Photstability Chamber Operation, Calibration and Maintenance

1.0 OBJECTIVE

To lay down the procedure for Operation, Calibration and Maintenance of Photostability Chamber. 

2.0 SCOPE

This SOP procedure is applicable Operation, Calibration and Maintenance of   Photostability Chamber in company Name

3.0 BACKGROUND

NIL

4.0 RESPONSIBILITY

4.1 All Analytical Research personnel to follow the SOP.

4.2 Group Leader Analytical Research to ensure proper and safe operation of equipment.

4.3 Head Analytical Research or his designee to ensure overall compliance.

5.0 PROCEDURE

5.1 Safety Instructions

5.1.1 This is not an explosion resistant chamber. Do not place test articles that may release explosive or flammable vapors in the chamber.

5.1.2 Do not place the unit near combustible materials or hazardous fumes or vapors.

5.1.3 Do not place the unit in a corrosive environment, corrosive environment may lead to poor performance and deterioration of unit.

5.2 Cleaning of Photostability chamber

5.2.1 Turn Off the main power supply to equipment.

5.2.2 Remove the trays and clean it with the help of cloth soaked in water and soap solution.

5.2.3 Clean the walls of the equipment with dried cloth.

5.3 Operating procedure             

5.3.1 ALARMS

Alarms are generated for deviation in temperature, relative humidity, utility failure or system problem. These alarms are generated to attract attention of operators. ALARM SILENCE SWITCH: An audio hooter is activated with the alarm. The alarm message is displayed on the screen. The audible alarm can be silenced by touching ACK button on the screen (HMI) .The alarm silence circuitry will automatically reset when the out of limit condition returns to normal. 

Following is the list of alarms generated and its description

ALARM	DESCRIPTION
Door open Alarm	Door of chamber open alarm (more than 5 minutes)
High Temperature Alarm	Temperature of controller or scanner above high temperature limit (more than 10 minutes)
Low Temperature Alarm	Temperature of controller or sensor below low temperature limit (more than 10 minutes)
HT Alarm	High thermostat alarm for cutting of heater( above 30°C)
LT Alarm	Low thermostat alarm for cutting of cooling system( below 15 °C)

5.3.2 Procedure for operating software

5.3.2.1 Before starting configuration of equipment, equipment and PC shall be networked  or Ethernet LAN

5.3.2.2 After switch on the system, software shall open automatically. Click on login button, a login window will open, the user has to login individually with Login Name and Password.

5.3.2.3 Equipment setting

5.3.2.3.1  Click on Equipment setting on the menu bar, it displays Equipment master, Equipment status, Mobile No. details, Synchronize Date and Time, Reset Lux and UV, component running hours, Header and Footer master. Click on Equipment  Master, It consist of list equipments which are connected to the software. It consists of different options like Browse Equipments, Equipment details and Equipment parameters. Click on Browse Equipment and select equipment PE027  (Double click)Click on Equipment details, the window displays Equipment name, IP  address , log rate and  On Line status.

5.3.2.3.2 IP Address: Displays unique TCP/IP address for communication.

5.3.2.3.3 Log Rate: This option displays the recording / logging interval for temperature, Lux values and UV values (Minimum 5 min)  . Note: User has to change the log rate (if required). Press edit to change any   displayed values and press save.( only admin level user can Edit the  parameters)

5.3.2.4  Equipment parameters

5.3.2.4.1 Click on equipment parameters, the option helps to view the below parameters.

5.3.2.4.2 Set value for Temperature: This field allows creating the set valve (25°C) for temperature (10°C - 40°C).

5.3.2.4.3 Lower Limit: User has to assign the lower (alarm) limit (23°C).

5.3.2.4.4 Upper Limit: User has to assign the upper (alarm) limit (27°C).

5.3.2.4.5 Set Lux Value: 1200 k Lux hours (as per ICH Guidelines).

5.3.2.4.6 Set Measured Lux value: User has to assign measured intensity in K lux hours.

5.3.2.4.7 Set UV value: 200 watt hours / Sq.m (as per ICH Guidelines).

5.3.2.4.8 Set Measured UV value: User has to assign measured intensity in watt hours/Sq.m.

NOTE: Only admin level user can Edit and Save set Measured Lux and UV values.

NOTE: Accuracy control parameters PID KP, PID TL, PID TD , PID TS ,PID cycle time are factory set. Default value will be shown. Do not modify or change those  values. Changing of these values to be done after consulting with technical support team of  Newtronic Equipment Company (P) Ltd.

5.3.2.5 Equipment Status

Equipment Status option displays equipment is active or inactive (admin level user  can activate or deactivate the connection of equipment to the software).

5.3.2.6 Mobile Number Details

By enabling this option mobile numbers of concern person to whom the software will send alarm SMS in case of out of limit in temperature. In this form maximum 6  persons can be listed. PLC which will transmit alarms to defined numbers in the  event of PC communication failure.(Note: only admin level user can perform this  action)

5.3.2.7 Synchronize date and time

This option will synchronize the real time clock of the equipment with system clock. (Note: only admin level user can perform this action)

5.3.2.8 Reset LUX and UV

Click on Re set Lux and UV (user has to reset Lux for one time and reset UV twice) and enter respective comments and password.

5.3.3  Measurement of Lux values and UV values using Lux meter and UV meter.

5.3.3.1 According to ICH (Q1B) guideline for confirmatory studies, samples should be exposed to light providing an overall illumination of not less than1.2 million Lux hours and an  integrated near ultraviolet energy not less than 200 watt  hours/square meter.

5.3.3.2 Calibrated Lux meter needs to be used for monitoring overall illumination of visible light in photostability chamber.

5.3.3.3 Power on LUX meter by sliding the power on switch and select 50000(x100) LUX.

5.3.3.4 Keep the light sensor at the floor of work place, a minimum of five readings are to be taken to measure the Lux  level in  photostability chamber at four corners and one at the center of the chamber.

5.3.3.5 Average out the readings to arrive at the final value (in kilo Lux).

5.3.4  Calculation for visible light

Measured Lux =A Lux

For Lux   required exposure time= C hours

C=1200 kilo lux hours / A Lux

For example:      

136x100

118x100

94x100

107x100

175x100 (readings at 5 different places)

Average value: 12600 Lux (12.6 kilo lux), measured value.

Calculation: 1200/12.6 = 95.2 hours (exposure time for visible light).

5.3.5 Calibrated UV meter needs to be used for monitoring intensity of ultraviolet light. Power on the UV meter by pressing the power switch, and select 19.99mW /sq.cm  

to measure the intensity of UV  light in photostability chamber. Keep the light sensor  at the floor of work place, a minimum of 5 readings are to be taken to measure the intensity of UV light in photostability chamber, at 4 corners and 1 at center of the chamber, average out  the readings to arrive at the final value.(in W / sq.m).

5.3.6 Calculation of UV Light:

Measured UV = B watts / sq.m

For UV required exposure time = D hours

D = 200 watt hours / sq.m / B watt hours / sq.m

For example: 

0.49

0.60

0.41

0.41

0.90 (readings at 5 different places)

Average value: 0.52 milli watts/sq.cm (5.2 watts/sq.m), measured value.

Calculation: 200/5.2=38.5 hours (exposure time for UV light).

5.3.7 After calculation of measured values for UV and Lux, user has to ensure the set temperature has attained (Real Time Summary) and keep the sample for study in   chamber. Close the doors of the chambers properly and click on” Equipment settings” Enter the Set Measured Lux and St Measured UV intensities in Equipment parameters  

and then click on Reset Lux and UV.( reset Lux for one time and reset UV for twice)each time user has to enter respective comments and password. Now the cycle starts and the values are recorded at fixed log intervals.

Note: Once the light (Lux) cycle is over, tube lights will be switched off and when UV exposure is over UV lights will be switched off. To switch on lights again for next cycle test user has to reset Lux and UV using software.

5.3.8 Analysis Report

5.3.8.1 Click on “Analysis Reports” and click on “Equipment Data Log”

5.3.8.2 Select Equipment PE027, date and time to get the data of Temperature, Lux and UV and click on “search” button.

5.3.8.3 To get a tabular representation, click on report. The report will be generated based on the above data. In the report, out of limit values will be displayed in Bold and to print the report, click on “print” button.

5.3.8.4 For exporting data in other format, e.g, Acrobat, click on “Export” button, select the  path and type File name to export the displayed data.

5.3.8.5 To get a graphical representation, click on “Graph” icon. Select the option of 2D line graph or 2D bar graph. Three straight lines, one each of set value, upper limit and  lower limit shall be displayed on the graph along with the graphical display of actual acquired values.

5.3.9 History Report

This field allows taking history report of Master (Equipment Master, Mobile Detail Master, User Master, Header Footer Master) Equipment Data Log, Alarm Log and Audit trails (Equipment Audit Trails, Alarm Audit Trials, SMS Transmission Trial, User Audit Trial).

5.3.10 Mobile Detail Master

5.3.10.1 By enabling this option mobile numbers of concern person to whom the software will send alarm SMS in case of out of limit in temperature or humidity. In this form maximum 6 persons can be listed. PLC which will transmit alarms to defined  numbers in the event of PC communication failure.

5.3.11 User Master

5.3.11.1 It Consist of Browser user (consisting of User name, Login name of all personal Using Equipment ID) and User Details (Consisting of User Name, Login Name, Status, Password Change Duration etc.)

5.3.12 Alarm Log

5.3.12.1 Select the Equipment Name (Instrument ID) Date and Time for which alarm log is to be viewed and click on the search button to get details. To get print click on report option followed by print option. 

5.3.13 Equipment audit Trail

5.3.13.1 Select the Equipment ID, User name, Date and Time for which audit trail is to be viewed and click on the search button to get audit trails details. To get print click on report option followed by print option.

5.3.14 Alarm Audit Trail

5.3.14.1 Select the Equipment ID, User name, Date and Time for which audit trail is to be viewed and click on the search button to get audit trails details. It consists of Alarm Ack Date, Ack Time and comments, to get print click on report option followed by print option.

5.3.15  User audit Trail

5.3.15.1 In search filter option, select the User, Date and Time for which the data has to be viewed and click on the search button. It will display the audit Trail details. To get  print click on report option followed by print option.

5.3.16 Real Time Display and Real Time Summary to check the status of the controlled parameters in the chamber in a graphical representation click on Real time display. To check the status of the controlled parameters in the chamber in a tabular form, click on” Real Time Summary”

5.3.17 Inputs and Outputs

By clicking on “inputs and outputs” button it shall show online status of the Device utilities and the subsystems of the equipment with digital input, digital output and analog inputs to the system.

5.3.18 Alarm Log of the Photostability Chamber

5.3.18.1 During taking print outs of the chamber data when temperature chamber found out of  the limits, click on  “Alarm log”.

5.3.18.2 In this window the user shall view list of Equipments connected to the software. Select equipment name PE027, date, time and click on the search icon. User can view the list of alarms and status of the alarm.

5.3.18.3 “Alarm Log” icon is continuously blinking indicating Unacknowledgement of alarms.

5.3.18.4 After reviewing the alarm log intimate the group leader or head of department and service engineer for corrective action (if required). Take report of the alarms by clicking on the “Report” icon and attach to the data report in case of temperature readings found out of limits and comment on it.

5.3.19  Alarm Acknowledge

5.3.19.1 To acknowledge the alarm, double click on the status of alarm (Not ACK) .Click on Acknowledge button, the software shall ask for conformation, after clicking “Conformation” enter comments in comment box. Once the alarm is acknowledged it will not be displayed in the alarm log.

5.3.19.2 Whenever, for any equipment alarm is logged, acknowledge the alarm.

5.3.20  Review of print outs

5.3.20.1Group leader shall review the print outs of photostability chamber including alarm log. He shall prepare a report on the nature as well as duration of deviations, if any and submit the same to Head Analytical Research or his designee for appropriate  action.

5.3.21 Investigation of Abnormal Events

5.3.21.1 Incase any outage is recorded, review the same for the duration of the outage due to power failure or is generated by the software.

5.3.21.2 If the total duration of the outages recorded on a single day is more than 4 hours report the same to engineering department through “Reporting, Investigating and Disposing of Incidents and Deviations.

5.3.22 Monitoring of Photostability chamber Monitoring photostability chambers shall be done after completion of each cycle.

5.4 Enter details of photostability chamber usage in “Usage Log Book of photostability Chamber.” (Annexure-1).

5.5 Performance Verification of Photostablity chamber

Performance verification shall be performed with the help of external agency.

5.5.1 Performance verification of Temperature:

5.5.2 Distribute temperature sensors in chamber at four corners and load the chamber with dummy loads(approximately 70% of its capacity),set the recording interval as 10 min in data logger. Close and lock the door of equipment, allow the equipment to attain the required temperature, now start recording the temperature, run the equipment for minimum of 24 hours.

Frequency: Yearly once or after every major maintenance job.

Acceptance criteria: Temperature shown by the chamber sensors and data loggers shall not differ by 25±2°C.

5.5.3 Performance verification of Lux and UV exposure testing:

Measure the light and UV exposure using calibrated Lux and UV meter at 25 °C.Set the desired Lux and UV exposure as 1200 kilo Lux hours and 200 watt hour/sq

meter. Set the Measured Lux and UV values as per point 5.3.4 to 5.3.6 and Reset the values of timers and run the equipment till all the lights get off and exposure to 

complete.                

Acceptance criteria: The exposure should not be less than desired exposure.

5.6 Maintenance

Periodic maintenance of equipment is essential. Maintenance shall be done by Service Engineer (or) External Vendor.

6.0  VERSION HISTORY

7.0 ANNEXURES

Annexure-1 Usage Logbook of Photostability Chamber

Annexure-2 Calibration for Lux and UV Exposure Testing