Follow
1.0 OBJECTIVE
To set up a guideline for the operation, calibration and cleaning of Water Bath (Model:1004)
2.0 SCOPE
This SOP is applicable for operation, calibration and cleaning of Water bath (Model: 1004) installed in IPQA Room of OSD facility under Quality Assurance Department of (Company Name).
3.0 RESPONSIBILITY
3.1 Operating personnel is responsible for carrying out the procedure.
3.2 Calibration must be done by QA personnel.
3.3 Overall responsibility for training, implementation and follow-up shall be with QA Manager or designee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Ensure water bath and surrounding area is clean before use.
5.2 Disconnect the main power source of water bath prior to cleaning.
5.3 Never use any chemical solution inside the bath, except cleaning detergents.
5.4 Before operation, ensure the bath is filled with purified water.
5.5 Make sure that the water outlet tap at the back of the unit is closed before operation.
5.6 The water level must be maintained between the “min” (50 mm above the perforated tray and “max” (50 mm below the upper bath rim) marking.
5.7 Ensure that the calibrated thermometer, which is being used for calibration, is calibrated and the certificate along with validity of calibration is available.
6.0 PROCEDURE
6.1 Operation
6.1.1 Fill the water bath with purified water up to the desired level.
6.1.2 Connect the instrument to the main power supply.
6.1.3 Switch on the equipment.
6.1.4 Wait until the bath temperature reaches the desired temperature.
6.2 Temperature setting procedure (If required)
6.2.1 Press and hold “0C” key and then press “+” or “-” key for setting the required temperature.
6.2.2 Release “0C” key to save the required temperature.
6.2.3 The yellow pilot lamp shows that heating is in progress.
6.3 Calibration
6.3.1 Set the temperature at 300C and wait until the display shows the temperature 300C.
6.3.2 Place a calibrated thermometer into the water bath at three different places as follow and observe the bath temperature.
6.3.3 Record the values in Annexure-I (FRM. No.: FQA/203).
6.3.4 Repeat the steps (6.3.1 to 6.3.3) by increasing the temperature to 400C, 500C and 600C.
6.3.5 Acceptance criteria: ± 10C.
6.3.6 Calibration Frequency: Annual ± 15 days and after maintenance.
6.3.7 If the acceptance criteria for calibration is not satisfied, then follow the procedure for handling of out of calibration for instrument and equipment (SOP No.: QA049).
6.3.8 After completion of the calibration activity, affix the duly filled and signed calibration status label on the instrument.
6.4 Cleaning
6.4.1 Clean the water bath using a solution of mild detergent and water.
6.4.2 Use sufficient amount of water to wash the bath after detergent cleaning and again drain out the water. To remove the rest of the water use a clean and dry piece of soft cloth.
6.4.3 Record the information in the cleaning log book- “CLEANING LOG BOOK OF WATER BATH (FRM No.: FQA/086).
6.5 Cleaning Frequency
6.5.1 Daily
6.5.2 Before calibration.
6.5.3 After maintenance.
