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Allergen Management
Supplier Quality Forum
December 2011
Introduction
Allergen Management System
Allergen risk Assessment
Allergen Managment
SQE Allergens
Allergens and HACCP
Manufacturing control
Allergen testing, verification & validation
Q&A
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Allergen SQE
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Allergen Procedures
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Allergen Risk Assessment
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Allergen Risk Assessment
Unavoidable allergens
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Allergen Risk Assessment Scenario 1
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Allergen Risk Assessment Scenario 2
Output from risk assessment: The sites allergen control measures are
sufficient to minimize the risk of cross-contact
Outcome = avoidable allergen; No need for cross-contact labeling)
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Allergen Risk Assessment Scenario 3
Output from risk assessment: Visual inspection of the line and equipment
after through cleaning demonstrate sesame seeds still to be present
Outcome = Unavoidable allergen; cross-contact labeling required
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Food Safety and Quality Systems
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An Integrated Quality Chain Approach
Focuses on Preventative Systems
Risk
Categories Chemical Microbiology Physical
Scope
Category of Positive List of Ingredients or Foods Examples of foods Exemptions to the Category of Food
Food Allergen includes (but not limited to): that often contain this Allergen
material
Crustacean e.g., Shrimp, crab, lobster, crawfish Glucosamine
Each species within this category, must be Hydrochloride
regarded as a separate allergen containing foods
Egg e.g. Hens and other avian species Mayonnaise, meringue
Ovalbumin, whole egg, egg yolk, egg
white, lysozyme, hydrolyzed egg protein
Fish e.g., Cod, Haddock, Flounder, Trout Gelatin from fish.
Each species within this category, must be
regarded as a separate allergen
Lupine/ Lupin Lupine flour, lupini beans
Milk e.g., Cows, sheeps, goats Margarines, milk Lactose and lactitol which contains no
Butter, buttermilk, casein, cheese, cottage chocolate, ice cream, protein (specification must indicate
cheese, curds, whey, lactoglobulin, custard, nougat pudding process for protein removal)
lactose*, malted milk, cream, sodium
caseinate, sour cream, yoghurt, hydrolyzed
milk protein
*Only if it contains protein
Mollusk e.g., Clams, oysters, mussels Calcium Supplements
Each species within this category, must be
regarded as a separate allergen
Peanut Peanut butter, nut pieces, peanut flour, Mixed nuts
peanut protein, hydrolyzed peanut protein
Allergens HACCP Approach
Category of Positive List of Ingredients or Foods Examples of foods that Exemptions to the Category of Food
includes (but not limited to): often contain this Allergen
Food Allergen material
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Allergens HACCP Approach
Example of a allergen
control checklist
Allergens HACCP Approach
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Manufacturing Controls
Hierarchy of Controls
Precautionary Labelling should only be used as a last resort when
the risk for contamination is uncontrollable, sporadic and
documented (cleaning controls, test results, substantiated
consumer reaction)
1) Avoid the introduction of an allergen into a facility that does not
already contain the allergen.
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Manufacturing Controls
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Manufacturing Controls
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Manufacturing Controls
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Manufacturing Controls
Control Measures
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Manufacturing Controls
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Manufacturing Controls
Control Measures
Control Measures
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Manufacturing Controls
Control Measures
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Manufacturing Controls
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Manufacturing Controls
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Manufacturing Controls
Control Measures
Includes totes, bins, containers, tanks, tankers, rework
systems, cleaning tools, maintenance tools
Written cleaning/change over procedures with verification and
validation program in place.
Shared tools shall be colour coded/labelled OR included in the
allergen cleaning program.
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Manufacturing Controls
Control Measures
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Manufacturing Controls
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Manufacturing Controls
Control Measures
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Manufacturing Controls
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Manufacturing Controls
Control Measures
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Manufacturing Controls
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Allergen Validation
Training
Uniformity
Informed Validation Prerequisite
of Practice
Labelling Programmes
(GMP)
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Allergen Validation
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Designing a Cleaning Validation Program
Select Conduct
samples on Select an validation: Cross-
Allergen Risk- a worst- appropriate 1. Visual validate
mapping assessment case target Inspection method for
scenario allergen 2. Sampling verification
basis & Testing
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Risk Assessment Considerations
Heterogeneous or homogeneous
Concentration in recipe
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Select Samples - Worst-Case Scenario
Rule of thumb If you cant see it and you cant easily reach it,
you cant clean it
Types of sample
surface swabs
Purge sample (dry systems)
Rinsate (CIP)
Settle plates / air monitoring
Finished product
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Selecting a Target Allergen
Criteria
Clinically relevant
Validated methodology
Resistant to processing
Difficult to remove (tenacious)
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Risk-based Approach To Sampling
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Sampling & Analysis
Representative
sample
size reliability
Sample size
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Training for operatives taking samples
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Analytical Techniques
Lab-based
Factory-spot tests
Rapid lateral flow devices
Non-specific protein tests
ATP bioluminescence
Coomassie
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Rapid Lateral Flow Devices
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Analytical Techniques
Lab-based
Protein based techniques:
Enzyme linked immunosorbent assay (ELISA)
DNA techniques
Polymerase chain Reaction (PCR)
Separation methods
Liquid chromatography-mass spectrometry (LC-MS)
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ELISA Kraft Method of Choice
1 2 3 4 5 6 7 8 9 10 11 12
A
B
C
D
E
F
G
H
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ELISA
Advantages
Improved sensitivity and selectivity (low mg/kg)
Developed in house improved extraction techniques
Larger range of commercial kits available
Fast generation of results
Disadvantages
Matrix interference (+ve/-ve /synergic)
Decreased sensitivity to modified proteins (thermal,
mechanical and enzymatic)
Inter-kit variability (different targets)
Kits not available for all allergens
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Limits of Reporting
Casein 2.5
BLG 5
Egg 2
Gluten 10
Peanut 1
Hazelnut 5
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What Does The Result Mean?
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Lab Validation
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Summary
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Kraft Foods Supplier Quality Web Site
The Kraft Foods Supplier Quality web site is designed to facilitate the
communication between Kraft Foods and our suppliers.
Here you will find all of the Quality Requirements and Guidelines for
Suppliers to Kraft Foods, as well as the slides used in our Supplier Forums.
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Visit the Kraft Foods Supplier Quality and Food Safety web site at:
http://brands.kraftfoods.com/kraftsupplier/
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