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SOP for Control Environment Chamber (30 °C/75 % RH)


Standard operating procedure of control environment chamber used for storage for stability samples at 30 °C and 75 % RH.
1.0  OBJECTIVE
       To ensure that the humidity chamber performs satisfactorily and maintains required temperature and relative humidity for stability study samples. 

2.0  SCOPE 

       This SOP is applicable for the humidity chamber performs satisfactorily and maintains required temperature and relative humidity for stability study samples. 
3.0  RESPONSIBILITY 
       Microbiologist - Quality Control 
4.0  ACCOUNTABILITY 
       Manager - Quality Control 
5.0  PROCEDURE 
5.1  Procedure for general cleaning 
5.1.1  Ensure the power supply to the humidity chamber is switched 'OFF'. 
5.1.2  De-dust the chamber externally with a clean dry cloth. 
5.1.3  Once a week remove adhered dust by wet mopping using detergent solution
5.1.4  Subsequently wipe the surface with a clean dry cloth to remove trace of detergent. 
5.1.5  Once in a month, mop the interior surfaces with clean dry cloth. 
5.2  Operating procedure
5.2.1  Ensure that the humidity chamber is properly connected to the power supply. 
5.2.2  Check the water supply to the humidity chamber 
5.2.3  Switch 'ON' the main switch and the power switch of the chamber 
5.2.4  Set the temperature of the chamber to 30° C by pressing the 'READ' switch (red color  and adjust the desired temperature with the set knob. 
5.2.5  Similarly set the humidity of the chamber to 65% by pressing the 'read' switch (green color  and adjust the desired humidity with the set knob. 
5.2.6  Ensure the thermohygro sensor is used as follows: 
5.2.5.1  The wick of the wet sensor should be properly dipped in a water container so that the wick remains wet. 
5.2.5.2  The dry sensor should be in a clean condition i.e. without any dust or moisture on it. 
5.2.5.3  Monitor the conditions of the chamber by recording the temperature and humidity daily. 
5.2.5.4  Report if the temperature shows beyond 30°C + 2° C and humidity 75 % + 5% RH during monitoring to Quality Assurance Manager and notify the defect to Engineering Department. Put an 'out of order' label on the chamber. Transfer the stability samples to the standby oven within 2 hours. 
6.0  ABBREVIATIONS 
6.1  SOP - Standard Operating Procedure 
6.2  °C - Degree Centigrade

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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