Oven Validations and In-Bakery Data Collection at ARYZTA Bakeries for Baked Goods. Wafa Birbari, Ph.D. October 2018

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2 Oven Validations and In-Bakery Data Collection at ARYZTA Bakeries for Baked Goods Wafa Birbari, Ph.D. October 2018

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4 HACCP Food Safety Preventive Control Plan - Hazard Analysis Biological hazards, control measures may include: Measures that directly kill the pathogen (e.g. of lethal step baking, cooking, frying) or prevent growth of microbial vegetative cells (e.g. ph, time and temperature controls such as cooling, freezing, refrigeration and limiting the time at temperatures that support growth).

5 INTRODUCTION Validation consists of activities designed to determine if the HACCP plan effectively controls the hazards of concern. It Involves obtaining evidence that control measures, when properly implemented, are capable of controlling the identified hazards (Codex). Two main criteria have to be met for a validation; 1) The scientific or technical support for the judgments made in designing the HACCP system; and 2) Evidence derived from the HACCP plan in operation to demonstrate that the establishment is able to implement the critical operational parameters necessary to achieve the results documented in the scientific or technical support.

6 FDA Guidance Definitions Validation: Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards. Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

7 HACCP Validation Definitions: Validation consists of activities designed to determine if the HACCP plan will effectively control the hazards of concern NACMCF: It is an element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the hazards Codex: Involves obtaining evidence that control measures, when properly implemented, are capable of controlling the identified hazards

8 Validation Purpose Purpose of Validation is to determine: Hazard analysis is appropriate and realistic HACCP plan is controlling hazards HACCP plan is based upon current science

9 PURPOSE The primary purpose of this work was to develop and implement a procedure that validates and verifies the effectiveness of the baking process and provide actual data to support the effectiveness of GMPs, hygiene, and environmental monitoring as additional intervention strategies in controlling the microbiological hazards in the finished food.

10 SUMMARY An oven validation test run starts after a full line cleanup and is followed by another full cleanup. During baking validation run, samples are removed from line at different steps of the process and tested at third party laboratory for microbiological and chemical attributes. Samples, before baking, such as batter & dough, and after baking, such as muffins & bread, are tested for microbiological indicators and for pathogens of concern. Concurrently, a temperature recording device is run through the oven to record oven and food temperatures throughout baking process. Temperature data is used to calculate pathogen kill and log reduction of baking process using published models. In some instances, a humidity probe is also run through oven during baking and a humidity profile of the process recorded.

11 RESULTS Results: More than 25 oven validations has been completed for a variety of bakery foods. All oven validation studies has been successful in achieving 5 or more log reductions after baking and all microbiological results were acceptable. Significance: This work provides: (1) scientific support for pathogen destruction during the baking process; (2) a risk assessment of the process and the environment; and (3) a practical approach to generate comprehensive data to provide scientific support to an effective food safety plan. 11

12 ARYZTA s Validation Model for Baked Foods

13 Validation Test Outline 1. Product Selection 2. Process Preparation & Review 3. Scheduling 4. Protocol (examples): Continuous Oven/Stationary-rack oven 5. Review of Temperature Data & Lab results 6. Decisions Release food/destroy food, corrective action (re-do validation study) 7. Summarize/Report - HACCP Support Documentation 8. Repeat at TBD Frequency

14 Product Selection Select worst case food from a line/haccp Plan Criteria: history of under-bake issues lowest oven temperature profile lowest water activity highest fat high-risk ingredients highest ph largest food Other Document reason for selection (consult knowledgeable bakery personnel, corporate team members, or outside experts on selection).

15 Scheduling & Prior Prep Prepare & calibrate oven verification temperature probe Monitoring should include: Oven air temperature Humidity, if applicable Product at several locations (different sides of belt - temperature variability) Food coldest point Calibrate manual temperature measuring devices (for post-bake temp) Inform third party lab of test and sample volume

16 Scheduling & Prior Prep Schedule Validation Test after a full sanitation (Pre-run sanitation) Verification step will establish a clean surface pre-validation to prevent contamination of samples Carry out Full sanitation following test run (post-run sanitation) Pay particular attention (intensified cleaning) to RTE Postbake Area Verify Pre-run Sanitation & Post-run Sanitation

17 Cleaning & Sanitation Full sanitation prior to Validation test Clean, Sanitize, & follow SSOPs Entire line from initial mixing to packing Include all Food Contact equipment Wet operations - apply detergent & sanitizer Dry operations - apply alcohol wiping, CO 2 blasting, steam cleaning or other appropriate method Verify post-bake equipment surfaces & record by location APC ATP Coliforms/Enterobacteriaceae or other (follow SSOPs) This provides a clean break for future production

18 Protocol Raw Sampling Applies to All Oven Types: Samples are pulled at Beg, Middle, & End of run (B, M, E) One person takes raw samples before oven at B, M, & E Chemistry tests - samples at each time point (B, M, & E) Micro analysis - samples at each time point (B, M, & E) Stored in separate shipping container for lab (prevent crosscontamination of baked food) Sample size should be sufficient for all testing Should be labeled as RAW with other identifiers Placed in refrigerator to cool raw food or freezer (dough)

19 Temperature Protocol Continuous Oven Start temperature monitoring after oven is full Temperature probes are placed into raw food s cold spot at left, right, and middle of belt (might need practice beforehand) Send through the oven After exit from oven, probes are removed from food, temperature profile uploaded, and results reviewed Manual internal temperatures at oven exit are also taken Temperatures & location on belt (right, middle, left) are documented. Process is repeated for middle and end of run (B, M & E)

20 Temperature Protocol Stationary Rack Ovens Probes are placed inside raw food s cold spot on different racks, front and back of oven To ensure temperature variability in oven is captured and reflected in test Start the oven and bake according to procedures After completion of baking process, probes are remove from food, temperature profile uploaded, and results are reviewed Manual internal temperatures of food are taken right after rack removal Repeat process for 3 runs (B, M & E)

21 Protocol RTE Post Bake Sampling RTE Product - Person different than raw food sampler Samples are pulled at oven exit, aseptically, across oven band, OR from different racks and locations Sampled at each time point (B, M & E), both for micro and chemistry testing Each sample is placed in separate bag (allow to cool before packing in shipping containers) Sufficient weight samples for all testing needed Food pieces with temp probes should not be used as samples (discard).

22 Protocol Packaged RTE Sampling Packaged food samples are pulled representing production from the B, M & E of run (e.g. time stamps) Samples are taken at each time point (B, M & E), for micro and chemistry testing Each sample is placed in separate bag (allow to cool before packing) Sufficient weight samples for all testing needed (micro & chemistry).

23 Place Food ON HOLD Enough production to fill the line completely for 3 probe runs If longer production, ensure available space in warehouse to hold Place on HOLD from clean-up to clean-up Hold finished food and animal feed Facility should be prepared to hold food for up to 10 days Have enough inventory so not to short customers Product should NOT be released until ALL lab results are received in writing, reviewed by QA, & determined acceptable

24 Laboratory Testing Samples are shipped in separate shipping containers and each food bag is marked RAW or RTE Samples are labelled with enough information such as; Left, Middle, Right; or Top, Middle, Bottom racks; for each of the B, M, and E test samples Test for the following:

25 Tests - Micro Microbiological (pathogen & non-pathogen Tests) APC (instruct lab about enough dilutions, if fermented) Quantitative Yeast & Mold with dilutions for raw food Pathogen testing: Coliform, E. coli, Salmonella, Listeria monocytogenes, B. cereus, S. aureus Product should stay on hold until all results are received

26 Tests - Chemistry Chemistry: ph Water activity (Aw) Total % fat % Salt % Moisture Product should stay on hold until all results are received

27 Summarize/Report - HACCP Support Documentation The Validation Team will summarize validation and verification data in a report Use temperature data to generate log reduction of baking process using published models (e.g. AIB, or other) Include thermal calculation lethality in the report Use Validation test report as support in HACCP plan.

28 Decisions & Corrective Actions When results are NOT acceptable: For post-bake RTE samples with high counts (>10 5 ) on APC, Yeast, Staph, or Bacillus destroy held food Conduct and document a Root Cause Analysis (RCA) to determine source of high counts Ingredients hold times for in-process batter/dough/filling post-bake handling procedures Implement corrective action, re-schedule another validation

29 Decisions & Corrective Actions for Pathogen Results Salmonella and L. monocytogenes positives: Destroy food Never retest the same food for a different result Begin and document a Root Cause Analysis (RCA) with team: verify temperature was adequate to achieve lethality review/modify post-bake handling procedures aseptic sampling procedures SSOPs environmental monitoring program other possible corrective actions Implement corrective action and re-schedule another validation

30 Repeat & Frequency Recommendations Baking Process Temperature Profile (Oven) Best practice Yearly, by oven manufacturer Verify each of the different bake profiles Or, if internal temperature monitoring data indicates potential change in settings HACCP Pathogen Validation Annually, complete all food types per oven For lines with only one food, additional production days may be completed to demonstrate variability Review each validation frequency according to data

31 Process Lethality Determination Core temperature T ref= 140 ºF z = ºF D = 4.83 min Temperature (F) Time (min) F-value (min) Lethality Log Reduction of Process Data Table Time (min) Core Temp (ºF) F-value (min) Time (min)

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