MHL-VLP-XX Fumigation Validation

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
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

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

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

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

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

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

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
solution
solution
22/01/ Blister D 7942 20 % v/v 40 114 02 106 Absent 28/01/20 Not ok
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


solution
26/01/ Blister D 7942 20 % v/v 60 90 Absent 58 Absent 01/02/20 ok
solution
28/01/ Blister D 7942 20 % v/v 70 95 Absent 55 Absent 03/02/20
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
*
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

SITE ADDRESS

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

MHL-VLP-XX Fumigation Validation

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Fumigation Validation

Validation No. MHL-VLP-xxx

1. PROTOCOL APPROVAL TEAM

Name Department Date & Signature

Prepared by Mujeeb Ahmad QC Microbiologist

Approved by Rajat Ray QA Manager

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

Validation No. MHL-VLP-xxx

Sr. No. Topics Page No.

Validation No. MHL-VLP-xxx

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

5. DEFINITION & ABBREVIATION

6. VALIDATION & RE-VALIDATION CRITERIA

Validation No. MHL-VLP-xxx

Designation Level Responsibility

Sr. No Document No Title

1. ISO 14644 Cleanrooms and associated controlled

2. WHO GMP TRS 957 Recommended Limits For Microbiological

10. BACKGROUND INFORMATION

Validation No. MHL-VLP-xxx

Environmental monitoring describes the systems that allow pharmaceutical

What is the Benefit of fumigation in Clean Room?

11. DESCRIPTION OF FOGGER MACHINE

Name of Machine ULV Micro Fogger

12. Operating Procedure for Fogger Machine

Validation No. MHL-VLP-xxx

13. Procedure of Fumigation

14. Selection of Room performing to Fumigation Validation.

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

15. Standard Microbial Count as per WHO GMP TRS 957

Validation No. MHL-VLP-xxx

Validation No. MHL-VLP-xxx

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

Validation No. MHL-VLP-xxx

Validation No. MHL-VLP-xxx

18. Rational timing for fumigation of different area

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