Field Evaluation Report Pall QPointTM Tap Water Filter Assembly Reusable Docking Station - Tap Assembly (QDTC) and Disposable Filter Capsule for 62 Day Use - Tap (QJ212U and QJ22U) QPoint - More than Filtration 12.8216USa Introduction The Pall QPoint Tap Water Filter Assembly consists of two components, a non-sterile, reusable Docking Station (QDTC) and a sterile disposable Filter Capsule with a jet outlet (QJ212U, QJ22U). The Filter Capsule may be used for a maximum of two calendar months (62 days) and has been validated to industry standard laboratory liquid microbial challenge tests using Brevundimonas diminuta for validating 0.2 μm sterilizing grade filters. As part of the validation process, field evaluation sites were selected throughout Europe to assess the performance of the QPoint Tap Water Filter Assembly with a variety of influent water quality throughout the 2 months use. This report details performance at locations in France, Germany, Spain and the United Kingdom. Materials and Methods A total of 35 points of use (POU) at sites in France, Germany, Spain and the United Kingdom were identified for installation of filters. A study of 27 POU across France, Germany and the United Kingdom was conducted to assess removal of microorganisms from the water supply and water flow through the Filter Capsule over 2 months use. A second study of 8 POU, at a location in Spain where particulate and colloidal loading of the water supply was high, considered water flow characteristics through the Filter Capsule over time. Prior to initiating the study, a survey of each evaluation site was undertaken to identify any systemic water treatments in place, routine hygiene practices and general environmental conditions. Water quality was assessed by a silt density index test to obtain an arbitrary measure of particulate and colloidal material within the water. Static water pressures were also recorded. In addition, water samples were collected after a 1 minute flush for microbiological analysis for Pseudomonas aeruginosa, Legionella spp. and aerobic colony count at 20-22°C and at 36-37°C (France, Germany and United Kingdom only). Evaluation sites were provided with appropriate Quick Connect Adaptors, QPoint Docking Stations – Tap Assembly with Quick Connect Inlet and QPoint Filter Capsules with a jet outlet. Throughout the 62 day Filter Capsule installation period, water samples were collected after a 1 minute flush for microbiological analysis for Pseudomonas aeruginosa, Legionella spp., and aerobic colony count at 20-22°C and at 36-37°C (France, Germany and United Kingdom only). Flow rates from each POU were also monitored. Following Filter Capsule removal, further water samples were taken for microbiological analysis (France, Germany and United Kingdom only) to assess the effect of filter installation on the systemic water supply. 2 Results Static pressure and Silt Density Index (SDI) measurements are shown in Table 1. Table 1. Summary of static water pressure and SDI results Water Pressure (bar) SDI Site Cold Hot Mixed Cold Hot Mixed France (FR) nd nd nd <6 nd n/a Germany (DE) 5.5 5.3 n/a 8 7 n/a United Kingdom (UK) n/a n/a 3.7 n/a n/a 2 Spain (ES) 4.1 4.4 n/a 27 32 n/a nd = not determined n/a = not applicable 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. Microbiological analysis of unfiltered and filtered water samples is summarized in Tables 2 and 3. Full results are shown in Appendix 1. Table 2. Summary of microbiological analysis of water samples: percentage of samples positive for the presence of Legionella spp., Pseudomonas aeruginosa and aerobic bacteria % Positive samples prior to filter installation (n=81) % Positive samples filtered (n=135) % Positive samples post filter removal (n=54) Legionella spp. 6.2 0.0* 3.7 P. aeruginosa 0.0 0.0 0.0 24.7 7.4+ 13.0 33.3 17.8+ 25.9 ACC @ 20 - 22°C ACC @ 36 - 37°C Table 3. Summary of microbiological analysis of water samples: mean (range) colony counts of Legionella spp., Pseudomonas aeruginosa and aerobic bacteria Prior to filter installation (n=81) Filtered (n=135) Post filter removal (n=54) Legionella spp. (CFU/L) 55.4 (0-2600) 0* 0.4 (0-160) P. aeruginosa (CFU/100 mL) 0 0 0 ACC @ 20 - 22°C (CFU/mL) 4.4 (0-278) 0.3 (0-18.0)+ 13.3 (0->300) 9.6 (0-220) 1.1 (0-32.0)+ 8.1 (0->300) ACC @ 36 - 37°C (CFU/mL) *+ For full details refer to Appendix 1 Flow rate data obtained during the field evaluation is shown in Figure 1 (A-D) demonstrating that the Filter Capsules can be used for a period of up to 62 days dependent on water quality. www.pall.com 3 Figure 1. Flow rates through QPoint Filter Capsules installed at locations in France, Germany, Spain and the United Kingdom A Tap Filter Capsule flow rates - France evaluation B Tap Filter Capsule flow rates - Germany evaluation 4 C Tap Filter Capsule flow rates - Spain evaluation D Tap Filter Capsule flow rates - UK evaluation www.pall.com 5 Discussion This field evaluation has demonstrated that the Pall QPoint Tap Water Filter Assembly can be used effectively for up to two calendar months (maximum of 62 days) under routine conditions. 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 French, German and UK field evaluation sites had a lower particulate and colloidal loading than the water at the evaluation site in Spain (Table 1). At French, German and UK sites, 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, B and D). Even at the test site in Spain, where there was an exceptionally high particulate and colloidal loading in the water, flow through the Filter Capsule could be maintained to a usable level (Figure 1, C) for up to the conclusion of the 41 day evaluation period. This compares favorably to existing POU water filters which will typically only provide an acceptable flow for a maximum of 7 days in the same environment. Microbiological analysis of collected unfiltered and filtered water samples is summarized in Tables 2 and 3. The results in Table 2 demonstrate that the percentage of water samples positive for the presence of microorganisms is significantly reduced by the installation of the QPoint Tap Water Filter Assembly. The mean and range of counts observed is also significantly reduced by the installation of the QPoint Tap Water Filter Assembly (Table 3). Full data tables are presented in Appendix 1, Tables 4 – 7. Furthermore, installation of Pall QPoint Tap Water Filter Assembly did not have an adverse effect on systemic water quality as “pre-filter installation” and “post filter removal” was comparable. While the Filter Capsule incorporates a bacteriostatic additive within the plastic housing material and inner shield protection to minimize the risk of retrograde contamination, the extent of such contamination will depend heavily on local environmental factors. 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. Conclusions This field evaluation report confirms that the Pall QPoint Tap Water Filter Assembly provides an effective barrier to bacteria 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). 6 Appendix 1 Table 4. Pseudomonas aeruginosa (CFU/100 mL) in unfiltered and filtered water samples Pre filter installation Filtered Post filter removal POU Day -28 Day -7 Day 0 Day 0 Day 14 Day 31 Day 45 Day 63 Day 0 Day 7 FR 1 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 FR 2 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 FR 3 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 Pre filter installation Filtered Post filter removal POU Day -12 Day -7 Day 0 Day 0 Day 14 Day 30 Day 44 Day 62 Day 0 Day 7 DE 1 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 2 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 3 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 4 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 5 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 6 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 7 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 8 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 9 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 10 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 11 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 12 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 13 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 14 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 15 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 16 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 17 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 Pre filter installation Filtered Post filter removal POU Day -14 Day -7 Day 0 Day 0 Day 14 Day 33 Day 47 Day 62 Day 0 Day 7 UK 1 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 UK 2 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 UK 3 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 UK 4 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 UK 5 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 UK 6 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 UK 7 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 Note: Where microorganisms 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 “<”. www.pall.com 7 Table 5. Legionella spp. (CFU/L) in unfiltered and filtered water samples. Pre filter installation Filtered Post filter removal POU Day -28 Day -7 Day 0 Day 0 Day 14 Day 31 Day 45 Day 63 Day 0 Day 7 FR 1 <250 <250 <250 <250 <250 <250 <250 <250 <250 <250 FR 2 <250 <250 2600 <250 <250 <250 <250 <250 <250 <250 FR 3 500 <250 <250 <250 <250 <250 <250 <250 <250 <250 Pre filter installation Filtered Post filter removal POU Day -12 Day -7 Day 0 Day 0 Day 14 Day 30 Day 44 Day 62 Day 0 Day 7 DE 1 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 2 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 3 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 4 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 5 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 6 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 7 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 8 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 9 680 390 320 <1 <1 <1 <1 <1 80 160 DE 10 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 11 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 12 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 13 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 14 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 15 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 16 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 17 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 Pre filter installation Filtered Post filter removal POU Day -14 Day -7 Day 0 Day 0 Day 14 Day 33 Day 47 Day 62 Day 0 Day 7 UK 1 <50 <50 <50 <50 <50 <50 <50 <50 <50 <50 UK 2 <50 <50 <50 <50 <50 <50 <50 <50 <50 <50 UK 3 <50 <50 <50 <50 <50 <50 <50 <50 <50 <50 UK 4 <50 <50 <50 <50 <50 <50 <50 <50 <50 <50 UK 5 <50 <50 <50 <50 <50 <50 <50 <50 <50 <50 UK 6 <50 <50 <50 <50 <50 (100*) <50 <50 <50 <50 <50 UK 7 <50 <50 <50 <50 <50 <50 <50 <50 <50 <50 * Legionella spp. was detected in one filtered water sample. It was not detected on re-sample of that POU and was not detected in subsequent samples. Inadvertent contamination may have occurred due to maintenance to the plumbing system at that location during the sampling period. The Filter Capsule installed at that POU was confirmed to be integral at the end of the evaluation. This result has therefore been excluded from the data analysis, potentially arising from environmental contamination. Note: Where microorganisms 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 “<”. 8 Table 6. Aerobic colony counts (CFU/mL) at 20 – 22 °C in unfiltered and filtered water samples Pre filter installation Filtered Post filter removal POU Day -28 Day -7 Day 0 Day 0 Day 14 Day 31 Day 45 Day 63 Day 0 Day 7 FR 1 <1 <1 <1 <1 <1 <1 <1 <1 15 <1 FR 2 3 1 <1 1 <1 <1 1 <1 >300 <1 FR 3 <1 1 1 <1 <1 <1 <1 <1 >300 <1 Pre filter installation Filtered Post filter removal POU Day -12 Day -7 Day 0 Day 0 Day 14 Day 30 Day 44 Day 62 Day 0 Day 7 DE 1 <1 <1 <1 <1 <1 <1 5 (123)+ <1 <1 <1 DE 2 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 3 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 4 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 5 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 6 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 7 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 8 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 9 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 10 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 11 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 12 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 13 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 14 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 15 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 16 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 17 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 Pre filter installation Filtered Post filter removal POU Day -14 Day -7 Day 0 Day 0 Day 14 Day 33 Day 47 Day 62 Day 0 Day 7 UK 1 <1 <1 4 <1 <1 <1 <1 <1 <1 1 UK 2 6 2 3 <1 <1 <1 <1 1 <1 2 UK 3 2 1 7 <1 <1 <1 2 1 <1 <1 UK 4 2 3 5 <1 5 <1 1 <1 <1 37 UK 5 3 <1 7 <1 18 <1 <1 <1 <1 <1 UK 6 <1 <1 5 <1 <1 <1 <1 <1 <1 <1 UK 7 20 <1 278 <1 <1 <1 <1 1 <1 62 + ACC @ 20-22 °C > 100 CFU/mL was detected in one filtered water sample. On re-sampling and in subsequent samples, counts were < 10 CFU/mL. Furthermore, the Filter Capsule installed at that POU was confirmed to be integral at the end of the evaluation. This result has therefore been excluded from the data analysis potentially arising from environmental contamination. Note: Where microorganisms 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 “<”. www.pall.com 9 Table 7. Aerobic colony counts (CFU/mL) at 36 – 37 °C in unfiltered and filtered water samples Pre filter installation Filtered Post filter removal POU Day -28 Day -7 Day 0 Day 0 Day 14 Day 31 Day 45 Day 63 Day 0 Day 7 FR 1 5 <1 <1 <1 1 <1 <1 <1 34 <1 FR 2 <1 <1 <1 1 1 1 <1 <1 >300 14 FR 3 220 1 <1 <1 3 <1 <1 1 11 9 Pre filter installation Filtered Post filter removal POU Day -12 Day -7 Day 0 Day 0 Day 14 Day 30 Day 44 Day 62 Day 0 Day 7 DE 1 1 <1 <1 <1 <1 <1 3 (151)+ <1 <1 <1 DE 2 3 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 3 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 4 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 5 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 6 1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 7 <1 <1 <1 <1 <1 <1 13 <1 <1 <1 DE 8 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 9 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 10 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 11 <1 <1 <1 <1 <1 24 <1 <1 <1 <1 DE 12 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 13 <1 <1 21 <1 <1 <1 <1 <1 <1 <1 DE 14 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 15 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 16 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 DE 17 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 Pre filter installation Filtered Post filter removal POU Day -14 Day -7 Day 0 Day 0 Day 14 Day 33 Day 47 Day 62 Day 0 Day 7 UK 1 8 2 8 <1 1 <1 <1 6 1 12 UK 2 45 39 95 <1 1 <1 14 <1 1 9 UK 3 8 <1 5 <1 32 <1 3 14 <1 1 UK 4 21 7 14 <1 2 <1 <1 9 1 4 UK 5 37 14 16 <1 2 <1 <1 11 <1 <1 UK 6 15 43 18 <1 2 <1 5 <1 <1 38 UK 7 89 13 25 <1 <1 <1 1 2 <1 4 + ACC @ 36-37 °C > 100 CFU/mL was detected in one filtered water sample. On re-sampling and in subsequent samples, counts were < 10 CFU/mL. Furthermore, the Filter Capsule installed at that POU was confirmed to be integral at the end of the evaluation. This result has therefore been excluded from the data analysis potentially arising from environmental contamination. Note: Where microorganisms 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 “<”. 10 Pall Corporate Headquarters 25 Harbor Park Drive Port Washington NY 11050 (877) 367-7255 phone pouwater.us@pall.com email Visit us on the Web at www.pall.com 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. © 2015 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 5/15, PDF, GN15.9740 12.8216USa