Collecting data for modeling: Product heat penetration, equipment temperatures, and residence time Presentation to the GMA Science Forum April 4, 2012 David Anderson Food Safety Manager Del Monte Foods Company Pittsburgh PA V1 Discussion points A. Introduction B. Methods to validate processes C. Validation tasks D. Further information E. References A. Introduction: Examples of processes Milk, Eggs: Pasteurize (wet) Almonds: Water blanch Hot, humid air Steam Kibbles: PreCondition Treats: Extrude Bones: Bake Jerky: Steam Dry Dry Roast Oil Roast Extrude Cool Dry Dry Dry Cool Cool Cool Dry Cool B. Methods to validate processes Methods to validate processes Codex (CAC/GL 69-2008) and Scott (2005): • Use scientifically valid data • Conduct experiments (microbiological tests, and measures of the system & product) • Use mathematical modeling Σ[(10 (T – Tref)/z )Δt]/D Experiments • Tests of the system • Temperature mapping; Heat transfer distribution • Retention time • Other required process conditions (e.g. rel. humidity) • Tests of the product • Heat penetration studies • Analyses (e.g., moisture/aw, preservative level) • Microbiological tests • Thermal death time studies • Count-reduction tests in lab or in process • End-point lethality (presence/absence) tests Temperature mapping Continuous baking oven: Entry Datalogger spans the width of the belt Exit Temperature mapping To confirm minimum temperatures; adjust the process… Continuous baking oven (from top, looking down): Heat Transfer Distribution To confirm uniform heat transfer & adjust the process… Moist heat (retorts) Lowmoisture Material Reference Lexan® blocks (Campbell and Ramaswamy, 1992) Aluminum or steel bricks (Tung and others, 1984) Silicone food simulants (Smout and others, 1998) Product-filled containers (IFTPS, 2008) 5% Bentonite-filled containers, or other material of known heating (FDA, 2011c) Aluminum almond ABC, 2007d (Photo from Harris, 2009) Product heat penetration To understand heating rates & model the process… Example, pet treats: Temperature probes and location in product: Product entry into the oven: Heat penetration Wireless datalogger examples DataTrace MPIIITM and MadgeTech Temperature dataloggers, with protective insulation for high temperatures. Scorpion Data Logging System for ovens (Temperature, air velocity, heat flux, humidity). Examples of equipment suppliers Manufacturer DataTrace MPIII TM (Mesa Labs) Dickson Ecklund Harrison Ellab Tracksense® Pro MadgeTech, Inc. Omega Engineering Scorpion Systems Super M.O.L.E.® TechniCAL, Inc. ThermoLog TM TMI Web address www.mesalabs.com www.dicksondata.com www.ecklund-harrison.com www.ellab.com www.madgetech.com www.omega.com www.readingbakery.com www.ecd.com www.tcal.com www.c-p-e.be www.tmi-orion.com (Not an endorsement of any supplier. Exclusions are unintended.) Retention time studies To demonstrate retention, prepare for lab simulations; model the process… Options: - Mark product or belt, use a stopwatch - Analytes (e.g. salt in product, in preconditioner or extruder) - Note that some particles may travel faster than the mass average in dryers with a tumble C. Validation tasks 1. The source document describes a scheduled thermal process… Example 1:“Guidelines for Validation of Blanching Processes” (ABC, 2007c) “Guidelines for Validation of Oil Roasting Processes” (ABC, 2007e) • (ABC commissioned the TDT tests.) • Measure uniformity of heating medium temperature (e.g., a “temperature distribution” test). • Measure residence time in equipment. • ABC requires three validation runs. • Control incoming, cold almond temperature and other critical factors in production. 1. The source document describes a scheduled thermal process… Example 2:“Guidelines for Validation of Dry Roasting Processes” (ABC, 2007d) • ABC commissioned TDT tests. • Identify the coldest spot or path for each roasting line (e.g., a “temperature distribution” test). • Use an aluminum almond, or similar device (e.g., a “heat transfer distribution” test). • Measure residence time and temperatures achieved during “worst case” conditions. • ABC requires three validation runs. • Control, monitor, verify CCPs in process. 1. The source document describes a scheduled thermal process… Example 3:“Appendix A, Compliance Guidelines … for Certain Meat And Poultry Products” (FSIS, 1999) • Temperature must be maintained in all parts of each piece of meat for the required time (e.g., a “heat penetration” test) • 90% relative humidity is maintained during processing. • Control, monitor, verify CCPs in process. 2. The source document describes D- and z-values… • (TDT tests were conducted by the source.) • Justify ‘substantial similarity’ of the product and process to the source data. • Obtain temperature distribution and/or heat transfer distribution data from the process. • Collect heat penetration data for the product • Model the process for cumulative log reduction. • General method models, Weibull model • Consult your friendly neighborhood statistician! • Control, monitor, verify CCPs in process. D. Further Information E. References Validation guidance • Guideline for the Validation of Food Safety Control Measures (CAC/GL 69-2008) (Codex) • ICMSF Microorganisms in Foods 8: Use of Data for Assessing Process Control and Product Acceptance (ICMSF, 2011) • Validating the Reduction of Salmonella and Other Pathogens in Heat Processed Low-Moisture Foods. (Anderson and Lucore, April 2012) http://community.pmmi.org/Alliance/Home/ References ABC (Almond Board of California), 2007a. Considerations for Proprietary Processes for Almond Pasteurization and Treatment, v1.0, April 13, 2007. Almond Board of California, Modesto, CA. www.almondboard.com ABC, 2007b. Guidelines for Process Validation Using Enterococcus faecium NRRL B-2354, v1.2, October 2007. Almond Board of California, Modesto, CA. www.almondboard.com ABC, 2007c. Guidelines for Validation of Blanching Processes, v1.0, April 13, 2007. Almond Board of California, Modesto, CA. www.almondboard.com ABC, 2007d. Guidelines for Validation of Dry Roasting Processes, October 2007. Almond Board of California, Modesto, CA. www.almondboard.com ABC, 2007e. Guidelines for Validation of Oil Roasting Processes, v1.0, April 13, 2007. Almond Board of California, Modesto, CA. www.almondboard.com ABC, 2007f. Guidelines for Validation of Propylene Oxide Pasteurization, v3.0, October 1, 2008. Almond Board of California, Modesto, CA. www.almondboard.com ABC, 2007g. Guidelines for Validation of Propylene Oxide Treatment for In-shell Almonds, v2.0, October 1, 2008. Almond Board of California, Modesto, CA. www.almondboard.com References ABC, 2007h. Pasteurization Treatments. December 2007. Almond Board of California, Modesto, CA. www.almondboard.com Anderson, D. G. and L. A. Lucore. 2012. Validating the Reduction of Salmonella and Other Pathogens in Heat Processed Low-Moisture Foods. Alliance for Innovation & Operational Excellence, Alexandria, VA. Published online at http://community.pmmi.org/Alliance/Home/ ASTA (American Spice Trade Association), 2011. Clean, Safe SPICES: Guidance from the American Spice Trade Association., 2025 M Street, NW, Suite 800, Washingt5on, DC 20036. www.astaspice.org Campbell, S. and H.S. Ramaswamy. 1992. Distribution of heat transfer rate and lethality in a single basket water cascade retort. J. Food Process Engineering. 15:31-48. Center for Meat Process Validation, 2012. www.meathaccp.wisc.edu. Accessed February 6, 2012. Codex (Codex Alimentarius Commission), 2008. Guideline for the Validation of Food Safety Control Measures (CAC/GL 69-2008). Joint FAO/WHO Food Standards Program, FAO, Rome, Italy. www.codexalimentarius.net References FDA (Food and Drug Administration). 2011. Processing in Steam-Air Retorts (Retort Survey). FDA Inspection Form FDA 3511h (1/11). FSIS (U.S. Department of Agriculture - Food Safety Inspection Service), 1999. Appendix A. Compliance guidelines for meeting lethality performance standards for certain meat and poultry products. Available at http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/95-033F/95033F_Appendix%20A.htm . Accessed October 26, 2011 Harris, L. J., 2009. Process Validation for Low-Water Activity Foods. Presentation for IAFP: Salmonella in Peanut Products. Found at http://www.foodprotection.org/files/rr_presentations/RR_07.pdf ICMSF (International Commission on Microbiological Specifications for Foods), 2011a. Microorganisms in Foods 8: Use of Data for Assessing Process Control and Product Acceptance. Katherine M. J. Swanson, ed. chair. New York: Springer Science+Business Media, LLC. IFTPS, 2008. Temperature and Heat Transfer Distribution Guidelines for Processing in Batch Agitating Retorts. From www.iftps.org, accessed February 13, 2012. References NACMCF (National Advisory Committee on Microbiological Criteria for Foods), 2006. Requisite Scientific Parameters for Establishing the Equivalence of Alternative Methods of Pasteurization. J. Food Prot. 69:1190-1216. NACMCF. 2010. Parameters for Determining Inoculated Pack/Challenge Study Protocols. J. Food Prot. 73:140-202. Scott, V. N.. 2005. How does industry validate elements of HACCP plans? Food Control. 16:497-503. Smout, C., A. Van Loey, M. Hendrickx. 1998. Heat Distribution in Industrial-scale Water Cascading (Rotary) Retort. J. Food Sci. 63:882-886. Tung, M. A., H. S. Ramaswamy, T. Smith and R. Stark. 1984. Surface heat transfer coefficients for steam/air mixtures in two pilot scale retorts. J. Food Sci. 49:939-943. Thank You David Anderson Food Safety Manager Del Monte Foods Company Pittsburgh PA
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