Total Pharmaceutical Solution

Procedure for operation and cleaning of cooling cabinet

1.0 PURPOSE:

To define the procedure for operation and cleaning of cooling cabinet.

2.0 SCOPE:

This procedure for operation and cleaning of cooling cabinet is applicable to warehouse department (Company name).

3.0 REFERENCE:

Nil

4.0 DEFINITION:

Cooling cabinet is an equipment which is perfect for storage and protecting the integrity of temperature sensitive materials/products of 2°C-8° C.

5.0 RESPONSIBILITY:

5.1 Personnel of warehouse is responsible for execution of the procedure.
5.2 Head warehouse is responsible for overall compliance of the procedure. 

6.0 PROCEDURE:

6.1.1 Ensure the cooling cabinet is connected to UPS for monitoring the function.
6.1.2 Open the door and place the material in the cooling cabinet; gently close the door and update the ‘list of materials in cooling cabinet’.
6.1.3 Ensure the door of the cooling cabinet is closed properly after every opening.
6.1.4 To ensure the temperature limit of cooling cabinet between 2ºC to 8ºC, hygrometer and data logger shall be placed inside the cabinet.
6.1.5 If the cooling cabinet is showing the temperature limit of 2ºC to 8ºC then store the material.
6.1.6 Warehouse personnel shall monitor and record the minimum and maximum temperature daily once from the hygrometer placed inside the cabinet.
6.1.7 If the temperature is showing out of limit in the hygrometer then take the printout of temperature report from the data logger placed inside the cabinet and verify the temperature report.
6.1.8 If the temperature excursion is not more than 30 minutes then allow the cooling cabinet to stabilize automatically and if the excursion continues for more than 30 minutes then inform to engineering department.
6.1.9 QA head/designee along with warehouse head/designee shall evaluate the fate of the material stored in the cooling cabinet and necessary QMS document shall be raised if required.
6.1.10 In case there is no material in the cooling cabinet switch off the cooling cabinet and put the status label as ‘COOLING CABINET NOT IN USE’; remove the data logger and erase the temperature data recorded in the data logger.
6.1.11 In case any material is received with storage condition of 2˚C to 8˚C then restart the cooling cabinet and ensure the temperature condition is within the limit.
6.2 Cleaning procedure of cooling cabinet:
6.2.1 Outer Surface:
6.2.1.1 Clean the outer surface of cooling cabinet starting from top to bottom with wet lint free cloth followed by dry lint free cloth.
6.2.1.2 Frequency of the cleaning for the outer surface of the cooling cabinet is daily once or as and when required.
6.2.2 Inner surface: 
6.2.2.1 Switch off and unplug the main power supply of cooling cabinet.
6.2.2.2 Open the door of cooling cabinet and ensure that all the materials are in well closed condition.
6.2.2.3 Immediately clean the top, side wall and base of the cabinet with dry lint free cloth.
6.2.2.4 Inner surface cleaning of cooling cabinet shall be done fortnightly or as and when required.
6.2.2.5 Visually inspect and ensure for proper cleaning of the equipment; gently close the door and switch on the mains.
6.2.3 Affix cleaned status label on the cooling cabinet after completion of cleaning activity.
PRECAUTION:
•Keep the door of cooling cabinet in locked condition.
•If temperature reading of cooling cabinet is not found within the limit then inform engineering and quality assurance department for immediate corrective action.
•Ensure thermostat of the cabinet is fixed in qualified position.
•In case of major breakdown of the cooling cabinet it shall be informed to QA department and tracked through the QMS system.

7.0 ABBREVIATIONS:

UPS : Uninterrupted Power Supply 
QMS :Quality Management Systems
˚C : Degree Centigrade

8.0 ENCLOSURES:

Nil

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