Technical Report 160209.1WGL Chemical Compatibility of the Pall QPoint TM Filter Capsule - Rose Outlet with Systemic Water Treatments QPoint - More than Filtration
1.0 Background A wide variety of systemic chemical treatments are used globally as part of a multi-barrier approach to control microbial contamination within water supplies of hospitals and other large public and private buildings. Such treatments are often used in conjunction with point-of-use water filters. Therefore point-of-use water filters need to be compatible with systemic chemical disinfection. The Pall QPoint Shower Water Filter Assembly consists of a chromed reusable Docking Station, designed to fit all standard shower hose outlets, and a disposable Filter Capsule with rose outlet. The Pall QPoint Filter Capsule (Figure 1) is indicated to remove bacteria, protozoa, fungi and particles from the water supply for up to 2 calendar months (maximum 62 days). The Filter Capsule is supplied sterile. Figure 1 Pall QPoint Filter Capsule Tests to confirm compatibility of the QPoint Filter Capsule with common systemic chemical treatments are documented within this report. The Docking Station can also come into contact with surface disinfectants and specific compatibility with these chemicals is documented in report 160127.2WGL. Compatibility testing involves subjecting Filter Capsules that have been exposed to a selected chemical treatment to a non-destructive integrity test which is correlated with bacterial retention. Tests to demonstrate compatibility of the QPoint Filter Capsule with active chlorine (continuous treatment at <7 ppm and/or 1 hour shock treatment at 100 ppm), ph >12 and peracetic acid have been conducted and are summarised. 2
2.0 Active Chlorine 2.1 Shock treatment with active chlorine (100 ppm) Five QPoint Filter Capsules were soaked for 1 hour in a solution of sodium hypochlorite containing 100 ppm active chlorine at a temperature of 22 ± 2 C. Following the test period, all 5 Filter Capsules were subjected to a non-destructive integrity test. Testing was conducted on Filter Capsules with a jet outlet that share the same materials and processes of construction and sterilizing grade filter media as Filter Capsules with a rose outlet. Table 1: results following exposure to 100 ppm active chlorine for 1 hour J074004535151 J074007635151 J074011435151 J074012835151 J074005635151 All 5 Filter Capsules passed the integrity test (Table 1) and no visual abnormalities were observed. 2.2 Continuous treatment with active chlorine (<7 ppm) followed by shock treatment with active chlorine for (100 ppm) Five QPoint Filter Capsules were soaked in a solution of sodium hypochlorite containing <7 ppm active chlorine at a temperature of 22 ± 2 C over the life of the product. After 31 and 62 days, the Filter Capsules were subjected to a non-destructive integrity test. At the end of the continuous treatment period, the QPoint Filter Capsules were soaked for 1 hour in a solution of sodium hypochlorite containing 100 ppm active chlorine at a temperature of 22 ± 2 C and again subjected to a non-destructive integrity test. Testing was conducted on Filter Capsules with a jet outlet that share the same materials and processes of construction, and sterilizing grade filter media as Filter Capsules with a rose outlet. Table 2: results following exposure to <7 ppm active chlorine for 93 days followed by 1 hour at 100 ppm active chlorine (22 ± 2 C) after 31 days continuous treatment (<7 ppm) after 62 days continuous treatment (<7 ppm) after shock treatment (100 ppm) J074011835151 J074010735151 J074004935151 J074003935151 J074003235151 All 5 Filter Capsules passed the integrity test (Table 2) following each treatment period and no visual abnormalities were observed. Pall QPoint Filter Capsules are therefore considered to be compatible with continuous treatment with active chlorine at <7 ppm over their indicated life of 62 days and/or shock treatment of 100 ppm active chlorine for 1 hour. www.pall.com/medical 3
3.0 Shock treatment with ph > 12 Five QPoint Filter Capsules were soaked for 1 hour in a solution of sodium hydroxide (ph > 12) at 22 ± 2 C. Following the test period, all 5 Filter Capsules were subjected to a non-destructive integrity test. Testing was conducted on Filter Capsules with a jet outlet that share the same materials and processes of construction and sterilizing grade filter media as Filter Capsules with a rose outlet. Table 3. results following exposure to ph >12 for 1 hour J074003735151 J074003835151 J074008035151 J074009735151 J074007335151 All Filter Capsules passed the integrity test (Table 3) and no visual abnormalities were observed. Pall QPoint Filter Capsules are therefore considered to be compatible with ph >12 for 1 hour. 4.0 Shock treatment with peracetic acid (1000 ppm) Five QPoint Filter Capsules were soaked for 2 hours in a solution containing 1000 ppm peracetic acid at 60 ± 2 C. Following the test period, all 5 Filter Capsules were subjected to a non-destructive integrity test. Testing was conducted on Filter Capsules with a jet outlet that share the same materials and processes of construction and sterilizing grade filter media as Filter Capsules with a rose outlet. Table 4. results following exposure to 1000 ppm peracetic acid J074006535151 J074008835151 J074003035151 J074004035151 J074012135151 All Filter Capsules passed the integrity test (Table 4) and no visual abnormalities were observed. Pall QPoint Filter Capsules are therefore considered to be compatible with 1000 ppm peracetic acid for 1 hour. 5.0 Conclusions Pall QPoint Filter Capsules are compatible with continuous systemic treatment with active chlorine at <7 ppm over their indicated life of 62 days and/or shock treatment of 100 ppm active chlorine for 1 hour. These Filter Capsules are also compatible with ph >12 for 1 hour or 1000 ppm peracetic acid for 2 hours 4
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