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Standard Operating Procedure (SOP) for Management of Walk in and stand-alone Stability Chamber used for Stability Study and also to determine the self life of the drug product.

Stability Chamber / Incubators Management

1.0   Objective :

• • To lay down a procedure for Management of Walk in and stand-alone Stability Chamber.

2.0   Scope :

• • This SOP is applicable for Management of Walk in and stand-alone Stability Chamber.  

3.0   Responsibility – Stability Chamber Management:

• • QA Chemist / Officer: Follow the procedure and maintain record as applicable.

• • Security personnel: Attend the alarm during off hours and holidays and inform to Stability section In charge, Head of Engineering department and Head of Quality Assurance Department

• • Engineering department: Maintenance of alarm system.

4.0   Procedure for Handling of Stability Chamber:

• • Operating Procedure for Walk-in Stability Chamber:

• • Put ON the mains of the control panel and display of HMI should be as shown below

• • For Login to click on Login/Logoff button, User shall enter user name and password and click login

• • Admin has only right to create new user as per requirement.

• • There shall be more than one Admin for one system.

• • Administrator password shall be written and enclosed in a sealed envelope in custody of Head QA.

• • Press stop button to shutdown the chamber.

• • To press View below screen will display.

• • Current valve of all the temperature sensor and humidity sensor is display.

• • Value with red background indicates out of limit from upper limit and value with blue background indicates out of range from lower limit.

• • If the sensor open the instead of reading the text OPEN will be displayed.

Related : Stability Study as per ICH Guideline

• • For further checking of GSM, Door, Audit, Event logged press on individual icon.

• • On pressing Main menu below screen will display.

• • Main menu screen allow user to enter into different page to view different parameter in HMI.

• • User only view and review the parameter only.

• • Admin set the parameter as per requirement.

• • To check the status of chamber press on Status and below screen will display

• • For door access press on door access and after entering the password will open.

• • Form view the alarm detail press on Alarm and after entering the password detail of alarm logged displayed.

• • For view the any single process password is required.

• • Operating Procedure for standalone stability chamber:

• • Check the following before switching ON the chamber.

• • Availability of water in boiler heater.

• • Check the continuous supply of water.

• • Put ON the mains of the control panel.

• • Temperature Controller, Humidity Controller, Safety Controller, Scanner will show the status ON.

• • Put on the main switch on the control panel.

• • Display will show Set point and process value of the Controlling sensor at Top of the Screen.

• • SYS indicates which refrigeration system is running.

• • HUMID SYS indicates which humidity system is running.

• • Chamber indicates chamber status with countdown time e.g. Off mode, Running mode, stabilization etc.

• • SENSOR indicates which temperature sensor is in control MAIN or Standby.

• • HUMID sensor indicates which humidity sensor is in control MAIN or Standby.

• • Strip just below the sensor shows active alarm status if the strip is red it indicates that alarm is active if the strip is is yellow it indicates alarm is accepted.

• • Monitoring of Temperature & Relative Humidity Data and Alarm and excursion History

• • Login by user name and password

• • Select the menu option.

• • Go to the offline print option.

• • Enter password.

• • Enter the start print date, start print time and end print date, end print time.

• • Select print interval of 60 minutes and press set option.

• • Proceed for the printout by selecting print command.

• • Take print out for temperature and Relative Humidity of stability chamber on daily basis and maintain the online record.

• • Put on the main switch on the control panel.

• • On PLC Zelio should show as drawn below i.e. the PLC display should show current date, month and time.

• • Display on Temperature controller, humidity controller, safety controller and the PC/Printer interface unit.

• • All the above should be on when the main switch is on.

• • Switch ON the Chamber through the PLC.

• • Four keys are provide i.e. Z1, Z12 Z3 and Z4 (Z1 is to start the chamber, Z2 is to emergency stop, Z3 is to mute the Buzzer, Z4 is to reset any alarm text).

• • Press the Z1 key PLC should show Blower On, Main contractor On, Cooling system 1 on And humidity system 1 on.(main menu/Ok should not touch as it may change the programme parameter)

• • Temperature and humidity shall be set by pressing increment and decrement key provided.

• • Safety controller is provided with fixed lower and upper threshold temperature and adjustable primary band setting for temperature and humidity the user can enter the programming mode by using the ‘SEL’ key.

• • The safety controller shall cut off the mains contactor in case of 2°C overshoot / undershoot of temperature when alarm band is set at 2°C.

• • The cut-off shall give audio alarm.

• • The safety controller shall cut off the mains contactor in case of 5% RH overshoot of humidity when alarm band is set at 5% RH.

• • The cut-off must give audio alarm.

• • The temperature and humidity must stabilize within 20 minutes

• • Monitoring of Temperature & Humidity Data:(By direct printing)

• • Direct print outs can be taken by connecting the printer.

• • Print of every one hour shall be taken.

• • Print out shall be taken daily and record shall be maintained.

• • Review of Alarm and excursion History or Audit Trail:

• • All alarm acknowledged by the security personnel shall be reviewed.

• • Review the print outs taken on daily basis and address the excursion by putting remark with sign and date.

• • All alarm logged during running condition shall be reviewed by user

• • If any excursion of more than 24 hours observed shall be address through QMS system.

• Re-validation of walk-in and stand-alone stability chamber:

  • Re–validation:

• • Calibration and revalidation of stability chambers are carried out for set temperature and humidity for their performance at a frequency of once in every year by Authorized External Agencies.

• • The calibration and revalidation shall be carried by means of external data logger with calibrated temperature and humidity sensors.

• • Frequency: Yearly ± 1month

• • Use and Cleaning( walk-in stability chamber):

• • The stability chambers shall be maintained in a clean room free from any environmental contamination.

• • At the time of charging and withdrawal of sample from walk in stability chamber person wear the Shoe cover, Cap before entering in the chamber.

• • Clean the Inner floor, Side well, empty space, rack and outer surface with dry non shedding cloth. And also keep the surrounding area clean.

• • Enter the cleaning details as Annexure-II.

• • Cleaning frequency: Weakly and After Preventive Maintenance.

• • Maintenance of Stability Chamber:

• • Planned preventive maintenance of stability chamber shall be carried out by Approved External agency as per AMC.

• • Frequency: Six monthly ±15 days

• • Handling of Alarm system in Stability Chamber:

• • If set temperature / relative humidity go out of limit, an audible alarm blow, which is available at security gate and stability room, the available staff shall attend the alarm, if required switch on the stand by control panel and monitor the temperature / relative humidity till to maintain the required temperature / relative humidity.

• • However during off hours and holidays, it shall be the responsibility of security personnel to attend the alarm and he shall inform to Stability section In-charge, Head of Engineering department and Head of Quality Assurance.

• • Security personnel shall enter the type of alarm i.e. either UPS failure alarm or alarm due to temperature/ relative humidity go out of limit in Annexure- III

• • Engineering personnel shall rectify the problem and if required switch on the stand by control panel and monitor the temperature / relative humidity till to maintain the required temperature / Relative humidity 

• • Short term spikes due to opening of doors of the chamber are accepted as unavoidable.

• • If any discrepancy is more than 24 hours then Stability section In-charge shall initiate the incident report and inform to Engineering department for rectifying the cause and maintenance.

• • The effect of excursion due to equipment failure shall be assessed.

• • Set the temperature and humidity of Back Up stability chamber at desired requirements and transfer all stability samples.

• • Verification of Alarm System in Stability Chamber:

• • The alarm system of stability chamber shall be verified as per annexure IV

• • Simulate the following conditions and create the alarm.

• • Increase the set Temperature displayed by 2.1°C than the actual Temperature displayed.

• • Decrease the set Temperature displayed by 2.1°C than the actual Temperature displayed.

• • Increase the set Humidity displayed by 5.1 % than the actual Humidity

• • Observe the audio produced at the security gate.

• • Acknowledge the alarm system.

• • Record the observations.

• • Acceptance Criteria:

• • Audio alarm should be generated when the actual Temperature/RH deviates from set Temperature/RH and on acknowledge the alarm, audio and shall goes off.

• • Frequency of verification of alarm system:

• • Service engineering shall verify the alarm system during his preventive maintenance visit and enter the details in Annexure-IV

• • Frequency: 6months ± 15 days

Annexure(S)

Annexure I: Temperature and RH Excursion  log

Annexure II: Cleaning record of walk in stability chambers.

Annexure III: Stability Chamber alarm system log

Annexure IV: Stability chamber alarm system verification

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