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WITAUT2

WITAUT2

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Published by MWJornitz

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Published by: MWJornitz on Oct 22, 2008
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06/16/2009

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1
AUTOMATIC INTEGRITY TESTING OF
 
AUTOCLAVES INLET FILTERS
M.W.Jornitz 
 
The Water Intrusion Test, based on the use of water as the testing medium, can be integrated toautoclave processes by using an external pressure sensor. This article discusses the IQ/OQinstructions and the SOP to conduct the WIT with an external pressure sensor linked with the PLC of the autoclave, on hydrophobic membrane filters used for the sterile venting of autoclaves.
 
Principle of the Water Intrusion Test
The Water Intrusion Test (WIT), is a completely non-invasive integrity test for sterilisinggrade hydrophobic filters. The principle of the test relys on the fact that membrane filtersdesigned for air sterilisation duties are constructed from highly hydrophobic materials such asthe ePTFE membrane found in commercially available filters. In this case Sartofluor filter cartridges were used. The test method involves filling the upstream of the filter housingincluding the filter with water, till the airvolume above the water column reaches 2.5 bar. Thispressure of 2.5 bar is also the test pressure, which is applied during stabilization and the testperiod. After 10 min. stabilisation, during 10 min. test time, the pressure drop in the air volume is measured and compared to the max. allowable pressure drop installed into thePLC of the autoclave. Each 0,2 µm sterilising grade filter cartridge is characterised by a max.allowable pressure drop value established by correlation to the HIMA Bacteria ChallengeTest (1,2,3,4,5). In this case the pressure drop measured is compared to a max. allowablepressure drop established by the max. allowable intrusion and the upstream air volumeaccording to the formula bellow :
max.
P = max. WIT x Vm
Equation 1
 P
0
x t
 
where
WIT
is the intrusion rate in ml/min,
P
the pressure drop in mbar,
P
o
the atmospheric pressure,
V
m
the upstream gas volume in ml, and
t
the test time in min.
 
 
2The pressure drop is caused by the intrusion of water into the pores of the PTFEmembrane can be accurately measured by a sensitive pressure sensor fitted on the top partof the filter housing. The upstream volume (Vm) imposed by the compacting of the cartridgeat 2,5 bar (standard test pressure) depends on the cartridge size, the pipework configurationon the top part of the housing and the filling conditions of the filter assembly. That means thata filtration system filled with a reproducible process, will produce a constant air volume. Theupstream volume determination and its reproducibility are the key points of the validationprocedure proposed in this article.
Qualification of an equipment designed for automatic integrity testing
 Many autocalves vent filters are positioned such that access for integrity testing isextremely difficult and manual WIT procedures under these circumstances are not sopractical. This is the main reason why such equipment requires a fully automatic methodwhich only involves the measurement of the pressure drop during the test. In order tocalculate the maximum pressure drop allowed in a filter system, the airspace volume abovethe water must be determined by mean of an integrity test device measuring the upstreamvolume, in this case a Sartocheck 3. The qualification of a new plant designed for anautomatic Water Intrusion Test will therefore focus on the following objectives :
Determination of the upstream volume
: The upstream volume (V
M
) measured bySartocheck 3 also takes into account the inlet volume of Sartocheck and the outlet pressuretubing fitted to the housing (V
mo
). The real upstream volume (V
m
) when using a pressuresensor is then calculated by substracting V
mo
from V
M
( see table A).
Determination of the maximum allowable pressure drop
: The maximum allowablepressure drop for a filter assembly is calculated by using the equation 2 resulting from the
equation 1 :
 
P
max
= ( WIT
max
x P
o
x t ) / V
m
 
Equation 2 
where
WIT
max
is the Intrusion rate limit value established in correlationwith the HIMA bacteria challenge test, and
V
m
the upstream volume in ml ( V
M
- V
mo
.).
 
3 
IQ/OQ instruction and establishment of the validation certificate
:
The tests required for the validation of the filter system shown in figure 1 are conducted 3 times on 3 cartridgesfrom different batches according to the following procedure :
Determination of Vmo
Waterfill of the filter housing: open V
1
, V
2
, and V
3
 
Vent the compressed air volume produced during the filling operation : close V
1
and V
2
, open V
4
 
Connect Sartocheck 3
Start a WIT program ( printing of the V
M
, pressure drop and WIT values )
Calculate Vm = V
M
- Vmo
Calculate the maximum allowed pressure decay (equation 2)
Compare the pressure drop measured by sartochek 3 and the pressure sensor 
Disconnect Sartocheck 3
 
Drain the housing : open V
2
and V
7
Dry the cartridge : close V
2
and V
7
. Open V
3,
V
5
and V
6
during 10 minutes.Table A shows the results obtained for the test set up illustrated in figure 1. This document issupplied as a qualification document for the individual filter assembly.
cartridge 5181507T9 A 5181507T9 B 5181507T9 C
MEANparameters test 1 test 2 test 3 test 1 test 2 test 3 test 1 test 2 test 3 VALUE
Vmo at 2.5bsartocheck 3in ml
33 33 33 33 33 33 33 33 33
33
VM at 2.5bsartocheck 3in ml
57 59 59 60 56 60 62 58 58
59
Vm in mlVm = VM - Vmo
24 26 26 27 23 27 29 25 25
26
DPmax in mbar equation 2
167 154 154 148 174 148 138 160 160
156
 
Table A
 
: Determination of the maximum allowable pressure drop. This data is installed inthe software of the machine as the limite value for an integer filter.
 

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