Supracap Depth Filter Capsules Providing the Benefits of Seitz

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USD 2463b
Supracap™ Depth
Filter Capsules
Providing the Benefits of Seitz® High Performance
Depth Filter Media in Scalable
Capsule Formats
Scalable Single-use Depth Filtration
The range of Supracap capsules provides a scalable and
Inside Supracap 100 Capsules
reliable depth filter platform for rapid process development
Benefitting from the proven Pall Supradisc II mechanically
for volumes from < 1 liter to over 100 liters, utilizing the
robust module design, Supracap 100 capsules enable
same design, flow path, and filter media as larger scale
consistent, reliable filtration results from batch to batch.
Pall Supradisc™ depth filter modules and Stax™ capsules.
Through the use of dual drainage plates, the Supradisc II
Scalable both linearly in performance and seamlessly through
module design imparts the structural integrity necessary for:
product format transitions, Supracap capsules will save time
Unobstructed process flow
and costs during critical screening, development and process
Consistent filtration results
operations. The fully disposable design eliminates any
Minimized risk to filter media rupture in the event
of reverse pressure
cleaning or handling concerns typically associated with
housings, especially when dealing with biological and
hazardous products.
The Supracap range of capsules has been designed to
provide cost effectiveness, flexibility and ease-of-use,
while minimizing the exposure risks for operators.
Supracap 60 Capsules
Ideal for developing and optimizing processes during
scale-up and scale-down studies, the Supracap 60
capsules (effective filtration area [EFA] 26 cm2) can be
used to quickly and accurately determine the exact Seitz
depth filter media necessary for process filtration success.
And because the Supracap 60 capsules utilize similar
design, filter media, and flow path construction as the
larger Supracap 100 capsules, assurance of performance
and process design during scale-up and scale-down
studies is achieved.
2
S ca la bility
Following on from Supracap 60 capsules, Pall Supracap 100
capsules are available in 4 sizes ranging from 0.025m2 to
0.3m2 (0.27 ft2 to 3.23 ft2) EFA. These capsules can also be
manifolded together to create even larger systems, to ensure
we can meet your process requirements for perfect scale up
when transitioning from small scale development through to
commercial phase manufacturing.
Comparison of Scalability - CHO Clarification
(Post Fermenter) Filter Grade - PDK5 at 150 Lmh
1.6
1.4
∆p (bar)
1.2
1.0
0.8
0.6
0.4
0.2
0
0
50
100
150
200
250
300
Volumetric Throughput (L/m²)
Supracap 60 capsule (1)
Supracap 60 capsule (2)
Supracap 60 capsule (3)
Supracap 100 5 in. capsule
Supracap 100 10 in. capsule
Stax capsule
Culture Harvest Conditions - Total Cells - 9.68 x 10 6/mL,
Viable Cells - 1.99 x 10 6/mL, Viability - 20.6, Turbidity - >1000 NTU
Top: Supracap 100 internal cartridge.
Bottom: (from left to right) 5 in. and 10 in. Supracap 100
capsules, Stax capsule and center bottom Supracap
60 capsule.
www.pall.com
3
Flexibility of Design
Designed to Provide Choice and Flexibility
The Supracap range of disposable capsules comes in a
variety of options to enable you to select the correct capsule
to meet your specific process requirements, offering different
configurations for:
Filter area
Depth filter media grade
Capsule configuration
Inlet/outlet connections
Complete Single-Use Systems
With the additional benefit of being able to manifold
the Supracap 100 capsules together, or with other Pall
Kleenpak™ Nova capsule filters, the Supracap 100
capsules can be easily incorporated into Pall Allegro™
disposable systems.
These Allegro systems can combine depth filters, final
sterile filters and biocontainers – making a complete filter
train – What could be better? A complete single-use
system designed to your specifications, ready to use
straight out of the box!
Simple, Scalable, Disposable. Pall Supracap
capsules provide high performance filtration and
flexibility, in single-use format.
Applications
Appropriate for use in primary and secondary filtration
steps in applications including:
Mammalian cell cultures
Yeast
E.coli lysates and refolds
Vaccines
Blood plasma proteins and serum
Media
4
10 in. in-line Supracap 100 capsule.
Features and Benefits
Complete flexibility – Choices in filter media, effective
filtration area, capsule configuration, and connection
styles enables customized filtration solutions
Low hold-up volume – Increased product recovery
requiring low post use rinse volumes
Seamless linear scalability – Greater flexibility and
assurance of process success from <1 to 100+ liters.
Scalable to Pall’s entire line of traditional Supradisc
modules as well as Stax capsules
Minimized risk – Mechanically robust design provides
unobstructed process flows, consistent and scalable
filtration results, as well as a high filter media integrity
Technical Service
For the best possible results and maximum reliability,
Pall recommends performing filter evaluations utilizing your
process and process conditions. Pall specialists can provide
valuable assistance, either at your facility or in our SLS
(Scientific and Laboratory Services) laboratories. Pall offers
hands-on assistance and places its extensive technical
resources at your disposal in the form of worldwide
technical advice, including cost-reduction programs,
process review and problem solving.
No housings – Easier to use and manipulate while
eliminating capital expenditures
Completely disposable – Eliminates the need for cleaning
and cleaning validation
Encapsulated design – Reduces operator exposure to
potential biohazards
www.pall.com
5
Proven High Performance Depth Filter Media
Incorporating Seitz Depth Filter Media
Applications
Supracap capsules are available in a wide range of
With Pall’s wide ranging Pharmaceutical grade depth
advanced pharmaceutical grade Seitz depth filter media.
filter sheets for use in the entire Supracap line of disposable
Supported with comprehensive validation guides, Seitz depth
capsules, flexibility to meet your unique process demands
filter media meet the highest pharmaceutical standards for:
is attainable.
Quality
P-series:
Lot-to-lot consistency
Seitz P-series depth filter sheets were specifically
Manufacturing control
developed for the strict requirements in biotechnological
Low extractable content
and pharmaceutical industries. Manufactured with stringent
Low endotoxin content
in-process control methods assures consistent filtration
quality, a very high purity of filter medium, and alignment
Scalability - Depth Filter Sheet Media Formats
with the requirements of the pharmaceutical industry.
For further information, please reference Pall data sheet
USD 2205 or validation guide USTR 2366.
Advanced
Pharmaceutical
Grade Depth
Filter Media
HP-series:
Seitz HP-series depth filter sheets are comprised of two
distinct layers of Seitz P-series depth filter sheets; a coarser
layer upstream followed by a finer layer downstream.
These performance-enhanced depth filter sheets have
been designed for use in low viability, high solids containing
P-series
HP-series
Bio-series
Biopharm
Product
Filtration
High
Performance
Cell Culture
Clarification
100 % Organic
Filter Matrix –
Low Product
Binding
(10 grades)
(Double layer
w/20+ grades)
(2 grades)
applications. As small shifts in process conditions can cause
dramatic differences in filtration requirements, the flexibility of
combining any combination of P-series media in an HP
format allows for improved process optimization. For further
information, please reference Pall data sheet USD 2335
or validation guide USTR 2404.
Bio-series:
Supracap
60 capsules
Supracap
100 capsules
Supracap
200 capsules
Supradisc I
modules
Supradisc II
modules
Stax
capsules
Seitz Bio-series depth filter sheets are specially developed
< 1-3
liters
3-100+
liters
50-2000+
liters
50-20,000+
liters
50-20,000+
liters
50-20,000+
liters
from highly purified natural and modified cellulose fibers and
contain no inorganic materials such as diatomaceous earth
(DE), perlite or glass fibers. The lack of these inorganic
substances significantly reduces the levels of ash and heavy
metal extractables. For further information please reference
Pall data sheet USD 2201.
6
Typical Permeability (L/m²/min at 1 bar)
Permeability - P-series
2500
2000
1500
1000
500
K 900 P
K 700 P
K 250 P
K 200 P
SUPRA 80 P
K 100 P
KS 50 P
SUPRA EK 1-P
EKM-P
EKS-P
0
Depth filter sheets.
Permeability - Bio-series
200
Typical Permeability (L/m²/min at 1 bar)
Typical Permeability (L/m²/min at 1 bar)
Permeability - HP-series
180
160
140
120
100
80
60
40
20
0
PDD1
PDE2
PDH4
120
110
100
90
80
70
60
50
40
30
20
10
0
Bio 10
PDK5
Bio 20
The above HP grades are examples of only 4 of the
many grades available.
Nominal Retention Rating of Seitz P-series, HP-series and Bio-series Depth Filter Sheet Media
Bio 20
Bio 10
PDK5
PDH4
PDE2
PDD1
K900P
K700P
K250P
K200P
K100P
S80P
KS50P
SEK1P
EKMP
EKSP
0.1
0.5
1
5
10
25
50
100
Micron
www.pall.com
7
From Bench-top to Process
A well integrated suite of single-use devices is critical when
Scalability - Effective Filter Area
scaling up or down a process for further analysis. Apart
from the ease of use aspect of these disposable products,
designing them with similar flow resistance, flow paths and
filter area utilization will produce results that more accurately
predict what will be demonstrated at larger scales.
Supracap 60 capsules (<1 to 3 liters)
Capsule
Supracap 100 capsules (3 to 100 + liters)
5 in. capsules
0.05 m² (0.54 ft²) SL(1) EFA
0.025 m² (0.27 ft²) DL(2) EFA
10 in. capsules
0.1 m² (1.08 ft²) SL EFA
0.05 m² (0.54 ft²) DL EFA
20 in. capsules
0.2 m² (2.15 ft²) SL EFA
0.1 m² (1.08 ft²) DL EFA
30 in. capsules
0.3 m² (3.23 ft²) SL EFA
0.15 m² (1.61 ft²) DL EFA
Supported by these complimentary technologies, Pall has
extended this seamless approach to products to their larger
Stax capsule system (50 to 20,000+ liters). Building upon the
same criteria for design, flow path, and filter media Pall has
established a comprehensive suite of enabling single-use
technologies providing seamless linear scalability in filtration
26 cm² (0.028 ft²) of EFA*
performance from bench to process.
Stax capsules (50 to 20,000 + liters)
Small capsules
0.5 m² (5.38 ft²) SL EFA
0.25 m² (2.70 ft²) DL EFA
Medium capsules
1.0 m² (10.8 ft²) SL EFA
0.5 m² (5.38 ft²) DL EFA
Large capsules
2.0 m² (21.5 ft²) SL EFA
1.0 m² (10.8 ft²) DL EFA
* EFA = Effective Filtration Area
(1)
SL = Single layer Seitz depth filter media such as P-series and BIO-series
(2)
DL = Double layer Seitz depth filter media such as HP-series
Top: Pilot Scale Stax chassis arranged
with one large capsule, one small capsule
and the vent manifold kit.
Right: Supracap 60 capsule
8
Technical Specifications
High Quality Standards
Batch tested in order to meet all quality requirements
Manufactured under a Quality Management System
certified to ISO 9000 and ISO 9001 and an Environmental
Management System certified to ISO 14001
All plastic components used in construction meet the
specifications for Biological Reactivity Tests in vivo for
Class VI Plastics (121 °C) as described in the current
United States Pharmacopoeia (USP).
Materials of Construction
Supracap 60 Capsules
Capsule
Vent
Supracap 100 Capsules
Housing Bowl
Housing Head(1)
O-rings
(1)
Maximum Operating Pressure(2)
Supracap 60 & 100 Capsules
From drug discovery and basic research, through process
(2)
single source for all your filtration and separation needs.
Our UpScale program provides you with the scalable
products and support you need to bring new products
to market faster.
Supracap Capsules Meet
Industry Requirements
Polypropylene
Polypropylene
Silicone elastomers
Formulated with TiO² whitener which does not contribute to
organic extractables
Pall UpScaleSM Program
development and production, Pall Corporation is the
Polycarbonate
Polypropylene
3 bar (44 psi) @ 40 ºC
In compatible fluids which do not soften, swell, or adversely
affect the filter or its materials of construction
Maximum Differential Pressure
Supracap 60 Capsules
Supracap 100 Capsules
1.5 bar (22 psi)
2.4 bar (35 psi)
Sterilization - Autoclaving
Supracap 60 Capsules
Supracap 100 Capsules
1 cycle: 125 ºC at 30 minutes
1 cycle: 125 ºC at 60 minutes
designed to have minimal hold-up volumes.
Supracap 60 and Supracap 100 Capsule Filter Area
SC6
NP5
N*6
N*7
Single layer 26 cm²
0.05 m2
0.1 m2
0.2 m2
(0.028 ft²) (0.54 ft2)
(1.08 ft2)
(2.15 ft2)
2
2
HP-version
26 cm²
0.025 m
0.05 m
0.10 m2
2
2
(0.028 ft²) (0.27 ft )
(0.54 ft ) (1.08 ft2)
The translucent shell makes venting and draining easier
* Insert either P (for in-line version) or T (for T-style version)
Supracap capsules have been designed to meet industry
requirements including autoclaving and low extractables.
They offer high flow rates and throughputs and are
as liquid levels are now visible.
Supracap 100 Capsules Void Volumes(3)
Capsule Length
NP (mL)
127 mm (5 in.)
652
254 mm (10 in.)
1125
508 mm (20 in.)
2291
762 mm (30 in.)
3399
(3)
N*8
0.3 m2
(3.23 ft2)
0.15 m2
(1.61 ft2)
NT (mL)
NA
1160
2578
3747
Void volume is defined as amount of liquid required to fill entire
capsule with cartridge installed inside
www.pall.com
9
Technical Specifications
Supracap 60 Capsules Nominal Dimensions
Maximum Height (A)
Maximum Diameter (B)
Single layer media
32.5 mm (1.28 in.)
75 mm (2.95 in.)
HP media
36 mm (1.42 in.)
75 mm (2.95 in.)
Supracap 100 Capsules Nominal Dimensions
In-line
NP5
NP6
NP7
NP8
Maximum diameter (B) including valves
154 mm (6.1 in.)
154 mm (6.1 in.)
154 mm (6.1 in.)
154 mm (6.1 in.)
Height (A) with hose barb inlet/outlet
263 mm (10.4 in.)
397 mm (15.6 in.)
644 mm (25.4 in.)
895 mm (35.2 in.)
Height (A) with sanitary inlet/outlet
213 mm (8.4 in.)
335 mm (13.2 in.)
584 mm (23.0 in.)
834 mm (32.8 in.)
T-style
NT5
NT6
NT7
NT8
Maximum diameter (B)
NA
240 mm (9.5 in.)
240 mm (9.5 in.)
240 mm (9.5 in.)
Height (A) including valves
NA
349 mm (13.7 in.)
598 mm (23.5 in.)
848 mm (33.4 in.)
Supracap 60 Capsules
Supracap 100 NP Style Capsules
Supracap 100 NT Style Capsules
A
A
A
B
B
B
10
Ordering Information
Supracap 60 Capsules
Pall Part Number: SC060
Code
Media Grade
PEKS
EKSP
PEKM
EKMP
PEK1
SEK1P
P050
KS50P
P080
SUPRA 80P
P100
K100P
P200
K200P
P250
K250P
P700
K700P
P900
K900P
B010
BIO10
B020
BIO20
PDD1
PDD1
PDE2
PDE2
PDH4
PDH4
PDK5
PDK5
Supracap 100 Capsules
Pall Part Number:
N
Code
Capsule Format
Code
Nominal Length
Code
Media Grade
Code
Connection Options
P
In-line
5L(1)
5 in. (127 mm)
PEKS
EKSP
1
1 – 11⁄2 in. sanitary flange inlet and outlet
T
T-style
6
10 in. (254mm)
PEKM
EKMP
9
7
20 in. (508 mm)
PEK1
SEK1P
25 mm (1 in.) single barb hose barb
inlet and outlet
8
30 in. (762 mm)
P050
KS50P
19(2)
P080
SUPRA 80P
1– 11⁄2 in. sanitary flange inlet and
25 mm (1 in.) single barb hose barb outlet
P100
K100P
6(2)
`
13 mm (1⁄2 in.) single barb hose barb
inlet and outlet
P200
K200P
7(3)
1
P250
K250P
16(2)
P700
K700P
1– 11⁄2 in. sanitary flange inlet and
13 mm (1⁄2 in.) single barb hose barb outlet
1H1(4)
1– 11⁄2 in. sanitary flange inlet and out
let with additional 1⁄2 in. sanitary port
on inlet
1H9(4)
1 – 11⁄2 in. sanitary flange inlet and 11⁄2 in.
single barb hose barb outlet, with
additional 1⁄2 in. sanitary port on inlet
Note: Staübli vent and stepped hose barb drain fitted as standard
(1)
(2)
(3)
(4)
Currently available only with In-line capsule format and
connection codes 1, 6, or 7.
Currently available only with In-line capsule formats.
Currently available only with 5 in. capsule formats.
Currently available only with T-style capsule formats.
P900
K900P
B010
BIO10
B020
BIO20
PDD1
PDD1
PDE2
PDE2
PDH4
PDH4
PDK5
PDK5
⁄4 in. hose barb inlet and outlet
www.pall.com
11
™
AllegroSystems
The Single- Use Solution
Visit us on the Web at www.pall.com/biopharm
e-mail us at biotech@pall.com
United States
800.717.7255 toll free (USA)
516.484.5400 phone
516.801.9548 fax
biotech@pall.com e-mail
Europe
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com e-mail
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, South Africa, 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.
© 2009, Pall Corporation. Pall,
, Allegro, the Allegro design, Kleenpak, Seitz, Stax, Supracap,
and Supradisc are trademarks of Pall Corporation. ® indicates a trademark registered in the USA.
Filtration. Separation. Solution.SM and UpScale is a service mark of Pall Corporation. Stäubli is a
trademark of Stäubli AG.
9/09, PDF, GN09.3517
USD 2463b
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