Integrity Test Services
Determining if a sterilizing grade filter is integral can be done via Diffusion flow test
non-destructive integrity testing. In the diffusive flow test the membrane is wet with
water, and the upstream gas is then held constant
The test parameters for sterilizing grade membrane filters are at a specified pressure near, but somewhat below,
based on correlating the test parameters with the LRV of the filter the bubble point of an integral filter. A measurement
against a 107 CFU/cm2 challenge with Brevundimonas diminuta. is made of the flow rate of gas through the filter and
compared to the manufacturer’s specification.
The filter cartridges can be tested by industry standard
procedures as recommended in PDA Technical Report 26. A measured flow rate equal to or less than the
specified value indicates that the filter Is integral. A
The test parameters are dependent on the surface tension of the higher flow rate indicates that the filter being tested
wetting fluid to be used. Therefore, the parameters used in the has pores or defects which were purged of water at
procedures, listed below, assume the wetting fluid to be water. the test pressure, resulting in bulk flow through the
For test values using wetting fluids other than water the adjusted filter.
parameters have to be determined.
Hall Pyke can carry out and advise on the following integrity test Water Intrusion Test (WIT)
procedures: The water intrusion test measures the decay rate of
a pressure level imposed upon a hydrophobic filter
• Bubble Point enveloped by water. Using an automated integrity
• Water intrusion test tester, a particular decay level is identified as the
• Forward Flow Diffusion point at which water enters the largest pores of the
filter.
Hall Pyke can carry out tests on site or in house, in our lab in
Dublin. We can carry out tests on all makes of filters including
PALLTM, Parker Dominick HunterTM, AmazonTM, MilliporeTM and
SartouriousTM.
Bubble point test
The basis for the integrity testing of filters depends upon the
interpretation of airflows through membranes wetted by water or
other fluids. The bubble point measurement identifies the largest
(diameter) pores present in a membrane by the differential
pressure required to empty them of their water. The largest
(diameter) pores are vacated first. The pores thus sized are
correlated with their ability to restrain the passage of organisms.
It is this correlation that enables a filter to be characterized and
selected for an application requiring a given pore retention value.
The differential pressure supplies the work function necessary to
disrupt the bonding between the water molecules and the
molecules of the hydrophilic pore surface that constitutes wetting,
and to forcibly separate the water from the pore walls. The
bonding strength of the wetting interaction to be overcome is
peculiar to each filter/fluid combination
The utility of the bubble point derives from its identifying a filter’s
View our
largest pores as measured by the differential pressure required
to expel the water from a wetted filter tutorial videos
at [Link]
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Hydrophilic Surface Deposits
The water intrusion test depends upon and
measures the hydrophobicity of the filter. Only the
experimentally demonstrated correlation of its values
with the entrance of water into the hydrophobic pore
structure establishes it as an integrity test. But the
basic measurement of filter hydrophobicity is itself
an inherent requirement in its pertinence to air filter
reuse. Consider an integral air filter that contains
hydrophilic deposits upon its surface. They may
encourage microbial growth and ultimately, organism
penetration. Solely ensuring air filter integrity,
however essential, is not enough in air filter usage.
The filter’s full hydrophobicity must also be assessed
to ensure freedom from compromising hydrophilic
impurities.
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