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New ISO standard to validate Innovative Food Microbiological Methods

 

International Standards Organization means….

ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. ISO started February 23, 1947, and since then have published more than 21000 International Standards covering almost all aspects of technology and business. Today we have members from 163 countries and about 150 people work full time for our Central Secretariat in Geneva, Switzerland. Both series of standards were published by ISO, the International Organization for Standardization. The purpose of ISO is to facilitate international trade and cooperation in commercial, intellectual, scientific and economic endeavors by developing international standards. ISO originally focused on industrial and mechanical engineering standards. Now, it has ventured into setting standards for an organization’s processes, policies, and practices.

Introduction

Today, many alternative, mostly proprietary, methods exist that are used to assess the microbiological quality of raw materials and finished products and the microbiological status of manufacturing procedures. These methods are often faster and easier to perform than the corresponding standardized method. The developers, end users, and authorities need a reliable common protocol for the validation of such alternative methods. 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 method. The data generated can also be the basis for the certification of a method by an independent organization.

This part of ISO 16140

  • —is intended to provide a specific protocol and guidelines for the validation of proprietary methods intended to be used as a rapid and/or easier method to perform than the corresponding reference method,
  • —can also be used for the validation of other non-proprietary methods that are used instead of the reference method,
  • —is intended as the successor of the validation protocol published in the first version of ISO 16140 (ISO 16140:2003), and
  • —is mainly written for the validation of methods that are capable of culturing the target microorganism, but can also be applied to methods for microorganisms that cannot be cultured such as viruses (e.g. Norovirus) and protozan parasites (e.g. Cryptosporidiumor Giardia). In these cases, some wordings are to be interpreted so as to fit the situation for non-culturable organisms.

The use of this part of ISO 16140 involves expertise on relevant areas such as microbiology, statistical design, and analysis as indicated in the respective sections. The statistical expertise encompasses overview of sampling theory and design of experiments, statistical analysis of (qualitative and quantitative) microbiological data, and overview of statistical concepts on random sampling, sample heterogeneity, sample stability, design of experiments, and variance components.

When this part of ISO 16140 is next reviewed, account will be taken of all information then available regarding the extent to which the guidelines have been followed and the reasons for deviation from them in the case of particular products.

The harmonization of validation methods cannot be immediate and for certain groups of products, International Standards and/or national standards may already exist that do not comply with this part of ISO 16140. It is hoped that when such standards are reviewed, they will be changed to comply with ISO 16140 so that eventually, the only remaining departures from this part of ISO 16140 will be those necessary for well-established technical reasons. For example, ISO 16297[3] deals with a very specific validation for a specific subject (the hygienic status of raw milk samples) and will remain as a vertical standard besides ISO 16140. If such a validation is needed, the vertical standard is more important.

 

ISO 16140:2003

Microbiology of food and animal feeding stuffs — Protocol for the validation of alternative methods

ISO 16140:2003 defines the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuffs and environmental and veterinary samples for the validation of alternative methods which can be used in particular in the framework of the official control, and the international acceptance of the results obtained by the alternative method.

It also establishes the general principles of certification of these alternative methods, based on the validation protocol defined in ISO 16140:2003.

Where an alternative method is used on a routine basis for internal laboratory use without the requirement to meet (higher) external criteria of quality assurance, a less stringent comparative validation of the alternative method than that set in ISO 16140:2003 may be appropriate.

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.

ISO 16140-1:2016

Microbiology of the food chain — Method validation — Part 1: Vocabulary

ISO 16140-1:2016 defines general terms and definitions relating to method validation of microbiology in the food chain.

It is applicable to the validation of methods for the analysis (detection or quantification) of microorganisms in

– products intended for human consumption,

– products intended for animal feeding,

– environmental samples in the area of food and feed production, handling, and

– samples from the primary production stage.

 

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

ISO 16140-2:2016 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies according to ISO 16140-2:2016 are intended to be performed by organizations involved in method validation.

It is applicable to the validation of methods for the analysis (detection or quantification) of microorganisms in

– products intended for human consumption,

– products intended for animal feeding,

– environmental samples in the area of food and feed production, handling, and

– samples from the primary production stage.

It is in particular applicable to bacteria and fungi. Some clauses of ISO 16140-2:2016 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (e.g. viruses and parasites) will be included in ISO 16140:2016 (all parts).

 

New validation insights included

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.

Benefits of International Standards

Different Users of EN ISO 16140

The main users of EN ISO 16140 (Part 2 for its revision) are the validation/certification bodies and their partners, in particular the expert laboratories, which conduct validation of test kits at the request of kit manufacturers. The second type of user is expected to be public authorities who are to refer to this standard in order to accept AMs, which couldbe used for official controls. Regarding the other parts of EN ISO 16140 under rev ision, users would be (1) laboratory networks, such as in Europe the networks ofNational Reference Laboratories, each coordinated by a European Union Reference Laboratory for different bacteria or viruses, or (2) individual laboratories, which have developed their own methods and intend to validate them against the corresponding RMs, or verify their correct implementation in the specific context of the laboratory, for accreditation purposes. Depending on the method and its scope, the estimated cost of implementing EN ISO 16140 is
expected to lie between 50,000 and 150,000 Euros for a test kit manufacturer in the context of a validation/certification scheme.

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ISO also has an online platform for policy makers related to how to use conformity assessment standards in regulations.

 

Conclusion

In numerous cases, laboratories performing routine food microbiological analyses do not use the RMs based on conventional microbiology but increasingly often choose proprietary methods, based on innovative technologies,
which provide results in a shorter amount of time, are easier to perform, require fewer resources in terms of
skilled staff, and are more automated. The validation of these proprietary methods according to EN ISO 16140, and
their subsequent certification, give assurance to the laboratories and their customers (in the food industry, food
distribution, public control authorities) that the results obtained with these methods are valid and at least as good, if not better, than those obtained with the corresponding RMs, the ‘gold standards’. In certain cases, laboratories may also use in-house methods that they have developed. The revised EN ISO 16140 will provide a tool to the laboratories to validate these methods and to give confidence in their reliability, both to their customers and to accreditation bodies. The revised EN ISO 16140 will also define what method verification in food microbiology is, guiding the laboratoriesin its implementation and allowing a harmonised assessment by accreditation bodies. To further ensure the reliability of results obtained with these innovative methods, ISO and CEN should develop general requirements and guidance to use these methods in food microbiology laboratories, such as the EN ISO 22174 Standard (Anonymous 2005c) for PCR.

References

https://www.iso.org/obp/ui/#iso:std:iso:16140:-2:ed-1:v1:en

Validation of Innovative Food Microbiological Methods According to the EN ISO 16140 Standard
https://www.researchgate.net/publication/225744225_Validation_of_Innovative_Food_Microbiological_Methods_According_to_the_EN_ISO_16140_Standard

http://www.sis.pitt.edu/mbsclass/standards/martincic/iso14000.htm

http://www.iso.org/iso/home/standards/benefitsofstandards.htm

http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2093

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