SOP for Temperature Mapping of Incubator and Refrigerator

OBJECTIVE

To lay down the procedure for temperature mapping.

SCOPE

This SOP shall be applicable for walk-in coolers, biological incubators, refrigerators, and freezers.

RESPONSIBILITY

Officer / Executive / Assistant Manager

ACCOUNTABILITY

HOD of Engineering and QA

PROCEDURE

• Temperature mapping is to be carried out by using the calibrated temperature probes and data logger.
• Identify positions & number of locations for temperature mapping such that, it covers every corner & center of the chamber.
• Prepare a protocol for temperature mapping indicating objective, scope, responsibilities, methodology, acceptance criteria, calibration status, summary, and conclusion.

• Protocol to be prepared by the officer/executive of the concerned department, checked by the head of the concerned department, and shall be approved by the head QA/QC.
• Place temperature probes at the identified locations without touching the tip to any surface inside the chamber.

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• Select the number of channels and set the print interval of 30 minutes on the data logger.
• Start the mapping after stabilization of the displayed temperature.
• Record the temperature readings of each probe in the temperature mapping record.
• If results do not fall within the specified limit, take necessary corrective actions to rectify the failure & perform the mapping again.
• Final report for temperature mapping to be prepared by officer/executive of the concerned department based on results obtained indicating the summary and conclusion.
• The report shall be checked by the head of the concerned department and shall be approved by the head of QA/QC.

• After approval of the report daily monitoring shall be done at the identified hot spot.
• For new equipment, mapping is to be done for three consecutive days.
• Remapping is to be done for equipment once in year for 24 hours.
• Acceptance Criteria: The temperature shown by individual temperature probes should not be more than 25±2°C.

ABBREVIATIONS

SOP: Standard Operating Procedure

QA: Quality Assurance

QC: Quality Control

REVISION HISTORY

Nil

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