What is ISO 16140‑4 about?
ISO 16140‑4 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 16140‑4 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.
Single-laboratory validation is the second step in the standardization of a reference method. It is only applicable to methods that fully specify about all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized.
Who is ISO 16140‑4 for?
ISO 16140‑4 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 16140‑4?
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.
The ISO 16140-4 standard provides a validation method to validate results within a single laboratory. The results are therefore valid for the laboratory that performed the study.
ISO 16140-5 describes protocols for non-proprietary methods where more rapid validation is required or when the method to be validated is highly specialized and the number of participating laboratories cannot be reached.
ISO 16140-5 provides two strategies for the single-laboratory method validation of detection and quantification methods.
Determination of the in-house reproducibility for quantitative methods are described.
ISO 16140-5 is suitable for validation both against a reference method and without one.
Using ISO 16140-4, users can detect and/or quantify, confirm, and type microorganisms in food, animal feed, and environmental samples that belong in food, animal feed, or are intended for human consumption.