In-Use Evaluation Report
160330.3WUS
Pall QPointTM Shower Water Filter Assembly
Reusable Docking Station - Shower Assembly (QDS) and
Disposable Filter Capsule for up to 62 Day Use - Shower
(QR212U and QR22U)
QPoint - More than Filtration
Introduction
The Pall QPoint Shower Water Filter Assembly has been designed to provide an effective barrier to microorganisms
present within the water supply. It consists of two components, a non-sterile, reusable Docking Station (QDS)
and a sterile disposable Filter Capsule with a rose outlet (QR212U, QR22U). The Filter Capsule may be used
for a maximum of two calendar months (62 days) and has been validated in the laboratory according to industry
standard laboratory liquid microbial challenge tests using Brevundimonas diminuta employed for validating
0.2 μm sterilizing grade filters (ASTM F838-05). The Filter Capsule incorporates a bacteriostatic additive and inner
shield protection device to minimize the risk of inadvertent retrograde contamination.
Following performance validation under controlled laboratory conditions, an evaluation under real life conditions
has been conducted in an In-house site and a Hospital site to assess the performance of the QPoint Shower
Water Filter Assembly throughout the 2 months use. In this evaluation, performance with respect to removal
of microorganisms found within the water supply and water flow through the Filter Capsule has been assessed.
Materials and methods
The evaluation was conducted under real life conditions at 2 sites; an in-house site (5 Points-of-Use (POU)) and
a Hospital site (12 POU). Prior to installing filters, a survey of each site was undertaken to identify systemic water
treatments in place, routine hygiene practices and general environmental conditions. Water quality was assessed
by a silt density index (SDI) test to obtain an arbitrary measure of particulate and colloidal material within the
water. Static water pressures were also recorded. In addition, unfiltered water samples were aseptically collected
directly from the shower hose for microbiological analysis. In the Hospital, unfiltered samples were taken before
and after the filtration period to assess differences in bacterial concentration upstream of the filter as a significant
increase of bacteria concentration after QPoint Filter Assembly removal could indicate bacterial back contamination
into the water network.
Both sites were provided with QPoint Docking Stations – Shower Assembly and QPoint Filter Capsules with a
rose outlet. Throughout the 62 day Filter Capsule installation period, water samples were aseptically collected
for microbiological analysis. Flow rates from each POU were also monitored.
In the In-house site evaluation, water samples were collected immediately and after a one minute flush and
analysed for the presence of P. aeruginosa and aerobic colony count (ACC) at 72 ºF (22 ºC) and at 99 ºF (37 ºC).
In the Hospital evaluation, water samples were collected after a one minute flush and analysed for the presence
of P. aeruginosa, Legionella spp. and aerobic colony count at 72 ºF (22 ºC) and at 99 ºF (37 ºC). Further water
samples were also taken for microbiological analysis following filter removal.
In both evaluations, water samples were analysed by independent accredited laboratories. 2
Results
Five QPoint Shower Water Filter Assemblies were installed In-house (OFFICE). Four were installed across 3 floors
in 1 building (OFFICE1) and 1 was installed in a second building (OFFICE2).
Twelve QPoint Shower Filter Assemblies were installed in a Hospital (HOSP). Four were installed in each of
3 wards on different floors of the hospital (HOSPA1, HOSPA2 and HOSPA3). The wards were supplied by
different water misers.
Static pressure and SDI measurements are shown in Table 1.
Table 1. Summary of static water pressure and SDI results
Site
Mixed Water Pressure (bar)
Mixed Water SDI
OFFICE12.9
OFFICE22.5
HOSPA13.4
HOSPA2
0.8 (HOSPA2 -3)
1.8 (HOSPA2 -1)
HOSPA32.4
6.0
4.6
3.3
6.1
nd
<1
Higher SDI values are indicative of higher particle loading which may vary from day to day, depending on a range
of factors such as regional fluctuations, local environmental conditions, maintenance or building works, etc. An
SDI value of approximately 3 represents low to moderate levels of particulate in the influent water.
Microbiological analysis of unfiltered and filtered water samples from both evaluation sites is summarised in
Tables 2 to 4. Full results are shown in Appendix 1.
Table 2. Summary of microbiological analysis of water samples from the In-house site evaluation of
5 shower POU: percentage of samples positive for the presence of aerobic bacteria and the mean (range)
colony counts
Pre filter installation (n = 15)
Filtered (n = 25)
% Positive
% Positive Mean (range) CFU/mL
Mean (range) CFU/mL
ACC @ 99 ºF (37 ºC)
Immediate
1 min flush
100
100
2516.3 (23 - >3000)
986.6 (13 - >3000)
8
8
11.2 (0-300)
0.1 (0 – 2)
ACC @ 72 ºF (22 ºC)
Immediate
1 min flush
100
100
2703.5 (35 - >3000)
968.1 (2 - >3000)
12
0
0.1 (0 - 2)
0
Note: No Pseudomonas aeruginosa was detected in either unfiltered or filtered water samples from the In-house evaluation site and therefore
results are not included in the summary table.
Table 3. Summary of microbiological analysis of water samples from the Hospital site evaluation of
12 shower POU: percentage of samples positive for the presence of Legionella spp., Pseudomonas
aeruginosa and aerobic bacteria
Pre filter installation (n=34)
% Positive
Legionella spp.30.3
P. aeruginosa 2.9
ACC @ 99 ºF (37 ºC) 91.2
ACC @ 72 ºF (22 ºC)
94.1
Filtered (n=58)
% Positive
Post filter removal (n=10)
% Positive
0
0
13.8
15.5
20.0
0
100
100
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Table 4. Summary of microbiological analysis of water samples from the Hospital site evaluation
of 12 shower POU: mean (range) colony counts of Legionella spp., Pseudomonas aeruginosa and
aerobic bacteria
Pre filter installation (n=34)
Filtered (n=58)
Post filter removal (n=10)
Legionella spp. (CFU/L)
P. aeruginosa (CFU/100 mL)
ACC @ 99 ºF (37 ºC) (CFU/mL)
ACC @ 72 ºF (22 ºC) (CFU/mL)
>1824.4 (0 - >31000)
0.24 (0-8)
>686.4 (0 - >1000)
>648.7 (0 - >1000)
0
0
0.8 (0 – 41)
0.7 (0 – 28)
5 (0-40)
0
>603.6 (26 - >1000)
>572.6 (15 - >1000)
Flow rate data obtained during the evaluation is shown in Figure 1 (A-B) demonstrating that the Filter Capsules
can be used for a period of up to 62 days dependent on the particulate load in the water system.
Figure 1. Flow rates through QPoint Shower Filter Capsules installed In-house and at a Hospital
A. Shower Filter Capsule flow rates – In-house site
OFFICE2-1
OFFICE1-1
OFFICE1-2
OFFICE1-3
OFFICE1-4
B. Shower Filter Capsule flow rates - Hospital site
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Discussion
This evaluation has demonstrated that the Pall QPoint Shower Water Filter Assembly can be used effectively
for up to two calendar months (maximum of 62 days) under routine real life conditions.
In-house site
Microbiological analysis of collected unfiltered and filtered water samples at the In-house site is summarized
in Table 2. P.aeruginosa was not detected in any unfiltered water samples; however there was significant
contamination at all 5 POU by heterotrophic bacteria as indicated by high aerobic colony counts at 72 ºF (22 ºC)
and 99 ºF (37 ºC) incubation temperatures in both immediate and 1 minute flush samples. While there was
significant contamination at the outlet as indicated from immediate unfiltered sample results, the reduced, but
significant counts in the 1 minute unfiltered flush samples were also indicative of systemic contamination of the
water distribution system.
Installation of the QPoint Shower Water Filter Assembly significantly reduced the percentage of bacteria positive
water samples in both immediate and 1 minute flush samples. The mean and range of counts was also
significantly reduced in filtered samples. While the Filter Capsule incorporates a bacteriostatic additive within
the plastic housing material and an inner shield protection device to minimize the risk of retrograde contamination, the extent of such contamination will depend heavily on local environmental factors. This is illustrated by the
observation that one immediate filtered water sample taken 45 days after installation showed an aerobic colony
count at 99 ºF (37 ºC) incubation of 300 CFU/mL. The 1 minute flush sample and all subsequent water samples
at this incubation temperature showed counts of ≤ 1 CFU/mL. This result therefore most likely arose from
environmental retrograde contamination. The incorporation of the bacteriostatic additive is not intended to
replace local hygiene procedures and the device’s instructions for use should always be followed to minimize
the extent of such contamination.
Hospital site
Microbiological analysis of collected unfiltered and filtered water samples at the Hospital is summarized in
Tables 3 and 4. The results from the analysis of unfiltered water samples showed a significant Legionella spp.
and heterotrophic bacteria challenge from the water distribution system. Installation of the QPoint Shower Water
Filter Assembly also significantly reduced the percentage of water samples positive for the presence of bacteria
and the mean and range of counts observed were also significantly reduced. Furthermore, Legionella spp. were
not detected in any filtered water sample. Installation of the QPoint Shower Water Filter Assembly did not have
an adverse effect on systemic water quality as the bacterial concentration in unfiltered samples before and after
the filter installation period was comparable.
Figure 1 shows water flow rates through the Filter Capsules installed at each evaluation site. Flow rate is
dependent on a number of factors including variation in water quality, available pressure and general demand
on the water supply. SDI measurements showed that the water in both the Hospital and Office Building had a
relatively low particulate and colloidal loading.
At the in-house site, water flow through the Filter Capsule was well maintained over the life of the Filter Capsule
with over 80% of the flow observed at day 0 still achieved at day 62 (Figure 1 A).
At the Hospital, over 80% of the flow observed on day 0 was still achieved at day 62 at 8 of the 10 POU that
were installed over the full lifetime of the Filter Capsule. In the remaining 2 POU that were installed for the full
lifetime of the Filter Capsule, over initial 50 % flow was achieved (Figure 1 B). These POU were in an area where
the highest SDI and lowest water pressures were recorded.
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Conclusions
This evaluation report confirms that the Pall QPoint Shower Water Filter Assembly provides an effective barrier to
bacteria from within the water supply and associated biofilm at good flow rates over the Filter Capsule lifetime of
up to 2 calendar months (maximum of 62 days) under real life conditions.
Appendix 1
Table 6. Microbiological analysis of immediate and post 1 minute flush unfiltered and filtered water
samples taken during the evaluation of the QPoint Water Filter – Shower assembly at the In-house site
ACC 99 ºF (37 ºC) CFU/mL
Pre-Filter Installation Filtered
Location
Day -7
Sample
Day 0
Day 0
Day 14 Day 31
OFFICE2-1 Immediate 1 min flush
OFFICE1-1 Immediate 1 min flush
OFFICE1-2 Immediate 1 min flush
OFFICE1-3
Immediate 1 min flush
OFFICE1-4 Immediate 1 min flush
236
927
<1
<1
<1
61
13
<1
<1
2
>3000
>3000
<1
<1
<1
>3000
259
<1
<1
<1
>3000
>3000
<1
3
<1
112
95
<1
<1
<1
>3000
>3000<1<1 <1
207
119
<1
<1
<1
>3000
>3000
<1
<1
<1
>3000
>3000
<1
<1
<1
ACC 72 ºF (22 ºC) CFU/mL
Pre-Filter Installation Filtered
Location
Day -7
Sample
OFFICE2-1Immediate
1 min flush
OFFICE1-1Immediate
1 min flush
OFFICE1-2Immediate
1 min flush
OFFICE1-3
Immediate
1 min flush
OFFICE1-4Immediate
min flush
Day 0
Day 0
Day 14 Day 31
Day 41
Day 45
NA
NA
NA
NA
NA
NA
NA
NA
<1
<1
<1
NA
<1
<1
NA
<1
<1
NA
<1
<1
NA
<1
<1
NA
<1
<1
NA
<1
>300
<1<1
<1
<1
1
<1
NA
<1
<1
NA
<1
Day 41
Day 45
35
>3000
<1
<1
<1
NA
<1
40
2
<1
<1
<1
NA
<1
>3000 >3000
<1
<1
<1
NA
1
>3000
123
<1
<1
<1
NA
<1
>3000 >3000
<1
<1
<1
NA
<1
30
59
<1
<1
<1
NA
<1
>3000
>3000
1<1<1NA 2
308
119
<1
<1
<1
NA
<1
>3000 >3000
<1
<1
<1
<1
<1
>3000
>3000
<1
<1
<1
<1
<1
Note: Samples that have not been collected and analyzed are reported as NA.
6
Day 55 Day 62
Day 55 Day 62
NA
<1
NA
<1
NA
<1
NA
<1
NA
<1
NA
<1
<1
<1
<1
<1
NA
<1
NA
<1
Table 7. Microbiological analysis of post 1 minute flush unfiltered and filtered water samples taken during
the evaluation of the QPoint Water Filter – Shower assembly at the Hospital site
ACC 99 ºF (37 ºC) CFU/mL
Pre filter installation
Filtered
Post filter removal
Location
Site survey
Day 0
Day 0
Day -7
Day 0
Day 14
Day 30
Day 44
Day 62
HOSPA2-1 >1000
>1000>1000ND ND
ND
ND
ND
330
HOSPA2-2a >1000
>1000 >1000 ND
FC removed at Day 14 due to shower hose leak
HOSPA2-2bNA
NA
2
1
ND
ND
1
ND
26
HOSPA2-3
>1000
>1000 >1000 ND
ND
ND
ND
Removed due to visible external
contamination
HOSPA2-4 >1000
>1000>1000ND ND
ND
ND
ND
>1000
HOSPA3-1
>1000 520>1000
ND
1 NDNDND>1000
HOSPA3-2
250
980230NDND ND ND ND 480
HOSPA3-3 >1000
>1000>1000ND ND
ND
1
ND
>1000
HOSPA3-4 >1000
>1000>1000ND 1
ND
ND
ND
>1000
HOSPA1-1
NA
ND14ND
ND NDNDND40
HOSPA1-2
NA
13035ND
1 1 NDND160
HOSPA1-3a NA
ND
ND
ND
FC removed at Day 14 due to shower hose leak
HOSPA1-3b NA
NA
140
ND
ND
Removed at Day 30 due to visible external contamination
HOSPA1-4 NA
>100038
ND ND
ND
ND
41
>1000
ACC 72 ºF (22 ºC) CFU/mL
Pre filter installation
Filtered
Post filter removal
Location
Site survey
Day 0
Day 0
Day -7
Day 0
Day 14
Day 30
Day 44
Day 62
HOSPA2-1
>1000 >1000
720ND
ND NDNDND120
HOSPA2-2a >1000
>1000 >1000 ND
FC removed at Day 14 due to shower hose leak
HOSPA2-2b
NA
NANDND
ND NDNDND15
HOSPA2-3
460
>1000 >1000 ND
ND
ND
ND
Removed due to visible external
contamination
HOSPA2-4
>1000 5801501 ND ND ND 3 >1000
HOSPA3-1
>1000 140>1000
ND
ND NDNDND>1000
HOSPA3-2 >1000
>1000>1000ND ND
ND
ND
1
660
HOSPA3-3 320
>1000>1000ND ND
ND
ND
ND
>1000
HOSPA3-4 >1000
>1000>1000ND 1
ND
ND
ND
>1000
HOSPA1-1NA
ND 34 1 ND 1
ND 2
21
HOSPA1-2
NA
8253ND
ND NDNDND110
HOSPA1-3a NA
1
8
ND
FC removed at Day 14 due to shower hose leak
HOSPA1-3b NA
NA
66
ND
ND
Removed at Day 30 due to visible external contamination
HOSPA1-4 NA
>1000440 ND ND
ND
1
28
800
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Pseudomonas aeruginosa CFU/100 mL
Pre filter installation
Filtered
Post filter removal
Location
Site survey
Day 0
Day 0
Day -7
Day 0
Day 14
Day 30
Day 44
Day 62
HOSPA2-1
ND
NDNDNDND ND NDNDND
HOSPA2-2a ND
ND
ND
ND
FC removed at Day 14 due to shower hose leak
HOSPA2-2b
NA
NANDND
ND NDNDNDND
HOSPA2-3
ND
ND
ND
ND
ND
ND
ND
Removed at Day 62 due to visible
external contamination
HOSPA2-4
ND
NDNDNDND ND NDNDND
HOSPA3-1
ND
NDNDNDND ND NDNDND
HOSPA3-2
ND
NDNDNDND ND NDNDND
HOSPA3-3
ND
NDNDNDND ND NDNDND
HOSPA3-4
ND
NDNDNDND ND NDNDND
HOSPA1-1
NA
NDNDNDND ND NDNDND
HOSPA1-2
NA
NDNDNDND ND NDNDND
HOSPA1-3a NA
HOSPA1-3b NA
HOSPA1-4
NA
ND
8
ND
FC removed at Day 14 due to shower hose leak
NA
ND
ND
ND
Removed at Day 30 due to visible external contamination
NDNDNDND ND NDNDND
Legionella sp. CFU/L
Pre filter installation
Filtered
Post filter removal
Location
Site survey
Day 0
Day 0
Day -7
Day 0
Day 14
Day 30
Day 44
Day 62
HOSPA2-1
<10
<1030 <10
<10 <10<10<1010
HOSPA2-2a <10
40
50
<10
FC removed at Day 14 due to shower hose leak
HOSPA2-2b
NA
NA <10<10
<10 <10<10<10<10
HOSPA2-3
<10
<10
40
<10
<10
<10
<10
Removed due to visible external
contamination
HOSPA2-4
<10
20 20 <10
<10 <10<10<10<10
HOSPA3-1
<10
<1031000
<10
<10 <10<10<10<10
HOSPA3-2
<10
>1000
27000
<10
<10 <10<10<1040
HOSPA3-3
<10
<10<10<10
<10 <10 <10<10<10
HOSPA3-4
<10
NR >1000
<10
<10 <10<10<10<10
HOSPA1-1
NA
<10<10<10
<10 <10 <10<10<10
HOSPA1-2
NA
<10<10<10
<10 <10 <10<10<10
HOSPA1-3a NA
<10
<10
<10
FC removed at Day 14 due to shower hose leak
HOSPA1-3b NA
NA
<10
<10
<10
Removed at Day 30 due to visible external contamination
HOSPA1-4
NA
<10<10<10
<10 <10 <10<10<10
Note: Where bacteria have not been detected in filtered water samples, data has been reported as below the
level of sensitivity of the test method used by the laboratory conducting microbiological analysis and is recorded
as “ND” for aerobic colony counts and P. aeruginosa or “< 10” for Legionella spp. Samples that have not been
collected and analysed are reported as NA. NR refers to no result due to a laboratory incident. FC refers to
Filter Capsule.
8
At 2 Hospital POU, leaks from split shower hoses (not related to QPoint Assembly use) developed after 6 days
of QPoint Shower Water Filter Assembly installation that necessitated removal and replacement. This action
prompted replacement of the existing Filter Capsule according to Instructions for Use due to the potential for
Filter Capsule contamination whilst handling and air entrainment. Furthermore, 2 Filter Capsules were removed
due to visible external contamination as per Instructions for Use; one after 28 days installation and one after
58 days and therefore the full 62 day installation period was not completed at these 2 outlets. All results, including
those from Filter Capsules that were not installed for the full 62 days have been included in the results analysis
in tables 2 to 4 since all operations have been made according to Instructions for Use and the Filter Capsule is
indicated for use for up to 62 days.
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The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be
subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.
© 2016 Pall Corporation. Pall,
and QPoint are trademarks of Pall Corporation. ® indicates a trademark
registered in the USA. TM indicates a common law trademark.
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