SOP for Operation and cleaning of Stability Chamber

Objective: To set up a procedure for the operation and cleaning of Stability Chamber-II (Instrument ID: QC/039).

Scope: This SOP is applicable for the operation and cleaning of Stability Chamber-II (Instrument ID: QC/039).

Responsibility
1. Operating personnel is responsible for carrying out the procedure.
2. Overall responsibility for training, implementation & follow-up with the QC Manager or his nominee.

Accountability : Head of Quality.

Precautions:
1. Wear protective clothing (aprons) during unloading and loading of the sample.
2. Ensure cleanliness of the Stability Chamber before closing the door.

Procedure:
6.1 Operation:
6.1.1 Turn ‘ON’ the main switch provided on the main control panel.
6.1.2 All of the display should be ON when the main switch is ‘ON’ (Display of the Temperature controller, Humidity Controller , Safety Controller and inside conditioning unit become ‘ON’)
6.1.3 Now set the temperature (40°C) on the temperature controller by pressing increment and decrement key, the bottom display will show the set temperature and the top display will show the actual temperature.
6.1.4 Now set the humidity (75%RH) on the humidity controller as step 6.1.3.
6.1.5 Set the safety controller with the same set temperature as that set on the temperature controller. Also set the required alarm band and initial time. The safety controller will cut of the mains contactor in case of overshoot or undershoot of the temperature above the alarm band. In case when the safety controller trips, one has to reset the safety controller to restart the chamber.
6.1.6 Set the print interval on PC/ Printer Interface Unit.
6.1.7 Now switch ‘ON’ the heating switch, cooling no.1, & humidity no.1 switch. The air heater will be ‘ON’, the regular cooling system will start after 2 minutes of time delay and the boiler system will start.
6.1.8 Chamber light should be switched ‘ON’ only for the observation purpose or to illuminate the internal chamber while loading or unloading. Normally the chamber light should be kept ‘OFF’.
6.1.9 Take printout of the stability temperature/ humidity record data periodically (3-4 times in a month) and critically review the data and make comments on the data. Also take a back-up of the recorded electronic data in a Compact Disk (CD) every after 6 months and preserve in the document Archive cell maintaining a logbook.
6.1.10 Daily check the stability chamber and in case there is any anomaly found in the stability chamber (e.g. temperature and humidity settings etc.), immediately call the factory engineer’s or supplier engineer’s to attend the stability chamber. In case the problem is rectified within short period then document the anomaly situation. In the event that the rectification takes longer time, then transfers the product to another stability chamber unit with similar stability study condition until the stability chambers is rectified and raise a deviation note.
6.2 General Cleaning:
6.2.1 Clean the chamber from inside and outside every month.
6.2.2 Clean the boiler tank, boiler heater and reservoir tank once in seven days and remove the scales.
6.3 Record the operation in the stability user log book (Annexure-I) (FRM No.: FQC/ 095-04) and Troubleshooting/Maintenance Logbook (Annexure-II) (FRM No.: FQC/610).

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