1.0 Objective:
To lay down the procedure for operation, cleaning and maintenance of Fogger and Fogging of Microbiology Testing Areas.
2.0 Scope:
This SOP is applicable for operation, cleaning and maintenance of Fogger and Fogging of Microbiology Testing Areas of pharmaceutical formulation plant.
3.0 Responsibility:
Microbiologist or above of Microbiology Laboratory.
Head – Microbiology section / Nominee.
4.0 Accountability:
Head – Quality Control / Nominee.
5.0 Abbreviations & Definitions
SOP : Standard operating procedure
QC : Quality Control
QA : Quality Assurance
MLT : Microbial Limit Test
6.0 Procedure:
6.1 Operation:
6.1.1 AHU should be switched OFF before fogging.
6.1.2 The room should be completely closed without any vent/opening and should be thoroughly cleaned.
6.1.3 Use 20% virosil solution for fogging and pour into the fogger through the funnel provided on the tank lid as per Table-1.
6.1.4 Place the fogger at one corner of the room mounted at height of 2 feet and keeps the angle of the nozzle at 45 degrees with the help of adjustment knobs.
6.1.5 Adjust the timer switch of the fogger according to the volume of the dilution added (Refer Table-1).
6.1.6 Connect the Electrical cord of the fogger to the power supply and then switch on the mains.
6.1.7 Move out of the room and close the door completely and do not enter the room for minimum 40 minutes after the fogging has completed.
6.1.8 Switch ON the AHU not before 40 minutes has completed.
6.1.9 Record the details as per Annexure No.-I and put the label ‘Area Under Fogging’ as per Annexure No.-II
6.2 Cleaning and maintenance:
6.2.1 Clean the fogger tank with purified water after every fogging operation by removing the tank from the blower.
6.2.2 Clean the nozzle hole with the help of the pin after every fogging operation.
6.2.3 Wash the Suction-air filter after every fogging operation, dry thoroughly and then replace it.
6.2.4 Thoroughly wipe the outer body of the fogger with plain cloth after successive fogging.
6.2.5 The nozzle hole needs to be cleaned after every fogging.
5.2.6 Do not touch the blower head while the fogger is in operation as it gets warmed up.
5.2.7 After every fogging add Purified water and then start the machine for 2 minutes for cleaning the inner tubes and nozzle to prevent it from getting choked.
5.2.8 Record the details as per Annexure No-I.
6.3 Frequency:
6.3.1 Once in a week at the end of working hours.
6.4 Fogging of Microbiology Testing Areas:
6.4.1 Prepare the fogging solution as mention in Table-1.
6.4.2 Operate the fogger as per operating procedure mention in points 6.1.1 to 6.1.9.
6.4.3 Perform the fogging as per following sequence in Microbiology testing areas:
Table-I. Dilution and Use Volume of Virosil
| Name of the Area | Name of Fogging Solution | Volume of fogging Solution Concentrate (ml) | Volume of WFI / PW (ml) | Total
Volume (ml) |
Timer setting for fogging
(Minute) |
| Sterility Testing Room | Virosil | 200 | 800 | 1000 | 24 |
| Sterile Buffer Room | Virosil | 200 | 800 | 1000 | 24 |
| Sterility change Room-2, 3 and 4 | Virosil | 100 | 400 | 500 | 12 |
| Sterility Return Buffer, Return Air Lock and Change Room-1 | Virosil | 100 | 400 | 500 | 12 |
| Sub-culture Room | Virosil | 100 | 400 | 500 | 12 |
| MLT Testing Room | Virosil | 100 | 400 | 500 | 12 |
| MLT Air Lock and Change Room | Virosil | 200 | 800 | 1000 | 24 |
| Media Preparation Room | Virosil | 100 | 400 | 500 | 12 |
| Media Decontamination Room | Virosil | 100 | 400 | 500 | 12 |
| Sterilization Area and Air Lock | Virosil | 200 | 800 | 1000 | 24 |
7.0 List of Annexure / Formats:
Fogging Record : Annexure-I
Label for Area Under Fogging : Annexure-II
8.0 References (if any).
8.1 Fogger Manual
8.0 Distribution
7.1 Master Copy : Documentation Cell (Quality Assurance)
7.2 Controlled Copies : Quality Assurance, Microbiology-QC
9.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Fogging Record
Area: _____________________
| Date | Fogging
Solution used |
Done By | Equipment
cleaned by |
Checked By | Remarks |
Annexure-II
 |
Pharmaceuticals Formulation Plant |
| Area Under Fogging: ____________________________.
Date of Fogging : ____________________. Done by : ____________________. Checked by : ____________________.
|
|
| DO NOT ENTER | |
