Technical Report 160209.1WGL Chemical Compatibility of the Pall QPointTM Filter Capsule - Rose Outlet with Systemic Water Treatments QPoint - More than Filtration 1.0Background 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. T he 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. F igure 1 Pall QPoint Filter Capsule 2 ests to confirm compatibility of the QPoint Filter Capsule with common systemic chemical treatments are documented T 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. ompatibility testing involves subjecting Filter Capsules that have been exposed to a selected chemical treatment to a C 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. 2.0 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: Integrity test results following exposure to 100 ppm active chlorine for 1 hour Filter ID Integrity test J074004535151 Pass J074007635151 Pass J074011435151 Pass J074012835151 Pass J074005635151 Pass 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: Integrity test results following exposure to <7 ppm active chlorine for 93 days followed by 1 hour at 100 ppm active chlorine (22 ± 2 °C) Filter ID Integrity test after 31 days continuous treatment (<7 ppm) Integrity test after 62 days continuous treatment (<7 ppm) Integrity test after shock treatment (100 ppm) J074011835151 Pass Pass Pass J074010735151 Pass Pass Pass J074004935151 Pass Pass Pass J074003935151 Pass Pass Pass J074003235151 Pass Pass Pass 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. Integrity test results following exposure to pH >12 for 1 hour Filter ID Integrity test J074003735151 Pass J074003835151 Pass J074008035151 Pass J074009735151 Pass J074007335151 Pass 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. Table 4. Integrity test results following exposure to 1000 ppm peracetic acid 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. Filter ID Integrity test J074006535151 Pass J074008835151 Pass J074003035151 Pass J074004035151 Pass J074012135151 Pass 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. 5.0Conclusions 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 Pall Corporate Headquarters 25 Harbor Park Drive Port Washington NY 11050 (877) 367-7255 phone pouwater.us@pall.com email Pall International Sàrl Avenue de Tivoli 3 1700 Fribourg Switzerland +41 (0)26 350 53 00 phone LifeSciences.EU@pall.com email Visit us on the Web at www.pall.com/medical 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. © 2016 Pall Corporation. Pall, and QPoint are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. TM indicates a common law trademark. 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 QPoint - More than Filtration 2/16, PDF, GN160209.1WGL 160209.1WGL