BS EN ISO 16140-6:2019 - Microbiology of the Food Chain

Discover the essential standard for ensuring the accuracy and reliability of microbiological methods in the food chain with the BS EN ISO 16140-6:2019. This comprehensive document provides a detailed protocol for the validation of alternative (proprietary) methods used in microbiological confirmation and typing procedures, making it an indispensable resource for professionals in the food industry.

Overview

The BS EN ISO 16140-6:2019 standard is a critical tool for laboratories and organizations involved in food safety and quality assurance. Released on December 17, 2019, this standard outlines the necessary steps and criteria for validating alternative methods that are used to confirm and type microorganisms in the food chain. With a total of 36 pages, it provides a thorough and structured approach to method validation, ensuring that alternative methods meet the required performance characteristics.

Key Features

• Standard Number: BS EN ISO 16140-6:2019
• Pages: 36
• Release Date: December 17, 2019
• ISBN: 978 0 580 89056 7
• Status: Standard

Why Choose BS EN ISO 16140-6:2019?

In the ever-evolving landscape of food safety, the ability to accurately confirm and type microorganisms is paramount. The BS EN ISO 16140-6:2019 standard provides a robust framework for validating alternative methods, ensuring they are as reliable and effective as traditional methods. This is particularly important for proprietary methods that may offer advantages in terms of speed, cost, or ease of use.

By adhering to this standard, laboratories can demonstrate their commitment to maintaining high standards of accuracy and reliability in their microbiological testing procedures. This not only enhances the credibility of their results but also supports compliance with regulatory requirements and industry best practices.

Comprehensive Validation Protocol

The validation protocol outlined in the BS EN ISO 16140-6:2019 standard covers all aspects of method validation, from initial planning and design to the final evaluation and reporting of results. It provides clear guidance on the selection of reference methods, the design of validation studies, and the statistical analysis of data. This ensures that alternative methods are thoroughly evaluated and meet the necessary performance criteria.

Applications in the Food Industry

The BS EN ISO 16140-6:2019 standard is applicable to a wide range of microbiological confirmation and typing procedures used in the food industry. Whether you are involved in the production, processing, or distribution of food products, this standard provides the tools you need to ensure the safety and quality of your products.

By implementing validated alternative methods, food industry professionals can enhance their testing capabilities, reduce turnaround times, and improve overall efficiency. This is particularly beneficial in high-throughput environments where rapid and reliable results are essential.

Conclusion

The BS EN ISO 16140-6:2019 standard is an invaluable resource for anyone involved in microbiological testing within the food chain. Its comprehensive validation protocol ensures that alternative methods are rigorously evaluated and meet the highest standards of accuracy and reliability. By adopting this standard, laboratories and organizations can enhance their testing capabilities, support regulatory compliance, and ultimately contribute to the safety and quality of the food supply.

Invest in the BS EN ISO 16140-6:2019 standard today and take a proactive step towards ensuring the integrity of your microbiological testing procedures.

BS EN ISO 16140-6:2019

This standard BS EN ISO 16140-6:2019 Microbiology of the food chain. Method validation is classified in these ICS categories:

• 07.100.30 Food microbiology

This document specifies the general principle and the technical protocol for the validation of alternative confirmation methods for microbiology in the food chain. This document compares the result of the alternative confirmation method against the confirmation procedure of a reference method or, if needed, a reference confirmation method (e.g. whole genome sequencing).

This document is applicable to the validation of alternative confirmation methods used for the analysis (detection or quantification) of isolated microorganisms in:

• products intended for human consumption;

• products intended for animal feeding;

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

• samples from the primary production stage.

Validated alternative confirmation methods can be used to replace (partly or completely) the confirmation procedure described in:

• the reference method;

• an alternative method validated in accordance with ISO 16140-2 only if one of the isolation agars specified in the validation study of the alternative confirmation method is used.

This document is also applicable to the validation of alternative typing methods, where the reference method can be, for example, a serological method (e.g. serotyping of Salmonella) or a molecular method (e.g. typing of Shiga toxin-producing E. coli).

This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, to be determined on a case-by-case basis.

Validation studies in accordance with this document are primarily intended to be performed by organizations or expert laboratories involved in method validation, but can also be used by a single laboratory, especially when performing in-house validation under certain conditions (see ISO 16140-4).