1, the purpose of validation: to clarify the purpose of validation, such as validation of the product starting microbial load.
2, equipment and materials: list all the equipment and materials used for validation, such as test media, plate counter, sterilizer.
3, method description: a detailed description of the validation method, including sample collection, sample processing, media type and composition, culture conditions, reading methods.
4, validation criteria: the development of appropriate validation criteria, such as for which microorganisms to validate, the validation results should meet which requirements.
5, validation program: the development of a complete validation program, including sample collection time, validation frequency, validation time.
6, records and analysis: collect and record all the experimental results, timely statistical analysis, including the number of microbial colonies, microbial species, detection rate.
7, validation report: prepare a complete validation report, analyze and summarize the experimental results, and put forward improvement measures or recommendations.