Thermal Validation System, Purpose:
Thermal Validation System, The purpose of this SOP is to define the Operation of Thermal Validation system situated at Calibration Lab of XX Pharmaceuticals Ltd.
Thermal Validation System, Scope:
This SOP covers the operating procedure of Thermal Validation System manufactured by Anville Instruments Ltd., UK and located at Calibration Lab of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]Pre-calibration: Calibration of thermocouples before performing any qualification.
[][]Post-calibration/Calibration check: Calibration Check of thermocouples after performing any qualification.
[][]USB: Universal Serial Bus.
Responsibilities:
[][]The roles and responsibilities are as follows:
Validation Department
[][]Preparing the SOP and revise it when necessary.
Head of Engineering
[][]To ensure the proper operation of the system following the SOP.
Head Quality Assurance
[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.
Procedure:
Precautions:
[][]Do not touch the thermocouples with bare hands as it might create itching on the skin due to having glass wool insulation.
Do not touch the thermal bath, thermocouples and reference temperature probe with bare hand when working under high temperature.
[][]Ensure that the thermocouples are properly inserted in the thermal bath due to having no erroneous readings while performing pre and post-calibration.
[][]When the thermocouples are inserted or affixed inside the autoclave or Depyrogenation Tunnel, be careful that these do not get stuck with anything. This is because, thermocouples might be torn apart.
System Description:
[][]The thermal validation system is comprised of following components:
[][]Data Logger: This 18 (16 temperature and 02 pressure) channels data logger of model Series 825 is manufactured by Anville Instruments Ltd., UK.
[][]Reference Temperature Probe: This probe, having model no. P750 is manufactured by Dostmann Electronic, Germany, which is used to perform the pre and post-calibration of thermocouples.
[][]Thermal Bath: The thermal bath of model TECAL 425F has been manufactured by TECHNE which is used as a source of temperature while performing the pre-calibration and post-calibration.
[][]Reference Pressure Calibrator: The reference pressure calibrator is used for pre and post-calibration of pressure transducer used in qualification of Autoclave.
[][]Thermocouples and pressure transducer: There are total 16 nos. T type thermocouples which are used to perform any kind of thermal validation.
[][]TQ Software: The software of version 6.1.2 and license number 2265486119 is used to interface the Data logger, Reference Temperature probe, thermocouples as well as pressure transducer. There is a dongle which holds the license for the software.
[][]Laptop: The laptop is used to operate all the components using TQ software.
Operating Procedure:
[][]There are mainly three steps involved in performing any thermal validation using this system such as pre-calibration, qualification as well as post-calibration/calibration check. All of these steps are described below:
[][]Pre-calibration of thermocouples and pressure transducer: All components must be connected to the laptop using USB port. Then, start the TQ soft by double clicking the TQSOFT icon. After that, following screen will be displayed:
[][]Click the Setup and enter electronic ID and password and the specific persons will be logged in the software.
[][]Click the ‘Logger’ option and choose “Calibration”. After that, following screen will be shown:
[][]Enter any suitable Job Ref in the respective box and press OK.
[][]Insert three different temperature values for calibration covering the operating range during validation. For instance, for autoclave validation set the Low point, High point and check point at 900C, 1300C and 121.10C respectively.
Set other parameters as follows:
[][]Stability 0.20C per minute for 3 minutes.
[][]Allowed deviation from reference 0.80C
[][]Reference stability criteria 0.020C for 01 minute.
[][]Report after stability for 1 minute.
[][]Report interval 20 secs.
[][]Report maximum deviation allowed 0.50C
[][]Then press OK and following screen will appear:
[][]Set the temperature of Thermal bath at low point and wait till all the probes are stabled. The “Countdown on Stability Requirements” will be zero for both thermocouples and reference probe when the readings are stable.
[][]Complete the Calibration by pressing “Proceed” and repeating the procedure for High and Check points.
Annexure:
Annexure I Equipment Use Log Book