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SOP for Control Environment Chamber (40 °C/75 % RH)


Standard operating procedure of Control Environment Chamber used to store the stability samples at 40 °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.
5.2.3  Check the water supply to the humidity chamber
5.2.4  Switch 'ON' the main switch and the power switch of the chamber
5.2.4  Set the temperature of the chamber to 40° 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 75% by pressing the 'read' switch (green color and adjust the desired humidity with the set knob.
5.2.6  Ensure that thermohygro sensor is used as follows:
5.2.6.1  The sensor should be in a clean condition i.e. without any dust or moisture on it.
5.2.6.2  Monitor the conditions of the chamber by recording the temperature and humidity daily.
5.2.6.3  Report if the temperature shows beyond 40°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 stand by oven within 2 hours.

6.0  ABBREVIATIONS 

6.1  SOP - Standard Operating Procedure
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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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