Certainly! Below is a template for a Standard Operating Procedure SOP for Cleaning, Mopping, and Fumigation of a Sterility Room. This SOP is essential for maintaining a sterile environment in facilities such as pharmaceutical or biotechnology cleanrooms.

Ensure that this SOP complies with any applicable regulatory guidelines and industry standards. Additionally, adapt the template to match the specific requirements and processes of your organization. Regularly review and update the SOP to reflect any changes in procedures or equipment.

PURPOSE

To describe the procedure for cleaning, mopping and fumigation of the sterility test Lab to avoid area / equipment generated Microbial contamination in sterility test Lab.

SCOPE

This procedure applies to sanitization by disinfecting mopping and fumigate through fogger sterility testing suite whenever is required.

RESPONSIBILITIES & AUTHORITIES

1. Microbiologist is responsible to monitor mopping and Fumigation process.
2. Lab attendant is responsible to conduct assigned task in safe manner.

REFERENCES & REQUIREMENTS

WHO guidelines of good practices for pharmaceutical microbiology laboratories.

DEFINITIONS & ABBREVIATIONS

Cleaning: Cleaning is the process which is use to free the area from marks, pollutants and any remaining residues of previous batch.
Mopping: Mopping is the process which can be done by the aid of antiseptic solution of different recommended percentages to clear the area from viable & non-viable microorganism.
Fumigation:- Fumigation is the process which is used for the killing of microorganisms (Insects)
Decontaminate:-To render (an area, building, object, etc.) harmless by the removal, distribution, or neutralization of poisons, radioactivity.
Disinfectant Solution:- The solution used to clear the area from viable micro-organisms (microbes)

PROCEDURE

1. MATERIALS & EQUIPMENT’S:
2. Measuring flasks
3. Dusters
4. Disinfectant
5. 70% IPA Spray
6. Fumigation Solution
7. Fogger

DISINFECTANTS & MOPPING SOLUTIONS

1. Alcohol 75% V/V:-
2. Isopropyl Alcohol 75 ml
3. Distilled water 25 ml to make 100 ml of 75% Alcohol and filter it through 0.45μm filter under LFH. They are normally used where prolonged disinfection is not required.
4. This concentration is used to disinfect the gloves, surfaces of Laminar Flows, outer surfaces of samples containers and Petri-dishes etc.
5. Adverse Effects:-
6. Alcohols are toxic and irritant to skins and generally unsuitable for application to mucous membranes.
7. Rubber swells and plastics may be hardened by frequent or prolonged contact with alcohols.
8. Storage:- Filtered Alcohol can be stored up to one month.

Dettol 2% V/V (Chloroxylenol):-

1. Dettol concentrated 20 ml
2. Distilled water 980 m
3. It can be used as disinfecting surfaces, gloves, outer surfaces of sample containers etc.

Adverse Effects:

They are poisonous if swallowed.

The odor is irritating.

They may stain wool, cotton and synthetic fabrics.

Storage:- Freshly prepared solution should be used.

Chemgen 5%

1. Chemgen 50ml
2. Make up the volume to 1000 ml
3. It is basically used for Mopping in sterile areas in Pharmaceutical industries. The spray after work to disinfect hazardous microbes is recommended.

Adverse Effects:
Vapors are extremely irritant to the eyes and respiratory tract.
Direct contact causes skin irritation and allergic dermatitis

Phenol 5%

1. Phenol 50ml
2. Make up the volume to 1000ml
3. It is basically used for mopping in sterile are in pharmaceutical industries

Criteria for Sanitization( Procedure)

1. Use different disinfectant on Consecutive days (from approved list of sanitization disinfectants)
2. Disinfectants of different chemical types should not be mixed and disinfectants should not be mixed with cleaning agents. Mixing can results in drastic reduction in antimicrobial activity.
3. Disinfectant and cleaning agents should be freshly prepared .Only water for injection should be used for dilution as per need.
4. Mop the test area after test completion or after area exposure to open environment (due to maintenance work).
5. Fumigate area at the end of the week or as and when required.
6. Wash hands thoroughly with a good, preferably a germicidal soap
7. Take distilled water in the mopping container and prepare the disinfectant solution (Chemgen, Proceine, Q-Bac, Protect & Vanoquat as per manufacturer instructions & 5% phenol)
8. Take the prepared disinfectant to the sterility testing suit by following the gowning procedure as per sop.
9. Soak a clean duster or clean sponge (Preferably sterilized) in the disinfectant solution for one hour prior to mopping.
10. Start mopping in the following sequence, using new duster for each location.
11. Laminar flow hood bench and then side walls.
12. Roof of the testing room.
13. Walls of the testing room.
14. Floor of the testing room.
15. Finally once again laminar flow hood.
16. Switches
17. HEPA grills
18. After completing mopping of the testing room, mop the exterior areas i.e., Air shower, change # 02 and change room # 01.
19. Mop the working area with 70% Isopropyl alcohol daily after completion of sterility test.
20. Fumigate area at the end of the week or as and when required.

FUMIGATION SOLUTIONS:

1. Glutraldehyde 2%:
2. 2% glutraldehyde ± sodium bicarbonate to adjust the PH (PH=7.5-8.5)
3. Glutraldehyde 2ml
4. Water for injection 98ml
5. Make up the volume to 100ml

H2O2 6%:(hydrogen per oxide)

1. Hydrogen per oxide 6ml
2. Water for injection 94ml
3. Make up the volume to 100ml

Biocide 25% :

1. Biocide 125ml
2. Water for injection 500ml

Hi Clean 5%

1. Hi Clean 5ml
2. Water for injection 95ml
3. Make up the volume to 100 ml
4. It is basically used for fumigation purposes in sterile areas in Pharmaceutical industries. The spray after work to disinfect hazardous microbes is recommended.

Adverse Effects:

1. Vapors are extremely irritant to the eyes and respiratory tract.
2. Direct contact causes skin irritation and allergic dermatitis.

Storage:-

Freshly prepared solution should be used. Store in original sealed container.

Emergency Cases:-
Immediately inform the Area IN charge.
In case of injury contact for medical help

Pre-Checks:

1. Check that the AHU is ‘off’.
2. Remove all the materials from inside of the suite which are not required in fumigation like all uniforms and sterility unit and its parts etc.

Procedure

1. Place the hot plate in the testing room.
2. Pour Fumigation solution in the SS bowl and place over the hot plate.
3. Set the thermostat knob too approximately at two third positions and ‘on’.
4. Connect the shoe of hot plate to the socket of the extension wire.
5. The other end of extension wire is taken out of the Micro-Lab and connected to the socket in the
6. Chemical lab. It will ease the person who is responsible to off the hot plate.
7. Confirm that the hot plate and socket switches are at ‘ON’ position.
8. Seal the outer door of sterility testing suite with tap.
9. Now “on’ the hot plate from the socket switch. Preferably it is done at the end of day’s work. After about 2 hours a person responsible to off the hot plate will off the switch and will move out. Leave the area as such for overnight or longer as Area in charge decides. The next morning a person goes in wearing full face mask to remove the tap. After removing the tap, engineering staff is asked to run AHU.

Precautions

1. A second person with full face mask should always be there to assist the entering person in case of any accident.
2. In case of any injury immediately inform supervisor and get medical help as soon as possible.
3. Never let un-skilled persons to do the job.
4. Always wear goggles and gloves while handling the hazardous materials
5. Before fumigation, ensure complete cleaning and mopping of floors, walls with disinfectant.

Frequency

1. Fumigate the area weekly.
2. When the area is disturbed.
3. After any maintenance work.
4. Power failure for more than 6 hours

DOCUMENTS/ RECORDS (FORMS / ANNEXURE)

1. Cleaning log sheet
2. Fumigation and fogging log book
3. Fumigation log book