Flipkart

Thursday, April 24, 2014

Cleaning Procedure for Dissolution Media preparation and Dispensing unit

1.0 OBJECTIVE :  
   
  To lay down the procedure for the Cleaning of media preparation
  and Dispensing unit.  
   
2.0 RESPONSIBILITY :  
   
2.1 Quality Control / Analytical R & D Officer, whoever performs the analysis.
   
2.2 Head - Quality Control / Analytical R & D Manager to ensure the Compliance.
   
3.0 PROCEDURE :  
   
3.1 Cleaning of Jacketted Pressure Vessel.  
   
3.1.1 Disconnect the electrical connections to the Jacketted pressure vessel.
   
3.1.2 Take the Jacketted pressure vessel to the washing area.
   
3.1.3 Open the lid of the vessel.  
   
3.1.4 Wash the lid and vessel with enough of potable water.  
   
3.1.5 Wash the vessel and lid with 2% Extran solution using soft nylon brush. Then wash
  with potable water followed by  purified water.  
   
3.1.8 After cleaning, place the jacketted vessel in its position.  
   
3.2 Cleaning of Vaccum filtration vessel  
   
3.2.1 Disconnect  the vaccum attachment, media transfer line and compressed air
  line from the vaccum filtration vessel.  
3.2.2 Take the vaccum filtration unit to the washing area.  
   
3.2.3 Repeat the steps 3.1.3 to 3.1.7  
   
3.3 Cleaning of media transfer tube.  
   
3.3.1 Pass about 5 litres of potable water followed by 1 litre of 2% Extran  solution
  through the media transfer tube using the Watson Marlow Pump.
   
3.3.2 Then pass the enough of  potable water followed by purified water through the 
  media line using the Watson Marlow pump.  
   
3.4 Cleaning of Media Filtration unit :  
   
3.4.1 Disconnect the media transfer lines form the filtration unit.
   
3.4.2 Take the filtration unit to the washing area.  
   
3.4.3 Open the lid and discard the previously used membrane filter and wash the
  unit with enough of potarble water followed by 2% Extran solution using soft
  nylon brush.  
   
3.4.4 Then wash with potable water followed by  purified water.
   
3.4.5 Place the filtration unit in its position.  
   
   
4.0 Documentation  : Nil  

No comments: