Event Awareness Training on

PR # 41502

Module No.LM134.01
Description of Event
• Media leakage occurred during FSIP cycle (at cooling phase) for batch No. 202403520 due to chamber
temperature probe moved out from port resulted in media spillage at Pertussis expansion Block on 29.02.20.

Desired State:
• As per SOP No. 100631.08 Calibration shall be performed onsite for the Temperature sensors.

Immediate Corrective Action:

• Informed to concerned supervisor and communicated to Engineering department. Batch was aborted and
the seed culture was decontaminated. Thorough cleaning of area and equipment was performed to remove
spilled media. All the areas and equipment's inspected and no media traces observed.
• A deviation PR No: 41502 was initiated to identify the root cause for the media spillage.
Root cause
• The sensor might have not tightened properly with the check nut post completion of Calibration due to
which the media leakage had occurred. The sensor port was withstanding due to presence of ‘O’ rings on the
ingold port. During the Media FSIP as there was availability of media and the sensor port was not tightened
properly it resulted in the leakage of media. The sensor port was not tightened properly due to overlook of
the person

• CAPA Proposed:

• Awareness Training to be provided to all the concerned person on calibration of temperature sensor to
ensure that the temperature sensors check nuts are tightened properly after Post completion of calibration.
Checks to be performed for temperature sensor During calibration

1. Verify the temperature sensor Physical condition at the Equipment before starting the calibration.
2. Ensure the availability of all the master instrument accessories.
3. Ensure that the equipment to be calibrated is free to carry out the calibration.
4. Choose the required master instrument Digital dry bath and master temperature probe for the
calibration of temperature sensor.
5. Verify the thermo well type temperature sensor for sufficient glycerol during calibration if not fill the
same as per the requirement.
6. Remove the Temperature sensor cable connection from the instrument and loose the check nut of
the sensor with the adjustable spanner. Post removal of sensor reconnect the sensor cable.
7. Insert the sensor in the digital dry bath.
8. Calibrate the temperature sensor as per the SOP.NO: 100631.08
9. Post completion of calibration remove the sensor cable and reinstall the sensor at the required
location and tightened the sensor check nut with the adjustable spanner. Post which reconnect the
sensor cable to the instrument.
Pictorial Representation of sensor in the ingold port
Before calibration:
Pictorial Representation of sensor in the ingold port
after post calibration: