In-Use Evaluation Report

In-Use Evaluation Report 160127.3WIN Pall QPoint TM Shower Water Filter Assembly Reusable Docking Station - Shower Assembly (QDS) and Disposable Filter Capsule for up to 62 Day Use - Shower (QR212 and QR22) QPoint - More than Filtration

Introduction The Pall QPoint Shower Water Filter Assembly has been designed to provide effective protection from microorganisms 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 (QR212, QR22). 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 sterilising grade filters. Furthermore, retention of other waterborne microorganisms such as Legionella pneumophila, Pseudomonas aeruginosa, Escherichia coli, Cryptosporidium parvum, Mycobacterium gordonae and Aspergillus fumigatus has been demonstrated in laboratory testing. The Filter Capsule incorporates a bacteriostatic additive and inner shield protection device to minimise 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 from 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 22 C and at 37 C. 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 22 C and at 37 C. 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 OFFICE1 2.9 6.0 OFFICE2 2.5 4.6 HOSPA1 3.4 3.3 HOSPA2 0.8 (HOSPA2-3) 6.1 1.8 (HOSPA2-1) nd HOSPA3 2.4 <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 ACC @ 37 C Pre filter installation (n = 15) Filtered (n = 25) % Positive Mean (range) CFU/mL % Positive Mean (range) CFU/mL Immediate 100 2516.3 (23 - >3000) 8 11.2 (0-300) 1 min flush 100 986.6 (13 - >3000) 8 0.1 (0 2) ACC @ 22 C Immediate 100 2703.5 (35 - >3000) 12 0.1 (0-2) 1 min flush 100 968.1 (2 - >3000) 0 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) Filtered (n=58) Post filter removal (n=10) % Positive % Positive % Positive Legionella spp. 30.3 0 20.0 P. aeruginosa 2.9 0 0 ACC @ 37 C 91.2 13.8 100 ACC @ 22 C 94.1 15.5 100 www.pall.com/medical 3

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) >1824.4 (0 - >31000) 0 5 (0-40) P. aeruginosa (CFU/100 ml) 0.24 (0-8) 0 0 ACC @ 37 C (CFU/mL) >686.4 (0 - >1000) 0.8 (0 41) >603.6 (26 - >1000) ACC @ 22 C (CFU/mL) >648.7 (0 - >1000) 0.7 (0 28) >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 4

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 summarised 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 22 ºC and 37 C 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. Whilst the Filter Capsule incorporates a bacteriostatic additive within the plastic housing material and an inner shield protection device to minimise 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 37 C 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 minimise the extent of such contamination. Hospital site Microbiological analysis of collected unfiltered and filtered water samples at the Hospital is summarised 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. www.pall.com/medical 5

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 37 C CFU/mL Pre-Filter Installation Filtered Location Sample Day -7 Day 0 Day 0 Day 14 Day 31 Day 41 Day 45 Day 55 Day 62 OFFICE2-1 Immediate 236 927 <1 <1 <1 NA <1 NA <1 1 min flush 61 13 <1 <1 2 NA <1 NA <1 OFFICE1-1 Immediate >3000 >3000 <1 <1 <1 NA <1 NA <1 1 min flush >3000 259 <1 <1 <1 NA <1 NA <1 OFFICE1-2 Immediate >3000 >3000 <1 3 <1 NA <1 NA <1 1 min flush 112 95 <1 <1 <1 NA <1 NA <1 OFFICE1-3 Immediate >3000 >3000 <1 <1 <1 NA >300 <1 <1 1 min flush 207 119 <1 <1 <1 NA <1 <1 1 OFFICE1-4 Immediate >3000 >3000 <1 <1 <1 <1 <1 NA <1 1 min flush >3000 >3000 <1 <1 <1 <1 <1 NA <1 ACC 22 C CFU/mL Pre-Filter Installation Filtered Location Sample Day -7 Day 0 Day 0 Day 14 Day 31 Day 41 Day 45 Day 55 Day 62 OFFICE2-1 Immediate 35 >3000 <1 <1 <1 NA <1 NA <1 1 min flush 40 2 <1 <1 <1 NA <1 NA <1 OFFICE1-1 Immediate >3000 >3000 <1 <1 <1 NA 1 NA <1 1 min flush >3000 123 <1 <1 <1 NA <1 NA <1 OFFICE1-2 Immediate >3000 >3000 <1 <1 <1 NA <1 NA <1 1 min flush 30 59 <1 <1 <1 NA <1 NA <1 OFFICE1-3 Immediate >3000 >3000 1 <1 <1 NA 2 <1 <1 1 min flush 308 119 <1 <1 <1 NA <1 <1 <1 OFFICE1-4 Immediate >3000 >3000 <1 <1 <1 <1 <1 NA <1 min flush >3000 >3000 <1 <1 <1 <1 <1 NA <1 Note: Samples that have not been collected and analysed are reported as NA. 6

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 37 C CFU/mL Pre filter installation Filtered Post filter removal Location Site survey Day -7 Day 0 Day 0 Day 14 Day 30 Day 44 Day 62 Day 0 HOSPA2-1 >1000 >1000 >1000 ND ND ND ND ND 330 HOSPA2-2a >1000 >1000 >1000 ND FC removed at Day 14 due to shower hose leak HOSPA2-2b NA 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 >1000 ND ND ND ND ND >1000 HOSPA3-1 >1000 520 >1000 ND 1 ND ND ND >1000 HOSPA3-2 250 980 230 ND ND ND ND ND 480 HOSPA3-3 >1000 >1000 >1000 ND ND ND 1 ND >1000 HOSPA3-4 >1000 >1000 >1000 ND 1 ND ND ND >1000 HOSPA1-1 NA ND 14 ND ND ND ND ND 40 HOSPA1-2 NA 130 35 ND 1 1 ND ND 160 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 >1000 38 ND ND ND ND 41 >1000 ACC 22 C CFU/mL Pre filter installation Filtered Post filter removal Location Site survey Day -7 Day 0 Day 0 Day 14 Day 30 Day 44 Day 62 Day 0 HOSPA2-1 >1000 >1000 720 ND ND ND ND ND 120 HOSPA2-2a >1000 >1000 >1000 ND FC removed at Day 14 due to shower hose leak HOSPA2-2b NA NA ND ND ND ND ND ND 15 HOSPA2-3 460 >1000 >1000 ND ND ND ND Removed due to visible external contamination HOSPA2-4 >1000 580 150 1 ND ND ND 3 >1000 HOSPA3-1 >1000 140 >1000 ND ND ND ND ND >1000 HOSPA3-2 >1000 >1000 >1000 ND ND ND ND 1 660 HOSPA3-3 320 >1000 >1000 ND ND ND ND ND >1000 HOSPA3-4 >1000 >1000 >1000 ND 1 ND ND ND >1000 HOSPA1-1 NA ND 34 1 ND 1 ND 2 21 HOSPA1-2 NA 82 53 ND ND ND ND ND 110 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 >1000 440 ND ND ND 1 28 800 www.pall.com/medical 7

Pseudomonas aeruginosa CFU/100 ml Pre filter installation Filtered Post filter removal Location Site survey Day -7 Day 0 Day 0 Day 14 Day 30 Day 44 Day 62 Day 0 HOSPA2-1 ND ND ND ND ND ND ND ND ND HOSPA2-2a ND ND ND ND FC removed at Day 14 due to shower hose leak HOSPA2-2b NA NA ND ND ND ND ND ND ND HOSPA2-3 ND ND ND ND ND ND ND Removed at Day 62 due to visible external contamination HOSPA2-4 ND ND ND ND ND ND ND ND ND HOSPA3-1 ND ND ND ND ND ND ND ND ND HOSPA3-2 ND ND ND ND ND ND ND ND ND HOSPA3-3 ND ND ND ND ND ND ND ND ND HOSPA3-4 ND ND ND ND ND ND ND ND ND HOSPA1-1 NA ND ND ND ND ND ND ND ND HOSPA1-2 NA ND ND ND ND ND ND ND ND HOSPA1-3a NA ND 8 ND FC removed at Day 14 due to shower hose leak HOSPA1-3b NA NA ND ND ND Removed at Day 30 due to visible external contamination HOSPA1-4 NA ND ND ND ND ND ND ND ND Legionella sp. CFU/L Pre filter installation Filtered Post filter removal Location Site survey Day -7 Day 0 Day 0 Day 14 Day 30 Day 44 Day 62 Day 0 HOSPA2-1 <10 <10 30 <10 <10 <10 <10 <10 10 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 <10 31000 <10 <10 <10 <10 <10 <10 HOSPA3-2 <10 >1000 27000 <10 <10 <10 <10 <10 40 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. Visit us on the Web at www.pall.com/medical Pall International Sàrl Avenue de Tivoli 3 1700 Fribourg Switzerland +41 (0)26 350 53 00 phone LifeSciences.EU@pall.com email Pall Filtration Pte Ltd. 1 Science Park Road, #05-09/15 East Wing, The Capricorn Singapore Science Park II, Singapore 117528 +65 6389 6500 phone sgcustomerservice@pall.com email International Offices Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, Spain, 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 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. This document is not for distribution in the USA. 2016 Pall Corporation. Pall, and QPoint are trademarks of Pall Corporation. indicates a trademark registered in the USA. TM indicates a common law trademark. QPoint - More than Filtration 4/16, PDF, GN160127.3WIN 160127.3WIN www.pall.com/medical 9