Cooling Chamber Operation, Calibration and Maintenance procedure

1.0 OBJECTIVE 

To lay down the procedure for Operation, Calibration and Maintenance of Cooling Chamber, Make: Newtronic, Model No: NLCC16SI, Serial No: CC/14-072U

2.0 SCOPE

This SOP is applicable for Operation, Calibration and Maintenance of Cooling 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 departments to ensure proper and safe operation of the equipment.

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

5.0 PROCEDURE

5.1 Safety Instructions

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

5.1.2 Do not install unit in a corrosive environment, a corrosive environment may lead to poor performance and deterioration of unit.

5.2 Cleaning of cooling chamber

5.2.1 Periodic maintenance of equipment is essential.

5.2.2 Turn OFF the main power supply to equipment.

5.2.3 Remove the trays and clean with the help of cloth soaked in water and soap solution. Finally clean the walls and trays with RO water and then wipe the walls of the equipment with dried cloth.

5.3 Operating Procedure

5.3.1 Turn ON the main power supply and switch on mains switch provided at back side top.

5.3.2 ICDAS VER 1.2 SOFTWARE 

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

5.3.2.2 After switching 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 Main menu bar shows File, Equipment settings, Analysis Reports, History Report and Help.

5.3.2.4 Click on File it shows Change password and Log out.

5.3.3 Equipment setting

Click on Equipment setting on the menu bar, it displays Equipment master, Equipment status, Header and Footer master. 

5.3.3.1 Click on Equipment Master, it shows the list of equipments which are connected to  the software. It consists of different options like Browse Equipment, Equipment Details and Equipment Parameters. In Browse Equipment, select Equipment Name PE028 (Double click), then it goes to Equipment Details, the window displays    Display Name, IP address, Log Rate , Code , Type, No of Parameters , No of Sensors and On Line status.

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

5.3.3.1.2 Log Rate: This option displays the recording / logging interval for temperature and   Humidity. (Minimum 5 minutes).

Note: User has to change the log rate , if required.( with the approval of departmentHead). 

5.3.3.1.3 Equipment parameters

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

5.3.3.1.5 Set value for Temperature: 

This field allows to create the set valve ( 5 °C). 

5.3.3.1.6 Lower Limit : User has to assign the lower (alarm) limit (3°C).

5.3.3.1.7 Upper Limit : User has to assign the upper (alarm) limit ( 8°C).

NOTE: Accuracy control parameters PID KP, PID TI, PID TD, PID TS, PID cycle time Cooling (ON) 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.

5.3.3.2 Equipment Status

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

5.3.3.3 Header and Footer Details

5.3.3.3.1 Used to create Header and footer for Report formats. 

5.3.4 Analysis Report

5.3.4.1 Click on “Analysis Reports” on menu bar and click on” Equipment Data Log”

5.3.4.2 Select Equipment PE028, mention date and time to get the data of Temperature and click on search button.

5.3.4.3 To get a tabular representation, click on report. The report will be generated based on the above data and to print the report, click on “print” button.

Note: In the report, out of limit values will be displayed in Bold.

5.3.4.4 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.

5.3.4.5 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.

5.3.5 History Report

This field allows to take 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).

5.3.5.1 Mobile Detail Master

5.3.5.1.1 By enabling this option 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.

5.3.5.2 User Master

5.3.5.2.1 It Consist of Browser user (consisting of User name, Login name of all personal using PE028) and User Details (Consisting of User Name, Login Name, Status, Password Change Duration etc.)

5.3.5.3 Alarm Log

5.3.5.3.1Select the Equipment Name ( PE028 ) 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. 

5.3.5.4 Equipment audit Trail

5.3.5.4.1Select the Equipment PE028, 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.

5.3.5.5 Alarm Audit Trail

5.3.5.5.1 Select the Equipment PE028, 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.

5.3.5.6 User audit Trail

5.3.5.6.1  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.

5.3.6 Real Time Display and Real Time Summary

Select Equipment PE028.

5.3.6.1 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”.

5.3.7 Inputs and Outputs

Select Equipment PE028.

5.3.7.1 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.

5.3.8 Alarm Log of the Cooling Chamber

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

5.3.8.2 In this window the user shall view list of Equipments connected to the software. Select equipment name PE028 in search filter, select date & time and click on the search icon. User can view the list of alarms and status of the alarm.

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

5.3.8.4 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.

5.3.9 Alarm Acknowledge

5.3.9.1To 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.

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

5.3.10 Review of print outs

5.3.10.1 Group leader shall review the print outs of cooling 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.

5.3.11 Investigation of Abnormal Events

5.3.11.1Incase any outage is recorded, review the same for the duration of the outage due to power failure or is generated by the software.

5.3.11.2 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 in Analytical Research Laboratory”.

5.3.12 Monitoring of cooling chambers

Monitoring of cooling chamber shall be done every day. During the holidays print outs shall be taken on the next working day.

5.4 Enter details of cooling chamber usage during loading of samples or withdrawing of samples in “Usage Log Book of Cooling Chamber.” (Annexure-1).

5.5 Calibration

5.5.1 Calibrate the cooling chamber for Temperature.

5.5.2 Calibration shall be performed by Qualified Personnel (or) External Vendor.

5.5.3 Performance verification of Cooling Chamber.

5.5.3.1 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(5degC ) , now start recording the      temperature of the equipment for minimum of 24 hours and Usage details shall be captured in usage log book.

5.5.3.2 Collect the data at three different time intervals in a day (i.e. morning, afternoon and evening) and record the observations in “Performance verification test for temperature” ( Annexure-2).

5.5.3.3 After completion of 24 hours take the print outs of both external data loggers data and chamber sensors data. Group leader or Head of department shall review the data and shall submit the data to service engineer.

5.5.3.4 Frequency: Yearly once or after every major maintenance job.

5.5.3.5 Acceptance criteria: Data loggers temperature and chamber temperature shall not  differ by  5 ± 3°C.  

5.6 Maintenance

5.6.1 Maintenance shall be performed by Service Engineer (or) External Vendor and details shall be recorded in respective Usage Log Books.