Operation and Cleaning of Refrigerator

Operation and Cleaning of Refrigerator

Objective: To lay down a procedure for the Operation and Cleaning of the Refrigerator in the Raw Material Store.

Scope: This Standard Operating Procedure is applicable for the operation and cleaning of the Refrigerator in the Raw Material Store at the formulation plant.

Responsibility

Raw material Store personnel shall be responsible for following the procedure mentioned in this SOP.

The raw material Store in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability

The raw material Store in charge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

SOP: Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.

QA: Quality Assurance

Ltd.: Limited

RM: Raw material

Procedure

Operation of Refrigerator

The refrigerator is leveled with suitable means.

Ensure the plug and socket have proper connections.

Switch ‘ON’ the main supply and open the refrigerator door to check the room lamp.

Adjust the thermostat to the required extent by thermostat knob and thereby the temperature is maintained between 2 and 8º C.

Locate a calibrated thermometer in the refrigerator.

Ensure tight closure of refrigerator door.

Expose the thermometer for a minimum period of 15 Minutes.

Open the refrigerator door to remove the thermometer.

Check the temperature immediately.

The temperature inside the refrigerator should be not more than 8°C.

When the temperature is found out of the limits (above 8°C) shift all the material into

another refrigerator and inform head of the department and QA.

Inform the engineering department of necessary action.

The refrigerator must not be overcrowded at any time.

Cleaning procedure for refrigerator

The refrigerator should be cleaned weekly or when required.

Switch off the mains of the refrigerator.

Remove all the items from the refrigerator and put them in another refrigerator, clean with the warm Purified water.

Replace all the required items and arrange them properly.

Ensure every item is labeled properly.

After completion of cleaning, record the cleaning time in their log book.

Fix the ‘Cleaned’ label on the refrigerator.

Forms and Records (Annexures)

Not Applicable

Distribution

Master copy           –             Quality Assurance

Controlled copies         –             Quality Assurance, Raw Material Store

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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