ISO
16140:2003 for the validation of alternative (proprietary) microbiological
methods has just been revised. The new multipart standard provides a specific
protocol and guidelines for the validation of methods both proprietary
(commercial) or not. Proprietary methods are generally cheaper to use, produce
results faster than traditional culturing methods and are simpler to perform as
they require fewer technical skills. What’s more, most are partly or completely
automated, so easier to use in less experienced laboratories, such as factory
and commercial laboratories and with less technical human resources.
Two
parts of ISO 16140 series now published
ISO
16140-1:2016, Microbiology of the food chain – Method validation – Part 1:
Vocabulary, describes the terminology used in microbial testing, while ISO
16140-2:2016, Microbiology of the food chain – Method validation – Part 2:
Protocol for the validation of alternative (proprietary) methods against a
reference method, is dedicated to the validation of proprietary microbiological
methods. They are designed to help food and feed testing laboratories, test kit
manufacturers, competent authorities, and food and feed business operators to
implement microbiological methods. ISO 16140-2 includes two phases, the method
comparison study and the interlaboratory study, with separate protocols for the
validation of qualitative and quantitative microbiological methods.
Over
a hundred alternative methods have been validated based on the previous version
of ISO 16140, and the standard was updated to provide new insights on the
validation of microbiological methods and experience gained from conducting
validation studies across the world. Today, many alternative (mostly
proprietary) methods exist that are used to assess the microbiological quality
of raw materials and finished food products and monitor the microbiological
status of manufacturing processes. The developers, end-users and authorities
need a reliable common protocol for the validation of such alternative methods.
With this new protocol, the data generated will also provide potential
end-users with performance data for a given method, thus enabling them to make
an informed choice on the adoption of a particular (alternative) method. This
data can also serve as a basis for the certification of a method by an
independent organization.
Posted by Dr. Tim Sandle
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