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Oven Validations and In-Bakery Data Collection at ARYZTA Bakeries for Baked Goods

Wafa Birbari, Ph.D.October 2018

#ABATechConhttps://www.fda.gov/downloads/food/guidanceregulation/fsma/ucm517402.pdf

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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).

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INTRODUCTIONValidation 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.

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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.

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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”

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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

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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.

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SUMMARYAn 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.

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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.

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ARYZTA’s Validation Model for Baked Foods

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Validation Test Outline1. 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

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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 foodOther

• Document reason for selection (consult knowledgeable bakery personnel, corporate team members, or outside experts on selection).

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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

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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 Post-bake Area

• Verify Pre-run Sanitation & Post-run Sanitation

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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, CO2 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

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Protocol – Raw SamplingApplies 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 cross-contamination 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)

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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)

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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)

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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).

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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).

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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

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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:

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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

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Tests - Chemistry• Chemistry:

pH Water activity (Aw) Total % fat % Salt % Moisture

• Product should stay on hold until all results are received

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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.

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Decisions & Corrective Actions

When results are NOT acceptable:

• For post-bake RTE samples with high counts (>105) on APC, Yeast, Staph, or Bacillus destroy held food

• Conduct and document a Root Cause Analysis (RCA) to determine source of high counts Ingredientshold times for in-process batter/dough/fillingpost-bake handling procedures

• Implement corrective action, re-schedule another validation

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Decisions & Corrective Actionsfor 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

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Repeat & Frequency Recommendations

• Baking Process Temperature Profile (Oven) – Best practice Yearly, by oven manufacturerVerify each of the different bake profilesOr, 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

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Process Lethality Determination

T ref= 140 ºFz = 38.18 ºF D = 4.83 min

Time (min) Core Temp (ºF) F-value (min)0.43 70.25 0.0000.87 70.655 0.0071.30 69.17 0.0131.73 69.485 0.0192.17 75.47 0.0272.60 82.04 0.0383.03 88.205 0.0533.47 99.365 0.0823.90 109.265 0.1344.33 119.39 0.2304.77 130.46 0.4175.20 143.285 0.8005.63 156.425 1.6416.07 169.16 3.5116.50 184.325 7.8736.93 193.64 16.4507.37 199.895 30.1897.80 204.215 48.4908.23 206.915 70.9898.67 208.67 97.2729.10 209.615 125.108

Log Reduction of Process 25.90

Data Table

0

50

100

150

200

250

0.00 2.00 4.00 6.00 8.00 10.00

Tem

pera

ture

(F)

Time (min)

Core temperature

0.0

20.0

40.0

60.0

80.0

100.0

120.0

140.0

0.00 2.00 4.00 6.00 8.00 10.00

F-value (min)

Time (min)

Lethality

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QUESTIONS

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