Você está na página 1de 20

Gas Filtration Products for

OEM Health Care Devices

Pall Corporation
For more than fifty years, Pall Corporation has
provided the global medical manufacturing
industry with the widest selection of
customized membranes and devices. Because
we manufacture our own membranes, we
can control the OEM manufacturing process
every step of the wayfrom raw materials
to final medical filtration device assembly.
As a result, you can be assured of total
product quality.
Whether you are filtering intravenous solutions, protecting
equipment from contamination, or providing bacteria-free air
for breathing circuits, Pall Medical has membranes for your
most demanding and critical applications.
By combining our strengths with yours, we can design
and produce a cost-effective product, manufactured to the
highest quality standards, that meets your specific needs.

Support

Total OEM Support


Global Sales Structure
As an OEM supplier, customer satisfaction is at the core of our success. To meet customer needs,
we have organized our global sales force to make representatives available to you locally. Whether
located in Asia, Europe, or the Americas, a Pall Medical sales representative can meet with you
within a matter of hours. Additionally, we have an experienced inside sales staff ready to help place,
track and expedite your orders. It is our goal to be a resource for your organization.
Our experienced staff can help develop filtration and separation solutions to address your unique
application needs. Backed by a wealth of engineering and product development support, we look
forward to working with you on your next project.

Manufacturing Capability
Poised to meet a variety of needs, Pall Medical is equipped to produce a wide variety of filtration
devices. Our manufacturing team has a proven record in satisfying customer demands and solving
filtration problems. Our people, from engineers to line operators, are focused on improvement always
seeking to further our capability to address changing needs. Our manufacturing processes employ
many advanced technologies, and we can offer devices of excellent quality matched to specific
requirements and designed for easy integration into customer applications. The wide and varied
use of our products speaks to the manufacturing flexibility we possess and to our responsiveness
in providing solutions.

Supply Chain Management


Pall Medical subscribes to the principles of Lean Manufacturing. By incorporating these fundamentals,
we look through the entire supply process, from our raw component suppliers to our end customers,
with the determination to identify and eliminate non-value added activities and reduce costs.
Areas within the supply chain where we focus our energy are quality at the source and continuous
supply replenishment.
In the area of quality Pall Medical has a vision of delivering quality to our customers within the
expectations of six-sigma. In order to succeed, we must drive the same expectation to our
component suppliers. We accomplish this through supply agreements that include defined quality
requirements, working with our suppliers quality departments to explain our needs, and monitoring
our raw component designs to aggressively look for ways to improve consistency in the manufacturing of our component parts.
To ensure timeliness of delivery, we implement continuous supply programs, such as visual Kanban
pull systems. These continuous supply systems utilize standard shipping quantities (where applicable).
With the establishment of continuous supply programs, we have been very successful in reducing
our supplier lead-times, with resulting benefits to our end customers.
By allowing Pall Medical to work with you as we do our suppliers, we believe we can help you
achieve your business objectives. In concert with you and our suppliers, we can create a supply
chain that cannot be broken.

888.676.7255 www.pall.com

Total OEM Support


Product Development
Pall Medical Research and Development delivers complete product development, customization,
and technical support service to our OEM customers. Our team of highly trained and experienced
engineers is available to assist in specification development, design and development of innovative
filtration solutions, and product testing/validation support. We can serve as an adjunct to the
customers own R&D group, providing assistance and education regarding filtration technology,
applications and devices.
Utilizing the Pall Medical R&D group, our customers get both the focus of a small team specialized in
medical filtration applications, as well as access to the full technical resources of Pall Corporation,
with the broadest range of filtration technologies in the world.

Quality Systems
Pall Medical, located in Ann Arbor, Michigan, is the primary location for the OEM Medical manufacturing
group. The quality system on the Ann Arbor campus has been registered to ISO9001 and
EN46001/ISO13485, allowing us to apply the CE mark to direct sale medical devices, or to assist
in the customers CE mark registration. Additionally, the manufacturing facilities are FDA registered
for the manufacturing and distribution of medical devices. Regardless of the product, all practices
meet current medical device good manufacturing practices now more commonly known as FDA
Quality System Regulation, 21CFR Part 820.

888.676.7255 www.pall.com

Abstracts

Basic Filtration Concepts


Filtration is a dynamic science of growing information,
distinctive terminology and proprietary knowledge. Selection
of appropriate filter media is critical to achieve specific
goals within your application. These basic filtration concepts
have been compiled to establish a common ground from
which we can work to determine your needs.

Hydrophobicity

Air and Liquid Filtration Differences

Hydrophobic filters lack an affinity for, or repel, water. A hydrophobic filter


will not wet in water, but will wet in low surface-tension liquids, such as
organic solvents. Hydrophobic filters are best suited for gas filtration and
venting (Example: Pall Medicals PTFE membrane).

To measure retention efficiency of hydrophobic membranes (depth or


membrane media), the media is typically exposed to aerosolized particles
of a standard size. The DOP test method is a standardized test to measure
this retention efficiency. By definition, this is the measure of the efficiency
of a filter for the production of ultrapure air based on the concentration of
0.3 m Dioctylphthalate aerosol particles that penetrate a filter at a
predetermined flow. It is usually expressed as a percentage of retention.

Flow Rate and Throughput


are two important related
measures of filter media and
device performance. This
performance is affected by
many different variables. The
most important variables are described below.
Differential Pressure (psid) is the difference between inlet and outlet
pressure. As the filter becomes laden, differential pressure increases.
Porosity is the measure of all of the open spaces (pores) in the
membrane. Generally, membranes are 50 to 90% open space. Flow rate
is directly proportional to the porosity of the membrane (more pores =
higher flow rate).
Effective Filter Area (EFA): Filter devices are available in a wide range
of sizes with different Effective Filtration Areas (EFA). EFA is the filter area
that is available for filtration. Given a solution, a larger filter area allows
faster flow rates at a given differential pressure and larger expected filter
throughput volumes prior to filter loading.

One of the most common misconceptions about air filtration is that an


efficient sterilizing grade hydrophobic filter must have a rating of 0.2 m.
This is not true because a 1.2 m pore size membrane has a 99.98%
efficiency when challenged with a 0.3 m DOP aerosolized particle. Due
to the nature of gas filtration through microporous membrane media,
particles smaller than the pore size, usually on the order of 10 1, are
retained. Therefore membranes even as high as 3 m can provide a
sterile air barrier for equipment and instruments.
In aerosol retention, there are five mechanism by which an aerosol particle
can be deposited on a filter media. These mechanisms are interception,
inertial impaction, diffusion, gravitational settling and electrostatic attraction.
Interception and inertial impaction have the greatest impact on aerosol
retention because adsorptive mechanisms are much more powerful in air
filtration than they are with corresponding cases in liquid filtration. Because
of the difference in the properties of gases and liquids (e.g., the density of
air is about 1000 times lower than liquid) filtering particles from air is not
as difficult. In fact, relatively large pore size filters should efficiently remove
small particles from air.
If you have any questions about these concepts or specific questions about
your application, please call us at 734.913.6124 or 888.676.7255.

888.676.7255 www.pall.com

Technical Reports
Following are abstracts of a number of studies specific to filtration topics that Pall has on file. Contact your Pall representative,
or call us at 888-676-7255 for a complete copy of the any of these reports.
Can Surgery Be Made Safer?

Entry of Abdominal Fluids into Laparoscopic Insufflators

Medical Design News, May/June 2002.


Within the last few years minimally invasive surgery, specifically
laparoscopy which deals with the abdomen, has become a replacement
for many open procedures. Advances in filters and membranes make
laparoscopy more accurate.

ECRI Problem Reporting System 21 (5): 180-181 (1992).


Member hospital recently reported an incident in which blood was
delivered from inside a laparoscopic insufflator to a patient. Using a
filter prevents the backflow of abdominal fluids and precludes passage
of almost all micro-organisms. Use a hydrophobic filter between the
insufflator and the patient.

Surgical Smoke
Operating room personnel have been exposed to surgical smoke and
aerosol for years without fully understanding whether they contain
hazardous particles. Not until the introduction and acceptance of laser
surgery technology in the early 1980s did the constituents of surgical
smoke come under scrutiny. The research to date has focused on four
potential health risks to operating room personnel and patients: hazardous
chemicals, viable viruses, viable cells, and nonviable particles.

Aerosol Challenge Summary for the Evaluation of Microbial


and Viral Retention Characterizes of Membrane Filters
This test is based on Pall Corporation SLS test methodology
(document # MB04), and is designed so that a concentration of bacteria
(Brevundimonas diminuta) or viruses (Bacteriophage MS-2), in aerosol
form, is passed through a filter device, after which effluent downstream
of the filter device is collected. Aerosol bacterial and viral retention levels
and removal efficiencies are then calculated through comparisons of
input and effluent concentrations of said microorganisms.

Hysteroscopic and Laparoscopic Insufflators


Food and Drug Administration (1995).
Submission Guidance for a 510(k).
For gas hysteroscopic insufflators, use of a hydrophobic filter between
the patient and the insufflator to prevent patient cross-contamination is
highly recommended.

888.676.7255 www.pall.com

Gas Filters

Vacuum Protection Filter


Superior air flow rates and low back pressure maximizes
application performance

Vacuum protection
General hydrophobic barrier
Small to medium volume vent

0.30 in

1.49 in

Product Features:

Vacuum Protection Specifications:

Low system pressure resistance maximizes pump performance


Effective barrier protects vacuum pumps from biohazardous
contamination
Filter delivers viral and bacterial protection at 15 psi
Custom colored printing option for product and/or company identification
Assists in meeting 29CFR1910.1030 OSHA Bloodborne Pathogen
Standard by serving as an Engineering Control to reduce
employee exposure
Meets bacterial filter requirements suggested by the Center for
Devices and Radiological Health Guidance Development for Powered
Suction Pump 510(k)s

Bacterial/Viral Filtration Efficiency


Bacterial removal efficiency 99.999%
with test organisms Brevundimonas
diminuta. Test organism: Serratia
marcescens (0.45 m)
Brevundimonas diminuta (0.30 m)
Viral Filtration Efficiency
Viral removal efficiency 99.999%
with MS-2 Bacteriophage.
Test organism: MS-2 Bacteriophage

Inlet/Outlet Connections
1/4 in (6.4 mm) HB
Typical Air Flow Rate
41 L/min @ 5 psi
Minimum Water Breakthrough
750 mmHg (15 psi)
Pyrogenicity
< 0.25 EU/mL using the LAL
test method

HEPA
Exceeds filtration efficiency
requirements for HEPA rating*

Sterilization Compatibility
EtO

Effective Filtration Area


18 cm2

Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Materials of Construction
Media: PTFE with a prefilter support
Housing: Acrylic

Ordering Information: Vacuum Protection Filter


Product No. Description
8001052
Vacuum Protection Filter, bulk, non-sterile
* Data available upon request.

888.676.7255 www.pall.com

General Gas Filter


Nebulization
Respiratory therapy
Oxygen concentration
Smoke evacuation

2.60 in

2.05 in

Product Features:

General Gas Filter Specifications:

Effective barrier bacterial removal efficiency greater than 99.999%


Effective removal of particulate, and other contaminants from oxygen
and other medical gases
May be used with all medical gases such as CO2, N2, and 02
Bi-directional hydrophobic media effectively removes gas-borne
particulate down to 0.2 m in size
Multiple connectors for easy installation in gas lines
High flow rates with low resistance
High particulate loading capability to maintain flow rates over
extended periods
Cost effective solution the filter reduces maintenance time and
extends the life of the oxygen concentrator
Disposable, single-use

Bacterial Filtration Efficiency


Bacterial removal efficiency 99.999%
with test organisms Brevundimonas
diminuta. Test organism: Serratia
marcescens (0.45 m)
Brevundimonas diminuta (0.30 m)
Viral Filtration Efficiency
Viral removal efficiency 99.99%
with MS-2 Bacteriophage.
Test organism: MS-2 Bacteriophage
HEPA
Exceeds filtration efficiency
requirements for HEPA rating*
Effective Filtration Area
11.8 cm2
Materials of Construction
Media: Ceramic bonded Hydrophobic
Glass (Pallflex media)
Housing: Polypropylene

Ordering Information: General Gas Filter


Product No. Description
9004500
Pallflex media, 4.8 to 3.2 mm (3/16 to 1/8 in) HB
* Data available upon request.

888.676.7255 www.pall.com

Inlet/Outlet Connection
4.8 to 3.2 mm (3/16 to 1/8 in) HB
Typical Air Flow Rate
15 L/min @ 1 psi
Minimum Water Breakthrough
5 min @ 1 psi
Pyrogenicity
< 0.25 EU/mL using the LAL Method
Sterilization Compatibility
EtO, Gamma, Autoclave
Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Gas Filters

FORS1 Filtration Odor Removal System


Designed specifically for evacuation of passive smoke during
minimally invasive surgery involving insufflation, electrocautery,
laser, or ultrasonic scalpel use

Product Features:

FORS1 Filtration Odor Removal System Specifications:

99.999% bacterial and viral removal efficiency


Particulate removal in surgical smoke ranging in size from
0.1 m to 1 m
Protects patients and surgical staff allows safe and rapid evacuation
of smoke throughout the surgical procedure, minimizing the exposure
to potentially harmful surgical smoke
Reduces odor and organic volatiles
Lightweight, low profile construction
Easy to use the universal luer connector meets ISO standards for
leak free connection to the trocar
Rotating hub prevents twisting of the tubing during connection
Disposable, single use

Bacterial Filtration Efficiency


Bacterial removal efficiency 99.999%
with test organisms Brevundimonas
diminuta. Test organism: Serratia
marcescens (0.45 m)
Brevundimonas diminuta (0.30 m)

Connections
Male luer with rotating hub, conforms
to ISO594-2:1996

Viral Filtration Efficiency


Viral removal efficiency 99.999%
with MS-2 Bacteriophage.
Test organism: MS-2 Bacteriophage

Sterilization Compatibility
EtO

Materials of Construction
Media: PTFE, Hydrophobic Glass,
Carbon, with polyester support
Tubing: PVC
Luer: Acrylic

Working Pressure
15 mmHg

Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Ordering Information: FORS1 Filtration Odor Removal System


Product No. Description
FORS1
FORS1 Filtration Odor Removal System, MLL, rotating hub

888.676.7255 www.pall.com

25 mm and 32 mm Filters
Select from a full line of barrier devices used by some of the
worlds most respected medical equipment manufacturers

Transducer protection
Small volume venting
Sterile air/gas delivery
Pump protection
Gas analyzer protection
1.10 in
1.37 in

1.75 in

.88 in

Product Features:

25 mm Specifications:

Protective hydrophobic barrier allows only sterile air to pass through,


protecting patients and equipment from cross contamination
Choice of media to accommodate sterilization methods
Selection of 510(k) cleared products for transducer protection reduces
your time to market
Colored housings available for identification
Mix and match over a dozen standard and custom connector styles
Custom printed blister packaging available
Housings designed to withstand pneumatic pulsing

Effective Filtration Area


2.8 cm2

Pore Size
0.2 - 5.0 m

Materials of Construction
Media: Versapor or PTFE
Housing: Modified acrylic

Pyrogenicity
< 0.25 EU/mL using the LAL
test method

Inlet/Outlet Connections
Inlet: FLL; Luers conform to ISO594
Outet: MLL, MSL; Luers conform
to ISO594

Sterilization Compatibility
Versapor: EtO, gamma irradiation
PTFE: EtO

32 mm Specifications:
Effective Filtration Area
5.3 cm2

Pore Size
0.2 - 5.0 m

Materials of Construction
Media: Versapor or PTFE
Housing: Modified acrylic

Pyrogenicity
< 0.25 EU/mL using the LAL
test method

Inlet/Outlet Connections
Inlet: FLL; Luers conform to ISO594
Outlet: MLL, MLS; Luers conform
to ISO594

Sterilization Compatibility
Versapor; EtO, gamma irradiation

Maximum Operating Temperature


55 C (131 F)

Maximum Operating Temperature


55 C (131 F)

Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Minimum Water Breakthrough


Versapor membrane: 0.8 bar (12 psi)/
30 seconds (0.2 m)
PTFE: 1.1 bar (16 psi)/
30 seconds (0.2 m)

Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Ordering Information: 25 mm and 32 mm Filters


Product No.
4197
6194292
6004197
6544192

Description
25 mm, Versapor, 0.2 m MLS/FLS, bulk, non-sterile
25 mm, Versapor, 0.2 m FLL/MLL, bulk, non-sterile
25 mm, PTFE, 0.2 m MLS/FLS, bulk, non-sterile
25 mm, PTFE, 0.2 m FLL/MLL, bulk, non-sterile

Product No. Description


6004700
25 mm, Versapor, 0.2 m HB, bulk, non-sterile
6004701
25 mm, Versapor, 1.2 m HB, bulk, non-sterile
6174196
25 mm, Versapor, 1.2 m FLL/MLS, bulk, non-sterile
Contact Customer Service for additional 25 mm and 32 mm part numbers.

888.676.7255 www.pall.com

Small Volume Filters

13 mm, 37 mm, and 50 mm Chemical


Resistant Filters
Sensible solutions for delivery of sterile air to patient

Insufflation
Oxygen concentration
Nebulization
Oxygenation
Sterile delivery of air
0.16 in

0.63 in

0.28 in

1.75 in

0.5 in

2.86 in

Product Features:

37 mm and 50 mm Specifications:

Variety of HEPA-rated filter media and inlet/outlet configurations


Custom colored printing option for product and/or company identification
High particulate-loading capability to maintain flow rates over
extended periods
High flow rates at low differential pressures
Rugged polypropylene housing withstands high temperatures, high
pressures and aggressive solvents
Autoclavable

HEPA
Exceeds filtration efficiency
requirements for HEPA rating*

13 mm Specifications:

Inlet/Outlet Connections
Inlet: 37 mm: 6.4 to 9.5 mm (1/4 to
3/8 in) HB; 3.2 mm (1.8 in) HB; 4.8 mm
(3/16 in) HB; FLL; Luers conform to
ISO594 50 mm: 6.4 mm (1/4 in) HB;
6.4 to 12.7 mm (1/4 to 1/2 in) HB;
3.2 mm (1/8 in) MNPT; 4.8 mm (3/15
in) HB; 9.5 mm (3/8 in) SP; Luers
conform to ISO594
Outlet: 37 mm: 6.4 to 9.5 mm (1/4 to
3/8 in) HB; 3.2 mm (1.8 in) HB; 4.8 mm
(3/16 in) HB; MLS; Luers conform to
ISO594 50 mm: 6.4 mm (1/4 in) HB;
6.4 to 12.7 mm (1/4 to 1/2 in) HB;
3.2 mm (1/8 in) MNPT; 4.8 mm (3/15
in) HB; 9.5 mm (3/8 in) SP; Luers
conform to ISO594

Effective Filtration Area


0.8 cm2

Pore Size
0.2 - 5.0 m

Materials of Construction
Media: Versapor or PTFE
Housing: Polypropylene

Sterilization Compatibility
PTFE: Autoclave, EtO
Versapor: Gamma irradiation, EtO

Inlet/Outlet Connections
Inlet: FLL; Luers conform to ISO594
Outlet: MLS; Luers conform to ISO594

Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Maximum Operating Temperature


PTFE: 130 C (266 F)
Versapor: 88 C (190 F)

Effective Filtration Area


37 mm: 7.5 cm2
50 mm: 19.6 cm2
Materials of Construction
Media: Hydrophobic laminated glass
media, Versapor or PTFE
Housing: Polypropylene

Maximum Operating Temperature


Glass: 121 C (250 F) for 15 min.
PTFE: 130 C (266 F)
Versapor: 88 C (190 F)
Typical Water Breakthrough
Glass: 0.13 bar (1.8 psi)
0.2 m PTFE: 2.1 bar (30 psi)
Pore Size
0.2 - 5.0 m
Pyrogenicity
< 0.25 EU/mL using the LAL test method
Sterilization Compatibility
Glass: Autoclave, gamma irradiation
PTFE: Autoclave, EtO
Versapor: EtO, gamma irradiation
Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Ordering Information: 13 mm, 37 mm, and 50 mm Chemical Resistant Filters


Product No.
6024423
6004137
6004210

Description
13 mm, PTFE, 0.2 m, FLL/ML, bulk, non-sterile
13 mm, PTFE, 1.0 m, FLL/ML, bulk, non-sterile
37 mm, Hydrophobic Glass, 1/4 to 3/8 in HB, bulk, non-sterile

Product No. Description


6154210
37 mm, Hydrophobic Glass, 1/8 in HB, bulk, non-sterile
6004270
50 mm, Hydrophobic Glass, 1/4 in HB, bulk, non-sterile
Contact Customer Service for additional 13 mm, 37 mm, and 50 mm part numbers.
* Data available upon request.

888.676.7255 www.pall.com

Intervene, Intervene High-Flow, and


Intervene Max-Flow Filters
Unique filter design maximizes hydrophobicity to prevent
cross-contamination between patient and equipment

Insufflation
Oxygen concentration
Oxygenation
Smoke evacuation
2.4 in

2.7 in

2.7 in

2.7 in

2.7 in

Vacuum protection

1.0 in

Product Features:
HEPA rated hydrophobic media allows effective removal of particles
and bacteria
Overall design maximizes air/gas flow rates and lowers pressure drop
Bi-directional filter media eliminate orientation concerns
Connector options for virtually every application and maximum
system flexibility
Lightweight housing prevents tube kinking
Low profile design fits easily into packaging or tight spaces

Intervene, Intervene High-Flow, and


Intervene Max-Flow Filters Specifications:
Bacterial Filtration Efficiency
Bacterial removal efficiency 99.999%
with test organisms Brevundimonas
diminuta. Test organism: Serratia
marcescens (0.45 m)
Brevundimonas diminuta (0.30 m)
Viral Filtration Efficiency
PTFE: Viral removal efficiency
99.999% with MS-2 Bacteriophage
Test organism: MS-2 Bacteriophage
Pallflex : Viral removal efficiency
99.99% with MS-2 Bacteriophage
Test organism: MS-2 Bacteriophage
HEPA/ULPA
Exceeds filtration efficiency
requirements for HEPA rating*
Devices containing PTFE meet ULPA
standards for air/gas delivery with
99.999% filter efficiency of 0.1 m
particles at test flows of 40 L/min.
Effective Filtration Area
18.5 cm2
Materials of Construction
Media: PTFE, Pallflex media
Housing: Modified acrylic

Inlet/Outlet Connections
Inlet: Intervene: 6.4 mm (1/4 in) HB;
Intervene High-Flow: 9.5 to
12.7 mm (3/8 to 1/2 in) HB;
Intervene Max-Flow: ISO 22 mm
F/15 mm M
Outlet: 6.4 mm (1/4 in) HB (available
for all Intervene products); 9.5 to 12.7
mm (3/8 to 1/2 in) HB (available for all
Intervene products)
Minimum Water Breakthrough
Pallflex: n/a
1 m PTFE: 0.62 bar (9 psi)
3 m PTFE: 0.21 bar (3 psi)
Pyrogenicity
< 0.25 EU/mL using the LAL
test method
Sterilization Compatibility
Pallflex media: EtO or gamma irradiation
PTFE: EtO
Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Ordering Information: Intervene, Intervene High-Flow, and Intervene Max-Flow Filters


Product No.
8001022
8002022
8004022
8001033
8002033

10

Description
1.0 m PTFE, 1/4 in HB, bulk, non-sterile
3.0 m PTFE, 1/4 in HB, bulk, non-sterile
Pallflex, 1/4 in HB, bulk, non-sterile
1.0 m PTFE, 3/8 to 1/2 in HB, bulk, non-sterile
3.0 m PTFE, 3/8 to 1/2 in HB, bulk, non-sterile

Product No. Description


8004033
Pallflex, 3/8 to 1/2 in HB, bulk, non-sterile
8003025
3.0 m PTFE, 15/22 inlet/1/4 in outlet, bulk, non-sterile
8004025
Pallflex, 15/22 inlet/1/4 in outlet, bulk, non-sterile
Contact Customer Service for additional part numbers.
* Data available upon request.

888.676.7255 www.pall.com

Mid-Volume Filters

BB25 and PF30 Filters


Designed for large volume requirements and extended service life

Insufflation
Gas filtration
Smoke evacuation
Ventilation
Barrier filter
Pulmonary Function Testing

Product Features:

PF30 Specifications:

Disposable, single-use patient filter


Effective barrier with bacterial/viral removal efficiency of 99.999% (BB25)
Bidirectional hydrophobic media prevents cross contamination
Large pleated filter surface offers minimal pressure drop
Transparent housing

Cross Contamination Reduction


Cross contamination reduction
efficiency: 99.9999%

Resistance
Clinically insignificant to at least
12 liters per second

Materials of Construction
Media: Polypropylene
Housing: Butadiene Styrene,
Polycarbonate and ethylene-vinyl
acetate co-polymer

Internal Volume
40 cc

BB25 Specifications:
Bacterial Filtration Efficiency
Bacterial removal efficiency 99.999%
with test organisms Brevundimonas
diminuta. Test organism: Serratia
marcescens (0.45 m)
Brevundimonas diminuta (0.30 m)
Viral Filtration Efficiency
Viral removal efficiency 99.999%
with MS-2 Bacteriophage.
Test organism: MS-2 Bacteriophage
Materials of Construction
Pleated, hydrophobic resin bonded
inorganic ceramic fibers
Housing: Butadiene Styrene,
Polycarbonate and ethylene-vinyl
acetate co-polymer

Inlet/Outlet Connections
Inlet: ISO 22 mm F/15 mm M
Outlet: ISO 22 mm M/15 mm F

Sterilization Compatibility
Gamma irradiation

Inlet/Outlet Connections
Inlet: 34 mm OD
Outlet: Tapered 30 mm OD

Resistance
~ 3.0 cm H2O @ 50 L/min or 3.5 cm
H2O @ 60 L/min.
Internal Volume
35 mL
Sterilization Compatibility
Gamma irradiation

Ordering Information: BB25 and PF30 Filters


Product No. Description
100-0171
BB25A, bulk, non-sterile

Product No. Description


PF30-Bulk PF30, Bulk, non-sterile

Contact Customer Service for additional part numbers.

888.676.7255 www.pall.com

11

Mid-Volume Filters

BB50 and BB100 Filters


Designed for large volume requirements and extended service life

Insufflation
Gas filtration
Smoke evacuation
Ventilation

Product Features:

BB100 Specifications:

Disposable, single-use patient filter


Effective barrier with bacterial/viral removal efficiency of 99.999%
Bidirectional hydrophobic media prevents cross contamination
Large pleated filter surface offers minimal pressure drop
ISO connector for universal fit
Transparent housing

Bacterial Filtration Efficiency


Bacterial removal efficiency 99.999%
with test organisms Brevundimonas
diminuta. Test organism: Serratia
marcescens (0.45 m)
Brevundimonas diminuta (0.30 m)

Inlet/Outlet Connections
Inlet: ISO 22 mm F
Outlet: ISO 22 mm M and ISO 15 mm F

Viral Filtration Efficiency


Viral removal efficiency 99.999%
with MS-2 Bacteriophage.
Test organism: MS-2 Bacteriophage

Internal Volume
90 mL

Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

BB50 Specifications:
Bacterial Filtration Efficiency
Bacterial removal efficiency 99.999%
with test organisms Brevundimonas
diminuta. Test organism: Serratia
marcescens (0.45 m)
Brevundimonas diminuta (0.30 m)

Inlet/Outlet Connections
Inlet: ISO 22 mm F
Outlet: ISO 22 mm M

HEPA
Exceeds filtration efficiency
requirements for HEPA rating*

Resistance
~ 1.0 cm H2O @ 60 L/min

HEPA
Exceeds filtration efficiency
requirements for HEPA rating*

Internal Volume
90 mL

Materials of Construction
Media: Pleated, hydrophobic resin
bonded inorganic ceramic fibers
Housing: Butadiene Styrene,
Polycarbonate and ethylene-vinyl
acetate co-polymer

Materials of Construction
Pleated, hydrophobic resin bonded
inorganic ceramic fibers
Housing: Butadiene Styrene

Sterilization Compatibility
Gamma irradiation
Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Ordering Information: BB50 and BB100 Filters


Product No. Description
BB50T-BULK BB50T, bulk, non-sterile

Product No. Description


100-0207
BB100-bulk, non-sterile

Contact Customer Service for additional part numbers.


* Data available upon request.

12

888.676.7255 www.pall.com

Resistance
~ 2.5 cm H2O @ 60 L/min

Sterilization Compatibility
Gamma irradiation

Large Volume Filters

Half, Full, and Stretch Capsule Filters


Designed for large volume requirements and extended service life

Adult respiratory main line


Pediatric respiratory main line
Vent for sterilizing equipment
Liposuction

Product Features:

Half, Full, and Stretch Capsule Specifications:

Three sizes to meet flow and space requirements


Rugged polypropylene housing withstands high temperatures, high
pressures and aggressive solvents
Variety of connectors to fit most tubing
Media protects equipment, environment, and personnel from a variety
of hazardous materials
99.97% DOP retention rated for effective bacteria removal

HEPA
Exceeds filtration efficiency
requirements for HEPA rating*
Effective Filtration Area
Half 500: 500 cm2
Full 1000: 1000 cm2
Stretch 1500: 1500 cm2
Materials of Construction
Media: Hydrophobic laminated
glass or PTFE
Housing: Polypropylene

Maximum Operating Temperature


121 C (250 F) for 15 min.
Pyrogenicity
< 0.25 EU/mL using the LAL
test method
Sterilization Compatibility
EtO, gamma irradiation, autoclave
Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Inlet/Outlet Connections
6.4 to 12.7 mm (1/4 to 1/2 in) HB
12.7 mm (1/2 in) HB
6 mm M quick disconnect
6.4 mm (1/4 in) MNPT
12.7 mm (1/2 in) MNPT
38.1 mm (1-1/2 in) sanitary flange

Ordering Information: Half, Full, and Stretch Capsule Filters


Product No. Description
94895
Hydrophobic Glass, 1/4 SHB, 1000 cm2, bulk, non-sterile
Contact Customer Service for additional part numbers.
* Data available upon request.

888.676.7255 www.pall.com

13

Large Volume Filters

Adult and Infant Filters


A complete line of reusable main-line ventilator capsule filters

Adult respiratory main line


Pediatric respiratory main line
Vent for sterilizing equipment
Liposuction

Product Features:

Adult and Infant Specifications:

Various housings compatible with most ventilator models, including


Puritan-Bennett*
Reduced risk of cross-contamination on expiratory circuit by restricting
entry of infectious microorganisms back into the ventilator
99.97% DOP retention rated for effective bacterial removal
Large pleated filter surfaces offer minimal pressure drop for extended use

HEPA
Exceeds filtration efficiency
requirements for HEPA rating*
Effective Filtration Area
Adult: 725 cm2
Infant: 255 cm2
Materials of Construction
Media: Hydrophobic laminated glass
Sealing: Polyurethane adhesive
Housing: Polypropylene
Inlet/Outlet Connections
Adult (Universal): 22 mm MSI,
22 mm MTO; Adult (P-Style): 22 mm
MSI, MSO; Infant: 22 mm MTI, MTO;
9.5 mm (3/8 in)

Typical Air Flow Rate


Minimum L/min at maximum 25 mm
H20 pressure drop
Adult Filter: 100
Infant Filter: 20
Maximum Recommended
Filter Resistance
Adult: 40 mm H2O at
100 L/min flow rate;
Infant: 40 mm H2O at
20 L/min flow rate
Sterilization Compatibility
Autoclave, up to 25 times at a
maximum 132 C (270 F) for 15 min
Biological Safety
Materials of construction pass USP
Biological Reactivity Tests, In Vivo <88>

Ordering Information: Adult and Infant Filters


Product No. Description
6004605
Adult Respiratory Filter; Universal; Short; White;
Inlet w/ No Lip; Outlet w/ No Lip
6004610
Infant Respiratory Filter; White; 3/8" Hose Barb Connections
6004618
Infant Respiratory Filter; White; 15/22 mm
6004619
Adult Respiratory Filter; P-Style; Tall; Opaque;
Inlet w/ Lip; Outlet w/ Lip
6004620
Adult Respiratory Filter; P-Style; Tall; White;
Inlet w/ Lip; Outlet w/ Lip

14

Product No. Description


6004626
Adult Respiratory Filter; Universal; Tall; White;
Inlet w/ Lip; Outlet w/ Lip
6004613
Adult Respiratory Filter; Universal; Tall; White;
Inlet w/ Lip; Outlet w/ No Lip
6004601
Infant Respiratory Filter; Universal; Tall; White;
Inlet w/ Lip; Outlet w/ No Lip
Contact Customer Service for additional part numbers.
* Data available upon request.

888.676.7255 www.pall.com

Accessories

Duckbill Check Valve/Large and


Small Tubing Connectors
Specifications:
Housing material bonds easily to tubing
Housing weld process locks valve into
proper position
Closes at 34 mbar (0.5 psi)
Low pressure valve

Functions on tubing ID 3.75 to 4.31 mm


(0.148 to 0.170 in), 2.79 to 3.22 mm
(0.110 to 0.127 in)
Applications:
Low pressure one-way valve in
primary IV administration sets
Materials of Construction:
Valve: Latex free/Latex
Housing: Modified acrylic

Max Flow Connector


High flow insufflators are electronically equipped to monitor,
maintain and control a constant intra-abdominal pressure
between 12 and 18 mm Hg. The inflow tubing is connected to
the insufflator port of the machine and to a V connector that is
attached to two different trocar insufflation ports for better
and faster insufflation.

Improved airflows
For high flow insufflators
High Flow Connector Comparative Flow Rate Study
50

Flow Rate (L/min)

Specifications:

Max Flow
Connector
Competitor V

40

Connections
ML, rotating hub 1/4 in tubing
Connector or 3/8 in tubing Connector

Competitor Q

30

Improved liquid flows

20
10
0
0

0.25

0.50
P (psi)

0.75

1.00

Ordering Information: Specialty Products


Product No.
993-52
993-53
995-69

Description
Duckbill Check Valve/Large Tubing Connectors
Duckbill Check Valve/Large Tubing Connectors, synthetic valve
Duckbill Check Valve/Small Tubing Connectors

Product No. Description


995-71
Duckbill Check Valve/Small Tubing Connectors, synthetic valve
MFC025
Max Flow Connector, MLL, 1/4 in HB
MFC375
Max Flow Connector, MLL, 3/8 in HB

888.676.7255 www.pall.com

15

Relative Size of Particles


Mol. Wt.

General
Filtration

80

Human Hair Diameter


Carbon
Black

60
Smallest Visible Particle

Pollens

40
20
105

Ragweed Pollen

10
Unstable Lipid
Micelles

8
6

Microfiltration

104

2
1

8,000

0.8

Red Blood
Cell

Human
Chromosome

Bacillus megaterium
Bacteria
Candida albicans
Staphylococcus aureus

Yeasts &
Fungi
Emulsions
(latex)

0.6
Serratia marcescens
4,000

0.4

1000

0.2
0.1

800

0.08

Brevundimonas diminuta; DOP


1,000,00

Mycoplasma
Tobacco
Smoke

500,000

Ultrafiltration

0.06
400

0.04

100

0.02
0.01

80

0.008

Proteins

300,000
100,000

50,000

MS-2 Bacteriophage
Endotoxins
<PYROGEN>
Albumin
Virus

Reverse
Osmosis

0.006
30,000

40

0.004

10,000

10

0.002
0.001

500
50

Soluble Salts
<Ions>

, ANGSTROM = 10-8 cm
m, MICROMETER (MICRON) = 104
1 mil = 0.001 inch = 25.4 m
Differential pressure increases with reduced micron ratings; dirt holding capacity and relative flow rates decrease with reduced micron rating.

16

888.676.7255 www.pall.com

Metal Ions

Reference

Pall Medical Facilities


Pall Corporation Facilities

Worldwide Offices

Where the World Turns for Medical Filtration and Separations Solutions
You will find Pall Medical filtration products in healthcare settings throughout the world. Our filtration devices provide our OEM customers with solutions for
contamination control, which is critical in infusion therapy, blood separation, delivery of epidural anesthetic and analgesic solutions, in the preparation of
irrigation and injectable solutions, and with cytotoxic drugs. Our devices are also found in critical applications like minimally-invasive surgery, respiratory
therapy, cardiovascular surgery, ophthalmic surgery, and in the delivery of microbiologically pure water.
Pall Medical was formed in 1998 by joining the global resources of Pall Biomedical, Pall OEM Healthcare, and Medsep Medical Components. This
partnership provides our customers with unprecedented access to filtration expertise and the widest array of filtration, system engineering, and separations
solutions available anywhere in the world. Together, our companies form the strongest sales, technical, and manufacturing organization within our industry.
All of this converges to serve you, our customer.
Our experienced sales representatives offer our global OEM customers convenient, rapid access to the filtration products you need to accomplish your business
objectives. For more information, please call your nearest office, or contact the Pall Medical Critical Care headquarters at 734.913.6155 or 888.676.7255.

Pall Medical (OEM)


674 South Wagner Road
Ann Arbor, MI 48103-9019 USA
Tel: 734-913-6124
888-676-7255 (in USA)
Fax: 734-913-6353

France
3, rue des Gaudines
B.P. 5253
78715 St. Germain-en-Laye Cedex
Tel: 01 30 61 39 92
Fax: 01 30 61 58 01

Australia
1-3 Wandarri Crt
Cheltenham Vic 3192
Tel: 61 3 9584 8100
Fax: 61 3 9584 6647

Germany
Philipp-Reis-Strae 6
D-63303 Dreieich
Tel: 6103-307-333
Fax: 6103-307-399

India
Pall Pharmalab Filtration Pvt. Ltd.
Sahney Kirkwood Compund
I floor, 27, Kirol, Vidyavihar (West)
Mumbai - 400 086, Maharastra State
Tel: 91-22-5956050
Fax: 91-22-5956051
Italy
Division of PALL Itala S.r.l.
20146 Milano
Tel: 02-477961
Fax: 02-4122-985
or 02-47796-394

888.676.7255 www.pall.com

Japan
Gotanda Nomura Shoken Building
1-5-1 Nishi Gotanda
Shinagawa-ku 141
Tel: 3-3495-8310
Fax: 3-3495-8366

Pall Corporation
2200 Northern Boulevard
East Hills, NY 11548 USA
Tel: 516-484-5400
800-289-7255 (in USA)
Fax: 516-484-6129

United Kingdom
Europa House
Havant Street
Portsmouth, Hampshire
PO1 3PD
Tel: 023 92 302600
Fax: 023 92 302601

17

for more medical device options. Lots more


553,560
553,560 and
and counting.
counting.
Our customers count on options. And us.
Count on Pall to save you time and money. With so many components, its likely we have the
right membrane in the right type of device with the right connectors to meet your needs. Add in
the expertise of our global support staff, technical and engineering support, and scientific
laboratory services and youll see how we can dramatically speed up your development.
Bring your challenging application to Pall. We offer the largest selection of proprietary media in the
world, plus state-of-the-art manufacturing facilities that will deliver a solution to you thats expeditious
and cost-effective.
When it comes to medical device filtration, count on Pall. Youll be in very good company.

Start with the one filtration company that does it all. Call Pall.

2003, Pall Corporation. Pall,


GN03.0739.

888-676-7255

, Versapor, Pallflex, and Intervene are trademarks of Pall Corporation. Indicates a trademark registered in the USA.
is a service mark of Pall Corporation. Puritan-Bennett is a registered trademark of Tyco Healthcare.

9/03 PN33340

Você também pode gostar