Validation of Control Measure Effectiveness of Machine Temperature

Setting in Laminating Process

Date: August 17, 2023 Validation Control No.: APPI – VAL - 003
Covered Area: Lamination Area
Validated by: Monik T. Manuel
Equipment: Luminometer, Clean Trace LM1

1.0 Pre Validation Tasks

1.1 Hazard (Identify hazards that are intended to be controlled):

1.1.1 Microbiological Hazards specially:

- Paper board that has bacteria (i.e. Escherichia Coli, Salmonella, Staphylococcus Aureus, Yeast and
Mold, Enteribacteriaceace, Coliform, Listeria Monocytogenes)

1.2 Food Safety Outcome & Objective required (Target; relevant to intended use; recognized international
standards; approved limits; effectiveness):

Target/ Post Heat Treatment

Pre Heat Treatment
Acceptable Limit (75°c to 95°c)

Target ≤75 RLU ≤25 RLU

Acceptable ≤100 RLU ≤30 RLU

1.2.1 The objective of the study is to measure the overall effectiveness of Laminating Machine Temperature
setting of 75°C in 10 seconds exposure to prevent microbiological contamination.

1.3 Control Measure to be validated: Heat application

Machine Temperature setting of 75°C in 10 seconds exposure in laminating process of paperboard to prevent
possible contamination of microbiological hazards.

2.0 Materials

2.1 ATP Swab Stick

2.2 3M Clean Trace Luminometer

3.0 Parameters: Check applicable parameter

Time Water Activity Calibration

4.0 Decision Criteria (Uncertainty, Variability,
Temperature pH & Performance of Control Measure)
Microbial Standard
Concentration Contact Time Spatial Configuration
4.1 Humidity
Accurate machine temperature
Pressure setting at 75°C in 10 seconds exposure
Viscosity will be considered validated if:
4.1.1 Fifteen (15) data samples collected during pre-heat treatment
Dwell time Equipment Settings Others:
4.1.2 Fifteen (15) data samples collected during post heat treatment (75°c to 95°c)

5.0 Assemble relevant validation information/ Methodology: (Duration/ frequency of the validation; detailed
experimental trials, etc.)

5.1 The following preliminary steps are performed prior to the start of the validation study:
- Paper board are clean and free from any physical contamination
- Surface ATP Swab Testing is taken by QA Analyst on paper board before and after lamination to

This document is a sole property of AP Printing and Packaging. Any disclosure, unauthorized reproduction or use is strictly prohibited except with permission from APPI.
Only documents with standard stamps of AP Printing and Packaging are considered official.
 Validation of Control Measure Effectiveness of Machine Temperature
Setting in Laminating Process

verify if heat application is effective as control measure of microbial contamination.

Target/
Sample Sample Size
Acceptable Limit
Printed Paper Board w/o 15 sheets Target ≤75 RLU
Lamination Acceptable ≤100 RLU
Printed Paper Board with 15 sheets Target ≤25 RLU
Lamination Acceptable ≤30 RLU
6.0 Analysis and Results (Discussion on the results gathered; tables on gathered data; pictures, graph, statistical data
result, etc.)

6.1 The following data were obtained during the beginning of the validation study:

Post Heat
No. Date Target/ Acceptable Limit Pre Heat Treatment Target/ Acceptable Limit Treatment
(75°C - 95°C)
Target: ≤75 RLU Target: ≤25 RLU
1. July 21, 2023 61 RLU 27 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
2. July 21, 2023 68 RLU 23 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
3. July 21, 2023 60 RLU 27 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
4. July 21, 2023 57 RLU 19 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
5. July 21, 2023 60 RLU 23 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
6. July 21, 2023 53 RLU 20 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
7. July 21, 2023 57 RLU 28 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
8. July 21, 2023 66 RLU 25 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
9. July 21, 2023 58 RLU 28 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
10. July 21, 2023 55 RLU 23 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
11. July 21, 2023 47 RLU 29 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
12. July 21, 2023 58 RLU 29 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
13. July 21, 2023 66 RLU 28 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
14. July 21, 2023 53 RLU 24 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU
Target: ≤75 RLU Target: ≤25 RLU
15. July 21, 2023 63 RLU 30 RLU
Acceptable ≤100 RLU Acceptable ≤30 RLU

ATP Swab Result

80
70
60
50
40
30
This document is a sole property of AP Printing and Packaging. Any disclosure, unauthorized reproduction or use is strictly prohibited except with permission from APPI.
20 Only documents with standard stamps of AP Printing and Packaging are considered official.
 0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Before Lamination of Control

Validation After Lamination Effectiveness
Measure Linear (After Lamination)Temperature
of Machine
Setting in Laminating Process

Before lamination 15 out of 15 printed sheets, the highest 68 RLU and lowest 47 RLU, average of 59 RLU. Reduction
is significant after lamination on highest reduction of 30 RLU and lowest reduction of 19 RLU, average to 25 RLU
reduction.

Percentage of Reduction
80%
70%
60%
50%
40%
30%
20%
10%
0%
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Total reduction of detectable micro or bacteria through ATP is recorded at 56 %

6.2 Analysis on reduction of detectable presence or growth of microorganism or bacteria on paper board

6.2.1 Before lamination 15 out of 15 printed sheets, the highest 68 RLU and lowest 47 RLU, average of 59 RLU.
6.2.2 Reduction is significant after lamination on highest reduction of 30 RLU and lowest reduction of 19 RLU,
average to 25 RLU reduction.
6.2.3 Total reduction of detectable micro or bacteria through ATP is recorded at 56 %

7.0 Document & References (Site references & attachments to this document)

7.2 Environmental Monitoring Procedure APPI - MGT - FSQP - 15

7.3 Environmental Monitoring Program APPI - EMP - 01
7.4 Work Instruction for ATP Swabbing APPI - XXXX

8.0 Conclusion Check the applicable box

Control measure Machine Temperature setting of 75°C in 10 seconds exposure in laminating process of paperboard is
capable of controlling the hazard to specified Food Safety outcome and objectives if properly implemented
Is not capable of controlling the hazard; needs revalidation

This document is a sole property of AP Printing and Packaging. Any disclosure, unauthorized reproduction or use is strictly prohibited except with permission from APPI.
Only documents with standard stamps of AP Printing and Packaging are considered official.
 Validation of Control Measure Effectiveness of Machine Temperature
Setting in Laminating Process

Recommendation:

Accurate Machine Temperature setting of 75°C in 10 seconds exposure in laminating process of paperboard is an effective
control measure to remove microbiological as verified in ATP Swabbing. Consistent monitoring of machine temperature
setting is required to sustain objectives.

Monik T. Manuel Lorna S. Duguran

Validated by Reviewed by

This document is a sole property of AP Printing and Packaging. Any disclosure, unauthorized reproduction or use is strictly prohibited except with permission from APPI.
Only documents with standard stamps of AP Printing and Packaging are considered official.