Validation of an alternative microbiological method for nutritional supplements and over-the- counter drugs

Validation of an alternative microbiological method for nutritional supplements and over-the- counter drugs

This project is focused on determining the efficacy of the alternative microbiological plate counting method, the 3M Petri-Film plate reading device. The 3M plate reader device is used for high volume microbial enumeration of food products in large food manufacturing facilities. This device claims to increase operator speed by 3 times providing considerable cost savings to companies performing 100+ microbiological tests daily. This study was conducted to validate this device for use in tablet, capsule, liquid, semi-solid dosage forms, cleaning validations, and water sample testing. With this project we were compared plate counts on the Petri film device to plate counts on standard media. We performed testing on USP listed microbes for testing of aerobic plate counts, total yeast and mold counts, and identification & enumeration of S. aureus, Salmonella, E Coli, and P. Aeruginosa, C. Albicans. We are also tested for total coliforms. This report shows equivalent counts when comparing known quantities of microbes in a range of dilutions on standard plate to dilutions on Petri-film plates. With this study we determined that the 3M Petri film device is capable of providing faster & equivalently accurate microbial growth results to standard plating methods.