Incubator Mapping Activity involves validating and documenting the uniformity and consistency of temperature inside an incubator to ensure it meets required specifications.
The BOD Incubator shall be used to Incubate the test samples at temperature 43.0ยฐC.
Temperature-mapping process has four stages:
*Prepare a mapping protocol.
*Carry out the mapping exercise
*Prepare a mapping report.
*Carrying out the remedial and other actions
*Ensuring that the sensors or thermocouples used are calibrated to traceable standards.
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- A total of 16 sensors shall be used for temperature mapping.
- One sensor shall be placed at each corner of every shelf, and one sensor shall be placed in the middle of each shelf.
- One sensor shall be placed parallel to the inbuilt sensor.
- Set the recording/printing interval of the data loggers to 30 minutes.
- Close the incubator door.
- Start recording the temperature.
- Record the temperature profile of the equipment for not less than 24 hours.
- Take the printout of the recorded data.
- Record the observations of the temperature mapping.
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*Temperature variation at different locations shall not be more than 43.0 ยฑ2.0ยบC.
*Any deviation observed during Temperature mapping shall be recorded.
*Observed deviation shall be reported to the Department Head and Quality Head.
*If the observed deviation does not have any major impact on the Temperature mapping study the final conclusion shall be provided.
*If the observed deviation has major impact on the Temperature mapping, deviation shall be reported to the manufacturer for the corrective action and mapping activity shall be done again.
*After mapping, generating reports to show compliance with validation requirements, such as GMP or other regulatory standards.