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Wednesday, May 12, 2010

STANDARD OPERATING PROCEDURE Title: HPLC Calibration

1. PURPOSE

It is established for the calibration of HPLC.

2. SCOPE

It is applicable to Quality Control Department.

3. RESPONSIBILITY:

  1. Quality Control Manager
  2. Assistant Manager Quality Control

4. PROCEDUR

RUNNING A FLOW STABILITY TEST:

The flow stability test is a common test of the pump’s performance. The pump must be running, purging or be in a READY or INIT state for this test to be initiated, and the flow rate must be greater than 0 ml/min. If you need the flow rate, edit the flow setting from the Status Menue, then proceed with the steps below.

  • NOTE: The flow stability test can be completed only when the pump is in a READY state although it may be initiated while the pump is in any of the states mentioned above.
  1. When the status Screen shows READY, press (MENU) and select/TESTS.
  2. Select/Diagnostics/from the Tests Menu.
  3. The cursor should be on / Flow Stability/Press (ENTER).

After a short time, the flow stability rating followed by a numerical value will appear.STABLE flow corresponds to a reading between 0 and 25,ACCEPTABLE is between 26 and 90, and UNSTABLE is a value greater than 90.

The calibration menu contains a flow calibration “test”, the flow calibration can be run in one of three modes.

  • 1.1 Flow Calibration


FLOW CALIBRATION:

The flow calibration asks the pump to perform some internal calculations based on user measured values. This is a passive test but it uses the (RUN) key. Unless run incorrectly, this test will not interfare with pump operation. Select /Flow Calibration / to access the flow calibration menus.

The test is run in one of three modes.Select Meter,Fixed Volume or Fixed Time from the flow Calibration Menu(Fig).

  • Fixed Time
  • Fixed Volume
  • Meter

Depending on your selection, the display will allow you to enter values that enable the test to be completed.These are described in Table below:

CALIBRATION MODE:

Value to Enter

/Meter/ Measured Flow (ml/min).

This calibration mode assumes that you have externally measured the precise flow rate that the pump is operating at while set at a specific flow rate. Keep the pump set at that flow rate while you run this test.(it is automatically entered in the Selected flow field) Press (RUN).The display will show old and new flow correction values,as percents.(Thois is the same value that appears in the Flow Correction Menu accessed whenever the liquid End Type Menu (/TESTS/,Maintenance Log/) You must determine whether ti use,Scrap,or save the new value.Make this selection in the field in the middle of the bottom line of the display.Enter values in the flow Correction Menu as desired then press (RUN) to complete the test.

/Fixed Volume/Measured Time (min).

This calibration mode assumes that youy have externally timed the period in which a specific volume has been pumped.Enter values as desired then press (RUN) to initiate the test. The Flow Correction Menu is displayed.Enter values as desired.

Press (RUN) to complete the test.

/Fixed Volume/Measured Vol (min).

This calibration mode assumes that you have collected and measured a specific volume pumped during a fixed time period.Enter values as desired then press (RUN) to initiate the test.The Flow Correction Menu is displayed.Enter values as desired.Press (RUN) to complete the test.

1 comment:

  1. This post is great. Thank you for this post. I like this kind of people who share their knowledge with others.

    Test Fixtures

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