RECORDING OF PRESSURE DIFFERENCES TEMPERATURE AND HUMIDITY

1.0    PURPOSE:
    
    To describe a  standard operating procedure (SOP) for  recording of pressure differences, temperature and humidity 
        
2.0    SCOPE:
    
    The SOP describes in detail the method  of  recording of pressure differences, temperature and humidity 
    
3.0    RESPONSIBILITY:
    
    The  responsibility of  recording of pressure differences, temperature and humidity in  pharma area lies with the staff of rank not lower than operator of production department.
    
         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      Pressure differences : 
    
4.1.1    Ensure that the doors are properly closed before recording the pressure differences.
    
4.1.2    Record the pressure differences as indicated in the respective magnehelic gauges of different areas as follows. 
    Annexure – I   : For primary pharma area
    Annexure – II  : For secondary pharma area
    Annexure – III : For wash area
    
4.1.3      If the recordings are not meeting the specification, inform to Maintenance department immediately for rectification and record in the remarks column. 
    
4.1.4      Frequency : 

             Pressure differences  shall be recorded daily between 12.00 hrs  and  13.00 hrs. 
    
4.2        Temperature and humidity : 
    
4.2.1    Temperature and humidity in various areas of pharma area shall be automatically monitored by  data logger and the readings are obtained every 6 hrs. through a printer.  
    
4.2.2    The data is reviewed by section incharge and preserved in pharma area. 

4.2.3    If the recordings are not meeting the specifications inform to Maintenance department immediately for rectification  and record in the  remarks  column. 
    
            Specification : Temperature is 26° ±  2°C and Humidity is 55 ± 5% related to Channel Nos. 01 to 10. 
    
4.2.4    Frequency : 

          Temperature and humidity shall be recorded by data logger for every 6 hours.

5.0      RECORDING:
    
         The  responsibility of recording the pressure difference in pharma area  lies with the staff of  rank not lower than operator of production department  in pressure differences record  as  shown  in annexure-I, II, III.
    

Production, pressure differences, humidity