SOP for Operation and Calibration of Critical flow controller

1.0 OBJECTIVE1.0 OBJECTIVE
To set up a procedure for the operation and calibration of Critical flow controller.

2.0 SCOPE
This SOP is applicable for operation and calibration of Critical flow controller, Model: TPK.

3.0 RESPONSIBILITY
3.1 QC Officer/Analyst shall carry out the activity as per 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
5.0 Before taking reading make sure that all the connection is air tight.
5.1 Stabilize the vacuum pump at least 30 minutes prior to taking readings.
5.2 Set timer for longer time.
5.3 For calibration use only certified instrument.
5.4 Do not open the rear panel without trained personnel or engineer during adjustment of P1, P2 and P3.

6.0 PROCEDURE
6.1 Operation
6.1.1 Connect the ‘High Capacity Pump Slave and Critical Flow Controller (TPK) to the mains.
6.1.2 Connect the flow controller to the High capacity pump slave.
6.1.3 Connect P1 inlet (Small port on the right side) to the DUSA.
6.1.4 Set a high value on the timer.
6.1.5 Switch on the High Vacuum Pump and critical flow controller.
6.1.6 Adjust the flow by turning the knob on the pump or flow controller.
6.1.7 After complete the analysis switch off the High Vacuum Pump.

6.2 Calibration
6.2.1 Timer calibration
6.2.1.1 Use a certified stop watch to perform timer calibration. Select three suitable test times in accordance with the used range of the instrument.
6.2.1.2 Prepared the timer having a suitable test time (60Sec, 100Sec, 200Sec).
6.2.1.3 Start the test run and stop watch simultaneously.
6.2.1.4 Stop the timer simultaneously when the timer stops. Repeat the timer twice.
6.2.1.5 Repeat with another two different test times.
6.2.1.6 The average of the three measurements is valid for the compliance.
6.2.1.7 Record all reading in the calibration data sheet (Annexure-I).
6.2.1.8 Acceptance range: Tolerance ± 2%
6.2.2 Leak test
6.2.2.1 P1 Leak test
6.2.2.1.1 Arrange the instrument set up as per suppler guide line.
6.2.2.1.2 Use a syringe to create a weak vacuum ( 15 kPa) on the P1 tubing. Close the tubing with a ball valve to prevent vacuum loss.
6.2.2.1.3 Check the P1 display over the one minute for pressure drop. Record all reading in the calibration data sheet (Annexure-II). If result dose not complies the limit, check all the connection and make sure they are air tight and repeat the procedure again.
6.2.2.1.4 Acceptance range: Tolerance  1.5 kPa.
6.2.2.2 P2 and P3 Leak test.
6.2.2.2.1 Arrange the instrument as per suppler guide line.
6.2.2.2.2 Connect the regulator with the VAC-inscription side to the vacuum source.
6.2.2.2.3 Connect the differential pressure gauge to the regulator and open the ball valve on the regulator.
6.2.2.2.4 Connect the regulator to the outlet (P3) of critical flow controller.
6.2.2.2.5 Close the screw valve on the critical flow controller tightly.
6.2.2.2.6 Set a high value on the timer and start the time.
6.2.2.2.7 Set the pressure regulator to give a reading on the absolute pressure gauge of about 15kPa.
6.2.2.2.8 Close the ball valve on the regulator and check the vacuum decrease over one minute.
6.2.2.2.9 Repeat this test with regulator connected to the inlet (P2) of the unit.
6.2.2.2.10 When testing at the inlet it is not necessary to operate the timer.
6.2.2.2.11 Record all reading in the calibration data sheet (Annexure-II). If result dose not complies the limit, check all the connection and make sure they are air tight and repeat the procedure again.
6.2.2.2.12 Acceptance range: Tolerance  1.5 kPa.
6.2.3 P1 calibration.
6.2.3.1 Arrange the instrument as per suppler guide line.
6.2.3.2 Connect outlet (P3) of the Critical Flow Controller to vacuum source.
6.2.3.3 Connect “cross ( ╬ )” fitting with small screw valve to the inlet (P2).
6.2.3.4 Connect the differential pressure gauge to the “cross ( ╬ )” fitting.
6.2.3.5 Connect P1 inlet (Small port on the right side of Critical Flow Controller) to cross fitting.
6.2.3.6 Set a high value on the timer and start the timer.
6.2.3.7 Adjust the Critical Flow Controller screw valve and /or the “cross” fitting screw valve to set 0kPa, 2 kPa and 4.0kPa on the differential pressure gauge.
6.2.3.8 Compare the P1 reading to the differential pressure gauge.
6.2.3.9 Record all reading in the calibration data sheet (Annexure-III).
6.2.3.10 If result dose not complies the limit, checks all the connection and make sure they are air tight and repeat the procedure again. If it does not complies yet open the rear panel of the instrument. Remove the black box attached to the left side wall inside the housing. Open it. There are two potentiometers available indicated as zero and slope. Switch between zero and 4kPa differential pressure to adjust the range. Start with zero adjustment. Calibrate it again.
6.2.3.11 Acceptance range: Tolerance  0.2 kPa
6.2.4 P2 and P3 Calibration.
6.2.4.1 Arrange the instrument as per suppler guide line.
6.2.4.2 Connect the regulator with the VAC inscription side to the vacuum source.
6.2.4.3 Open the ball valve on the regulator and connect the other side of the regulator to the outlet (P3) of the Critical Flow Controller.
6.2.4.4 Close the screw valve of the Critical Flow Controller.
6.2.4.5 Connect the absolute pressure gauge to the regulator next to the ball valve.
6.2.4.6 Set a high value on the timer and start the timer.
6.2.4.7 Press P3 and adjust the regulator to 30, 40, 50, 60, 70, 80, 90kPa absolute pressure one after another.
6.2.4.8 Compare readings on the instrument to the absolute pressure gauge.
6.2.4.9 Record all reading in the calibration data sheet (Annexure-IV).
6.2.4.10 If result dose not complies the limit, checks all the connection and make sure they are air tight and repeat the procedure again. If it does not complies yet remove the panel meter inside the housing by means of the two screws and turn it towards the rear. At bottom left of the display board is a potentiometer for zero adjustment. At bottom right of the display board are two potentiometers, one for fine adjustment of the span (left), one for coarse adjust of the span (right). Adjust “zero” at a low value such as 30kPa absolute pressure, then remove vacuum and adjust “slope” at room pressure. Switch back and forth between 30kPa and room pressure until the full range is within specification. Calibrate it again.
6.2.4.11 Acceptance range: Tolerance  2 kPa
6.3 Frequency: Two yearly ± 15 Daysb
To set up a procedure for the operation and calibration of Critical flow controller.

2.0 SCOPE
This SOP is applicable for operation and calibration of Critical flow controller, Model: TPK.

3.0 RESPONSIBILITY
3.1 QC Officer/Analyst shall carry out the activity as per 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
5.0 Before taking reading make sure that all the connection is air tight.
5.1 Stabilize the vacuum pump at least 30 minutes prior to taking readings.
5.2 Set timer for longer time.
5.3 For calibration use only certified instrument.
5.4 Do not open the rear panel without trained personnel or engineer during adjustment of P1, P2 and P3.

6.0 PROCEDURE
6.1 Operation
6.1.1 Connect the ‘High Capacity Pump Slave and Critical Flow Controller (TPK) to the mains.
6.1.2 Connect the flow controller to the High capacity pump slave.
6.1.3 Connect P1 inlet (Small port on the right side) to the DUSA.
6.1.4 Set a high value on the timer.
6.1.5 Switch on the High Vacuum Pump and critical flow controller.
6.1.6 Adjust the flow by turning the knob on the pump or flow controller.
6.1.7 After complete the analysis switch off the High Vacuum Pump.

6.2 Calibration
6.2.1 Timer calibration
6.2.1.1 Use a certified stop watch to perform timer calibration. Select three suitable test times in accordance with the used range of the instrument.
6.2.1.2 Prepared the timer having a suitable test time (60Sec, 100Sec, 200Sec).
6.2.1.3 Start the test run and stop watch simultaneously.
6.2.1.4 Stop the timer simultaneously when the timer stops. Repeat the timer twice.
6.2.1.5 Repeat with another two different test times.
6.2.1.6 The average of the three measurements is valid for the compliance.
6.2.1.7 Record all reading in the calibration data sheet (Annexure-I).
6.2.1.8 Acceptance range: Tolerance ± 2%
6.2.2 Leak test
6.2.2.1 P1 Leak test
6.2.2.1.1 Arrange the instrument set up as per suppler guide line.
6.2.2.1.2 Use a syringe to create a weak vacuum ( 15 kPa) on the P1 tubing. Close the tubing with a ball valve to prevent vacuum loss.
6.2.2.1.3 Check the P1 display over the one minute for pressure drop. Record all reading in the calibration data sheet (Annexure-II). If result dose not complies the limit, check all the connection and make sure they are air tight and repeat the procedure again.
6.2.2.1.4 Acceptance range: Tolerance  1.5 kPa.
6.2.2.2 P2 and P3 Leak test.
6.2.2.2.1 Arrange the instrument as per suppler guide line.
6.2.2.2.2 Connect the regulator with the VAC-inscription side to the vacuum source.
6.2.2.2.3 Connect the differential pressure gauge to the regulator and open the ball valve on the regulator.
6.2.2.2.4 Connect the regulator to the outlet (P3) of critical flow controller.
6.2.2.2.5 Close the screw valve on the critical flow controller tightly.
6.2.2.2.6 Set a high value on the timer and start the time.
6.2.2.2.7 Set the pressure regulator to give a reading on the absolute pressure gauge of about 15kPa.
6.2.2.2.8 Close the ball valve on the regulator and check the vacuum decrease over one minute.
6.2.2.2.9 Repeat this test with regulator connected to the inlet (P2) of the unit.
6.2.2.2.10 When testing at the inlet it is not necessary to operate the timer.
6.2.2.2.11 Record all reading in the calibration data sheet (Annexure-II). If result dose not complies the limit, check all the connection and make sure they are air tight and repeat the procedure again.
6.2.2.2.12 Acceptance range: Tolerance  1.5 kPa.
6.2.3 P1 calibration.
6.2.3.1 Arrange the instrument as per suppler guide line.
6.2.3.2 Connect outlet (P3) of the Critical Flow Controller to vacuum source.
6.2.3.3 Connect “cross ( ╬ )” fitting with small screw valve to the inlet (P2).
6.2.3.4 Connect the differential pressure gauge to the “cross ( ╬ )” fitting.
6.2.3.5 Connect P1 inlet (Small port on the right side of Critical Flow Controller) to cross fitting.
6.2.3.6 Set a high value on the timer and start the timer.
6.2.3.7 Adjust the Critical Flow Controller screw valve and /or the “cross” fitting screw valve to set 0kPa, 2 kPa and 4.0kPa on the differential pressure gauge.
6.2.3.8 Compare the P1 reading to the differential pressure gauge.
6.2.3.9 Record all reading in the calibration data sheet (Annexure-III).
6.2.3.10 If result dose not complies the limit, checks all the connection and make sure they are air tight and repeat the procedure again. If it does not complies yet open the rear panel of the instrument. Remove the black box attached to the left side wall inside the housing. Open it. There are two potentiometers available indicated as zero and slope. Switch between zero and 4kPa differential pressure to adjust the range. Start with zero adjustment. Calibrate it again.
6.2.3.11 Acceptance range: Tolerance  0.2 kPa
6.2.4 P2 and P3 Calibration.
6.2.4.1 Arrange the instrument as per suppler guide line.
6.2.4.2 Connect the regulator with the VAC inscription side to the vacuum source.
6.2.4.3 Open the ball valve on the regulator and connect the other side of the regulator to the outlet (P3) of the Critical Flow Controller.
6.2.4.4 Close the screw valve of the Critical Flow Controller.
6.2.4.5 Connect the absolute pressure gauge to the regulator next to the ball valve.
6.2.4.6 Set a high value on the timer and start the timer.
6.2.4.7 Press P3 and adjust the regulator to 30, 40, 50, 60, 70, 80, 90kPa absolute pressure one after another.
6.2.4.8 Compare readings on the instrument to the absolute pressure gauge.
6.2.4.9 Record all reading in the calibration data sheet (Annexure-IV).
6.2.4.10 If result dose not complies the limit, checks all the connection and make sure they are air tight and repeat the procedure again. If it does not complies yet remove the panel meter inside the housing by means of the two screws and turn it towards the rear. At bottom left of the display board is a potentiometer for zero adjustment. At bottom right of the display board are two potentiometers, one for fine adjustment of the span (left), one for coarse adjust of the span (right). Adjust “zero” at a low value such as 30kPa absolute pressure, then remove vacuum and adjust “slope” at room pressure. Switch back and forth between 30kPa and room pressure until the full range is within specification. Calibrate it again.
6.2.4.11 Acceptance range: Tolerance  2 kPa
6.3 Frequency: Two yearly ± 15 Days

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