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2.

Introduction

The Palltronic Flow Check II unit contains a capillary with a certified flow rate, protected against oil and
fluid contamination by an integral Gaskleen

®

filter on the ‘IN’ port.

The Palltronic Flow Check II unit can be used to perform a fast and simple check to verify the operation
and the calibration status of a Palltronic integrity test instrument. The Palltronic integrity test instruments
feature a ‘Flow Check’ test that will measure the flow rate through the Palltronic Flow Check II unit and
compare the measured value with the calibrated value supplied for the Palltronic Flow Check II unit. 
If the deviation in flow measurement is less than 5% then the Palltronic integrity test instrument is
functioning and measuring correctly. This ‘Flow Check’ test should be performed regularly to show that
the flow measurement function of the Palltronic integrity test instrument is working correctly.

The Palltronic Flow Check II unit is used in place of a filter for the purposes of the ‘Flow Check’ test and
is available in three flow ranges:

Table 2

Flow Ranges

Part Number

Flow Rate Range

Upstream Volume Requirements

FC02

8 ± 1 mL/min

0.5 to 2 meter hose

FC02M

90 ± 10 mL/min

0.5 to 2 liter vessel

FC02H

900 ± 50 mL/min

2.5 to 6 liter vessel

2.1

Key Features and Benefits

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
instrument is required to provide documentary evidence of filter integrity. The main benefit of the
Palltronic Flow Check II unit is to provide the operator with the ability to verify that a Palltronic
integrity test instrument is functioning and measuring correctly before using it to verify the
integrity of a critical filter.

2.2

Standard Functions

The Palltronic Flow Check II unit can be used to verify the operation and the calibration status
of a Palltronic integrity test instrument.

Important: The Palltronic Flow Check II unit can be used to verify the operation of a Palltronic
integrity test instrument that displays a ‘SERVICE!!!’ message on screen, but it cannot be used
to replace a regular calibration.

We recommend that integrity test instruments undergo a full service every 3 years by Pall,
during which all components are cleaned and checked and a recalibration is carried out. 
A calibration is recommended at least every 12 months. This can be performed locally on site
or at an approved Pall service centre. For more information regarding this, please contact your
local Pall office or distributor.

If the Palltronic integrity test instrument is displaying ‘SERVICE!!!’, please consult the Operating
Instructions for that instrument for further information and troubleshooting steps.

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...

Reviews: