Purpose: The purpose of this study was to develop a scientifically valid composite testing protocol per FSMA to perform sterility testing of RTE pudding products.
Methods: Two pudding formulations (vanilla and chocolate) were used for the study. Pudding samples were individually inoculated with a three strain gram-negative cocktail and a four strain gram-positive cocktail at target levels of 1.0 to 2.0 log cfu/pudding cup and incubated three days at 35°C. Samples were analyzed using Celsis® RapidScreen® per manufacturer’s instructions and confirmed with FDA-approved methods. Samples were then composited in levels of one to five samples (one part inoculated positive sample combined with zero to four parts uninoculated negative samples). Alpha-amylase as a process aid (should the enzyme be added before or after incubation) was also evaluated as part of the study. The study constituted three replicates.
Results: This study indicated that compositing of pudding samples (levels one to five) regardless of the addition of alpha-amylase before or after incubation resulted in 100% detection of the all the organisms evaluated in this study. However, samples where amylase was added post-incubation resulted in bioluminescence values significantly (P<0.05) lower compared to their counter parts.
Significance: These findings provide scientific basis for composite testing protocols utilized by Conagra Brands for sterility testing of RTE pudding products.