Validation of Adequacy of Handwashing and Hand

Sanitizing (Cleaning Protocol) for Workers’ Hands

Date: August 16, 2023 Validation Control No.: APPI – VAL - 002
Covered Area: Personnel Hands
Validated by: Monik T. Manuel
Equipment: Luminometer

1.0 Pre Validation Tasks

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

1.1.1 Microbiological Hazards:

1. Personnel Hands that contain bacteria (i.e. Escherichia Coli, Salmonella, Staphylococcus Aureus,
Yeast and Mould, Enterobacteriaceae, Coliform, Listeria Monocytogenes)

1.2 Food Safety Outcome & Objective required (Target; relevant to intended use; recognized international
standards; approved limits; effectiveness):
The objective of the study is to measure the overall effectiveness of sanitation facilities and personnel practices of
AP Printing and Packaging Inc. through hand washing.

Sampling Location Post Hand Washing Post Sanitizing

Production Operator Hands
Production Packer Hands Maximum of 75 RLU Maximum of 50 RLU
Quality Inspector

Target Reduction
RLU Significance
Above 50 highly
Below 50 moderately

1.3 Control Measure to be validated (Hand washing and Disinfection:

Introduction of Proper Hand Washing and Disinfection

1. Before entering the production area;
2. Before start of Food Packaging handling activities;
3. After handling re preparing raw and packaging materials;
4. After handling any contaminated material, such as waste, cleaning materials and chemicals where this
could result in contamination of other food packaging item;
5. Immediately after using comfort room;
6. When returning to work after break.

2.0 Materials

2.1 Materials needed during the study are the following:

2.1.2 Proper Hand Hygiene Guide Signage

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 Adequacy of Handwashing and Hand
Sanitizing (Cleaning Protocol) for Workers’ Hands

Instruction in Handwashing
1. Turn on the faucet using the pedalled switch. Wet your
hands until elbow thoroughly by keeping your hands in an
upward motion. Avoid splashing water on your PPE
uniform

2. Apply a palm-sized amount of hand soap

3. Rub palm to palm and fingers interlaced for ___10__

seconds

4. Back of right and left hand (fingers interlaced) __10_

seconds

5. Rotational rubbing of left and right thumbs for ____20_

seconds

6. Rub your fingertips against the palm of your opposite hand

for ___10_ seconds

7. Rub wrists going down to your elbow for __10__ seconds

8. Rinse your hands with water, keeping your hands in an

upward motion until it reaches to rinse your elbow area

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 Adequacy of Handwashing and Hand
Sanitizing (Cleaning Protocol) for Workers’ Hands

Instruction in Handwashing
9. Dry your hands thoroughly from your fingers to elbow
using air dryer

10. After drying hands, hand sanitizer shall be followed.

11. Dry your hands using air dryer

2.1.3 Hand Washing Lavatory made up of steel, pedalled switch faucet

2.1.4 Approved Liquid Hand Soap: Trucare Bio, Kalinisan Span Solo
2.1.5 Suitable method of Hand Drying: Air Dryer
2.1.6 Approved Hand Sanitizer: 70% IPA
2.1.7 ATP Swab Sticks
2.1.8 3M Clean Trace Luminometer
Adenosine triphosphate (ATP), has been found to be a sensitive indicator molecule for the presence of biological
residues due to its universal presence in all living cells (microbes, animal and plant cells). An increase in “dirt”
(biological residues) on a surface results in an increase in the amount of ATP present on that surface making ATP an
effective marker for the assessment of the hygienic status of an environmental surface.

2.2 Refer to the procedure manual for Hand Washing, Pre-requisite Programs on Food Safety under 7.4.3,
Document Code: APPI-FSQM-18

2.3 Refer to Work Instruction manual for Equipment, Work Instruction for ATP Swab Testing, Document Code:
APPI - XXXX

3.0 Parameters: Check applicable parameter and define target values for each parameter

☒ Time ☐ Water Activity ☐ Calibration

4.0 Temperature
☐Decision ☐ pH
Criteria (Uncertainty, Microbial Standard
☒ Measure)
Variability, & Performance of Control
☐ Concentration ☒ Contact Time ☐ Spatial Configuration
☐4.1Humidity
Proper Hand Washing ☐ Pressure
and Disinfection as control measure Viscosity
☐ will be considered validated if:
☐ Dwell 4.1.1
time Fifteen (15)
☐ data samplesSettings
Equipment collected during Pre Hand Washing
☐ Others:
4.1.2 Fifteen (15) data samples collected during Post Hand Washing
4.1.3 Fifteen (15) data samples collected during Post Sanitize

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

5.1 First trial validation failed on ATP Swabbing.

5.1.1 Hands shall be washed for at least 20 seconds as follows:
- Wet hands under running water;

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 Adequacy of Handwashing and Hand
Sanitizing (Cleaning Protocol) for Workers’ Hands

- Use palm size liquid hand soap to form a good lather;

- Rub all parts of hands with soap and water;
- Lather for at least 20 seconds, vigorously and thoroughly rubbing all hand surfaces; including the
finger, fingertips, areas between the fingers, and arms;
- Rinse hands thoroughly with running water;
- Immediately follow the cleaning procedure with thorough drying of cleaned hands and arms using
hand dryer.
- After drying hands, hand sanitizer shall follow.
- After performing Hand washing, QA Analyst verify the effectiveness of Hand Washing and to monitor
the microbiological contamination of personal hand thru ATP Swabbing.

5.2 Second trial validation passed on ATP Swabbing after adjustment on washing duration.
5.2.1 Hands shall be washed for at least 60 seconds as follows:
- Wet hands under running water;
- Use palm size liquid hand soap to form a good lather;
- Rub all parts of hands with soap and water;
- Lather for at least 60 seconds, vigorously and thoroughly rubbing all hand surfaces; including the
finger, fingertips, areas between the fingers, and arms;
- Rinse hands thoroughly with running water;
- Immediately follow the cleaning procedure with thorough drying of cleaned hands and arms using a
hand dryer.
- After drying hands, hand sanitizer shall follow.
- Dry hands using air dryer
- After Hand Sanitize, QA Analyst verify the effectiveness of Hand Sanitize and to monitor the
microbiological contamination of personal hand thru ATP Swabbing.

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:
20 seconds Post Hand 60 seconds Post Hand
Washing Washing Percentage
No. Date Personnel Post Hand Washing Post Sanitize
Pre
ResultHand Remarks Result Remarks Reduction
No. Date Personnel Total
Washing Result % Result %
1. August 10, 2023 Dela Cruz 200 RLU Failed 30 RLUReductionPassed 85 %Reduction
1. 2.AugustAugust
10, 2023
10, 2023 Dela Cruz
Ocomen 921
160RLU
RLU Failed30 RLU 57 RLU97 % Failed 19 RLU 64 %37 % 98 %
2. 3. AugustAugust
10, 2023
10, 2023 Ocomen
Malubag 471
300RLURLU Failed57 RLU 60 RLU 88 % Failed 28 RLU 80 51
%% 94 %
3. 4.AugustAugust
10, 2023
10, 2023 Malubag
Manuel 1,120
900 RLU
RLU Failed60 RLU 57 RLU97 % Failed 33 RLU 52 45
%% 98 %
4. 5. AugustAugust
10, 2023
10, 2023 Manuel
Naces 1,298
500RLU
RLU Failed57 RLU 98 RLU 96 % Failed 20 RLU 67 %65 % 99 %
5. 6.AugustJuly10,25,
2023
2023 Naces
Duguran 1,130
650 RLU
RLU Failed98 RLU 53 RLU94 % Failed 14 RLU 59 %86 % 99 %
6. 7. July 25, 2023
July 25, 2023 Duguran
Labolabo 1,100
330RLU
RLU Failed53 RLU 47 RLU96 % Passed22 RLU 53 % 58 % 98 %
7. 8.July 25, 2023
July 25, 2023 Labolabo
Hervias 1,150
900 RLU
RLU Failed47 RLU 46 RLU 98 % Passed23 RLU 69 % 51 % 99 %
8. 9. July 25, 2023
July 25, 2023 Hervias
Clores 1, 852
180 RLURLU Failed46 RLU 18 RLU98% Passed 12 RLU 74 %
90 % 99 %
9. 10.July 25, 2023
July 25, 2023 Clores
Camacho 865 RLU
200 RLU Failed18 RLU 35 RLU98 % Passed 13 RLU 28 %
82 % 98 %
10. 11.July 25, 2023
July 25, 2023 Camacho
Celestial 1,005 RLU
128 RLU Failed35 RLU 28 RLU97 % Passed 22 RLU 37 %
78 % 98 %
11. 12.July 25, 2023
July 25, 2023 Celestial
Ancla 968 RLU
260 RLU Failed28 RLU 53 RLU97 % Failed 20 RLU 29 %
80 % 98 %
12. July 25, 2023 Ancla 921 RLU 53 RLU 94% 22 RLU 58 % 98 %
13. July 25, 2023 Banadera 156 RLU Failed 56 RLU Failed 64 %
13. July 25, 2023 Banadera 1,125 RLU 56 RLU 95 % 45 RLU 20 % 96 %
14. July 25, 2023 Cabigo 237 RLU Failed 23 RLU Passed 90 %
14. July 25, 2023 Cabigo 768 RLU 23 RLU 97 % 12 RLU 48 % 98 %
15. July 25, 2023 Buhayo 200 RLU Failed 43 RLU Passed 78 %
15. July 25, 2023 Buhayo 485 RLU 43 RLU 91 % 35 RLU 19 % 93 %
Average: 175 RLU 47 RLU 73 %
Average: 1, 117 RLU 47 RLU 96 % 23 RLU 52 % 98 %

20 second Post Hand Washing and 60 seconds

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.
Post Hand Washing
Only documents with standard stamps of AP Printing and Packaging are considered official.
 1000
500
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Validation of Adequacy
Pre Handwashing ofHandwashing
20 Seconds Post Handwashing and Hand
Sanitizing (Cleaning Protocol) for Workers’ Hands
60 Seconds Post Handwashing

20 seconds Post Hand Washing 15 out of 15 personnel, the highest 300 RLU and lowest 98 RLU, average
of 175 RLU.
Reduction is significant from Post Hand Washing on highest reduction of 90% and lowest reduction of
52%, average to 73% reduction.

Post Hand Washinng and Post Sanitize ATP Swab Results

2000
1500
1000
500
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Pre Handwashing Post Handwashing

Post Hand Sanitize Linear (Post Hand Sanitize)
Pre Hand Washing 15 out of 15 personnel, the highest 1, 900 RLU and lowest 471 RLU, average
of 1, 117 RLU.
Reduction is significant from Post Hand Washing on highest reduction of 98% and lowest reduction of
88%, average to 96% reduction.

Percentage of Reduction
120%
100%
80%
60%
40%
20%
0%
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Reduction after Hand Washing Reduction after Hand Sanitize

Linear (Reduction after Hand Sanitize)
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 Adequacy of Handwashing and Hand
Sanitizing (Cleaning Protocol) for Workers’ Hands

Reduction is significant upon application of sanitizing solution composed of 70% IPA, gaining
highest reduction of 86% while lowest reduction recorded at 19%, average to 52%.
Total reduction of detectable micro or bacteria through ATP is recorded at 98%

6.2 Analysis on reduction of detectable presence or growth of microorganism or bacteria on personnel’s hands.
6.2.1 From Pre Hand Washing 15 out of 15 personnel, the highest 1, 900 RLU and lowest 471 RLU, average
of 1, 117 RLU.
6.2.2 Reduction is significant from Post Hand Washing on highest reduction of 98% and lowest reduction of
88%, average to 96% reduction.
6.2.3 Further reduction is significant upon application of sanitizing solution composed of 70% IPA, gaining
highest reduction of 86% while lowest reduction recorded at 19%, average to 52%.
6.2.4 Total reduction of detectable micro or bacteria through ATP is recorded at 98%

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

7.1 Pre Requisite Program on Food Safety APPI - FSQM - 18

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
7.5 Sanitation Weekly Testing Form APPI – QCD-F-12

8.0 Conclusion Check the applicable box

☒ Control measure 5.2 Hand Washing of 60 seconds + Hand Sanitation Protocol 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

Recommendations:
Proper Hand Washing, Hand Sanitizing and Hand Drying is an effective control measure to remove microbiological
hazard as verified thru ATP Swabbing. Consistent observation of personnel compliance to the
sanitation and hygiene discipline is required to sustain objectives.

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 Adequacy of Handwashing and Hand
Sanitizing (Cleaning Protocol) for Workers’ Hands

Lorna S. Duguran
Monik T. Manuel
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.