To lay down procedure for operation and cleaning of stability chambers.
This SOP is applicable for operation and cleaning of stability chamber used in Quality Control Laboratory at Sano-Cito Therapeutics, Vill. Loharan, P.O. Ghatti, Solan (H.P.)
Officers / Executive – Quality Control shall be responsible for follow that procedure.
Manager-Quality Control and Head QA Shall be accountable for compliance of this SOP.
Temperature Monitoring Record (Accelerated Chamber) – Attachment -I
Temperature Monitoring Record (Long Term Chamber) – Attachment -II
6.1.1 Ensure that the instrument is visibly clean.
6.1.2 Switch ON the mains switch on the control panel
Display on PLC Schneidor Zelio.
Display on Temperature Controller.
Display on Humidity Controller.
Display on Safety Controller.
Display on the Printer / PC Interface Unit.
6.1.3 All the above should be ON when the main switch is ON. Switch on the chamber through PLC.
6.1.4 PLC, Programmable Logic controller is provided on front panel of chamber, to start the chamber one has to switch ON the mains. Whenever alarm will occurred PLC display will show respective alarm text otherwise it will show status of running systems, when alarm will occurred one has to press Z3 to stop buzzer & Z4 to reset alarm text.
6.2.1 Temperature Set: The controller will control temperature at this value (°C).
6.2.2 Low Temperature alarm value: The controller will generate a low temperature alarm if the measured value is lower than Low Alarm value (°C).
6.2.3 High Temperature alarm value, the controller will generate a high temperature alarm if the measured value is more than high alarm value (°C).
6.2.4 For temperature alarm a 10 minutes delay is introduced, the alarm will be generated only if the measured value remains out of range for more than 10 minutes. By acknowledging the alarm audio hooter will be OFF.
6.3.1 Set Control humidity. The controller will control humidity at this value (%RH).
6.3.2 Low Alarm: Low humidity alarm value. The controller will generate a low humidity alarm if the sensor value is lower than Alarm than low alarm value(%RH).
6.3.3 High Alarm: High humidity alarm value. The controller will generate a high humidity alarm if the sensor value is more than Low Alarm value (%RH).
Alarm: Following Alarm will be generated during excursion.
|TEMP LOW ALARM||A low temperature Alarm will be generated if the measured (PV) temperature remains lower than the set low limit for more than 10 minutes.|
|TEMP HIGH ALARM||A high temperature Alarm will be generated if the measured (PV) temperature remains higher than the set high limit for more than 10 minutes.|
|TEMP WITH IN RANGE||If the measured (PV) temperature comes within the set limits (Low/High) the temp within range alarm will generate.|
|RH LOW ALARM||A low humidity alarm will generate if the measured (PV) Humidity remains lower than the set low limit for more than 10 minutes.|
|RH HIGH ALARM||A high humidity alarm will generate if the measured (PV) humidity remains higher than the set high limit for more than 10 minutes.|
|RH WITH IN RANGE||If the measured (PV) humidity comes within the set limits (Low/High) the RH within range alarm will generate|
|DOOR OPEN||The audible Door Open alarm is generated if generate if the chamber door remains opened.|
|DOOR CLOSE||The Door close alarm is generated if the chamber is closed after the door is opened.|
|MAIN FAIL||The mains fail alarm is generating if the mains supply to the chamber is fail.|
|MAIN RESUME||The mains resume alarm is generated if the mains supply to the chamber is restored after mains fail.|
|WATER LEVEL||The water level alarm is generated if the water level in the humidifier tank or storage tank is low.|
|WATER LEVEL OK||The water level OK alarm is generated if the water level in the humidifier tank or storage tank is ok after water level fails.|
|HUMIDIFIER HEATER CIRCUIT||The humidifier heater circuit fail alarm is generated if the feedback to the PLC form the Humidifier Heater safety relay fails.|
|HUMIDIFIER HEATER CHANGEOVER||The humidifier heater changeover Alarm is generated if the current humidifier heater system switches to the standby humidifier heating system and vice-versa.|
|DRY HEATER CIRCUIT FAIL||The dry heater circuit fail alarm is generated if the feedback to the PLC form the Dry heater safety relay fails.|
6.3.4 The temperature and humidity data shall be within the specified limit (Temperature ± 2°C and Humidity ± 5% RH) of set storage condition of each stability chamber. The details are as follow,
|Sr. No.||Storage Condition|
|01||40±2°C /75±5% RH|
|02||30±2°C /75±5% RH|
6.3.5 The temperature and humidity data of each chamber shall be verified, short term spikes due to opening of doors of the storage facility are accepted as unavoidable, if any excursion observed then the impact of excursion shall be assessed by officer/Executive-stability section.
6.3.6 Temperature / Humidity excursion of more than two hours from any stability chamber shall be notified from alarm in stability chamber. The Executive/ Manager- Stability section shall monitor the excursion and ensure that the present limits are restored.
6.3.7 Continues temperature / Humidity excursion of more than 8 hours from any stability section shall be notified from alarm log report and inform to engineering department.
6.3.8 The officer/Executive/Manager- Stability section shall initiate the corrective action by assessing the impact, If the chamber problem is not rectified within 24 hours, then the samples shall be shifted to controlled room temperature and room shall be monitored.
6.4 ALARM MONITORING AND NOTIFICATION:
6.4.1 during day time, working hours, QC personnel shall monitor alarm message and notify to stability section Head, Head-QA and Head Engineering, in case alarm is continuous.
6.4.2 Daily monitor the chamber twice in a day by stability section personnel.
6.4.3 Whenever alarm is generated the indicator light for respective chamber is also illuminated with audio hooter.
6.5 STARTING THE CHAMBER WITH REGULAR SYSTEMS:
6.5.1 If both the water levels or at least first or second water level is present and the door is closed, and the contacts of Safety Controller, Safety thermostat are closed and Mains Power is present PLC should switch ON the Main Contactor, and the regular systems. The default cooling system as per programming will turn ON after 2 minutes of main contactor ON.
6.5.2 When main switch is ON the PLC should switch ON the Mains contactor, Air Heaters should turn ON and work as per Logic recd from Temperature controller and Humidity system 1 should turn ON as by default Humidity system 1 should turn ON if both the water levels are present. The Main Condensing Unit should turn ON after 2 minutes from Main contactor ON.
6.5.3 The PLC Display should show a text
MAIN CONTACTOR ON
COOLING SYS 1 ON
HUMIDITY SYS 1 ON
6.6 SET TEMPERATURE ON TEMPERATURE CONTROLLER:
Now set the required temperature on the temperature controller by pressing the increment and decrement key, which will display the set point. Now the bottom display will show the set temperature and the top display will show the actual temperature.
6.7 SET HUMIDITY ON HUMIDITY CONTROLLER:
Now set the required humidity on the humidity controller by pressing the increment and decrement key, which will display the set point. Now the bottom display will show the set humidity and the top display will show the actual humidity. (For more details please refer the operating manual of the controller.)
6.8 SET SAFETY CONTROLLER:
The Safety Controller is provided with fixed lower & upper threshold temperature & adjustable primary band setting for temperature & Humidity. The user can enter the programming mode by using the ‘SEL’ key.
6.9 THERMO DATA MANAGEMENT SYSTEM SOFTWARE (STABILITY v7.4T):
6.9.1 Click on stability v7.4 T icon then enter the user name, password and user type and enter.
6.9.2 Click on report icon and select the chamber number which is required then click on envirowise and select the date and time and click on show reports.
6.9.3 Open the report then click on exit and select yes symbol, after that all report shows and select the print take out the print.
6.9.4 For printing click on the report select the chamber number which is required then click on enviroalarm and select the date and time and click on show reports which taken the print select the date and time click on the reports.
6.9.5 Open the report then click on exit and select yes symbol, after that all report shows and select the print and take out the print.
6.9.6 Sample has to stay in the confirmed area of tray.
6.9.7 Free space on the side of the trays should not be blocked by the sample.
6.9.8 Air circulation holes at the top and bottom side of the chamber should not be blocked.
6.9.9 Sensor should not be covered with sample.
6.9.10Daily Print of temperature and humidity record of stability chambers.
6.9.11Monthly print of Mean Kinetic Temperature (MKT) of all chambers of stability chambers.
6.10 LOADING SAMPLES IN TO CHAMBER:
6.10.1 Affix the appropriate color label on each sample before charging in various stability chambers. The color of labels for various storage conditions are as follows:
|30 ± 2° C/ 75 ± 5% RH||Green|
|40 ± 2° C/ 75 ± 5% RH||Red|
|30 ± 2° C/ 75 ± 5% RH||Orange|
|30 ± 2° C/ 75 ± 5% RH||Pink|
6.10.2 Charge the stability sample at stability condition as per respective protocol and make the necessary entries in stability sample “date in register and maintained the same entries in computer Master Grid program for monthly sample plan.
6.10.3 Assign the Date in to samples while charging in chamber and record the same in stability sample “date in register”.
6.10.4 Unlock the door and locate the place where the sample has to be place.
6.10.5 Open the inner door and load the sample.
6.10.6 While loading, the sample following care has to be taken.
6.10.7 Sample has to stay in the confirmed area of tray.
6.10.8 Free space on the side of the tray should not be blocked by the sample.
6.10.9 Air circulation holes at the top and bottom back side of the chamber should not be blocked.
6.10.10 Sensor should not be covered with samples
6.10.11 Now close the inner glass door properly and close the door latch.
6.10.12 Now close the outer door, lock it.
6.10.13 Withdrawn the quantity of sample from stability chamber as mentioned in stability protocol or each time station.
6.10.14 Withdrawn sample from all storage condition as per monthly sample plan.
6.10.15 Record the inward and outward details as per annexure-I.
6.11.1 Daily clean outer surface body with lint free cloth.
6.11.2 Daily clean outer surface body with lint free cloth.
6.11.3 Internal surface to be cleaned with lint free cloth on weekly or before as per requirement.
6.12 SAFETY PRECAUTION:
6.12.1 Do not leave the door open.
6.12.2 Inform the service engineer / Engineering department whenever the equipment do not achive the set temperature.
6.12.3 Do not place anything on the top of equipment or do not stand on the top of the equipment.
SOP: Standard Operating Procedure
Psi: Pound per square inch
9.0 DISTRIBUTION LIST:
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION:
|Version Number||Effective date||Reason for Revision|