Cleaning of Processing Cubicles or Areas
1.0 PURPOSE
To define a procedure for cleaning the Product Processing Cubicles or Areas used for production,
dispensing and storage activities.
2.0 SCOPE
2.1 This procedure applies for cleaning the Product Processing Cubicles or Areas used for production,
dispensing and storage activities
3.0 REFERENCE
3.1 References
3.1.1 SOP: Housekeeping
3.2 Attachments
3.2.1 Nil.
4.0 ABBREVIATION
4.1 Abbreviations
4.1.1 SS : Stainless Steel
4.1.2 SOP : Standard Operating Procedure
4.1.3 No. : Number
4.1.4 AHU : Air Handling Unit
4.1.5 CQA : Corporate Quality Assurance
4.1.6 v/v : Volume by volume
4.1.7 % : Percentage
4.1.8 No. : Number
5.0 RESPONSIBILITY:
5.1 Production and Stores Department:
6.0 PROCEDURE:
6.1 Wear Gloves, Goggles and 3M Nose Mask (as applicable) during cleaning of manufacturing area.
6.2 Cover all equipments and Panel boards with polythene bag and then start the cleaning operation.
6.3 Ensure the cleanliness of the cleaning aid like ladder, stacker etc. before taking it in to area.
After cleaning of area it is to be De-dusted properly and kept in designated area.
6.4 FOR PRODUCT TO PRODUCT CHANGE OVER (Type B Cleaning):
Start cleaning operation from top progressing to lower side of the cubicle and in following sequence:
6.4.1 CEILING: Clean the Ceiling of the cubicle with wet and dry lint-free cloth and colin solution if required.
6.4.2 LIGHT FIXTURES: Sprinkle the Colin solution on the acrylic cover of the light fixture and wipe out
by using dry lint free cloth.
6.4.2 AHU SUPPLY GRILLS (if applicable): Remove and clean with dry lint free cloth followed by wet
lint free cloth soaked in potable water and finally using dry lint free cloth.
6.4.3 CONTROL PANEL, SWITCHBOARD, PLUG POINTS AND ANY OTHER ELECTRICAL FIXTURE PRESENT IN THE AREA:
Clean with vacuum cleaner and wipe with dry lint free cloth.
6.4.4 PIPELINES AND EXHAUST DUCTS: De-dust the Pipelines and Exhaust duct with dry lint free cloth.
Clean it by wet lint free cloth soaked in potable water and finally using dry lint free cloth.
6.4.5 WALLS: Clean Walls using vacuum cleaner and wet lint free cloth soaked in potable water followed
by dry lint free cloth and if required clean the walls using scrubber dipped in 0.1% detergent solution
to remove the traces and finally clean with lint free cloth soaked in potable water followed by dry lint
free cloth.
6.4.6 WALL RAILINGS: De-dust the SS wall railings with dry lint free cloth. Clean it by wet lint free cloth soaked in potable water and finally using dry lint free cloth.
6.4.7 DOORS: De-dust the doorframe, handle, hinges, door closer with dry lint free cloth. Clean it by wet
lint free cloth soaked in potable water and finally using dry lint free cloth. Clean the door seal with
vacuum cleaner. Clean the glasses by sprinkling the Colin solution and wipe out by dry lint free cloth.
6.4.8 WINDOWS AND GLASSES: De-dust the window frames with dry lint free cloth. Clean it by wet lint free cloth
soaked in potable water and finally using dry lint free cloth. Clean the glasses by sprinkling the Colin solution
and wipe out by dry lint free cloth.
6.4.9 AHU RETURN GRILLS (if applicable): Remove the AHU return grills (wherever applicable) of the
cubicle, take it to the wash area and clean it using potable water and detergent. Finally dry it using dry cloth and compressed air.
6.4.10 RISERS (if applicable): Open the door of Riser (wherever applicable) clean it with potable water. Dry using
squeezer mopper from top to bottom.
6.4.11 PASS BOX (wherever applicable): Clean the Pass box and the pass box door as per respective SOP.
6.4.12 FLOOR: Clean the floor using vacuum cleaner with wiper and then wet cleaning using mopper and 2.5
% v/v disinfectant solution.
6.4.13 BALANCE STAND/SOP STAND (if any): Clean the Balance stand/SOP stand with wet cloth soaked in
potable water followed by dry lint free cloth.
6.4.14 SS FOLDING TABLE/GRANITE PLATFORM (if any): Clean the SS Folding table/Granite platform with wet
cloth soaked in potable water followed by dry lint free cloth.
6.4.15 LABEL BOX: Wipe the Label box with wet cloth soaked in potable water followed by dry lint free cloth.
6.4.16 HYGROMETER: Wipe the Hygrometer with dry lint free cloth and clean the hygrometer stand with wet and dry lint free cloth.
6.4.17 MANOMETER AND MANOMETER VENT: Wipe the Manometer and it’s vent using Colin solution and dry lint free cloth.
6.4.18 TELEPHONE AND IT’S STAND (if any): Clean the Telephone with dry cloth and wipe the telephone stand by wet cloth followed by dry lint free cloth.
6.4.19 EARTHING STRIPS (If Applicable): Wipe the earthing strips using wet and dry lint free cloth.
6.4.20 AHU INDICATOR AND FIRE/SMOKE SENSOR: Wipe the indicator/ sensor with wet and dry lint free cloth.
6.4.21 DATALOGGER (If Applicable): Wipe the data logger with the dry lint free cloth.
6.4.22 Any equipment and accessories (other than listed in 7.4) in the cubicle is to be cleaned as per respective
product changeover cleaning SOP.
6.4.23 For routine cleaning and upkeep of the area refer SOP for Housekeeping.
6.4.24 Get the area certified as clean and suitable as per SOP for Line clearance of area and equipment.
6.4.25 Equipments and control panel should be cleaned as per respective SOP for the equipment and
re- cleaning of the area should be done if required.
6.4.26 After cleaning of the area, update the respective area status board as ‘CLEANED’.
6.4.27 Get the area certified as per SOP for Line clearance of area and equipment.
6.4.28 After certification of cleanliness of the area, update the respective area status board as ‘UNDER PROCESS’.
6.4.29 Clean compressed air tubing, potable water hose and steam pipes using wet lint free cloth.
6.4.30 Clean utility pendent by using wet lint free cloth soaked in potable water followed by dry lint free cloth.
6.5 FOR BATCH TO BATCH CHANGE OVER (Type A Cleaning) :
6.5.1 CONTROL PANEL, SWITCHBOARD, PLUG POINTS AND ANY OTHER ELECTRICAL FIXTURE PRESENT IN THE AREA: Clean with vacuum cleaner and wipe with dry lint free cloth.
6 .5.2 PIPELINES AND EXHAUST DUCTS: De-dust the Pipelines and Exhaust duct with dry lint free cloth. Clean it by wet lint free cloth soaked in water and finally using dry lint free cloth.
6.5.3 WALLS: Clean the walls using vacuum cleaner and then by dry lint free cloth.
6.5.4 WALL RAILINGS: De-dust the SS wall railings with dry lint free cloth.
6.5.5 DOORS: De-dust the doorframe, door closer with dry lint free cloth. Clean the glasses by sprinkling the Colin solution and wipe out by dry lint free cloth.
6.5.6 WINDOWS AND GLASSES: De-dust the window frames with dry lint free cloth. Clean the glasses by sprinkling
the Colin solution and wipe out by dry lint free cloth.
6.5.7 FLOOR: Clean the floor using vacuum cleaner if applicable with wiper and then do wet cleaning using
mop and 2.5 % v/v disinfectant solution.
6.5.8 Any equipment and accessories (other than listed in 7.5) in the cubicle is to be cleaned as per respective
per respective batch changeover cleaning SOP.
6.5.9 After cleaning of the area, update the respective area status board as ‘CLEANED’.
6.5.10 Get the area certified as per SOP for Line clearance of area and equipment.
6.5.11 After certification of cleanliness of the area, update the respective area status board as ‘UNDER PROCESS’.
6.6 FREQUENCY OF CLEANING:
6.6.1 If the area is used on campaign basis, it should be cleaned as per step 7.4.1 to 7.4.28 on the last working day
of the week or after processing 05 nos. of batches (whichever is earlier).
6.7 CLEANING OF THE CLEANING AID:
6.7.1 LADDER: De-dust ladder by using dry lint free cloth followed by wet lint free cloth and again clean with
dry lint free cloth. Before taking the ladder into the area ensure that it is cleaned.
6.8 AREA CLEANING AFTER ANY MAJOR MAINTENANCE WORK:
6.8.1 After any major maintenance work of area or equipment, Area cleaning shall be performed
as per the steps mentioned from point number7.4.1 to 7.4.28.
7.0 Distribution:
I. Quality Assurance
II. Production
III. Ware house
8.0 REVISION HISTORY
| Version No. | 00 | Effective Date | |
| Details of revision: New SOP Prepared | |||