Refrigerator – Operation & Performance Check

Standard Operating Procedure (SOP) for Operation, Cleaning, and Performance Check for Refrigerator used to store the  Microbiology Culture, Spores, Media, etc in the Microbiology Lab.

Refrigerator Used in Microbiology Lab

1.0   Purpose:

    • The purpose of this SOP is to describe the Operation, Cleaning, and Performance check procedure of Refrigerator used for the storage of microbiology culture, media, etc.

2.0   Scope:

    • This Standard Operating Procedure is applicable to the Microbiology section of the Quality Control department for operation, cleaning, and performance check of the Refrigerator.

3.0   Reference : SOP for Refrigerator

    • Operation Manual supplied by the manufacturer.

4.0   Responsibility- SOP for Refrigerator:

    • Officer or Executive of the Microbiology department shall be responsible for Operation, Cleaning, and Performance check procedure of equipment.
    • Head of the department/designee of respective areas & QA shall be responsible for reviewing the SOPs.
    • Plant Head and Head-Quality shall be responsible for the approval of SOP.
    • QA shall be responsible for the distribution and control of SOPs to various departments.

5.0   Abbreviations :

    • °C: Degree Celsius unitRefrigerator
    • CC: Change Control
    • HOD: Head of Department
    • Lab: Laboratory     
    • Micro: Microbiology
    • P/N: Part Number

6.0   Procedure for Operation and Performance Check of Refrigerator:

    • Precautions

    • Close the door as early as possible.
    • Do not overload the chamber and freeze with samples.
    • Once the temperature is set, do not disturb the temperature and Freezer temperature button.
    • Operational procedure

    • Ensure that the equipment power supply is connected. Switch “ON” the mains.
    • Control the temperature through a temperature control knob.
    • The temperature setting range between “COLD” TO “COLDEST”.
    • Do not disturb the temperature controller knob, after getting the desired temperature (i.e. 2°C to 8°C).
    • Similarly, select and set the “Air Flow Control” button of the freezer.
    • Regulate the cooling by adjusting the thermostat switch to get the required temperature between 2°C to 8 °C, in different seasons i.e. winter, summer, or rainy season.
    • Daily measure the temperature using a calibrated temperature-indicating device (For microbiology twice in a day).
    • Record the temperature in the “Temperature log as per Annexure-1.
    • In case of any discrepancies observed, inform the Quality Head or Designee immediately and put the “NOT TO BE USED” label, duly signed with the date.
    • Cleaning procedure:

    • Frequency: Monthly / as and when required.
    • For cleaning, disconnect the electric power supply, transfer the items or keep in another Freeze; wipe the outer surface with a dry clean cloth after that wipe off the inner surface with 2.5% Dettol solution followed with the purified water.
    • Switch on the refrigerator and arrange the contents in an orderly manner.
    • Ensure the refrigerator is clean and do cleaning as and when required.
    • Make an entry in “Cleaning Log of Refrigerator” (Annexure–3).
    • List of refrigerator contents is to be maintained as per Annexure-4
    • Calibration procedure of Refrigerator : ( For Third Party)

    • As per validation protocol for Refrigerator.

7.0   Annexures – SOP for Refrigerator :

Annexure 1: Temperature Log of Refrigerator

Temperature Range: 2°C-8°C
Month : Equipment Code No. :

 

Date Time

Temperature (°C)

Checked by Remarks
Min. Max.

Annexure 2: Equipment History Card

Equipment   Code No.
Make   Model
Installation on   Page No.
Name of service agency

S. No.

Activity Date of rectification Date of Maintenance Type of  Maintenance Part of any replace or P/N Rectified by Checked by Done by Checked by

Remarks

Annexure 3: Cleaning Log of Refrigerator

Cleaning frequency: Monthly Code No.:

 

Month Date Cleaning agent used Cleaned by Checked by

Annexure 4: List of Refrigerator Contents

Equipment Code No.:   

 

S. No. Material name Quantity

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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