STANDARD OPERATING PROCEDURE Title: Cleaning Procedure for Sterile Area

1. Purpose
1.1 It is established to provide a standard procedure for “cleaning of sterile area”.
1.2 It is established to remove any contamination produced during working in sterile area.
1.3 It is established to meet the cleaning standard required for working in sterile area.
2 Scope
2.1 It is applicable to Sterile Areas.
3 References
3.1 Clean Room Regulations (GL/SOP/015)
3.2 Change Procedure for Sterile Area (GL/SOP/013)
3.3 List of clean room approved items.
3.4 List of clean room approved personnel.
4 Responsibilities
4.1 Production Pharmacist
4.2 Supervisor
4.3 Worker
5 Procedure
5.1 Cleaning/Disinfection
5.1.1 Collect the scattered waste of the process (broken glass pieces, rubber stoppers, flip off seals, powder, glass scrap etc.) from the floor with the help of clean room wiper and dispose this waste in buffer-II waste bin.
5.1.2 Collect the clean room disinfectant solution in clean room ss bucket/clean room approved container.
5.1.3 Empty the trashes, clean laminar hoods with clean room approved duster, clean the machines with clean room approved duster, clean the tool boxes etc; use, where required filtered (through 0.2 µ membrane filter) distilled water/disinfectant/detergent for cleaning.
5.1.4 Soak the clean room wiper in the disinfectant solution & wipe the ceiling so that no inches of ceiling are left without solution; wiping is to be done in parallel strokes of wiper on ceiling. Each stroke will overlap a portion of the previous stroke.
5.1.5 Wiper must not be dried; as rule soak the wiper every ten strokes.
5.1.6 Wipe the walls in the same manner as described for the ceiling.
5.1.7 Soak the clean room approved mop in the disinfectant solution.
5.1.8 Mop whole of the floor so that no inches of floor are left without solution; mopping is to be done in parallel strokes of mop on floor. Each stroke will overlap a portion of the previous stroke.
5.1.9 Mop must not be dried; as rule soak the mop every ten strokes.
5.1.10 Clean the buffer-II & buffer-I in the same way as described for the clean room (step 5.4 to 5.10).
5.1.11 Put all of the cleaning tools & spare disinfectant solution in the buffer-I; put off sterile uniform & come out of the area.
5.2 Fumigation
5.2.1 Use potassium Permanganate (KMnO4) in formaldehyde solvent (10 % KMnO4).
5.2.2 Place one fumigation bowl in each of the corners of the room to be fumigated.
5.2.3 Place one fumigation bowl in the centre of the room; place any additional bowl in the room if directed by the section in-charge/supervisor.
5.2.4 Pour formaldehyde in each of the fumigation bowls up to the mark (40 ml) on the bowl.
5.2.5 Add to each of the bowls Potassium permanganate (KMnO4) bag (4 g) starting from the bowl kept in the far most corner from buffer-II & ending to the corner nearest to the buffer-II.
5.2.6 Place one bowl in the buffer-II & add Potassium permanganate (KMnO4) bag to it. Immediately leave the buffer-II for buffer-I & put off your sterile uniform.
5.3 Disinfectant/Cleaning Solutions
5.3.1 Disinfectants used in the cleaning/disinfection have the following compositions & preparation methods.
5.3.1.1 MOPPING SOLUTION A
Phenol 500 g
IPA (70%) qs to make 50 Litres
Dissolve Phenol in IPA (70%) & filter the solution through 0.2µ membrane filter and store in the disinfectant plastic container after rinsing properly. Label the container as “Solution A”.
5.3.1.2 MOPPING SOLUTION B
Dettol (Brand) 500 ml
IPA (70%) 10 Litres
R/O water qs to make 50 Litres
Take IPA (70%) in a container; add to it Dettol & mix thoroughly. Make up the volume with R/O water. Filter the solution through 0.2µ membrane filter & collect in the disinfectant storage plastic container. Label the container as “Solution B”.

5.3.1.3. MOPPING SOLUTION C:
PROCEINE 40 SOLUTION
Introduction: It is a concentrate aqueous / glycolic solution of synergistic alkyl – amino – alkyl – glycines.
It has an exceptional spectrum of activity against benign, pathogenic and spoilage organisms including many fungi and spores.
Hazards: It presents little or no contact hazard to personnel and is very low in mammalian toxicity.
Solution Preparation: Add contents of 10 sachets to 2nd pass R.O. water and make up the volume to 50 liters. Mix in order to homogenize and then filter. Store in container after rinsing it with the same solution properly
Label it as Mopping Solution “C”.
5.3.1.4. MOPPING SOLUTION D
(VANAQUAT SOLUTION 1 %):
Introduction:
It contains Coco di- methyl benzyl ammonium chloride. It is effective against wide range of pathogenic and spoilage organisms. It is available in plastic container of 5 liters.
Solution Preparation: Add 500 ml of vanaquat concentratrd solution to 2nd pass R. O. water and make up volume to 50 liters. Mix it well thoroughly till homogenous solution is prepared. Filter it through 0.22  membrane filter and store in container after rinsing it with the same solution properly.
Label it as Mopping Solution “D”.
Safety and precautions:
1) It is irritant to skin
2) Risk of serious damage to eyes.
3) Wear suitable gloves and eye/ face protection.
4) In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
5) If swallowed, seek medical advice and show this container or label.
5.3.1.5. MOPPING SOLUTION “D”.
(VANAQUAT SOLUTION 2 %):
If required please prepare as follows:
Solution Preparation: Add 1000 ml of vanaquat concentratrd solution to 2nd pass R. O. water and make up volume to 50 liters. Mix it well thoroughly till homogenous solution is prepared. Filter it through 0.22  membrane filter and store in container after rinsing it with the same solution properly.
Label it as Mopping Solution E.


5.3.2 Use the solutions A or B on alternate days and fumigate the area.
5.3.3 Use the solution C or D on alternate weeks and change it subsequently and do not fumigate the area.
5.3.4 Use Mopping solutin E if required.

6 Quality Record
6.1 Personnel Hygiene Certificate
6.2 Sterile Area Cleaning Log Book