USP Harmonized Compendial Methods
|United States Pharmacopeia (USP)||Ph. Eur, EP||JP||NSI Catalog Item||Harmonized Description|
Microbiological Examination of Non-sterile Products: Tests for Specified Microorganisms
|<2.6.13>||JP <35> Microbial Limit Test||PHPT-015||Test for Specified Microorganisms in Non-sterile Products|
Qualitative Proficiency Test (PT) for Specified Microorganisms in Non-Sterile Products by USP <62> or equivalent. Samples are provided as a panel of five single-pellet vials plus five vials of talc powder. Each vial of talc contains 10 grams per vial. Participants will follow provided step-by-step instructions to prepare each sample for plating onto suitable microbiological media. Participants may report qualitative results of either present or absent for their samples. Three of the five samples will contain microorganisms and therefore be positive. Participants are asked to identify a positive sample by indicating present and identify a negative sample by indicating absent.
A positive sample will contain one of the following microorganism species:
Staphylococcus aureus, Salmonella enterica abony, Pseudomonas aeruginosa, Salmonella enterica typhi, Escherichia coli, or Candida albicans
A negative sample will be sterile and not contain any microorganisms.