Technical Report Chemical Compatibility of the Pall QPoint

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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
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