Incubator validation protocol
Pre-requisite of Performance Qualification/Validation of Incubator
General Precaution:
- Validation shall be carried out using at least 9 probes and out of 9 probes, one probe shall be kept near to the sensor of the Bacteriological Incubator.
- Ensure that all data loggers or external temperature sensors is calibrated prior to validation.
- Check the traceability certificates of the calibration devices used.
- Open the validation port of the Bacteriological Incubator and insert the external sensors into the chamber. Tightly close the validation port of the Chamber.
- If temperature monitoring devices are used, then they shall be kept at all the locations as mentioned in the loading diagram.
- Configure the same start and stop time for all the temperature mapping devices temperature sensors. Synchronizing the start/stop times will eliminate the collection of extraneous data.
The calibration details of external test equipment/ instruments are as given below:
Sr. No. | Instrument/ Equipment Name | Calibration Done On | Calibration Due Date | Checked By | Verified By |
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Qualification Plan & Methodology
To verify that the Bacteriological Incubator functions correctly in maintaining the correct temperature conditions throughout.
Justification to selection of number of external sensors:
· The number of external sensors to be used will vary based on a number of factors, including environment, temperature application.
· The typical number of sensors used to map chambers shall include 9 temperature sensors andthey shall be used to cover the locations mentioned in Annexure I.
· In chamber with four layered arrangements: Four layers of eight sensors, one near Incubator sensor shall be used.
· The location of probes shall vary depending on the number of trays, size of the Chamber, location of temperature controller or the alarm sensor, the locations shall be justified accordingly.
· Calibrated Type T (copper-constant) thermocouples or Calibrated temperature monitoring devicesshall be used and distributed evenly throughout the chamber interior.
· Table of sensor position
Temp sensor | Description | Temp sensor | Description | Temp sensor | Description |
T-1 | Near Incubator sensor | T-4 | Front Left Tray 2 | T-7 | Front Right Tray 3 |
T-2 | Back Left Tray 1 | T-5 | Back Right Tray 2 | P-8 | Front Left Tray 4 |
T-3 | Front Right Tray 1 | T-6 | Back Left Tray 3 | T-9 | Back Left Tray 4 |
Performance Qualification/Validation Procedure
· Operate the temperature maintained chamber as per the respective SOP.
· The chamber shall be Loaded during the study of Performance qualification.
· Set the temperature 42.5.
· Place all the temperature sensors as per Annexure-I.
· Allow the chamber to stabilize after the insertion of the Temperature sensors trough validation port in to the chamber and tightly close the validation port of the Chamber.
· Continue the temperature monitoring in all the sensors for a period of 24 hours.
· Temperature logging interval of print 1 minutes.
· Observe the temperature shown on the digital display. The Temperature should not be ±1.0°C from the Set temperature of 42.5°C.
· Download the data and evaluate for the variation at different location.
· Review the data and make the conclusion.
Alarm Challenge Test: |
Take hot water and immerse the temperature sensor/alarm sensor in it,due to sudden change in the temperature the controller/sensor temperature will increase and control panel/PLC/HMI shall sense a change in the temperature beyond the desired set temperature. |
Any increase in temperature beyond 44.0C will be read as temperature beyond the desired temperature and an alarm indication shall be visible, audible etc. as per the specific facility. |
· Take a print out of the changes done during the period from the software to which the chambers are connected. |
· Take Cool water and immerse the temperature sensor/alarm sensor in it, due to sudden change in the temperature the controller/sensor temperature will increase and control panel/PLC/HMI shall sense a change in the temperature beyond the desired set temperature. chamber is set to 42.0°C with a internal limit of deflection 1.0ºC. |
· Any decrease in temperature below 42.0°C will be read as temperature beyond the desired temperature and an alarm indication shall be visible, audible etc. as per the specific facility |
· Immediately after the indication of alarm is verified remove the temperature controller from the challenged water or set the limits as per the acceptance criteria specified. |
· Allow the temperature controller to attain the desired temperature. |
· Evaluate the impact of the change on the material/product if the time spend for the attainment is more (i.e. More than approx. 1 hour) during periodic verification. |
Temperature Recovery Study- (Door opening and Closing Study) |
· Change the temperature logging interval to time between 30 Seconds. |
· The chamber shall be loaded with material, preferably to its full capacity. |
· If the chamber is being used for microbiological testing especially Incubators and then fill the chamber with media either liquid (Media Bottle/tubes) or solid (agar plates). |
· Place the temperature monitoring devices/data logger with temperature sensors at the defined locations mentioned in Annexure I. |
· Allow the monitoring device or the temperature sensors to stabilize in the chamber for approx. 30 mins. |
· Open the door of the chamber or a period of time that is typical for normal operation of the chamber (5 minutes for laboratory scale chambers). |
· After the specified time interval close the door of the chamber. |
· Data collection shall continue until the chamber returns to specified operating range. |
· After the temperature has returned to the specified operating range the material/products shall be shifted to another chamber (if required) i.e. To fill the capacity if material/products are transferred from other chamber. |
· This test shows that material/product temperatures are not adversely affected during normal operation of the chamber. |
· After the study determine the time taken by the chamber to get disturbed from its acceptance criteria values of temperature after door opening. |
· Also determine the time taken by the chamber to regain to its acceptance criteria values of temperature after door closure. |
· If there is a significant difference in temperature due to the door opening and closing activity then the same shall be displayed on the chamber to avoid the deflections during routine operations. |
Temperature Change Study (Power Failure Study) |
· Change the temperature logging interval to time between 60 seconds. |
· The chamber shall be loaded with material, preferably to its full capacity. |
· If the chamber is being used for microbiological testing especially incubators then fill the chamber with media either liquid (Media Bottle/tubes) or solid (agar plates). |
· Place the temperature monitoring devices/data logger or the temperature sensors at the defined locations mentioned in Annexure I. |
· Allow the monitoring device or the temperature sensors to stabilize in the chamber for approx. 30 mins. for small chamber. |
· Remove the power from the temperature control unit for the chamber or switch OFF the temperature maintained chamber for a period varying from 5 hours. |
· After the specified time interval switch ON the power or connect the temperature control unit of the chamber. |
· Data collection shall continue until the chamber returns to specified operating range. |
· If the chamber is used for microbiological testing then the media inside the chamber shall be subjected to Growth Promotion testing. |
· This study shall provide information on how long the chamber remains within the |
Data from this study shall be used to help determine if material/product is adversely affected following a power failure. |
· The Door opening and closing study, power failure study for chambers used for microbiological testing shall be done one after another and the Growth Promotion test on the incubated media shall be done after the complete study. |
· The results of the Growth Promotion test shall be applicable for both the studies. |
· After the study determine the time taken by the chamber to get disturbed from its acceptance criteria values of temperature after power failure. |
· Also determine the time taken by the chamber to regain to its acceptance criteria values of temperature after the power is resumed. |
· If there is a significant difference in temperature due to the power failure study then the same shall be displayed on the chamber or addressed in specific SOP to avoid the deflections during routine operations. |
· An impact assessment/retesting etc. shall be required if the deflection in temperature is more than that validated during routine operations and shall be done as per the SOP on Handling of Deviations. |
Acceptance Criteria
Performance qualification shall be considered acceptable when all the conditions specified in various sections have been met.
Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component.
Requalification Criteria
Ø Modification in equipment.
Ø Major breakdown.
Ø Any Other activity which impact quality.
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