Microbiology of the food chain. Method validation - Protocol for factorial interlaboratory validation for nonproprietary methods

Microbiology of the food chain. Method validation - Protocol for factorial interlaboratory validation for nonproprietary methods

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What is ISO 161405 about?  

ISO 161405 specifies the general principles and the technical protocols (based on orthogonal, factorial studies) for the validation of non-proprietary methods for the microbiology of the food chain. 

ISO 161405 applies to bacteria and fungi. Some clauses can be applied to other (micro)organisms or their metabolites, to be determined on a case-by-case basis. 

ISO 161405 is only applicable to the validation of methods that are fully specified about all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized. 

Note: ISO 161402 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods against a reference method. 

Who is ISO 161405 for? 

ISO 161405 on microbiology of the food chain is useful for: 

  • Food laboratories  
  • Microbiologists  
  • Food scientists  
  • Any entity related to the study of microorganisms 

Why should you use ISO 161405?  

Microbiology is important to food safety, production, processing, preservation, and storage. Microbes such as bacteria, moulds, and yeasts are employed for the foods production and food ingredients such as the production of wine, beer, bakery, and dairy products.  

ISO 161405 specifies non-proprietary methods where a more rapid validation is required or when the method to be validated is highly specialized. 

ISO 161405 provides a validation protocol for analysing microorganisms in products for human consumption, animal feeding, and environmental samples. 

ISO 16140-5 benefits users by providing methods such as detection and/or quantification, confirmation, and typology of microorganisms in food, animal feed, and environmental samples that are intended for human consumption or animal feed.