Simulation Evaluation of Power of Sampling Plans to Detect Cronobacter in Powdered Infant Formula Production

Cronobacter is a hazard in Powdered Infant Formula (PIF) products that is hard to detect due to localized and low-level contamination. We adapted a previously published sampling simulation to PIF sampling and benchmarked industry-relevant sampling plans across different numbers of grabs, total sample mass, and sampling patterns. We evaluated performance to detect published Cronobacter contamination profiles for a recalled PIF batch [42% prevalence, -1.8 & PLUSMN; 0.7 log(CFU/g)] and a reference, nonrecalled, PIF batch [1% prevalence, -2.4 & PLUSMN; 0.8 log(CFU/g)]. Simulating a range of numbers of grabs [n = 1-22,000 (representing testing every finished package)] with 300 g total composite mass showed that taking 30 or more grabs detected contamination reliably (<1% median probability to accept the recalled batch). Benchmarking representative sampling plans ([n = 30, mass grab = 10g], [n = 30, m = 25g], [n = 60, m = 25g], [n = 180, m = 25g]) showed that all plans would reject the recalled batch (<1% median probability to accept) but would rarely reject the reference batch (>50% median probability of acceptance, all plans). Overall, (i) systematic or stratified random sampling patterns are equal to or more powerful than random sampling of the same sample size and total sampled mass, and, (ii) taking more samples, even if smaller, can increase the power to detect contamination.