in validating the total yeast and mold is it enough with 1 species representing molds and yeasts?
What is context - drug, cosmetic, food?
"Validating" - as in validating recovery in presence of product?
Hi
You can find different approaches for validating microbiological methods in ISO 16140 standards.
validation on drug samples. is it only enough with a spike sample representing 1 yeast and 1 mold. or how many microbes should I use @Phil Geis
thanks for all your answers Francesc Codony
Yes - Candida albicans and Aspergillus brasiiensis in "suitability" testing - but use the strains and methods specific in USP's 61/62. Do not use ISO 16140 - that is for foods.
https://www.usp.org/sites/default/files/usp/document/harmonization/gen-method/q05b_pf_ira_34_6_2008.pdf
https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/generalChapter62.pdf
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