growth-based rapid microbiological methods (RMMs). This was a good place to start my review of RMM technologies, as most…
16 February 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Last year, I provided an overview of rapid microbiological methods (RMMs), including validation strategies, regulatory expectations, the technical and quality benefits of RMMs as compared with conventional techniques,…
This is the sixth and final paper in a series of articles on rapid microbiological methods that have appeared in European Pharmaceutical Review during 2010. Over the past year, we have explored the world of rapid microbiological methods (RMMs), focusing on validation strategies, regulatory expectations, and the technical and quality…
1 November 2010 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the fifth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. In my previous four articles, I have provided an overview of the benefits of rapid microbiological methods (RMMs) as compared with conventional methods, validation strategies and regulatory perspectives…
19 August 2010 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the fourth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Believe it or not, today’s regulatory authorities encourage the use of rapid microbiological methods (RMMs), and when applicable, they have put policies in place that provide guidance on…
9 May 2010 | By Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC
This is the second in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical…
22 February 2010 | By
For decades microbiological quality has remain dormant while the pharmaceutical industry has continued to evolve. Compendial methods and limits, while now generally harmonised throughout the world, still reflect the same methods utilised 100 years ago. Although there is more clarification around the number and types of organisms permitted in products…
This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010.
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…
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…
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…
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…
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…
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…
