Demonstration of Inappropriate Validation Method for a Cracker Baking Process Using Predictive Modeling.

Validation of baking processes for the inactivation of Salmonella is complicated by the combined effects of product heating and drying. The goal of this study was to quantitatively evaluate a previously disseminated approach to validating baking processes utilizing a predictive model developed using only isothermal and single-moisture inactivation data for the initially formulated dough. A simple cracker dough was formulated using flour inoculated with a five-strain cocktail of Salmonella. Side-by-side isothermal and baking experiments were performed to estimate Salmonella inactivation kinetics and to quantify survivors in a dynamic environment, respectively. Isothermal, single-moisture inactivation experiments were performed with cracker dough (water activity, aw = 0.956 ± 0.002; moisture content = 0.50 ± 0.01 dry basis) at three temperatures (56, 60, or 63°C) with ≥6 time intervals. Baking experiments were performed in a convection oven at 177°C with samples pulled every 30 s up to 360 s, with an endpoint product aw (25°C) of 0.45. The Salmonella isothermal, single-moisture inactivation kinetics in cracker dough resulted in D60°C and z-values of 4.6 min and 4.9°C, respectively; this model was then integrated over the dynamic product temperature profiles from the baking experiments. In the baking experiments, an average of 5-log reductions of Salmonella was achieved by 150 s of treatment; however, >100-log reductions were predicted by the dough-based models at that time point. This fail-dangerous overestimation of Salmonella lethality in crackers explicitly demonstrated that single-level moisture-based prediction models are inappropriate for describing inactivation in a process with both dynamic temperature and moisture, and that model-based validations must incorporate moisture/aw. Furthermore, end-users should exercise caution when utilizing unvalidated models to validate preventive control processes.

Process Humidity Affects Salmonella Lethality at the Surface and Core of Impingement-Cooked Meat and Poultry Products.

ABSTRACT: Recent revisions to U.S. Department of Agriculture, Food Safety and Inspection Service (FSIS) compliance and safe harbor guidelines for ready-to-eat meat and poultry products addressed process humidity requirements. Given the lack of prior data for impingement-cooked products, the present study was conducted to evaluate the impact of process humidity on Salmonella lethality at the product core and surface and compliance of the results with FSIS lethality performance standards. Whole muscle beef strips, ground beef patties, whole muscle chicken breast fillets, and breaded ground chicken patties were inoculated with an eight-serovar cocktail of Salmonella. Beef and chicken samples were cooked in a pilot-scale moist-air impingement oven to a core temperature of 70.0 and 72.8°C, respectively, immediately quenched in liquid nitrogen, and dissected to obtain core and surface samples. Variables included oven temperature (218 and 232°C), air velocity (0.7 and 2.8 m/s), and oven humidity (0.7, 15, 30, or 70% moisture by volume [%, v/v]). Additional treatments were performed to examine the impact of supplemental critical control processes such as increased endpoint temperature, postoven carryover time, and pre- or postoven steam treatments. Salmonella reductions of >7 log units were reliably achieved in chicken patties regardless of the processing variables; however, none of the treatments reliably ensured >6.5-log reductions of Salmonella in ground beef. A majority of whole-muscle samples failed to meet the required performance lethality when processed at 0.7% (v/v) humidity; however, Salmonella inactivation was significantly improved (P < 0.05) at oven humidities of ≥30% (v/v). Dry oven conditions achieved greater Salmonella lethality at the core than at the surface for multiple products (P < 0.05). The efficacies of minimal and supplemental critical controls were dependent on product, process, and humidity (P < 0.05). Overall, process humidity and product variability should be considered in regulatory requirements and process validations.

Survival and Thermal Resistance of Salmonella Enteritidis PT 30 on Almonds after Long-Term Storage.

Salmonella survival and thermal resistance on the surface of almond kernels were evaluated after periods of storage. Almond kernels were inoculated with Salmonella Enteritidis PT 30 and equilibrated to 0.45 water activity. Samples were separated into two groups (I and II) and stored in sealed metal cans at room temperature. Group I samples (stored 7, 15, 27, and 68 weeks) were re-equilibrated in controlled humidity chambers to 0.45 water activity before performing the thermal treatments after each storage period, but group II samples (stored 70 and 103 weeks) were thermally treated immediately after the cans were opened. For thermal treatments, individual almond kernels were vacuum sealed in thin plastic bags, heated isothermally in a water bath (80°C) for nine intervals, immediately cooled in an ice bath, and assayed for surviving Salmonella. Log-linear and Weibull models were fit to the inactivation data. Salmonella population decreased ( P < 0.05) more than 2 log CFU/g during the long-term storage. Salmonella survival in group II at 70 weeks (7.3 log CFU/g) was higher ( P < 0.05) than in group I (which had been re-equilibrated multiple times) at 68 weeks (6.2 log CFU/g). However, the thermal resistance of Salmonella Enteritidis PT 30 did not decrease ( P > 0.05) for up to 68 weeks of storage, and the log-linear model best described the thermal inactivation data. Overall, the results suggest that re-equilibrating almonds (group I) multiple times may have increased the rate of reduction of Salmonella populations during long-term storage. However, Salmonella thermal resistance on almonds appears to be essentially unaffected by long-term storage, which is important information for designing and conducting validation studies for pathogen control processes.

Inoculation Protocols Influence the Thermal Resistance of Salmonella Enteritidis PT 30 in Fabricated Almond, Wheat, and Date Products.

Inoculation methods in pathogen inactivation studies ideally represent conditions that might occur in real-world scenarios. Surface contamination in or on low-moisture foods affects Salmonella thermal resistance, which is critically important for process validation applications. The objective of this study was to quantify the effect of inoculation protocol on the thermal resistance of Salmonella Enteritidis PT 30 in fabricated low-moisture foods. Almond meal, almond butter, wheat meal, wheat flour, and date paste were inoculated via prefabrication and postfabrication protocols. In the prefabrication protocol, kernels and fruits were surface inoculated and equilibrated to a target water activity (aw) (0.40 for almond and wheat products, 0.45 for date products) before fabricating meal, butter, flour, or paste and then reequilibrating the samples to the target aw. In the postfabrication protocol, meal, butter, flour, and paste were fabricated before inoculation and equilibration. All inoculated and equilibrated samples were subjected to isothermal treatment (80°C), pulled sequentially during processing, cooled, serially diluted, and plated to enumerate survivors. Log-linear and Weibull-type models were fit to the Salmonella survivor data and were compared via the corrected Akaike information criterion. Pre- and postfabrication protocols resulted in significant differences ( P < 0.05) in Salmonella thermal resistance in all products. Overall, the thermal resistance of Salmonella Enteritidis PT 30 in almond products was greater ( P < 0.05) than in wheat products, which was also greater ( P < 0.05) than in date paste. Additionally, Salmonella was more thermally resistant in almond products and date paste when inoculated pre- rather than postfabrication; however, the opposite was true for wheat products. These results indicate that the means of inoculation can significantly affect thermal resistance of Salmonella in low-moisture foods.

Comparing Thermal Process Validation Methods for Salmonella Inactivation on Almond Kernels.

Ongoing regulatory changes are increasing the need for reliable process validation methods for pathogen reduction processes involving low-moisture products; however, the reliability of various validation methods has not been evaluated. Therefore, the objective was to quantify accuracy and repeatability of four validation methods (two biologically based and two based on time-temperature models) for thermal pasteurization of almonds. Almond kernels were inoculated with Salmonella Enteritidis phage type 30 or Enterococcus faecium (NRRL B-2354) at ~108 CFU/g, equilibrated to 0.24, 0.45, 0.58, or 0.78 water activity (aw), and then heated in a pilot-scale, moist-air impingement oven (dry bulb 121, 149, or 177°C; dew point <33.0, 69.4, 81.6, or 90.6°C; vair = 2.7 m/s) to a target lethality of ~4 log. Almond surface temperatures were measured in two ways, and those temperatures were used to calculate Salmonella inactivation using a traditional (D, z) model and a modified model accounting for process humidity. Among the process validation methods, both methods based on time-temperature models had better repeatability, with replication errors approximately half those of the surrogate ( E. faecium ). Additionally, the modified model yielded the lowest root mean squared error in predicting Salmonella inactivation (1.1 to 1.5 log CFU/g); in contrast, E. faecium yielded a root mean squared error of 1.2 to 1.6 log CFU/g, and the traditional model yielded an unacceptably high error (3.4 to 4.4 log CFU/g). Importantly, the surrogate and modified model both yielded lethality predictions that were statistically equivalent (α = 0.05) to actual Salmonella lethality. The results demonstrate the importance of methodology, aw, and process humidity when validating thermal pasteurization processes for low-moisture foods, which should help processors select and interpret validation methods to ensure product safety.