MAINTENANCE CLEANING SANITATION AND FUMIGATION OF CLEAN ROOMS IN PHARMA AREA

1.0    PURPOSE
    
        To  describe  a  standard operating procedure (SOP) for  maintenance, cleaning / sanitation and fumigation  of clean rooms in pharma area.
        
2.0    SCOPE
        
        The scope of this  SOP  is to describe   in  detail  the  method  of maintenance, cleaning / sanitation and fumigation of clean rooms in pharma area.
        
3.0    RESPONSIBILITY
        
3.1    The  responsibility  of maintenance, cleaning / sanitation and fumigation of clean rooms in pharma area as per  the  SOP lies  with   the rank of not lower than  operator of production department.      
    
3.2    The responsibility of preparing, reviewing and approving the SOP lies with the Executive (Production), Head of Production and Head of QAD  respectively.
        
4.0      METHOD:
        
4.1       PHARMA AREA MAINTENANCE:
    
4.1.1    Air curtain should run all the time.
    
4.1.2    Filtered air system should work all the time to maintain positive pressure inside clean room of pharma area.
    
4.1.3    Not more than one set of doors should be opened for entry or exit. All other doors should remain closed. This should be followed even for internal doors also.
    
4.1.4    Uniforms of the phama area personnel should not be taken out side. Dress changing should be done before entering the primary pharma area and immediately after coming out.
    
4.1.5    Visitors should wear disposable shoe covers, cap and apron before entering the primary pharma area by following the entry and exit procedure displayed and should discard  while leaving  the area.
    
4.2    PHARMA AREA (CLEAN ROOM AREA) CLEANING / SANITATION.
    
4.2.1    Remove the stains  if any, by using detergent (Nirma Powder) water and hard brush.
    
4.2.2    Clean the walls and floor with vacuum cleaner.
    
4.2.3    Swab the floor with 0.5 - 1.0%  detergent solution and water followed by 1% Isopropyl alcohol solution (0.1 L  IPA + 10 L water).
    
4.3    Frequency:  The pharma area will be cleaned daily which is supervised by the shift incharge.
    
4.4    Fumigation:
    
4.4.1    Stop the production and other miscillaneous operations like centrifugation, drying, milling, sieving, micronizing etc., in the  entire pharma area.
    
4.4.2    Clean the pharma area as per clauses  4.2.1  to  4.2.3.
    
4.4.3    Keep the 1 L. formaldehyde, water (1:1)  in a open tray of about one feet dia and put  20 g of (Com/LR) potassium permanganate.
    
4.4.4    Keep the trays in each room over night (10 - 12 hrs).
    
4.4.5    After 10 - 12 hrs, remove all the trays from the pharma area and open the doors, keeping the positive air continuously, to evacuate Formaldehyde vapours.
    
4.4.6    Check the microbial content before and after fumigation.

    
4.5    Frequency:
    
4.5.1    Fumigation operation shall be carried in pharma area (clean area) when the microbial load in the product crosses the  limit of 80 cfu/gm.
    
5.0    RECORDING:
    
    The pharma area maintenance, cleaning / sanitation and fumigation operations shall be recorded by supervisor in the pharma area maintenance and cleaning record as shown in annexure - I.

Production,maintenance, cleaning sanitation, fumigation