1、Process Validation Considerations Nathan Anderson,Ph.D.Director,Div.Food Processing Science&TechnologyValidation of Preventive Controls Preventive controls should be implemented when pathogens in low moisture foods pose a risk.Preventive controls need to be validated.*Not all foreseeable hazards for
2、 a food require a preventive control in all facilities.Hazard Analysis and Risk-Based Preventive Controls for Human Food:Guidance for IndustrySource:FBM Machines,Inc.https:/ to Validation Government guidance Safe harbors Published scientific literature Mathematical models Data from previous studies
3、Data from new scientific experiments Any combination of these approachesExceptional lethalityGovernment GuidanceGuidance for industry:Juice hazard analysis critical control point hazards and controls guidance,first edition.Juice HACCP(FDA,2004)Fruit juices(pH 4.0 or less)160F(71.1 C)for 3 s(5-log re
4、duction of E.coli O157:H7,L.monocytogenes,Salmonella)https:/www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-pointhazards-and-controls-guidance-firstSafe HarborsOil Frying(Almonds/Salmonella)260F(127C)for 2.0 min(5 log)260F(127
5、C)for 1.6 min(4 log)Blanching(Almonds/Salmonella)190F(87.8C)for 2.0 min(5 log)190F(87.8C)for 1.6 min(4 log)Published Scientific Literature(same parameters on same product and process)5 log reduction achievedHard Cookies After 11.5 mins at 185C(365F)Soft Cookies After 20.5 min at 165.6C(330.1F)(Chann
6、aiah et al.2021)Whole Wheat Bread 5 log reduction achieved after 15 mins at 190.6C(375F)(Channaiah et al.2019)Toppings,Inclusions&FillingsLog reductions achieved Baked to match“bun color”standard 7 mins at 204C(400F)low(3%)RH 5 log reduction for plain buns 3.5 log reduction for Sesame topped buns 9