SOP FOR PROCEDURE FOR CLEANING AND DISINFECTION OF AREA
PURPOSE: To lay down the procedure for cleaning and disinfection of area.
SCOPE: This procedure is applicable for cleaning and disinfection of classified and unclassified area.
RESPONSIBILITY: Respective user department shall be responsible to prepare the disinfectant and clean the area according to the procedure defined in the SOP.
Respective user department shall be responsible for recording of activity in the logbook as per the activity.
Respective Department Head shall be responsible for checking the compliance of the SOP in performed respective area.
ACCOUNTABILITY: Head QA or His/her designee shall be accountable for proper implementation of the SOP in all areas.
PROCEDURE:
Definition:
Cleaning: An act of removing dirt or any undesirable material is called cleaning.
Disinfection: Reduction of microbial population to a safe level as determined by public health standard is called Disinfection.
Material Requirement:
- Purified water
- Water for injection
- Filtration unit
- Sterile 70% IPA
- Disinfectant container
- Measuring cylinder
- Containers
- Three bucket system
- Lint free mop
- Clean room wiper
Disinfectants:
- Imagard Biquat
- Imagard HD
- Imagard 401
- Iso Propyl Alcohol
Issuance of disinfectant: Raise the request for issuance of disinfectant from warehouse.
Disinfectant container shall be received from the warehouse after giving requisition. Check the disinfectant container/ bottle before dispensed by warehouse.
Paste the label on the container/bottle after receiving from the warehouse.
Enter the detail of disinfectant “Disinfectant receipt and issuance record.
Disinfectant solution preparation shall be done “Dilute disinfectant preparation record “.
Procedure for preparation of disinfectant:
Preparation of disinfectant for Grade C, D and unclassified area:
All the disinfectant to be used for disinfection of grade C, D and unclassified area shall be prepared in purified water.
Disinfectant solution shall be prepared on daily basis, as per concentration mentioned in the table 1.
Wear nose mask and gloves before preparation of the disinfectant.
Take required volume of disinfectant as per the concentration required from the stock to prepare. Take purified water in one container and add the required volume of concentrated disinfectant solution.
- Mix the disinfectant solution properly to ensure required strength.
- Label the container of prepared disinfectant, Disinfectant label.
- Record the preparation of disinfectant, Dilute disinfectant preparation record.
Preparation of disinfectant for Grade A and B area (Aseptic area):
All the disinfectant to be used for aseptic area shall be prepared in water for injection.
Disinfectant solution shall be prepared on daily basis as per the concentration mentioned table-1.
Prepare the disinfectant solution as per procedure.
After the preparation of disinfectant, before transferring the container to aseptic area, container shall be sanitized from the outside with Imagard HD 10%.
Container shall be transferred into the Aseptic area through dynamic pass box. Outer surface of the container shall be exposed with UV for 15 minutes.
All the disinfectant used in the asptic area shall be filtered through 0.22µm filter prior to use under LAF.
Record the preparation of disinfectant, “Dilute disinfectant preparation record.
Note: – At the day of Fogging activity, disinfection of the area shall be done with 10% Imagard HD disinfectant.
Filtered 70% IPA can be used up to 72 hrs. from the time of preparation.
Ready to use Disinfectant solution:
Ready to use disinfectant solution shall be used as it is without any dilution.
Use sterile 70% IPA as it is without dilution and can be stored up to the vendor recommended time.
Lable the container/ bottle of ready to use disinfectant “Disinfectant Label.
Disinfectant Concentration for Routine use:
| Table-1 | |||||
| Composition of Dilute Disinfectant (per 1000 ml preparation) | |||||
| Name of Disinfectant | Concentration (v/v) | Volume of disinfectant | Volume of Diluent | Application of Disinfectant | |
| Imagard Biquat | 1.0 % | 10 ml | 990 ml | Mopping | |
| Imagard HD
|
10.0% | 100 ml | 900 ml | Mopping | |
| 20.0% | 200 ml | 800 ml | Fogging | ||
| Imagard 401 | 0.4 % | 4 ml | 996 ml | Mopping | |
| IPA | 70% | 700 ml | 300 ml | Mopping and hand sanitization | |
| Table-2 | |||
| Routine Disinfectant preparation frequency | |||
| Name of Disinfectant | Concentration (v/v) | Frequency of use | |
| Imagard Biquat | 1.0 % | Daily on first week of month (W1) and third week of month (W3) | |
| Imagard HD | 10 % | As per requirement | |
| 20 % | On the day of fogging activity | ||
| Imagard 401 | 0.4 % | Daily on second week of month (W2) and fourth week of month (W4) | |
| IPA | 70% | On daily basis | |
Cleaning and disinfection procedure:
Cleaning and disinfection of general area (Unclassified area):
Disinfectant for disinfection of general area shall be prepared in purified water.
The house keeping personal or Lab attendant shall enter in the respective area of cleaning as per respective SOP of entry and exit.
Housekeeping personnel/ Lab attendant shall remove the undesirable material or dirt from the floor and put the unwanted material into S.S bin.
Housekeeping personnel/ Lab attendant shall collect the waste from the S.S. bins in all the rooms of the respective area.
Personnel shall broom the area with the help of lint free GMP wiper and collect in the disposable poly bag.
Finally mop the floor, wall and ceiling of the respective area with routine prepared disinfectant and frequency as mentioned in the table-3.
Cleaning and disinfection of C and D Grade Area:
Disinfectant for disinfection of C and D grade area shall be prepared in purified water.
Filtered purified water shall be used in bucket-2 to remove the residue of the disinfectant after disinfection.
Enter into the respective area as per respective SOP of the area.
For cleaning of C and D grade area, follow the steps.
Three bucket system shall be used for disinfection of C and D grade area.
Place all the three bucket on SS trolley.
Arrange the buckets on the SS trolley so that bucket-1 shall contain clean purified water for mopping, bucket-2 shall contain purified water to clean the dirty mop and bucket-3 shall contain disinfectant solution.
Dip the mop in bucket-1 containing purified water.
Take out the squeezed mop and start the area mopping with the purified water. After cleaning a required area, dip the dirty mop in bucket-2 containing purified water and squeeze out the mop so as to clean the mop.
Repeat the same procedure from above step for complete mopping of the area with purified water.
After completion of the mopping with purified water, dip the mop in bucket-3 containing disinfectant solution as start the mopping of the same area.
Purified water from the bucket-2 shall be changed if it is found dirty after use.
Note: – Before mopping the disinfectant solution, ensure that purified water has been dried from the applied area.
Allow a contact time of 10 minutes of disinfectant with the surface.
After 10 minutes of the contact time, dip the mop in the bucket-2 to clean the mop and again dip the mop in bucket-1 containing purified water. Take out the squeezed mop and clean the same area again with purified water to remove the residue of disinfectant.
Finally rinse the mop again in bucket-2 to clean the mop.
Cleaning and disinfection of grade A and B area (Aseptic area):
The qualified personnel shall enter in area as per respective SOP of the entry and exit.
The qualified personnel shall collect the waste from the S.S. bins in all the rooms of the aseptic area.
Perform the mopping as per procedure mentioned above from above step.
Disinfectant for grade A and B shall be prepared in water for injection. After preparation, disinfectant shall be filtered through 0.2µ filter before use.
Cleaning and disinfection of Ceiling, wall and floor:
The area shall be sanitized in following sequence:
Ceiling (including Light fixture, SS Supply ducts)
Walls (including Electric plates, Window glass panels)
Floor
Start the mopping of the ceiling from one end and slowly move towards another end. Mopping shall be done in a unidirectional, over lapping strokes.
Prior to disinfect the Light fixture, squeeze the mop of the disinfectant properly to remove the excess of the disinfectant and then finally mop as per the procedure defined in above step.
For disinfection of supply grill, mop the supply grills with approved disinfectant followed by 70% IPA after the contact time of 10 minutes.
Perform the mopping of the ceiling area as per procedure mentioned above from above step.
After completion of the ceiling, start mopping of the wall. For wall, start the mopping from upward to downward direction, mopping shall be done in a unidirectional, over lapping strokes.
Dry mopping shall be done for the electric plates installed in the wall.
Perform the mopping of the wall and glass panels as per procedure mentioned above from above step.
For mopping of the floor, start the mopping of the room from one end (opposite to the entry door) and slowly move backward toward the entry door while mopping. Perform the mopping as per procedure mentioned above from above step.
The process shall be repeated till disinfection of the room is completed.
Note: If cleaning and disinfection of ceiling, wall and floor comes on the same day then cleaning and disinfection of ceiling shall be done first, then wall and last floor.
Surface of the SS ancillaries shall be disinfected with routine disinfectant followed by 70 % sterile IPA solution. Glass and door shall be cleaned with the same disinfectant solution with disinfected with lint free mop.
Cleaning shall be done from most cleanliness area to lowest cleanliness area.
Discard the content of the three buckets in the washing area and clean the bucket and mop.
Frequency for disinfection of Ceiling, wall and floor:
Disinfection of Ceiling, wall and floor shall be done as per mentioned in the table-3.
| Table-3 | |||
| Class | Frequency of cleaning as per different area | ||
| Ceiling | Wall | Floor | |
| Class A | Daily | Daily | Daily |
| Class B | Weekly | Weekly | Daily |
| Class C | Fortnightly | Fortnightly | Daily |
| Class D | Fortnightly | Fortnightly | Daily |
| Unclassified area | Monthly | Monthly | Daily |
Disinfection of Instruments and equipments:
Equipment shall be sanitized with routine disinfectant followed by 70 % IPA.
For disinfection of the equipment, dip the lint free mop in the disinfectant and mop the surface of equipment.
Again, dip the mop in 70 % IPA and mop the surface of the equipment properly.
Contact time of 10 minutes shall be given to the surface of the equipments with each applied disinfectant.
Note: IPA 70 % used for the disinfection of the machinery shall be filtered through 0.22µ filter prior to use.
Disinfection planner of the area:
Cleaning and disinfection of the different area of the facility shall be done as per the class of the area defined in the table-3.
Room wise disinfection program of the facility is mentioned as per the table-4:
Record the cleaning and disinfection of the respective area, “Cleaning and disinfection of the area”.
Perform B type cleaning of the equipment along with cleaning of the area after every product change over.
All remaining rooms of the plant shall be considered as unclassified and shall be cleaned and disinfected as per the frequency mentioned for unclassified area.
All drain points of the room shall be cleaned and disinfected as per the SOP of microbiology, “Procedure for numbering, cleaning, sanitization & monitoring of drain points”.