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AcroPak™ 20 Filters with 0.1 µm
Fluorodyne® II Membrane
Instructions for Use
Description
Ideal for small batch sterile filtration of solutions containing dilute preservatives,
proteins, or other critical components. These filters can also be used for filtering
aqueous solutions, cell culture media, serum, and small-volume parenterals.
AcroPak 20 filters are designed to add convenience to small- and medium-volume
filtration. Their unique design generates twice the effective filtration area and double
the throughput and flow rate of conventional metal 47 mm reusable filter holders.
They are disposable, which reduces the labor required for disassembly, cleaning,
replacement of filtration membranes, reassembly, and integrity testing of reusable
stainless steel filter holders. Use of the AcroPak 20 filters can significantly reduce
the costs of repeat testing when scaling up your filtration system. The AcroPak 20
filters have the added benefits of being available sterile and non sterile, nonpyrogenic, and integrity testable.
Filtration Via Peristaltic Pump
AcroPak 20 Filter
Figure 1
Ordering Information
Prod. No. Description
12208
AcroPak 20 with Fluorodyne II Membrane
0.1 µm, non-sterile
12209
AcroPak 20 with Fluorodyne II Membrane
0.1 µm, sterile
1. Assemble filtration apparatus as shown in appropriate artwork below.
(see figure 1- 4)
2. Do not exceed the maximum operating parameters listed in the Specifications
section.
3. The AcroPak™ 20 filters are designed for Single Use Only.
Packaging
3/pkg
Small Batch Filtration
Hydrophobic Acro® 50 Filter
(Vent)
3/pkg
AcroPak 20
Filter
Certification
Pall Life Sciences certifies that this lot meets or exceeds the specifications listed
below.
Figure 2
Part Number:
Syringe Volume Filtration
Lot Number:
Date:
AcroPak 20 Filter
Leslie A. Harreld, Sr. Director, Quality Assurance
Figure 3
Vacuum Filtration
AcroPak 20 Filter
Specifications
Materials of Construction
Filter Media: Fluorodyne II membrane (hydrophilic polyvinylidene fluoride)
Housing: Polypropylene
Effective Filtration Area
20 cm2
Inlet/Outlet Connections
Stepped hose barbs, 6.4 to 12.7 mm (1/4 to 1/2 in.) diameter with female slip luer
ID in the hose barb.
Maximum Operating Pressure & Temperature
4.1 bar (410 kPa, 60 psi) at ambient temperature
60 °C (140 °F) at 1.0 bar (100 kPa, 15 psi)
Minimum Bubble Point
1.8 bar (180 kPa, 26psi) in 60% Isopropyl Alcohol/40% Water (v/v)
Bacterial Retention
Lot samples retain a minimum of 107 cfu/cm2 of Brevundimonas diminuta per
modified ASTM F838-83.
Typical Water Flow Rate
13 mL/min/100 mbar (9 mL/min/psi)
Endotoxin
< 0.25 EU/mL using Limulus Amebocyte Lysate (LAL) test
Biological Safety
Passes United States Pharmacopeia (USP) Biologigal Reactivity Test, In Vivo <88>
Autoclave Stability
One cycle, 131 ˚C for 30 minutes
Sterilization
PN 12209 sterilized by gamma irradiation
Figure 4
1259_88128C 7/16/07 12:50 PM Page 2
Integrity Testing
WARNING
Filter integrity confirmation is recommended before and after filtration using
standard techniques as summarized below. Warning – Due to the 0.1 µm rated
membrane in this filter, the unit’s bubble point, when wet with water or
aqueous solution, will exceed the maximum pressure rating of the housing
and may result in filter damage and personal injury. Additionally, exceeding
the bubble point of the upstream 0.2 µm prefilter layer during pre-use testing may
result in reduced liquid flow due to air blockage. Do not exceed the recommended
pressures indicated below.
Wetting Procedure – Pre-use
To ensure test validity, all membrane pores must be fully wetted with liquid prior to
applying air test pressure. The flushing procedure below is designed to ensure
adequate wetting.
1. Orient the filter vertically with the outlet port pointed up and the inlet port (side
with the bleed valve) pointed down.
2. Starting with low pressure (< 0.3 bar, 30 kPa, 5 psi), carefully initiate liquid flow.
3. Gradually increase liquid pressure to a minimum of 1.0 bar (100 kPa, 15 psi) and
pass a minimum of 50 mL of wetting solution through the filter
4. Release the liquid pressure and disconnect the flow source.
Forward Flow Test - Manual Test Method
These protocols enable filter testing pre-use without compromising downstream
sterility.
1. Connect a regulated compressed air supply or syringe pump with in-line
pressure gauge to the inlet port of the filter.
Caution - use of a hand-held syringe is not recommended as applied air
pressure is not easily controlled and may exceed the air pressure rating
of the filter housing.
2. Gradually increase the applied air pressure up to the recommended level
appropriate for the selected wetting solution.
3. As air pressure is applied, liquid inside the unit will be displaced and drops will
be expressed from the outlet port. Liquid displacement will be rapid at first, then
drops should form more slowly as pressure is maintained, and eventually they
should hang on the outlet without perceptible growth. If this state of apparent
stasis lasts for at least 20 seconds, with negligible flow of liquid or air, then filter
installation integrity has been confirmed.
4. After the test, carefully relieve the pressure before disassembling the equipment.
Employment of the products in applications not specified, or failure to follow
all instructions contained in this product information insert, may result in
improper functioning of the product, personal injury, or damage to property
or the product. See Statement of Warranty in our most recent catalog.
Wetting Fluid
Water
60% Isopropyl Alcohol/
40% Water (v/v)
Forward Flow Test Pressure
(Pre-use test)
3.0 – 3.1 bar
(300 - 310 kPa, 43 - 45 psi)
0.8 – 0.9 bar
(80 - 90 kPa, 12.0 - 13.5 psi)
Maximum
Allowable Flow
< 0.05 mL/min
ATTENTION
L’utilisation de nos produits dans des applications pour lesquelles ils ne
sont pas spécifiés ou le non-respect du mode d’emploi qui figure sur ce
document, peut entrainer un disfonctionnement du produit, endommager le
produit ou d’autres biens matériels ou représenter un risque pour l’utilisateur.
Se référer à la clause de garantie de notre catalogue le plus récent.
ACHTUNG
Der Einsatz dieses Produktes in Anwendungen für die es nicht spezifiziert
ist, oder das Nichtbeachten einiger, in dieser Bedienungsanleitung
gegebenen Hinweise kann zu einem schlechteren Ergebnis, oder Zerstörung
des Produktes oder anderer Dinge oder gar zu Verletzungen führen.
Beachten Sie auch unsere Garantiebedingungen im aktuellen Katalog.
ADVERTENCIA
El uso de este producto en aplicaciones no especificadas o el no considerar
las instrucciones indicadas en la hoja de información del producto puede
ocasionar un mal funcionamiento del producto, daños en las instalaciones o
en el producto y riesgo para el personal del laboratorio. Consulte el
apartado de Garantía en nuestro último catálogo.
ATTENZIONE
L’impiego dei prodotti in applicazioni non specificate, o il mancato rispetto
di tutte le istruzioni contenute nel presente bollettino tecnico, potrebbero
portare ad un utilizzo improprio del prodotto, ferire gli operatori, o
danneggiare le caratteristiche del prodotto stesso. Consultare la
dichiarazione di garanzia pubblicata nel nostro più recente catalogo.
< 0.05 mL/min
Bubble Point Test (Post-use ONLY)
The Post-use Bubble Point Test is correlated to quantitative bacterial retention and
recommended for post-use testing under GMP regulations. The recommended
wetting fluid for bubble point testing is 60% Isopropyl Alcohol/40% Water. The
lowered surface tension of this fluid enables testing of the 0.1 µm membrane layer
at a suitable pressure below the maximum operating pressure limit of the filter
housing.
1. Orient the filter vertically with the inlet port (side with the bleed valve) pointed up
and the outlet port pointed down (reverse of initial wetting procedure).
2. Introduce freshly prepared 60:40 IPA/Water solution into the filter to displace the
remaining fluid after filtration. Avoid introduction of air. Air bubbles may be
displaced by opening the upstream bleed valve during liquid flow.
3. Gradually increase liquid pressure to a minimum of 1.0 bar (100 kPa, 15 psi) and
pass a minimum of 50 mL of 60:40 IPA/Water wetting solution through the filter.
4. Apply a compressed air source to the filter on the inlet side and increase the
pressure to one psi below the recommended minimum bubble point.
5. Wait 30 seconds and place the filter outlet under water (either directly or via a
connected length of tubing). Any evidence of airflow (bubbles) indicates a bubble
point failure. Integral filters should show no visible bubbling. After the test,
carefully relieve the pressure before disassembling the equipment.
Alternate testing methodology may be used as determined appropriate by the
filter user.
Note: Testing of small area filters such as AcroPak™ 20 using automated filter
integrity test instruments requires modified protocols. For further information and
recommendations, contact your local Pall representative.
Chemical Compatibility
Chemical compatibility data can be obtained by contacting your local Pall Life
Sciences office listed below.
Pall Life Sciences
600 South Wagner Road
Ann Arbor, MI 48103-9019 USA
For ordering or technical information:
In USA and Canada
Tel: 734-665-0651
800-521-1520
Fax: 734-913-6114
Outside USA and Canada
+800 PALL LIFE
+800 7255 5433
Visit Pall Life Sciences on the
Web at www.pall.com/Lab or
e-mail us at Lab@pall.com
Offices:
Australia, Cheltenham, VIC, 03 8586 8150
Austria, Wien, 00 1 49 192 0
Canada, Ontario, 905-542-0330
Canada, Québec, 514-332-7255
China, P.R., Beijing, 86-10-8458 4010
France, St. Germain-en-Laye, 01 30 61 39 92
Germany, Dreieich, 06103-307 333
India, Mumbai, 91 (0) 22 55995555
Italy, Milano, 02 47 79 61
Japan, Tokyo, 03-6901-5800
Korea, Seoul, 82-2-560-7834
Malaysia, Selangor, +60 3 5569 4892
New Zealand, Hamilton, +64 7 957 9510
Poland, Warszawa, 22 510 2100
Russia, Moscow, 5 01 787 76 14
Singapore, (65) 389-6500
South Africa, Johannesburg, +27-11-2662300
Spain, Madrid, 91-657-9876
Sweden, Lund, (0)46 158400
Switzerland, Basel, 061-638 39 00
Taiwan, Taipei, 886 2 2545 5991
Thailand, Bangkok, 66 2937 1055
United Kingdom, Farlington, 02392 302600
Pall,
, AcroPak, and Fluorodyne are trademarks of Pall Corporation.
® indicates a registered trademark in the United States.
© 2007, Pall Corporation, 07/07
PN 88128C