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 to the humidity chamber performs satisfactorily and maintains required temperature and relative humidity for stability study samples.
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 a 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.
5.2.6.1 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 notifies 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.
3.0 RESPONSIBILITY
Microbiologist - Quality Control4.0 ACCOUNTABILITY
Manager - Quality Control5.0 PROCEDURE
5.1 Procedure for general cleaning5.1.1 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 a 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.
5.2.6.1 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 notifies 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
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