CLEANING / MOPPING & FUMIGATION OF ASEPTIC PROCESSING AREA SOPs


1.0    SCOPE:

This Standard Operating Procedure is for preparation of Sterile Area for filling of ampules.

2.0   RESPONSIBILITY:
 1.     Production Manager
  2.     Incharge Pharmacist
    
3.0    PROCEDURE:

A)           Cleaning

                1)  Cleaning on daily basis to be carried out in the presence of sterile section Supervisor.
                2)    At the end of filling, remove the powder by vacuum cleaner.  
                3)    Remove the broken Vial from machine & floor.
                4)    Collect the spilled rubber stopper from machine & floor.
                5)    Dismantle the machine parts and clean the machine and all aseptic area by using                   sterilized lint free duster.
     B)           Cleaning Utensils
               
                 1)    SS Bucket
                 2)    Cleaning Wiper 
                 3)    Duster 
                 4)    Vacuum Cleaner
      C)           Mopping 
           
            1. Stainless steel bucket being used for cleaning solution storage must be steam          sterilized (2 – 3 minutes) OR sterilize in Oven at 180 º C for 2.0 hours along                        with relative load. 

            2. Prepare Mopping solution (in rotation) as per relevant SOP.

                      a)    Mopping in area to be done in following order
                              1.     Dryer room or cooling Zone
                              2.     Filling Room
                              3.     Buffer Room 
                              4.     Changing Room
                      b) Mopping of a room is to be done in following sequence:
                         a) Ceiling           
                         b) Walls & Doors           
                         c) Equipment                
                         e) Floors
1.     Dip sponge / duster attached to cleaning roller / wiper in a cleaning solution
2.     Squeeze sponge / duster to avoid dripping of solution
3.     Start mopping of ceiling from one corner to other in the horizontal way.
4.     Start mopping of walls from corner, working down.
5.     Mop all equipment and table with 70 % IPA or disinfectant in rotation.
6.     Mop floor with 5 % Phenol or 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.
7.     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 or any other disinfectantin rotation after each interval during filling.

D)         Area Fumigation
                        Fumigate the aseptic area as per relevant.

                        Fumigation Solutions             (Reference SOP-)

            1) Formaldehyde 40%  (1.5 Liters   +     Distilled Water 1.5 Liters)

            2) Formaldehyde 40% (100 ml in one Petri Dish at different locations) KMnO4                              
            3) KmnO4 & Formaldehyde         One Petri dish         =     56.6 Cubic meter

Fogging or Fumigation must be done only when required (Alternate days during production process period)

Week-end Cleaning
Clean entire area thoroughly including ceiling, walls, equipment and followed by mopping with 5 % Phenol or disinfectant in rotation.

Week-end Fogging/ Fumigation 
On week-end either fogging with Jet fogger or Fumigation is to be done as advised by Supervisor.
1)    Strong Fogging Solution
5 % Phenol Solution                    «                    500 ml
70 % IPA                                      «                    100 ml
2)    Fumigation with formalin gas as per relevant SOP. .
Pure paraformaldehyde Powder     =          20 gm per 28.3 Cu. Meter Area
3)    1 gm KMnO4 in 100 ml Formaldehyde in Petri Dishes in all rooms.

E)       Petri Dishes Exposure For Area Count Monitoring
Petri dishes are to be exposed under Supervision of Microbiologist daily for 2 hours. Petri dishes are to be exposed at pre – determined locations.
F)       Swab Test
Carry out frequent Swab – Test of walls, floors, machines of all rooms to evaluate the prevailed Sterile Conditions.
G)         Preparation of the Area for Sterile Filling after Maintenance Work
1)    Clean Area thoroughly by duster including ceiling, walls, floor, equipment, air supply and return grills, light fixtures, pipes etc.
2)    Mop with germicidal solution ceiling, and air and return grills light fixtures, walls, pipes, equipment, tables, stools, and floor.
3)    Strong spray with Jet fogger as advised by Supervisor to be done at the end of the working
4)    All above steps to be carried out under supervision of area incharge.
5)    Steps 1 – 4 to be done until satisfactory conditions are achieved.
6)    Petri dishes to be exposed every day to know the conditions of the area. Test the floor, walls and machine by swab test (Q.C.)
7)    Once conditions of the area are satisfactory and exposure / swab test conforms to specification may be started after approval from Q.C.
H)            Precautions:-
1.         Wear safety mask & gloves before preparing strong fogging solutions.
2.    Ensure adequate ventilation of the area after specific exposure period to disinfectant fog before starting filling operation.

4.0  QUALITY FORMS AND RECORDS
­
         
      Fumigation report

5.0      DISTRIBUTION


Production Manager
Quality Assurance Manager
Quality Control Manager
          Production Pharmacist

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