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Note: The remote vent valve may be additionally installed between the integrity test instrument
and the Palltronic Flow Check II unit (or between the integrity test instrument and the upstream
volume, if required) so that leaks within the remote valve may be detected. Therefore, should
the Flow Check test fail, please repeat the Flow Check test without the remote vent valve
attached to determine whether the remote vent valve is the cause of the failure or not.

• Ensure that the ‘VENT’ connection on the Palltronic Flow Check II unit is open to atmosphere.

• It is recommended that the red pneumatic tubing supplied with the Palltronic Flow Check II

unit be used exclusively for this purpose. It is also highly recommended that this tubing is
kept clean and dry. In this way accidental contamination of the internal capillary within the unit
can be mitigated.

Important: Although the Palltronic Flow Check II unit has an integral Gaskleen filter in order to
limit the possibility of contaminating the internal capillary, the operator should still take great
care to avoid contamination. Should either the integral filter or the capillary become
contaminated, damaged or blocked, the operation of the Palltronic Flow Check II unit will be
severely compromised.

3.4

Performing a ‘Flow Check’ Test

Note: The following test procedure assumes that the integrity test instrument provides a
dedicated ‘Flow Check’ test (see your integrity test instrument Operating Instructions for the
instrument capabilities). If the dedicated ‘Flow Check’ test is not available, a ‘Forward Flow’ test
may be used instead. In this situation, the ‘Expected Flow’ becomes the ‘Maximum Flow’ test
parameter and the pass/fail result at the end of the test should be ignored: refer instead to
Section 3.5 for the interpretation of the result.

• 

Select a ‘Flow Check’ test on the Palltronic integrity test instrument (for more information, see
the relevant Operating Instructions for your integrity test instrument).

• Enter the following test parameters (and where indicated by 

1

below, using the relevant values

displayed by the Palltronic Flow Check II unit in use, see also Section 3.2. 

Test Pressure

1

: 2000 mbar (29 psi)

Test Time: 600 seconds

Ref. Unit Serial No.

1

: 1234567

Expected Flow:

1

X.XX mL/min

• Press the ‘Start’ button on the Palltronic integrity test instrument to activate the 

‘Flow Check’ test.

• On completion of the test (i.e. after the test time has elapsed), the measured value will be

given with a percent deviation value between the measured and the expected values (if the
dedicated ‘Flow Check’ test has been used).

Note: After use, the Palltronic Flow Check II unit should be carefully disconnected from the
Palltronic integrity test instrument, the protective caps should be replaced on the inlet and vent
ports and the unit stored in a dry place at room temperature.

3.5

Understanding the Test Results

The test result will be reported as a flow rate value. Under stable test conditions, the Palltronic
integrity test instrument should be within ± 5% of the expected flow value displayed by the
Flow Check II unit. 

The expected flow value is calculated from the reference value (as shown on the side of the
Palltronic Flow Check II unit and on the calibration certificate provided with the Palltronic Flow
Check II unit) by compensating for any variation in atmospheric pressure.

If the dedicated ‘Flow Check’ test has been used, the percent deviation value will be calculated
and presented by the integrity test instrument. If, however, the integrity test instrument does not

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7

Summary of Contents for Palltronic Flow Check II

Page 1: ...USD 2642 Instructions For Use Palltronic Flow Check II Unit Part numbers FC02 FC02M and FC02H...

Page 2: ...its 4 2 2 Standard Functions 4 3 Using the Palltronic Flow Check II Unit 5 3 1 Features 5 3 3 Display Function 6 3 3 Test Preparation 6 3 4 Performing a Flow Check Test 7 3 5 Understanding the Test Re...

Page 3: ...USD2363 Please contact your local Pall office or distributor if you require a copy of the latest revision of any of these documents 1 1 Personal Safety Appropriate protective clothing should be worn...

Page 4: ...Within the pharmaceutical industry there is a regulatory requirement to integrity test filters both before and after use in a production environment Therefore a fully functional integrity test instrum...

Page 5: ...l attached to the enclosure displays the certified flow rate using air at an atmospheric pressure of 1000 mbar 14 5 psi the associated test pressure and the unit serial number The display is switched...

Page 6: ...to extend the battery life The unit displays the pressure in mbar only The test pressure is normally 2000 mbar 29 psi 200 kPa 2 039 kp cm2 3 3 Test Preparation The integrity test assembly comprising...

Page 7: ...ass fail result at the end of the test should be ignored refer instead to Section 3 5 for the interpretation of the result Select a Flow Check test on the Palltronic integrity test instrument for more...

Page 8: ...failed message can be erased by pressing the Start button for more than 5 seconds to switch the unit off Used batteries should be discarded in accordance with relevant local and national regulations...

Page 9: ...for the ambient pressure Check that the test parameters especially test pressure are set correctly these details are available with the Palltronic Flow Check II unit see Section 3 4 for more informat...

Page 10: ...700 107 0 106 0 105 0 104 0 103 0 102 0 101 0 100 0 99 0 98 0 97 0 96 0 95 0 94 0 93 0 92 0 91 0 90 0 89 0 88 0 87 0 86 0 85 0 84 0 83 0 82 0 81 0 80 0 79 0 78 0 77 0 76 0 75 0 74 0 73 0 72 0 71 0 70...

Page 11: ...ain Sweden Switzerland Taiwan Thailand the United Kingdom the United States and Venezuela Distributors in all major industrial areas of the world The information provided in this literature was review...

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