Allergen Management and Cleaning Challenges

Transcription

1 Management and Cleaning Challenges Food Safety Summit Baltimore, MD May 1, 2013 Mark Domanico Principal Scientist, Food Safety Kellogg Company

2 Topics for Discussion management and sanitation Key considerations of sanitation effectiveness Verification and validation Assessing effectiveness of allergen sanitation Advisory Labeling Considerations Case study examples of cleaning validation situations May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 2

3 Management Options Avoid Segregate Clean Advisory Label May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 3

4 Recalls Reason For Recall Relative Incidence Incorrect ingredient statement Mixed food Inadequate allergen sanitation May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 4

5 Sanitation is a Key Element of Effective Control risk assessment Engineering and system design Scheduling Processing Controls Maintenance Sanitation / Change Over Cleaning Labeling / Packaging Controls Consumer Complaint Systems Training Auditing / Verification May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 5

6 Sanitation Begins with Good Sanitary Design Sanitary Design Principles Cleanable to a Predetermined Level Made of Compatible Materials Accessible for Inspection, Maintenance and Cleaning / Sanitation No Liquid Collection Hollow Areas Sealed No Niches Sanitary Operational Performance Hygienic Design of Utilities and Maintenance Enclosures Hygienic Compatibility with Other Systems Validated Cleaning and Sanitizing Protocol Separate Processes Wherever Possible May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 6

7 Definitions of Cleaning Targets Clean Removal of residual allergenic protein from the product zone and adjacent areas. Verified through visual inspection and/or testing. Visual Clean Removal of visible soils, particulates, films and dust. GMP / Quality Clean Removal of product residues and soil to a level that precludes misbranded/mixed food. May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 7

8 Determine Cleaning Method Wet Cleaning Removal of soil/residue with water and chemicals Foaming / CIP / COP Dry Cleaning Removal of soil/residue with physical or mechanical action Vacuum / brushing / blasting Push through or product flushing Combination Dry clean followed by wet (damp) wiping May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 8

9 Changeover Matrix Defines Sanitation Requirements Change Over Matrix (milk) A Product After Change Over (peanut) B (none) C (milk, egg) D (egg) E (none) F (milk) A milk milk GMP milk milk Product (peanut) B peanut peanut peanut peanut peanut Prior To (none) C GMP Push Through GMP GMP Push Through Change Over (milk, egg) D egg milk, egg milk, egg milk milk, egg (egg) E egg egg egg GMP egg (none) F GMP Push Through Push Through GMP Push Through May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 9

10 Develop Written Sanitation Standard Operating Procedures SSOP Fundamentals Equipment to be cleaned Cautionary notes (e.g. allergens) Step-by-step instructions Tools / utensils Chemicals and concentration Personal safety requirements Inspection and documentation May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 10

11 Sanitation Extras for Control Tool Management Dedicate where possible Color coded Defined tool cleaning procedure between uses Prevent Cross Contamination Segregate cleaning operations (physical / time) Protect/isolate adjacent materials and equipment Avoid high pressure water or air Traffic control Targeted training for allergen sanitation Sanitation crews / maintenance staff / inspectors Verification and Validation Heightened attention to post clean and pre-op inspections changeover/sanitation may be a CCP in HACCP Plan Utilization of analytical testing methods May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 11

12 Sanitation Validation Considerations Target allergen Concentration Food form (dry powder, paste, particulate, liquid) Contact surface material Rework process Type of food contact surface Texture and material (SS, plastic, cloth, etc.) Cleaning strategy Wet / Dry / CIP Effect of cleaning activity on adjacent lines Performance Standard Visual and analytical test as available May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 12

13 Sanitation Validation Considerations Analytical validation testing is just one part of a comprehensive allergen clean up strategy Diagnostic / investigative tool Must also look at: Dedication of lines Scheduling Formulation Packaging / labeling practices May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 13

14 Sanitation Validation Considerations Evaluation and documentation of the efficacy of the allergen sanitation procedures Define performance standard Visual Analytical Baseline qualification and periodic revalidation as part of HACCP / FSP review May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 14

15 Set Standards Review & Refine Cleaning Evaluation Cycle Execute Cleaning Validate Inspect / Audit May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 15

16 Cleanup Validation Typical Protocol Verify allergen in previous food Test for positive control Swabs of equipment prior to cleaning Clean the line / equipment Visible Clean is the standard Verify and document Sampling Strategy Swabs (8 12 depending on process) Intermediate products (dough, filling, batter, etc.) Final rinse water from CIP systems Finished food (5 cases/composites of first off food) May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 16

17 Cleanup Validation Typical Protocol Establish break in production Hold first 2 4 hrs of production Waste a quantity of product Not required if defensively labeled or clean & test between same product Test and review results Finished product results are key Swab results are diagnostic Require multiple successful trials to establish a validated process May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 17

18 Advisory Labeling Considerations Why do all this cleaning? Can t I just label May Contain? May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 18

19 Advisory Labeling Considerations FDA Guidance States: Advisory labeling should not be used as a substitute for GMPs. Should be considered only after rigorous food allergen controls are in place. Advisory statements must be truthful and not misleading. May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 19

20 Advisory Labeling Criteria Food Allergy Issues Alliance (FAIA) Guidance Conduct Hazard Assessment First Food allergen is known to be present in the manufacturing environment risk cannot reasonably be eliminated without major revisions to processes / equipment, above and beyond GMPs is likely to be present in some, but not all, of the food Consuming the unintended allergen constitutes a health hazard May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 20

21 Advisory Labeling Considerations If all of these criteria are not met, consider additional food allergen controls other than advisory statements. e.g. If the unintended food allergen is always present in the product, it would be appropriate to declare the allergenic ingredient in the ingredient list and/or contains statement It may be more appropriate to re-evaluate production scheduling and sanitation techniques. May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 21

22 Cleanup Validation Case Study Reviews May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 22

23 Cleanup Validation Case Study 1 Almond slices Issue: Almond skins separate from slices and invade plant and equipment Equipment: Large, live bottom surge bin Approximately 30 L x 10 W x 10 H Rinse-in-place design (CIP spray balls) Standard cleaning did not reach all areas inside bin Inspection revealed residue (skins) in protected sections of equipment which could migrate to subsequent products May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 23

24 May 1, Surge Bin

25 Almond skins on back side of surge bin metering May 1, 2013 tubes 25

26 May 1, 2013 Almond skins on framework in surge bin 26

27 Cleanup Validation Case Study 1 Almond slices (cont d) While finished product testing did not indicate presence of protein, almond skins and residue swabs did test positive Potential for one skin piece to elicit an allergenic reaction Solutions: Revised inspection and cleaning procedure Supplement automatic CIP with manual clean Addition of almonds later in process (post surge bin) May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 27

28 Cleanup Validation Case Study 2 Milk residual Issue: Repeated results of post cleanup product indicated low level of milk protein Results ranged from 3 to 8ppm in finished product samples after cleanup. Multiple clean up attempts with increased focus did not eliminate the issue. Idea proposed to test some of the empty bag liners at start of new run Results showed low level of milk protein! May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 28

29 Cleanup Validation Case Study 2 Milk residual (cont d) Investigation revealed that bag liner material from previous run was left near the line during cleaning and subsequently used on start up! Product dust/residual build up on liner material carried over to new run Solution: Protect material from contamination Waste a quantity of liner film at start up May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 29

30 Cleanup Validation Case Study 3 Automation of minor ingredient scaling system Issue: One time trial of milk allergen ingredient resulted in low level (<10ppm) contamination of subsequent products Solution: Added lots of flexibility to operation Engineering designed to be cleanable Problem was persistent through multiple clean up attempts and other material push through cycles Finally tested negative after much disassembly and multiple washings. <2.5ppm Changed procedures to hand scale allergen ingredients. May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 30

31 Sanitation Case Study 4 Dough Cutting Machine Issue: Post clean allergen tests on belts >2.5 ppm Hidden areas of the machine allowed dough migration onto contact surfaces 160 man hours to clean one piece of equipment Lost production 31

32 May 1, 2013 Dough Cutting Machine 32

33 Sanitation Case Study 4 (cont d) Dough Cutting Machine Resolution: Redesigned drive system, electrical and support surfaces to withstand wet cleaning Time of cleaning reduced by 50% 16 to 8 hours 33

34 Thank You May 1, 2013 FS Summit / Baltimore, MD / Mark Domanico 34