Mondelez International, Inc. · NASDAQ:MDLZ
Mondelez International — Technical Presentation (June 2023)
42 slides from Mondelez International's technical presentation, June 2023
Slide 1: Thermal Process Validation
THERMAL PROCESS VALIDATION June 2023
Slide 2: About Today's Session
ABOUT TODAY’S SESSION • This broadcast is being recorded • Please send any questions you have throughout today’s session using the Q&A panel • Questions will be addressed near the middle and at the end of the broadcast • If your questions are not answered, please contact us through email • Please be
Slide 3: Moderators and Presenter
Moderators For Today’s Training ChriS D’ANCONA Craig Sember Supplier Quality Coordinator Quality Program Leader Mondelēz Global Quality Compliance Mondelēz Global Food Safety East Hanover, NJ, United States Bournville, United Kingdom Today’s Presenter Karen Megumi Watanabe Thermal Process Authority
Slide 4: Objectives
Cover main aspects – not all - that need to be considered in thermal process validation Review requirements from SQE related to Thermal Process OBJECTIVES Validation Highlight main audit findings related to Thermal Process Validations **This session does not cover specific requirements from Processi
Slide 5: Agenda
AGENDA MDLZ requirements on thermal process validations Factors affecting microbial inactivation in a thermal processing Thermal processing validation Continuous process – fluids Continuous process – dry nut roasting Validation with surrogates – main aspects to consider Watch outs
Slide 6: MDLZ Expectations
MDLZ EXPECTATIONS From Supplier Quality Expectations Manual (SQE) • All sensitive ingredients (or sensitive ing. derived material) must be submitted to a pathogen kill step at supplier, supplier´s supplier or MDLZ Non • When the kill step is located at MDLZ, the ingredient specification is classifie
Slide 7: MDLZ Expectations
Common audit findings: MDLZ EXPECTATIONS • No formal validation performed From Supplier Quality Expectations Manual (SQE) • In-depth verification not performed every 2 years • Revalidation not performed after major changes • The pathogen kill step must be validated • Validation must prove that the p
Slide 8: Myths & Misconceptions
MYTHS & MISCONCEPTIONS • Microorganisms don’t survive or grow in dry (low moisture) foods like biscuits, chocolate, nuts, powders • A lot of microorganisms are needed to be able to cause disease • Contamination by microorganisms is only caused by contact to animals/fecal matters (sewage) • Tradition
Slide 9: Pathogen Log Reduction Controls (Pathogen Kill Step)
PATHOGEN LOG REDUCTION CONTROLS (PATHOGEN KILL STEP) Examples of controls • Pasteurization • Retorting • Irradiation • High Pressure Processing (HPP) • Pulsed Electric Field • Ultraviolet light • Ultrasound • Chemical treatments (Ozone, Peracetic acid, Hydrogen Peroxide, Chlorination, Ethylene Oxide
Slide 10: Validation Concept
VALIDATION CONCEPT Validation: Obtaining evidence that a control measure or combination of control measures, will be capable of effectively controlling the hazard to a specified outcome Validation is performed at the time a control measure is designed & implemented or whenever changes are made to th
Slide 11: Factors Affecting Microbial Inactivation in a Thermal Processing
FACTORS AFFECTING MICROBIAL INACTIVATION IN A THERMAL PROCESSING
Slide 12: Microorganism Target
MICROORGANISM TARGET Common audit finding: Validation does not consider target pathogen • Different inactivation profile for different microorganisms • Differences among strains (e. g. Salmonella Senftenberg 775W, Salmonella Enteritidis PT30) • Spores vs Vegetative • Injured/adapted cells • Gram+ vs
Slide 13: Effect of Matrix
EFFECT OF MATRIX • Different inactivation profile for same microorganisms in different matrices – Effect of pH – Effect of aw – Effect of particle size – Composition (salt, fat, solids content, preservatives, inhibitors, etc.) – Different organic acids – (…) Source: Bradshaw, J. G., et.al, 1985, The
Slide 14: Thermal Resistance of Salmonella Under Different Conditions
THERMAL RESISTANCE OF SALMONELLA UNDER DIFFERENT CONDITIONS Various compiled studies: Doyle, M. e.; Mazzotta, A. S., “Review of Studies on the Thermal Resistance of Salmonellae”, Journal of Food Protection, 2000, Vol 63, n. 6.
Slide 15: Effect of Temperature in Survival
EFFECT OF TEMPERATURE IN SURVIVAL
Slide 16: Effect of Temperature in Survival
Common audit findings: EFFECT OF TEMPERATURE IN SURVIVAL • Validation does not consider target log reduction • Equivalent time/temperature for critical limit D-value not calculated properly This curve is characterized by D-values (decimal reduction time), calculated by the time required at a particu
Slide 17: Z-Value
Z-VALUE z -value: The increase in Temperature C required for a 10-fold decrease in the D-value Extrapolation for D and z values for different matrices and different temperature ranges should not be done, except when it is supported by scientific data
Slide 18: Other Factors
OTHER FACTORS • Pressure • Stressed/Injured cells • Variation of matrix attributes during processing • (…)
Slide 19: Thermal Process Validation
THERMAL PROCESS VALIDATION
Slide 20: Thermal Process Validation
Common audit findings: THERMAL PROCESS VALIDATION • Not all critical operating parameters and calculations documented validation report • Validation does not consider worst case • The pathogen log reduction step or combination of steps must be validated at the time a control measure is designed & im
Slide 21: Validation Study: Experimental Design
VALIDATION STUDY: EXPERIMENTAL DESIGN 1) Product Description 2) Process Description, mapping all variables of the process 3) Establishment of Worst Case Conditions : the list is not exhaustive – Temperature? – Time, flow, belt speed ? – Bed depth (e.g. nut roasters) – Temperature distribution inside
Slide 22: Main Validation Options
MAIN VALIDATION OPTIONS Validation protocol - two options: Validation of processing parameters in relation to scientific data on D and z-values or established safe harbor processing conditions (i.e. milk 72°C 15sec) Validation using surrogate microorganisms • Shall be used when there is no scient
Slide 23: Pause for Questions
- ~ PAY Mondetér _ SNACKING MADE RIGHT
Slide 24: Continuous Process: Fluids
CONTINUOUS PROCESS: FLUIDS
Slide 25: Schematic Diagram
Hold tube SCHEMATIC DIAGRAM Temperature probe at exit of hold tube (Recorder) Temperature probe at exit of hold tube (Reference) Unpasteurized Divert Valve product Temperature probe at inlet of hold tube To process Heating P medium Cooling Regeneration Heating H Cooling E medium Pump Balance Tank Ma
Slide 26: For Continuous Processing of Fluids
FOR CONTINUOUS PROCESSING OF FLUIDS In general D and z values are used to validate the log reduction • Holding time and correct divert valve location depends on dimensions of the tube and flow regime ➢ Laminar flow (worst case scenario) : Velocities are maximum at center of tube. Maximum speed is 2x
Slide 27: Laminar Flow, Transition Flow, Turbulent Flow
Laminar Flow Transition Flow Turbulent Flow
Slide 28: Important Points to Consider
Common audit findings: IMPORTANT POINTS TO CONSIDER • Flow diversion device/valve distance and reaction time not assessed • Flow diversion is performed manually • Hold tube must have correct dimension and temperature probe located in the end of the holding – Design must consider flow rate, flow regi
Slide 29: Important Points to Consider
IMPORTANT POINTS TO CONSIDER • Location of divert valve shall consider flow regime – Time to divert all unprocessed material must be < to the response time for the system to detect drop in temperature/flow, send the signal and completely activate the valve
Slide 30: Divert Valve Step 1
Hold tube 1. Temperature probe or flow meter detects decrease in temperature or increase in flow Unpasteurized Divert Valve product To process P Cooling Regeneration Heating H E Pump Balance Tank Manometer
Slide 31: Divert Valve Step 2
Hold tube 2. Probe(s) send the signal to the control loop Unpasteurized Divert Valve product To process P Cooling Regeneration Heating H E Pump Balance Tank Manometer
Slide 32: Divert Valve Step 3
Hold tube 3. Control loop sends the signal to the divert valve to divert the flow Unpasteurized Divert Valve product To process P Cooling Regeneration Heating H E Pump Balance Tank Manometer
Slide 33: Schematic Diagram
Hold tube SCHEMATIC DIAGRAM 4. Valve is fully activated and diverts flow Unpasteurized Divert Valve product To process P Cooling Regeneration Heating H E Pump Balance Tank Manometer
Slide 34: Continuous Process: Dry Roasting
CONTINUOUS PROCESS: DRY ROASTING
Slide 35: Dry Nut/Seed Roasting
DRY NUT/SEED ROASTING • Mostly are continuous dry roaster • Preferably should be validated using surrogate organisms • Temperature distribution to be done to determine coldest spots • Validation studies should be done at least for 3 replicates considering variables that could impact the processing
Slide 36: Examples of Key Information Required
EXAMPLES OF KEY INFORMATION REQUIRED Product Design Parameters Procedure • Type of nuts /seeds • Zones • Temperature setting • Divert Mechanism • Size • Location of probes for each recipe • Change over • Initial form of (air/product) • Max Belt speed • Cleaning mechanism seed/nuts (raw, or pre- • He
Slide 37: Validation with Surrogates – Main Aspects to Consider
VALIDATION WITH SURROGATES – MAIN ASPECTS TO CONSIDER
Slide 38: Validation Using Surrogate Microorganisms
VALIDATION USING SURROGATE MICROORGANISMS • Validation using surrogate organisms' inoculum – Replaces the use of pathogens in manufacturing lines – Are non-pathogenic organisms – Shall have inactivation characteristics and kinetics equivalent to target pathogen • important to assess impact on matrix
Slide 39: Important Aspects to Consider
IMPORTANT ASPECTS TO CONSIDER • Before: – Have all details from the experimental design set **Do not overlook the micro methods used for preparing and recovering the surrogate** – Changes in matrix (e.g. pretreatment of samples, change in attributes after inoculation) – Naturally, initial contaminat
Slide 40: Important Aspects to Consider
Common findings: IMPORTANT ASPECTS TO CONSIDER • No correlation of setting of variables during study with critical limits • Inoculum preparation, inoculation affecting resistance of organisms • Not all critical limits from validation monitored in operation • During the runs: – Document all variables
Slide 41: Takeaways
• A robust validation relies on a robust experimental design and understanding of all aspects influencing the thermal processing TAKEAWAYS • Variables affecting microbial inactivation must be assessed in detail • The selected measurement to monitor the control measure must be able to ensure the targ
Slide 42: Thank You! Q&A
THANK YOU! Q&A Please complete the quiz and survey for today’s training by scanning the QR code or using the link provided. We value your feedback! https://forms.office.com/r/Tkx2GC6usx
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