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1.0 OBJECTIVE : To set up the operation and maintenance procedure for Temperature-Humidity Data logger.
2.0 SCOPE : This SOP is applicable for the operation and maintenance procedure of Temperature-Humidity Data logger (Model No.: OM-EL-USB-2-LCD & OM-EL-USB-2-LCD-PLUS) at Quality Control Department (Track-II) of Beximco Pharmaceuticals Limited.
3.0 RESPONSIBILITY
3.1 Operating personnel is responsible for carrying out the procedure.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his/her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Keep the Temperature-Humidity Data logger in a dry place.
5.2 Use the data logger to record data within the specified range (-35°C to 80°C).
5.3 Never expose the data logger in an environment where the temperature range is beyond the range mentioned in point 5.2.
5.4 Always bring the temperature of the Data Logger to room temperature before inserting the USB Data Logger to the USB port of a Computer.
5.5 Wipe the USB insert of the Data Logger with a dry tissue before inserting it to the USB port of a computer.
6.0 PROCEDURE
6.1 Set up and start the USB Data Logger
6.1.1 Insert the USB Data Logger to the USB Port of a computer where the OM-EL-WIN- USB Configuration Software (EasyLog USB) has already been installed.
6.1.2. Double click on the EasyLog USB software.
6.1.3 Click on the “Set up and start the USB Data Logger” from the menu.
6.1.4 Select Temperature Scale in Degree Centigrade (°C).
6.1.5 Select how frequently the USB Data Logger will log a reading from the Sample Rate down arrow menu.
6.1.6 Then Press Next.
6.1.7 Select the display function (i.e. LCD Always On).
6.1.8 Select the option how Logger should perform when full (i.e. Logger Stops).
6.1.9 Click Next.
6.1.10 Select Start Time & Start Date when like the Logger to start.
6.1.11 Press Finish.
6.1.12 It will show “EasyLog USB has been configured successfully. Remove the unit from the USB socket.”
6.1.13 Remove the USB from the USB socket.
6.1.14 Place the Data Logger in a suitable position for recording Temperature and / or Humidity readings.
6.2 Stop the USB Data Logger & Download Data
6.2.1 Insert the USB Data Logger to the USB Port of the computer and click on the EasyLog USB software.
6.2.2 Click on “Stop the USB Data Logger and Download Data”.
6.2.3 Click on Export and take printout of the Data & graph (as required).
6.2.4 After taking out the data, close the windows and Start the USB Data Logger as per procedure described in point 6.1.
6.3 MAINTENANCE
6.3.1 If the Data Logger is full, Red LED will give Triple Flash. If the Logger is full remove data from the Logger.
6.3.2 In case of the battery is empty, no LED will flash. Immediately change the battery with a new one.
