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SOP for Temperature Mapping of Incubator and Refrigerator

OBJECTIVE
To lay down procedure for temperature mapping.

SCOPE
This SOP shall be applicable for walk-in coolers, biological incubators, refrigerator and freezer.

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 officer / executive of concerned department, checked by head of concerned department and shall be approved by head QA/QC.
  • Place temperature probes at the identified locations without touching the tip to any surface inside the chamber.
  • Select the number of channels and set the print interval of 30 minutes on data logger.
  • Start the mapping after stabilization of the displayed temperature.
  • Record the temperature readings of each probe in temperature mapping record.
  • If results do not fall with in 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 concerned department based on results obtained indicating the summary and conclusion.
  • Report shall be checked by head of concerned department and shall be approved by head 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 to be done for equipment once in year for 24 hours.
  • Acceptance Criteria: Temperature shown by individual temperature probe 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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