Microbiological methods: validation, utilisation and interpretation
From January 2011 newsletter
In any type of analysis, it is important that the method used is effective and fit for purpose – i.e. that it works and is designed to answer the question that you are asking. In microbiology, there are specialised issues that need to be addressed in validating a specific method and in evaluating results from its use. We can advise clients on which methods best suit their needs – and we can also validate methods against international standards.
Microbiological methods can be complex
Roy Betts, Head of Microbiology, comments:
"They donít always give exact answers, and understanding what results mean is of great commercial importance when deciding on a manufacturing course of action. Therefore, it is vital that appropriate methods are used and that they are shown to be suitable for a particular situation. We can help in many ways – from validating the method itself on behalf of the method manufacturer, through advising clients on which methods are suitable, to evaluating results from analyses using the methods.
We can validate methods to a companyís own standard, or for one of several officially recognised validation bodies, such as MicroVal, AFNOR or AOAC. Many companies are now developing rapid methods for different purposes. If these are designed to monitor foods for microorganisms covered by the EU Microbiological Criteria Regulation (2005/2073), then they have to be validated and certified according to ISO Standard 16140, which in effect means meeting the criteria of MicroVal or AFNOR.
Our experience in validating methods means that we are well placed to advise clients on which ones are suitable for a particular need, on their limitations, if appropriate, and in then explaining the results obtained."
Don't use inappropriate methods, or draw the wrong conclusions from the right result!