1.0     PURPOSE:

This procedure is developed to ensure the cleaning of area from microbes & non-viable particles

2.0     SCOPE:

This Procedure is followed for preparation of “Sterile Area” of liquid & dry powder Injectable sections

3.0     HSE Statement:

3.1.      Follow the following instructions to perform cleaning and mopping in a safe manner.
Wear mask & gloves before preparing strong germicidal solutions.
Only trained and knowledgeable persons perform cleaning and mopping.
All work is performed in accordance with applicable regulatory requirements.
Report any job related injuries or illnesses, questions on health and safety, or any unsafe or unhealthy working conditions to supervisor.
Personal protective equipment necessary to perform cleaning and mopping in a safe manner.

4.0     Responsibilities:

Officer QC (Microbiologist) is responsible to expose media plates and to conduct the swab test

5.0     Materials:

i.          SS Bucket
ii.         SS Cleaning Roller
iii.        Lint Free Duster


Cleaning is the process which is use to free the area from marks, pollutants and any remaining residues of previous batch.
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 is the process which is used for the killing of microorganisms.
Aseptic Area
An Area which can be clear from microbial & Particle contamination.
A microbe is a microscopic organism, such as a bacterium, virus or parasite. Microbes are so small that you need to use a microscope and special staining techniques to see them.
Viable & Nonviable Particles
A viable particle contains one or more living microorganisms and can affect the sterility of the CSP. Viable particles generally range from 0.2micron to 30micron in size. Bacteria need a means to travel and inoculate the CSPs; their vectors can include bare or gloved hands and particles.
A nonviable particle does not contain a living microorganism, but acts as transportation for viable particles. Examples of nonviable particles can include metal, rust, dust, dirt, pollen, fibers, cloth, and chemical compounds found in makeup, including silicone, magnesium, sodium, potassium, and chloride. These particles can be introduced through employee movement, cleanroom garb or employee clothing, and the move- ment of products.
7.0     Responsibilities:

8.0    Description:


Cleaning on daily basis to be carried out in the presence of microbilogist.
At the end of testing, remove all the accessories used. Remove the broken Ampoule / Vial from machine & floor.
Collect the spilled rubber stopper from biosafty cabinet.
Dismantle the Biosafty cabinet parts and clean all aseptic area by using sterilized lint free duster.

Week-end Cleaning:

Clean entire area thoroughly including ceiling, walls, equipment and followed by mopping with any suitable disinfectant in rotation as per SOP-04-017.         


Stainless steel bucket being used for cleaning solution preparation must be steam sterilized at 121+5 º C for 30 min for Liquid Injectable section.
Prepare Mopping solution (in rotation) as per SOP-04-017.
Mopping in Micro Lab to be done in following order:
Inoculation Rooms
Buffer Room
Changing Rooms
Mopping of a room is to be done in following sequence:
Walls & Doors
Dip sponge / duster attached to cleaning roller in a disinfectant solution.
Start mopping of ceiling from one corner to other in the horizontal way.
Start mopping of walls from corner, working down.
Mop all equipment and table with 70 % IPA or disinfectant in rotation.
Mop floor with disinfectant solution in rotation with the help of squeeze sponge / duster starting from one corner. Change often dusters / solutions after mopping floor, walls & machine etc.
In the evening remove all waste materials and clean table and other machine parts followed by cleaning of walls and floors.
Note:         Mop all equipments and table with 70% IPA after each interval during filling.

Area Fumigation:

Fumigate the aseptic area as per SOP-04-002.
Prepare & use the solution as per SOP-04-017.

Petri Dishes Exposure for Area Count Monitoring:

Petri dishes are to be exposed under Supervision of Microbiologist daily for 4 hours. Petri dishes are to be exposed at pre – determined locations.

Swab Test:

Carry out frequent Swab Test of walls, floors, machines of all rooms to evaluate the prevailed Sterile Conditions.


Ensure adequate ventilation of the area after specific exposure period to disinfectant fog before starting filling operation.