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Stability Chamber – Operation, Cleaning and Performance check

Standard Operating procedure (SOP) for Operation, Cleaning, and Performance Check/Calibration of Stability chamber (Oven) used for the stability study of drug products. 

Handling of Stability Chamber/Oven

1.0   Purpose:

    • The purpose of this SOP is to describe the procedure for qualification and monitoring of the stability chamber/oven.

2.0   Scope:

    • This procedure is applicable to the stability chamber/oven (make-Newtronics)located in the Stability Study section in the Quality Control  Department.

3.0   References and Annexures – SOP for Stability Chamber:

    • References:

    • Operational manual
    • Stability Study Programme SOP
    • SOP for Maintenance of Laboratory Instruments
    • Procedure for withdrawal and analysis of stability study samples (SOP)Walk-In Stability Chamber

    • Annexures :

    • Performance check of stability chamber/oven (Annexure -1)
    • Format for opening and closing of stability chamber/oven (Annexure -2)
    • Cleaning logbook of stability chamber/oven (Annexure -3)

4.0   Responsibilities:

    • Analyst:

    • Qualify the stability chamber/oven as per the
    • Maintain the cleanliness of the stability chamber/oven as per the SOP.
    • Perform the related documentation and its maintenance as per the SOP.
    • Collect the print outs for the temperature and humidity record, alarm log report daily, to review the data and prepare monthly summary reports for excursions ( Alert level and action level).

    • Stability coordinator or Designee:

    • Review the monthly data and reports to understand the systemic drifts and abnormal changed in Temperature & Relative Humidity data variance.
    • Ensure the operation, performance check and cleaning of the instrument as per SOP
    • Ensure proper documentation as per SOP.
    • Initiate the breakdown activity of the Humidity control oven as per SOP.

    • QC Head or Designee:

    • Provide training to the concerned persons before the implementation of the SOP.
    • Approve the assessment report and assure proper documentation as per the SOP.
    • Ensure the qualification of the stability chamber/oven as per the SOP.

    • Quality Assurance :

    • Check the SOP.
    • Ensure the implementation of the system as per the SOP.

    • Regulatory Affairs, Quality Head, and Plant Head :

    • Review and approve the SOP.

5.0   Abbreviation used in the SOP for Stability Chamber:

    • Abbreviations:

    • CPP: Captive Power Plant
    • LAN: Local Area Network
    • MCB: Miniature circuit breaker.
    • NA: Not Applicable
    • NPL: National Physical Laboratory
    • %RH: %Relative humidity.
    • UPS: Uninterrupted power supply

6.0   Procedure for Handling of Stability Chamber:

    • Operational Procedure of Stability Chamber:

    • Fill the water tank by connecting the Water Inlet pipe at the back of the equipment to a water tap or any small water container. The equipment’s water tank is fitted with a float valve to maintain the water level.
    • Connect the overflow and bottom drainage to the drainage line.
    • Check electric supply (230 V AC ),
    • Set the high-temperature safety thermostat (HT) 10°C above the set temperature.
    • Set the Low-temperature safety thermostat (LT) 15°C below the set temperature.

    • Loading sample into the stability chamber :

    • Take the key from the authorized person.
    • Unlock the outer door and locate the place where the sample has to be kept.
    • Open the inner door and load the sample.
    • While loading the sample into the stability chamber following care has to be taken :
      • Place the samples in the stability chamber by keeping it in a tray.
      • Do not block the free space inside the tray by the sample.
      • Do not block the Air circulation holes at the top and the bottom or backside of the chamber.
      • Avoid covering the sensor with samples.
      • Now close the inner glass door properly and close the door latch.
      • Now close the outer door, lock it, and return the key to the authorized person.

    • Unloading sample from stability chamber:

    • Take the key from the authorized person.
    • Unlock the outer door and locate the sample, which has to be removed.
    • Open the inner door and remove the sample.
    • Now close the inner door properly and close the door latch.
    • Now close the outer door, lock it, and return the key to the authorized person.

    • Software operation of Stability Chamber (IC DAS) :

    • The software automatically appears with the default user as a guest.
    • If the software does not start, click on “Start”,  go to “Programs” and click on IC DAS.
    • The screen appears as follows :

Home Page - Stability Chamber

    • Click on ‘Log In’ button, a login window will appear. Enter the user name and password.
    • On clicking the report button the user will be navigated to the equipment data log where he will find another click button again as a report.
    • One can click on this button after selecting the equipment ID, date, and time for which the user wants to generate the reports.

    • To generate the report user has to follow the following procedure :

      • In search option first select data from, time from, date to and time.
      • Then select equipment from the Equipment name field and click on the search button.
      • The report will be generated based on the above data. In a report out of limit, values will be displayed in
    • To view/print the report in graphical form user has to follow the following procedure.
      • Select the parameter in the Equipment data log window whose graph to be plotted. (Temperature/Humidity).
      • Click on the graph button and the respective graph will be plotted.
      • By default, the graph will be plotted in a 2D line format.
      • To take print of displayed graph click on the Zoom button and print preview of the graph will be displayed.
      • Click on the Print button to take the print out on the selected printer.
    • To view the logged alarm clock on the alarm log button. Filter date and time, select the equipment to view its alarms.
    • To view alarms, the user has to follow the following procedure.
      • In search filter option first select the date from, time from, date to and time.
      • Now select equipment whose logged alarm is to be viewed and click on the search button.
      • To print the alarm on a printer click on the print button, the print preview will be displayed on the screen, click on the print button to print.

    • Alarm acknowledgment:

    • To acknowledge the alarm user has to double click on the status of the alarm (Not Ack).
    • Now click on the acknowledge button, the software will ask for confirmation.
    • After clicking confirm, the user has to enter comments in the comment field.
    • Once the alarm is acknowledged, it will not be displayed in the alarm log.

    • Real-time summary :

    • Clicking on the real-time summary button will give a summarized view of all the active equipment on the LAN.
    • This will contain details like the equipment ID the real-time values of the temperature and humidity corresponding to this equipment ID and the values which are out of limit shall be displayed in red color background.
    • It will also show the set point for humidity and temperature.
    • In case the system is offline, a communication failure message will be displayed.

    • Real-time display :

    • Clicking on this Real-time Display icon will give the real-time values of the temperature and Humidity corresponding to the sensors installed in the Equipment.
    • One can have real-time graphs of temperature and humidity as a function of time.
    • The values which are out of limit shall be displayed in a RED color background so that the user can discern between the in-limits and out of limits values.
    • The same is in the case of the graphs, that is there are two boundary lines on the graph depicting the out of limits and anything within this range is in limits value.

    • Alarm Audit Trail :

    • To view the alarm audit trail administrator has to follow the following procedure.
    • In Search filter option first select a date from, time from, date to and time.
    • Now select equipment and user name for which alarm audit trail is to be viewed and click on the search button.

    • Database Back up and Restore :

    • Backup Database :
    • To take the backup of data administrator has to click on Admin Utilities on the menu bar and select Backup Database.
    • Back up Database window will open. Select the path where the backup has to be stored and click on Create Backup.
    • The backup file name will be given by the software and it will be in the following format.

NECDMS-dd-mm-yyyy

    • Here, dd-mm-yyyy represents the system to date.

    • Restore Database :

    • To restore the old database administrator has to click on Admin Utilities on the menu bar and select Restore Database.
    • Restore the database window will open, select the file, and click on Restore.
    • The software will display a warning message Please note Application will be closed for restoration. Are you sure you want to Restore? The application automatically restarts after restoring the database.

    • Report print out: [ Frequency: Daily ]

    • Daily report print of temperature and humidity shall be done for all the equipment data accordingly.
    • Database back up: [ Frequency: Monthly ]
    • Data generated should be backed up on a monthly basis.

    • Note: Instructions to be strictly followed.

    • Always wear shoe cover while entering the walk-in stability chamber.
    • The only authorized person shall enter in walk-in stability chamber. Other people like QA person and auditor etc. shall enter only in the presence of an authorized person.
    • Do not block the air passage area with a sample in Walk-in Chamber.
    • Do not place anything on the top of the equipment or do not stand on the top of the equipment.
    • A continuous supply of water is necessary or else the boiler will turn OFF and humidity will go down when the water level in the boiler tank goes below the minimum level.

    • Performance to be carried out after following maintenance, or any other major breakdown.

Sr. No. Name of the module Type of maintenance Performance check required
01 Sensor Replacement of temperature and humidity Sensor Temperature and humidity Sensor Performance calibration
02 Compressor Replacement of Compressor Complete Performance Calibration check
03 Heater Replacement of Heater

 

 Complete Performance Calibration check
    • Performance Check Frequency- Half yearly± 15days (Third Party)

    • Calibration of Temperature sensors (Stability Chamber).

    • Temperature sensors should be calibrated by using Thermocouples which are calibrated at least against NPL, New Delhi (National Physical Laboratory New Delhi)e. they should be traceable to NPL, New Delhi or equivalent Laboratory
    • The calibrator should have resolution 0.1°C and the acceptance limit of calibration should be ± 0.5°C with respect to the calibrator value or more stringent accuracy considering the measurement accuracy required for the intended article.
    • Calibrate the inbuilt temperature sensor by placing the calibrator or thermocouple, at the same position of the inbuilt sensor and compare the difference which shall be within ± 0.5°C or more stringent accuracy considering the measurement accuracy required for the intended article.
    • Perform the monitoring of the temperature of sensors for 1 hour at 5 minute time interval, for at least three readings after the temperature stabilization.
    • Review the calibration certificate for the temperature sensor for adequacy.
    • In the case of any temperature sensor displays beyond acceptance limit (± 0.5°C) off-set.
    • Set during the calibration of the temperature sensor.
    • In case of temperature sensor displays beyond tolerance limit ( ± 1.5°C), replace the temperature sensor.

    • Calibration of Humidity sensors (Stability Chamber).

    • Calibrate humidity sensors by using external Humidity sensors which are calibrated at least against NPL, New Delhi e. traceable to NPL, New Delhi, or equivalent laboratory.
    • The calibrator should have resolution 0.1% RH ( Relative humidity) and the acceptance limit of calibration should be ± 2.0 %RH with respect to the calibrator value.
    • Calibrate the inbuilt humidity sensor by placing the calibrator or external thermocouple, at the same position of the inbuilt sensor and compare the difference which shall be within ± 2 %RH or more stringent accuracy considering the measurement accuracy required for the intended article.
    • Perform the monitoring humidity sensors for 1 hour at 5 minute time interval, for at least three readings after the humidity stabilization.
    • Review the calibration certificate for Humidity sensor calibration for adequacy.
    • In-case of any humidity sensor displays beyond acceptance limit (± 2.0 %RH) off-set. Set during calibration of the Humidity sensor.
    • In case Humidity sensor displays beyond tolerance limit ( ± 3.0 % RH), replace the humidity sensor.

    • Temperature and Humidity mapping in the loaded Stability chamber.

    • Ensure the instrument is ready for use.
    • Performance check of Humidity control oven shall carry out by outside agency using a traceable Multi-channel scanner in presence of QC representative as per the following procedure.
      • Put the “PT-100” type sensor into the Humidity control oven to measure the temperature and humidity as described in the temperature-humidity sensor position diagram below.
      • If the standby compressor / boiler-heater is available, then the scheduled half-yearly re-qualification of stability chamber/oven shall be performed using alternate compressor / boiler-heater. (In such case initial qualification shall be performed with both set). Also periodically it should be verified for its functionality.
      • As a part of qualification documentation, Attache the audit trail log and alarm challenge log-print out with qualification report.
      • External thermocouples and humidity probes used shall be at least equal to the number of sensors available in the stability chamber/oven.
      • External thermocouples and humidity probes shall be kept at different positions than in-built temperature and humidity sensors and remaining external thermocouples and humidity probes should be kept at other worst spots identified for the stability chamber/oven e.g near to the door.
    • In case of initial qualification procedure, temperature and humidity monitoring shall be done for at least 24 hours continuously in every thirty-minute interval for the empty and loaded chamber,
    • And in case of re-qualification procedure, temperature and humidity monitoring shall be done for at least 4 hours continuously in every ten minutes interval for loaded chamber only.

    • Acceptance criteria for the temperature – ±1.5°C and for humidity – ±3% RH.

    • Only one spike in temperature-humidity (beyond respective acceptance criteria) can be tolerable while qualification.
    • If more spikes found, then the qualification for temperature mapping should be performed for 8 hours. Still, if the spike is observed then contact to service engineer for rectification.
    • If the thermocouples fail to capture data, Perform the repeat study for the requalification of the chamber at all the positions.
    • For cooling chambers, in case of initial qualification procedure temperature monitoring should be done for at least 24 hours continuously every thirty-minute interval for the empty and loaded chamber, and in case of re-qualification procedure, temperature monitoring shall be done for at least 4 hours continuously for every ten-minute interval for loaded chamber only. The allowable variation for temperature is 3° to 7°C.

Placement of sensors for re-qualification of walk-in-Stability chamber

Sensor Location -Qualification of Stability Chamber

 

 

Placement of sensor for requalification of humidity oven

Sensor Location -Qualification of Humidity Oven

 

    • Carry out the Performance Check of temperature/humidity control oven up to 4 hours.
    • Record the temperature at 10 minutes interval and check against the criteria.
    • The allowable variation is ± 1.5 °C for temperature and ± 3.0 % for humidity.
    • The outside agency shall submit the performance check report, which includes (a) the calibration certificate traceable to National or International Standard of the reference instrument used and validity period of the same, (b) Report on heat distribution study indicating temperature of each reference sensor, the minimum and maximum temperature, hot spot, and cold spot.
    • Submit the report to the designated person for verification.
    • After the approval of Head QC, the outside agency person shall affix the Performance status label.
    • In case of non-compliance of calibration, inform the Head QC or designee.

    • Stability Chamber – Alarm challenge test : [ Frequency: Quarterly ± 7 days ]

    • The alarm challenge test shall be carried out by analyst and entry to be made in an alarm challenge log (Annexure-1).
    • An alarm challenge test should be performed for the following conditions.
      • These are the typical alarm challenge conditions and these conditions will vary depending on the model of the humidity chambers.
      • All the print outs of the “Alarm challenge test” should be attached in the performance record of the stability oven.

Note: Temperature high alarm, Temperature low alarm, Humidity high Alarm, and Humidity low Alarm challenge are must for any type of Stability Chamber/oven.

    • Stability Chamber -Temperature high Alarm:

    • The system should give an alarm when the temperature goes more than the set high-temperature alarm value.
    • It should be verified by setting high-temperature alarm value at upper tolerance of temperature limit (+0.1°C) e.g. For 25°C chamber temperature, high-temperature alarm value shall be set to 25.1°C.

    • Stability Chamber – Temperature low Alarm:

    • The system should give an alarm when the temperature falls below the low-temperature alarm value.
    • It should be verified by setting Low-temperature alarm value at lower tolerance of temperature limit (-0.1°C) e.g. For 25°C chamber temperature, low-temperature alarm value shall be set to 24.9°C.

    • Stability Chamber -Humidity high Alarm:

    • The system should give an alarm when the humidity goes more than the high humidity alarm value.
    • It should be verified by high humidity alarm value at upper tolerance of humidity limit (+ 0.1 %RH) e.g. For 60%RH limit, the humidity limit shall be set to 60.1 %RH.

    • Stability Chamber -Humidity low Alarm:

    • The system should give an alarm when humidity falls below a low humidity alarm value.
    • It should be verified by setting low humidity alarm value at lower tolerance of humidity limit (-0.1 %RH)e.g. For 60.0 %RH limit, the humidity limit shall be set to 59.9 %RH.

    • Water level low Alarm in Stability Chamber:

    • The system should give an alarm when the water level becomes low.
    • It should be verified by lowering the water level.
    • Equipment door open: The system should give an alarm when the equipment door is open.
    • Main supply Power failure: The system should give an alarm for the main supply power failure.

    • Emergency Alarm in Stability Chamber:

    • Walk inside the chamber and press the emergency alarm button. alarm should blow until the emergency alarm button is released from inside.
    • This condition is applicable only for the walk-in stability chamber/oven.
    • The contract for qualification shall sign with the external party for performing the tests and it shall renew on a periodic basis.
    • Review and sign all the calibration certificates upon receipt.
    • Set the alert limit for Temperature and Humidity alarm in stability chamber/oven ±1.5°C and ±3 %RH respectively for upper and lower levels in daily monitoring.
    • However, acceptance criteria for temperature and humidity remain ± 2.0°C and ±5.0 %RH or as per respective regulatory requirements.

    • Precautions during operating Stability Chamber:

    • A continuous supply of water is necessary otherwise the boiler turns OFF  and humidity goes down.
    • Store the samples in the chamber in such a way that the humidity sensor and temperature controller sensor does not get covered by the samples.
    • Keep these sensors uncovered at all times.
    • The UPS supply to controller and DG supply to the stability chamber/oven shall always be provided.
    • Ensure placement of temperature and humidity sensors as per diagram mentioned in respective equipments SOP.
    • Alarm should be available for every stability chamber/oven in the department at commonplace (where persons are available all the time) to have immediate action.

    • Monitoring of temperature/ humidity data of Stability Chamber:

    • The analyst shall make an entry in the register for opening and closing of stability chamber/oven (Annexure-2),
    • In the case of PLC operated stability chamber/oven if the facility is available then, the same reason for opening/closing of the chamber to be mentioned in it, in such case there is no need to maintain the register.
    • Analyst shall collect the print outs daily for the temperature and humidity record with reading printed at every one-hour interval, and alarm log report.
    • The analyst shall review the data and in case of any excursions (alert level or action level) observed, correlate the time of that excursion with the times recorded in the alarm log report.
    • Identify the reason(s) for the excursion(s) i.e. whether the excursion was due to planned interruption (e.g. door open/ close) by referring the register (Annexure -2) or any other reason (e.g. compressor changeover).
    • Mark the excursion reading and mention the reasons for each excursion in the temperature/ %RH record.
    • The supervisor shall verify the report.
    • The supervisor shall review monthly data and reports to understand systemic drifts and abnormal changed in T & RH data variance.

    • While assessment of the data, Review the following points ( but not limited to) whether :

      • Excursions are occurring at a particular place/sensor.
      • Excursions are occurring during a specific time period.
      • Any particular sensor shows drift.
    • The supervisor shall write a conclusion of the assessment and corrective & preventive actions taken/ to be taken if any.
    • Head QC shall approve the assessment report.

    • Handling of excursions in Stability Chamber:

    • If temperature and humidity excursions are observed continuously from the action limits for more than 8 hours, then inform the engineer to attend the breakdown.
    • Switch on the stand-by chamber and set at required conditions. If the chamber is not repaired within 24 hours transfer the samples to the stand-by chamber.
    • Raise the “Event” for action limit excursions beyond 24 hours, investigate the failure, and assess the impact on stability studies of the products.

    • Contingency Plan for Stability Chambers:

    • Power generation systems viz. Government Power Supply, CPP or DG sets shall be available for electricity supply to the stability chamber/ovens.
    • The PLCs of the stability chamber/oven shall get electricity from the UPS to get the actual temperature and relative humidity data during a power outage.
    • The stability chamber/oven shall be provided with dual compressors and heaters, and their changeovers shall be programmed to ensure their continuous functioning and backup in case of failure.
    • Provide a standby water tank to ensure uninterrupted water supply to the boilers of the stability chamber/oven.
    • Made available stand-by chambers at the site for transferring the samples in case of chamber failure.
    • In case of extreme emergencies, associated plants nearby the Factory, Where stability chamber/oven are available shall be contacted to accommodate the stability samples.

    • Cleaning of Walk-in Stability Chamber :

    • Frequency: As and when required.
    • Clean the floor of stability chamber/ovens as and when required.
    • Mop the bottom of the Walk-in Chamber with a lint-free cloth with the help of Colin as a cleaning agent or Iso-Propyl Alcohol (If required).
    • Record each cleaning activity in Annexure – 3

(Annexure -1 – Stability Chamber)

Performance check of stability chamber/oven

Instrument Name
Instrument Code Make/Model
Location Calibration frequency Half Yearly ± 15 days
Calibration Date Next Calibration due on

 

Alarm challenge test: Quarterly±7days

  • Temperature High alarm:

    • Go to ‘Equipment settings’-> ‘Equipment master’ →, select the equipment by double click and click on edit go to ‘ Equipment parameters’ and change the ‘ Upper limit’ of temperature.
    • Set the ‘Upper limit’ of the temperature to (set value – 0.1)°C e.g If the set value is 40 °C then the ‘Upper limit’ should be set to 39.9°C.
    • Observe if the ‘ Temperature High alarm’ rings.
    • Note the observation in the observation table. Acknowledge the alarm and put the remarks “Temp High alarm test”.

  • Temperature Low alarm:

    • Go to ‘Equipment settings’-> ‘Equipment master’ →, select the equipment by double click and click on edit go to ‘ Equipment parameters’ and change the ‘ Low limit’ of the temperature.
    • Set the ‘Upper limit’ of the temperature to (set value + 0.1)°C e.g If the set value is 30 °C then the ‘Upper limit’ should be set to 30.1°C.
    • Observe if the ‘ Temperature Low alarm’ rings.
    • Note the observation in the observation table. Acknowledge the alarm and put the remarks “Temp Low alarm test”.

  • Humidity High alarm:

    • Go to ‘Equipment settings’-> ‘Equipment master’ →, select the equipment by double click and click on edit go to ‘ Equipment parameters’ and change the ‘ Upper limit’ of Humidity.
    • Set the ‘Upper limit’ of the humidity (set value – 0.1) % RH e.g If the set value is 75 % RH then the ‘Upper limit’ should be set to 74.9 °C.
    • Observe if the Humidity High alarm rings.
    • Note the observation in the observation table. Acknowledge the alarm and put the remarks: “Humidity high alarm test”.

  • Humidity Low alarm:

    • Go to ‘Equipment settings’-> ‘Equipment master’ →, select the equipment by double click and click on edit go to ‘ Equipment parameters’ and change the ‘ Lower limit’ of Humidity.
    • Set the ‘Upper limit’ of the humidity to (set value + 0.1) % RH e.g If the set value is 75 % RH then the ‘Lower limit’ should be set to 75.1 °C.
    • Observe if the Humidity Low alarm rings.
    • Note the observation in the observation table. Acknowledge the alarm and put the remarks “Humidity low alarm test”.

  • Water level low alarm:

    • Cut off the water supply to the utility box located at the rear of the chamber.
    • Drain the water in the water storage tank using a pipe.
    • Observe if the Water level Low alarm rings.
    • Note the observation in the observation table. Acknowledge the alarm and put the remarks “ Water level low alarm test”.

  • Equipment door open alarm:

    • Open the door of the Stability chamber and observe if the ‘Door open alarm’ rings.
    • Note the observation in the observation table. Acknowledge the alarm and put the remarks “ Door open alarm test”.
  • Mains supply power failure alarm:
    • Cut off the power supply to the Humidity chamber from the MCB switch located at the rear of the chamber.
    • Observe if the mains fail alarm rings.
    • Note the observation in the observation table. Acknowledge the alarm and put the remarks “Mains fail alarm test”.
  • Emergency Alarm:
    • Walk inside the humidity chamber and push the red emergency alarm located at the top right-hand corner of the humidity chamber.
    • Observe if the alarm rings until the alarm – switched off using the same red button.
    • Note the observation in the observation table.

Remark: This alarm test is applicable only for the Walk-in humidity chamber.

  • Observation Table :

Sr. No. Alarm Test Specification Observation Remarks
1. Temperature High Alarm An alarm should sound when the set temperature crosses the upper limit of temperature.
2 Temperature Low Alarm An alarm should sound when the set temperature crosses the lower limit of temperature.
3 Humidity High Alarm An alarm should sound when the set humidity crosses the upper limit of humidity.

 

4 Humidity Low Alarm An alarm should sound when the set humidity crosses the lower limit of humidity.
5 Water level low Alarm An alarm should sound when the water tank is empty.
6 Equipment door open alarm An alarm should sound when the door of the chamber in an open condition.
7 Mains supply power failure alarm An alarm should sound when there is a mains power supply failure.
 

8

 Emergency alarm An alarm should sound when the emergency alarm is pressed from inside the chamber and which can stop only from inside the chamber.

Remarks: The equipment is qualified / not qualified for use.

(Annexure -2 – Stability Chamber)

Register for opening and closing of Stability Chamber

Stability chamber ID :_____________

Temperature/Humidity conditions :___________

Location:__________

Sr. No. Date Time of opening Time of closing Total time duration Purpose Opened and Closed By Remarks

 

(Annexure -3 – Stability Chamber)

Cleaning Logbook of Stability Chamber

Stability chamber ID :_____________

 Location:__________

Sr. No. Date Time Cleaned By Checked By
  From       To
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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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