4
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.