Harold Alexis Prada RamírezCoaspharma S.A.S. Laboratories, Colombia
Title: Performance equivalence and validation of a rapid microbiological method for detection and quantification of yeast and mold in an antacid oral suspension
Alternative and rapid microbiological methods can be effective replacements for more traditional plating approaches for ensuring quality and safety in the pharmaceutical industry. This article compares the efficacy of the Soleris automated method and the traditional plate-count method for the quantitative detection of yeasts and molds at three different microbial bioburden levels. Essential validation parameters such as precision (standard deviation 70%), linearity (R2 >0.9025), ruggedness (ANOVA, P < 0.05), operative range, and specificity were determined. It was shown that all the test results obtained using the alternative method were in statistical agreement with the those of the standard plate-count method. Thus, this new technology was found to meet all the validation criteria needed to be considered as an alternative method for yeast and mold quantification in the antacid oral suspension tested.
Harold Prada has completed his phD at the age of 31 years from Granada University, Spain. He is the head of research of Coaspharma Laboratoies, Colombia. He has over 8 publications.