SOP for Temperature Mapping Study : Pharmaceutical Guidelines

SOP for Temperature Mapping Study

Standard operating procedure of temperature mapping study in biological incubators, refrigerator and freezer using calibrated probes and data logger in pharmaceutical industries.


      To lay down procedure for temperature mapping.

2.0 SCOPE:

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


      Officer / Executive/ Assistant Manager


      HOD of Engineering and QA


5.1 Temperature mapping is to be carried out by using the calibrated temperature probes and data logger.
5.2 Identify positions & number of locations for temperature mapping such that, it covers every corner & center of the chamber.
5.3 Prepare a protocol for temperature mapping indicating objective, scope, responsibilities, methodology, acceptance criteria, calibration status, summary and conclusion.
5.4 Protocol to be prepared by officer / executive of concerned department, checked by head of concerned department and shall be approved by head QA/QC.
5.5 Place temperature probes at the identified locations without touching the tip to any surface inside the chamber.
5.6 Select the number of channels and set the print interval of 30 minutes on data logger.
5.7 Start the mapping after stabilization of the displayed temperature.
5.8 Record the temperature readings of each probe in temperature mapping record.
5.9 If results do not fall with in the specified limit, take necessary corrective actions to rectify the failure & perform the mapping again.
5.10 Final report for temperature mapping to be prepared by officer / executive of concerned department based on results obtained indicating the summary and conclusion.
5.11 Report shall be checked by head of concerned department and shall be approved by head QA/QC.
5.12 After approval of the report daily monitoring shall be done at the identified hot spot.
5.13 For new equipment, mapping is to be done for three consecutive days.
5.14 Remapping to be done for equipment once in year for 24 hours.

5.15 Acceptance Criteria:

Temperature shown by individual temperature probe should not be more than 25±2°C.


6.1 SOP: Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
[email protected] :liamENeed Help: Ask Question

Click Here

1 comment: Post Yours! Read Comment Policy ▼


Show All ❭❭Jobs by PharmaJobs

Write a Powerful CV

Click Here

Advertise Here

Get App for News Updates

Scan to Download

Android App
Android App

Recent Posts