Pall Kleenpak Disposable Shower Head Filter (KAQF4) Field Evaluation Report

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1 Technical Report Pall Kleenpak Disposable Shower Head Filter (KAQF4) Field Evaluation Report Vanessa Merefield. Scientific & Laboratory Services (SLS), Pall Life Sciences, Portsmouth, UK Introduction Pall Kleenpak Disposable Shower Head Filters (KAQF4) are designed to remove bacteria, protozoa and fungi from the water supply for up to one calendar month (maximum of 31 days), and have been validated for microbial removal using Brevundimonas diminuta 1. The products incorporate a bacteriostatic additive within the plastic housing material to minimise the risk of inadvertent retrograde contamination. As part of the validation process, one field evaluation site was selected to assess the performance of a filter, (ie AQF4) that uses identical media, materials of construction and manufacturing processes, with a variety of influent water qualities throughout the duration of use. This report details the feedback received from 30 points of use at one site during the evaluation period. Methods & Materials One evaluation site in Germany was supplied with sufficient filters and appropriate connectors. A total of 30 water outlet points (across 4 different locations) were equipped with filters during the evaluation. The external surfaces of the filter and connectors may be cleansed using sanitising agents containing alcohol, quaternary ammonium compounds, benzyl ammonium chlorides, iodides and non-ionic surfactants, either as part of a standard cleaning regimen or more frequently if an area is of increased risk of environmental contamination. During this evaluation, the filters were not surface sanitised during the month of use. Prior to installing the filters, general water quality with respect to filterability was assessed by performing a silt density index (SDI) test 2. The SDI value was calculated from the blockage rate of a 0.45 µm membrane, giving an arbitrary measure of water quality in terms of particulates and colloidal materials. Static water pressures were also recorded. Flow rates from each filter were monitored at the beginning and end of the evaluation. In addition, water samples were collected for microbiological analysis.

2 Results Water quality and static pressure are shown in Table 1, data was obtained from four different locations (A D) within the building. Table 1 Static Water Pressure and SDI Results Water Pressure (bar) Water Quality Site POU Ref Cold Hot Typical SDI Value A B C 5 17 nd nd 5.2 D nd = no data Higher SDI values are indicative of higher particulate loading, and these may vary from day to day, depending on a range of factors such as environmental conditions, maintenance or building works etc. Examples of flow rate data obtained during the field evaluation are shown in Appendix 1 (Figures 1 and 2), demonstrating that the filters can be used for a period of up to one calendar month. A summary of results from microbiological analysis is shown in Table 2, demonstrating effective retention of micro-organisms found within the water supply over 31 days use. Full results are shown in Appendix 2 (Tables 3 6). Table 2 Summary of Microbiological Data Unfiltered (n = 90) 31 Days (n = 30) % of Positive Data Points % of Positive Data Points Legionella spp.* Pseudomonas spp C > 100 CFU/mL C > 100 CFU/mL Unfiltered (n = 90) 31 Days (n = 30) Actual Data Actual Data 22 C Mean CFU/mL C Range CFU/mL C Mean CFU/mL > C Range CFU/mL 0 > CFU = colony forming unit * = all positive results identified as Legionella pneumophila, serogroup 1 Discussion This field evaluation has demonstrated that Pall Kleenpak Water Filters (KAQF4) can be used for up to one calendar month (maximum of 31 days) in the field. Figures 1 and 2 show the flow rates from the filters. It should be noted that flow rate can be dependent on several factors including constant variations in water quality and available pressure, and general demand on the water supply. 2

3 Data in Tables 2 and 4 6 illustrate the microbiological quality of unfiltered water samples at the time of the evaluation period, clearly demonstrating the microbial variability within the influent water between different water outlet points. Tables 2 and 3 show the microbial results of water samples collected post-filtration. Whilst the filters incorporate a bacteriostatic additive within the plastic housing material to minimise the risk of retrograde contamination, the extent of such contamination will depend heavily on local environmental factors. To summarise, the data in Tables 2 6 confirm that the filters are capable of retaining bacteria found within the water supply, and with minimised risk of retrograde microbial contamination. It is important to note that the bacteriostatic additive within the housing material is not intended to replace local hygiene procedures, and the product's instructions for use should always be followed to minimise the extent of such contamination. Conclusion This field evaluation report confirms that Pall Kleenpak Disposable Shower Head Filters (KAQF4) provide an effective barrier to bacteria within the water supply, with minimised risk of inadvertent retrograde contamination, for up to one calendar month (maximum of 31 days). References 1. Validation Guide. Pall Kleenpak Disposable Shower Head Filter (KAQF4) Literature code Pall Laboratory Standard Method (MED LSM 076) Silt Density Index (SDI) Testing Appendix 1 Figure 1 Flow Rate Data (POU 1 15) Water Pressure Approximately bar Flow Rate (L/min) Day 0 No Filter Day 0 Filter Day 31 Filter Sample Time Point POU 1 POU 2 POU 3 POU 4 POU 5 POU 6 POU 7 POU 8 POU 9 POU 10 POU 11 POU 12 POU 13 POU 14 POU 15 Figure 2 Flow Rate Data (POU 16 30) Water Pressure Approximately bar Flow Rate (L/min) Day 0 No Filter Day 0 Filter Day 31 Filter Sample Time Point POU 16 POU 17 POU 18 POU 19 POU 20 POU 21 POU 22 POU 23 POU 24 POU 25 POU 26 POU 27 POU 28 POU 29 POU

4 Appendix 2 Table 3 Microbiological Results (FILTERED) Water Samples Taken Downstream of Filter on Day 31 Day 31 (Filtered) Legionella spp. Pseudomonas spp. POU Ref (CFU/100mL) (CFU/100 ml) 22 C (CFU/mL) 36 C (CFU/mL) CFU = colony forming units 4

5 Table 4 Microbiological Results (UNFILTERED) Water Samples Taken Prior to Filter Use on Day -7 Day -7 (Unfiltered) Legionella spp. Pseudomonas spp. POU Ref (CFU/100mL) (CFU/100 ml) 22 C (CFU/mL) 36 C (CFU/mL) > CFU = colony forming units 5

6 Table 5 Microbiological Results (UNFILTERED) Water Samples Taken Upstream of Filter on Day 0 Day 0 (Unfiltered) Legionella spp. Pseudomonas spp. POU Ref (CFU/100mL)* (CFU/100 ml) 22 C (CFU/mL) 36 C (CFU/mL) CFU/mL CFU = colony forming units * = unless otherwise stated 6

7 Table 6 Microbiological Results (UNFILTERED) Water Samples Taken Upstream of Filter on Day 31 Day 31 (Unfiltered) Legionella spp. Pseudomonas spp. POU Ref (CFU/100mL) (CFU/100 ml) 22 C (CFU/mL) 36 C (CFU/mL) CFU = colony forming units 7

8 Visit us on the Web at Pall International Sàrl Avenue de Tivoli Fribourg, Switzerland LifeSciences.EU@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, South Africa, 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 and Canada. 2010, Pall Europe. Pall, and Kleenpak are trademarks of Pall Corporation. indicates a trademark registered in the USA and TM indicates a common law trademark. Filtration. Separation. Solution. is a service mark of Pall Corporation. 08/10, PDF, GN

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