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.
PEOPLE ALSO READ: SOP for Temperature monitoring of Refrigerator
- 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
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