Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 1 of 10 Reference

Fumigation Validation

1. PROTOCOL APPROVAL TEAM

Name Department Date & Signature

Prepared by Mujeeb Ahmad QC Microbiologist

05/02/2023

Approved by Rajat Ray QA Manager

06/02/2023

Completed Date: 06/02/2023 Next Due Date : 05/02/2024

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad-
382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email: medica@medicarehygiene.in
 Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 2 of 10 Reference

2. Table of Content:

Sr. No. Topics Page No.

1. Protocol Approval Team
2. Table of Content
3. Purpose
4. Scope
5. Definition & Abbreviation
6. Validation & re-validation Criteria
7. Responsibility
8. Reference
9. Requirements
10. Background Information
11. Description of fogger Machine
12. Operation procedure for fogger Machine
13. Procedure of Fumigation
14. Selection of Room performing to fumigation validation
15. Standard Microbial Count as per WHO GMP TRS957
16. Performance
17. Conclusion
18. Rational timing for Fumigation of different Area

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad-
382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email: medica@medicarehygiene.in
 Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 3 of 10 Reference

3. PURPOSE

This report is prepared in accordance with the Protocol (MHL-VLP-xx) dated

(06/02/2023) as a documentary evidence that Fumigation Validation of Clean Room &
this validation can be used routine control.

4. SCOPE

This validation report applies to Fumigation is the process to disinfect the sterile
manufacturing area and microbiology testing area.

5. DEFINITION & ABBREVIATION

Term Explanation
No. Number
NA Not Applicable
QA Quality Assurance
QC Quality Control
MIC Microbiology Department
TMC Total Microbial Count
TYMC Total Yeast & Mold Count

6. VALIDATION & RE-VALIDATION CRITERIA

6.1 Whenever there are changes in the experimental condition of the test
method, make, material and manufacturer & supplier etc.

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad-
382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email: medica@medicarehygiene.in
 Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 4 of 10 Reference

7. RESPONSIBILITY

Designation Level Responsibility

QC Microbiologist Primary Prepare this Protocol
Production Secondary Maintain this Procedure
Housekeeping Tertiary Maintain this Procedure

8. REFERENCES

Sr. No Document No Title

1. ISO 14644 Cleanrooms and associated controlled

environments — Part 1: Classification of air
cleanliness by particle concentration

2. WHO GMP TRS 957 Recommended Limits For Microbiological

Monitoring Of Clean Areas In Operation

9. REQUIREMENTS

9.1General requirement’s:
1000 ml Flask, Petri plates, Forceps, Media, Fogger Machine, Virosil pharma.
All the lab accessories used in Fumigation Validation.

10. BACKGROUND INFORMATION

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad-
382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email: medica@medicarehygiene.in
 Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 5 of 10 Reference

Environmental monitoring describes the systems that allow pharmaceutical

manufacturers to monitor and control the viable, non-viable, and environmental
contamination in their cleanrooms

What is the Benefit of fumigation in Clean Room?

Fumigation and fogging are commonly used in pharmaceuticals, Healthcare & Medical
Device to control microbial contamination in a controlled area. Fumigation is the
process of gaseous sterilization that kills microorganisms and prevents microbial
growth in the air or on the surface of the wall/floor.

11. DESCRIPTION OF FOGGER MACHINE

Name of Machine ULV Micro Fogger

Body & Tank 304 SS Grade Stainless steel
Tank Capacity 5 ltr
Blower Motor 26000 RPM Motor
Nozzle 1 counter routine vortex nozzle
Chemicals Can atomize both oil-based and water
based liquids.
Control valve One turn. Brass Valve
Particle range 0.5-30µ, adjustable. Viscosity and density
can affect particle size.
Range Visible fog. 20-40 ft
Input 230 V 50Hz Single phase AC supply
Dimension 33 L X 41 L X 23.5 Dia cm

12. Operating Procedure for Fogger Machine

 Switch OFF the AHU of the Clean room. Wear the mask, gloves & goggles before
starting the work.
 Add fogging liquid to tank (max up to 4 litres).
 Set the timer and set sprayer nozzle at 45 ° angle.
 Plug the fogger machine. And switch power on.
 Periodically clean the formulation tank using a hot water / detergent solution.

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad-
382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email: medica@medicarehygiene.in
 Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 6 of 10 Reference

13. Procedure of Fumigation

 It is the process of disinfecting a room and all its contents by spraying of the
fumigant substance Use hand gloves and safety goggles during fumigation.
 To carry out this process, first clean surface and walls of rooms with a
disinfection solution, and then take Virosil Pharma 20 % v/v this solution to
make distilled water. As per SOP MHL-QCD-007.
 After Fumigation Plate Exposure as per SOP MHL-MIC-018
 Note: Supplier recommended 20 % v/v solution of Virosil pharma should
be used for fumigation in clean room.

14. Selection of Room performing to Fumigation Validation.

We selected the Gauze Packaging Room (Blister Room) because it is highly

momentum area and last 6 months Environmental Monitoring report proved
that this room have maximum microbial load as compare to other clean room.

15. Standard Microbial Count as per WHO GMP TRS 957

According to WHO GMP Sterile product TRS 957,2010 Table No. 4 & Table No. 5
(90 mm diameter settle plates CFU / 4 hours)
Sr. No Class /Grade Frequency Action Limit
1. Class 100 / Grade B Daily < 5 CFU/4 hour for bacterial
count
2. Class 10000 / Grade C Weekly < 50 CFU/4 hour for bacterial
count
3. Class 100000 / Grade D Monthly < 100 CFU/4 hour for bacterial
count
4. Fungus count < 1 CFU/4 hour

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad-
382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email: medica@medicarehygiene.in
 Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 7 of 10 Reference

16. Performance

Date Name of Classifi Area Disinfectant Fumigat Without Without After After Complete Remar
Area cation Cubic concentrati ed time Fumigati Fumigati Fumigati Fumigati Date ks
of feet on and on result on result on result on result
Room grade in clean in clean in clean in clean
room room room room
Bacterial fungal Bacterial fungal
Count count Count count
CFU/4 CFU/4 CFU/4 CFU/4
hour hour hour hour
16/01/ Blister D 7942 20 % v/v 10 180 04 146 02 22/01/20 Not ok
2023 Room Cubic Virosil Minutes CFU/4 CFU/4 CFU/4 CFU/4 23
feet Pharma hours hours hours hours
solution
18/01/ Blister D 7942 20 % v/v 20 154 02 132 01 24/01/20 Not ok
2023 Room Cubic Virosil Minutes CFU/4 CFU/4 CFU/4 CFU/4 23
feet Pharma hours hours hours hours
solution
20/01/ Blister D 7942 20 % v/v 30 138 02 121 01 26/01/20 Not ok
2023 Room Cubic Virosil Minutes CFU/4 CFU/4 CFU/4 CFU/4 23
feet Pharma hours hours hours hours
solution
22/01/ Blister D 7942 20 % v/v 40 114 02 106 Absent 28/01/20 Not ok
2023 Room Cubic Virosil Minutes CFU/4 CFU/4 CFU/4 CFU/4 23
feet Pharma hours hours hours hours
solution
24/01/ Blister D 7942 20 % v/v 50 115 Absent 72 Absent 30/01/20 ok

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad- 382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email:
medica@medicarehygiene.in
 Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 8 of 10 Reference

2023 Room Cubic Virosil Minutes CFU/4 CFU/4 CFU/4 CFU/4 23

feet Pharma hours hours hours hours
solution
26/01/ Blister D 7942 20 % v/v 60 90 Absent 58 Absent 01/02/20 ok
2023 Room Cubic Virosil Minutes CFU/4 CFU/4 CFU/4 CFU/4 23
feet Pharma hours hours hours hours
solution
28/01/ Blister D 7942 20 % v/v 70 95 Absent 55 Absent 03/02/20
2023 Room Cubic Virosil Minutes CFU/4 CFU/4 CFU/4 CFU/4 23
feet Pharma hours hours hours hours Ok
solution
30/01/
2023
Blister
Room
D 7942
Cubic
20 % v/v
Virosil
80
Minutes
90
CFU/4
Absent
CFU/4
49
CFU/4
Absent
CFU/4
05/02/20
23
*
feet Pharma hours hours hours hours
solution

* But room surface, wall surface, and machine surface get xxxxxx, seems wet and for which this is not advisable.

17. Conclusion: Since, it is observed of 50 minutes fumigation we are getting the CFU within the accepted limit or less than alert
limit, for better approach. We selected 60 minutes for fumigation in routine.
Based on the same approach, we estimate time duration for fumigation of different area as per below mention table.

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad- 382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email:
medica@medicarehygiene.in
 Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 9 of 10 Reference

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad- 382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email:
medica@medicarehygiene.in
 Fumigation Validation

Validation No. MHL-VLP-xxx

Validation Done on 06/02/2023
Next Due date 05/02/2024 Standard In-House
Page No. 10 of 10 Reference

18. Rational timing for fumigation of different area

Time for
fumigatio
S.R No Room & sub room name Cubic feet n

60 Min
Blister room 7941.7344
1
6 Min
air lock change room 478.4128
21 Min
PGD medicated room 2822.70106
7 Min
dosing room 871.6288
7 Min
mixing room 933.888
2 6 Min
corridor 827.392
3 Min
quarantine 403.8656
2 Min
air lock 1 172.032
2 Min
air lock 2 172.032
2 Min
air lock 2 270.336
6 Min
air lock 1 838.0416
3
3 Min
buffer room 378.4704
4 Min
sterility room 518.455296
2 Min
air lock 2 294.912
2 Min
air lock 1 294.912
4
43 Min
Primary sealing room 5780.86502
9 Min
ABD inspection room 1235.3536
6 Min
Corridor 798.72
2 Min
air lock 1 294.912
5
2 Min
air lock 2 294.912
8 Min
PU room 1021.27862

SITE ADDRESS
Survey No. 1175 (Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad-
382220 (Gujarat), INDIA. Tel.: +91 9374202255, Email: medica@medicarehygiene.in