Validation & Verification of Plant Sanitization

VALIDATION & VERIFICATION

 VALIDATION & VERIFICATION

Recognized and expected practice in the food industry

GFSI-recognized programs (SQF, BRC, FSSC 22000, IFS) require:
Proof cleaning and sanitizing program is effective and carried out
consistently and safely while minimizing risk to raw
materials/ingredients/product and personnel

Zone Sampling Tools for Sampling Data Collection & Validation

Validation &
& Audit Preparation
Usage Verification
Verification

2
2015 Ecolab USA Inc. All rights reserved.
 DEFINITIONS

Validation Verification

Determining if the intervention,

when properly applied, Demonstrating that the system
Definition
will effectively control is operating as designed
the hazards
Will the control measures Are the control measures being
Simplified
work? followed?
Scientific proof your C&S Proof your C&S program is
program is effective in your being carried out in your plant
plant: as designed
For C&S
Chemicals, tools process, Proof its being done
personnel are suitable to consistently
control hazard

Zone Sampling Tools for Sampling Data Collection & Validation

Validation &
& Audit Preparation
Usage Verification
Verification

3
2015 Ecolab USA Inc. All rights reserved.
 VALIDATION &
VERIFICATION PROCESS
1. Conduct

Production
Process
Review

6. Re-Analyze
2. Develop
(Ongoing
C&S Control

VALIDATION
Verification)
VERIFICATIO
N

5. Execute 3. Test &

& Verify Modify

Validation
4. Document
Verification Final
Control

4
2015 Ecolab USA Inc. All rights reserved.
 VALIDATION & VERIFICATION
PROCESS
1. Conduct Production Process
1. Conduct
Production Review
Process
Review
Process flow
6. Re-
2. Develop
Process parameters:
Analyze
C&S Food Composition
VERIFICATION

VALIDATION
(Ongoing
Control
Temperature
Verification) Run Time
Down Time Before C&S
Equipment review
Environment Review
5. Execute 3. Test &
& Verify Modify
Chemistry Review

4. Document
Final
Control

Zone Sampling Tools for Sampling Data Collection & Validation

Validation &
& Audit Preparation
Usage Verification
Verification

5
2015 Ecolab USA Inc. All rights reserved.
 VALIDATION & VERIFICATION
PROCESS
2. Develop Cleaning & Sanitizing
1. Conduct Control
Production
Process
Review Determine Scope of Control
Specific piece of equipment
6. Re-
2. Develop
Line
Analyze
C&S Process
VERIFICATION

VALIDATION
(Ongoing
Control Determine End Goal: Level of Clean
Verification)
(E.g., Equipment cleaned to food
production standards, allergen clean,
microbial clean)
Design & Justify C&S Control for
Specific Equipment & Environment:
5. Execute 3. Test & Design: Establish Master Sanitation
& Verify Modify Plan, SSOPs/specific cleaning
procedures (who, what, where, when,
how, how often?)
4. Document Justify: Is the Control theoretically
Final sound?
Control Existing literature, studies, advice
Facility-specific data
Determine Acceptance Criteria:
Determine How to Measure Results
Zone Sampling Tools for Sampling Data Collection & Validation
Validation &
& Audit Preparation
Usage Verification
Verification

6
2015 Ecolab USA Inc. All rights reserved.
 SANITIZER REGISTRATION
Initial Validation

Use of an EPA-registered sanitizer provides initial validation that the

product is effective when used according to label instruction
EPA testing allows comparison of different sanitizers, but may not
duplicate operating conditions

Zone Sampling Tools for Sampling Data Collection & Validation

Validation &
& Audit Preparation
Usage Verification
Verification

7
2015 Ecolab USA Inc. All rights reserved.
 VALIDATION & VERIFICATION
PROCESS
3. Test & Modify
1. Conduct
Production
Process
Review Initial in-plant validation that Control
measures can be implemented per plan to
6. Re-
achieve intended result
2. Develop
Analyze
C&S
Perform the Control per plan
VERIFICATION

VALIDATION
(Ongoing
Control Evaluate Results
Need 3 consecutive passes vs.
Verification)
acceptance criteria
Confirm Control is:
Feasible
Comprehensive
5. Execute 3. Test &
& Verify Modify Understandable
Modify Control and procedures as needed
and retest
4. Document
Final
Control

Zone Sampling Tools for Sampling Data Collection & Validation

Validation &
& Audit Preparation
Usage Verification
Verification

8
2015 Ecolab USA Inc. All rights reserved.
 VALIDATION & VERIFICATION
PROCESS
4. Document Final Control Protocol
1. Conduct
Production
Process
Review Now Control is VALIDATED!
Train staff; document training
6. Re-
2. Develop
Analyze
C&S
VERIFICATION

VALIDATION
(Ongoing
Control

Verification)

5. Execute 3. Test &

& Verify Modify

4. Document
Final
Control

Zone Sampling Tools for Sampling Data Collection & Validation

Validation &
& Audit Preparation
Usage Verification
Verification

9
2015 Ecolab USA Inc. All rights reserved.
IN PLANT VALIDATION
CONSIDERATIONS
Need for Validation of Frequency and Procedure

100,000

CFU / mL
10,000

1,000
0 24 48 72 96

Time (hrs)
Bacterial count Rinse Only Clean & Sanitize
Example: Aerobic Colony Count in blanched vegetable flume water

10
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ICE CREAM VALIDATION EXAMPLE
Compare 2 CIP detergents on stainless steel ice
cream equipment
Protein
Detergents Detergent
Stain
ELISA Test

Built chlorinated alkaline CIP Soiled surface

Positive 1.2 g/cm
detergent (5 min. @ 140F) control

Protease enzyme based Water only control Positive 0.05 g/cm

alkaline CIP detergent <0.0125

4000 ppm Negative
(5 min @ 130F) g/cm
<0.0125
Concentrations Cl-Alk 2000 ppm Negative
g/cm

Recommended, and 1000 ppm Positive

<0.0125
g/cm
use concentration <0.0125
900 ppm Negative
g/cm
Soil
Slight <0.0125
Enzyme 450 ppm
Two high protein (2.6 4%) and Positive g/cm

high fat content ice cream mixes 225 ppm Positive

<0.0125
g/cm

12
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 VALIDATION & VERIFICATION
PROCESS
5. Verification Begins
1. Conduct
Production
Process
Execute & Verify Control Review

Ensure consistency in:

Implementation of Validated Control 6. Re-
2. Develop
Analyze
per Design & Schedule C&S

VERIFICATION

VALIDATION
(Ongoing
Control
Implementation of Sampling &
Analytical Procedures Verification)
Delivery of Acceptance Criteria

5. Execute 3. Test &

& Verify Modify

4. Document
Final
Control

Zone Sampling Tools for Sampling Data Collection & Validation

Validation &
& Audit Preparation
Usage Verification
Verification

13
2015 Ecolab USA Inc. All rights reserved.
 VALIDATION & VERIFICATION
PROCESS
6. Verification Continues Ongoing
1. Conduct
Production
Process
Re-Analyze Review
Continuous monitoring for ANY
issues/changes that may affect validated 6. Re-
2. Develop
C&S Control: Analyze
C&S

VERIFICATION

VALIDATION
(Ongoing
Formulation Control
Production Process
Verification)
Equipment
Scientific Information
Staffing
Water (source or season) 5. Execute 3. Test &
Validation begins again & Verify Modify
if change OR periodically

4. Document
Final
Control

Zone Sampling Tools for Sampling Data Collection & Validation

Validation &
& Audit Preparation
Usage Verification
Verification

14
2015 Ecolab USA Inc. All rights reserved.
 VALIDATION & VERIFICATION SUMMARY

Validation demonstrates intervention will control the hazard

Scientific proof it should be effective
Proof it actually works in a specific facility
Verification demonstrates on-going control is in place
React to verification data as appropriate; trend tracking essential
Both are essential for an effective program
Both must be documented so that the operator and the inspector
can understand the objective, approach and intended result

Zone Sampling Tools for Sampling Data Collection & Validation

Validation &
& Audit Preparation
Usage Verification
Verification

15
2015 Ecolab USA Inc. All rights reserved.