Sartocheck® 4 plus
Filter Integrity Testing & Bag Testing at its Best
Sartocheck® –
30 Years Experience in Integrity Testing
Sartorius introduced the very first Sartocheck® filter integrity
tester in 1980. Over the 30-year period of continual enhancement
that followed, the Sartocheck® product line evolved into the most
sophisticated automated integrity test solution and the preferred
choice of critical customers who insist on the best in performance
and quality. Sartorius’ unique innovations, such as the Water
Intrusion Test in 1991, introduced revolutionary new concepts and
paved the path for others to follow. With the Sartocheck® 4 plus
software version 3.00 that allows the testing of bags, Sartorius
remains firmly at the forefront of integrity testing and continues
to extend its three-decade tradition of unmatched innovation
and experience.
Sartocheck® 4 plus –
So Much More than Just a Great Product
Total customer satisfaction
can only be realized when an
outstanding product like the
Sartocheck® 4 plus is surrounded by extraordinary service
and support that enhances its
overall value. We at Sartorius
ensure that our customers
experience the highest return
on investment by placing equal
emphasis on the many complementary factors as we do on
the product itself.
A global team of Applications
Specialists are in place ready
to provide immediate assistance with filter and bag test
Documentation
Expanded
Capabilities
On-Site Validation
questions and troubleshooting.
A dedicated service group ensures maximum system uptime
to enhance productivity and
equipment longevity. Comprehensive documentation in the
form of manuals, validation
guides, and applications notes
provide the user with up-todate documentation covering
all aspects of the Sartocheck®.
A tireless R&D department
continues to create new and
innovative ways to perform
filter integrity testing and
bag testing that ensures
Sartocheck’s® leading edge
status.
Applications Expertise
World-Class
Service Support
Continual Research &
Development
Sartocheck® 4 plus –
Benefits that Count
GMP Production Proven
Full compliance with GAMP 5
and 21 CFR Part 11, individual
user access rights and audit
trail traceability of unauthorized log-on attempts, intuitive
programming and operation, and reliable Sartocheck®
performance over many years
of use in production are just
some of the key benefits that
make the Sartocheck® 4 plus
an invaluable member of
your production team – from
the moment of installation
throughout its extended
life cycle.
Lowest Cost-of-Ownership
The extraordinary benefits that
come with features such as
the automated cleaning function, on-site calibration, and
MultiUnit expansion serve to
minimize the operating costs
while maximizing the return
on investment over the years.
The Sartocheck® 4 plus ensures
that your wise decision to invest in the industry leader for
filter integrity test and bag
leak test equipment is continuously rewarded.
World-Class Support
Sartorius’ commitment to fully
support the Sartocheck® product line – by providing on-site
and factory Applications expertise, unparalleled Service and
detailed documentation just as
examples – is perfectly aligned
with our customers’ needs
and expectations for quality
and productivity. To that end,
Sartorius is dedicated and fully
equipped to furnish the level
of responsiveness that our customers require to achieve their
primary objectives.
Designed to Minimize
Service Costs
The patented cleaning function
of Sartocheck® 4 plus allows the
user to easily perform cleaning of the complete internal
pneumatics as required without
the need for costly down time
and factory service calls. This
unique automated cleaning
feature provides the highest
security without the burden of
additional service costs that can
add up over time.
Highest Process Safety
The optional use of an external
vent valve precludes any risk of
potential cross-contamination
during the daily routine of
filter integrity testing. Patented
decontamination with up to
1M NaOH of the pneumatics
gives unrivaled process safety,
batch afer batch. CMOs, in
particular, have come to appreciate the inherent safety of
the Sartocheck® when integrity
testing a broad range of filters
being in contact with a large
number of drugs.
Error-Free Data Entry
Using the optional barcode
scanner allows for simple and
error-free entry of filter data
into the Sartocheck® 4 plus.
After scanning the 1 or 2
dimensional bar code, only the
relevant test program(s) that
exactly match the scanned item
(cartridge, bag …) are displayed,
thereby making test program
selection both error free and
faster.
Intuitive Operation
A well organized menu
structure and clear on-screen
instructions allow any user to
operate the Sartocheck® 4 plus
with minimal training. First
time users acquire an immediate knowledge and comfort
in programming and running
the unit, ultimately resulting
in enhanced productivity and
error-free operation.
Parallel Filter and Bag Testing
In order to maximize productivity in the most cost effective
way up to four MultiUnits
may be connected to the
Sartocheck® 4 plus. Any kind
of combination of different
MultiUnits may be done
(e.g. 1 Bag tester MultiUnit and
3 Filter tester MultiUnits) for
total flexibility. This provides
the equivalent testing capacity
of five Sartocheck® 4 plus
units operating in parallel with
a reduced foot print and to
a significantly reduced cost
for the end user.
Audit Trail Traceability
The Sartocheck® 4 plus audit
trail gives full traceability of all
GMP relevant actions such as
unauthorized log-on attempts
and parameter changes with
documented settings before
and after. All relevant actions
will generate both an audit
trail event and a printout.
E.g.:
– all tests will generate
appropriate information
accordingly, if the test was
passed, failed or aborted with
the additional information
if it was a user break, a power
break or a pressure supply
break
– a cleaning cycle will automatically generate the
information if it was fulfilled
or not
The Sartocheck® 4 plus thus
gives the most comprehensive
traceability there is.
User and Program
Management
As the same users are likely
to use several different
Sartocheck® 4 plus units the
user accounts may be transfered from one unit to the
other, using the SD card or
the ethernet connection.
Programs may also be transfered easily from one unit to
the other. Each test program
is displayed with its date of
creation for easy detection
of any modifications. The
administrator may define the
minimum password length
and the password validity.
The administrator can also
decide that the user has to
change his password at the
very first log-on.
Sartocheck® 4 plus –
Precision Down to the Last Detail.
Sartocheck® 4 plus
Unique Combination of Features
– Barcode Scanner for easy and error-free data entry (optional)
– Intelligent selection of test program after scanning the filter
– Combination of large, color touch screen display with keypad
– Automated cleaning function eliminates expensive service costs
– Sophisticated Cleaning Kit available (optional)
– Automatic detection of improper test setup
(e.g. disconnected filters)
- External vent valve (optional) for highest process security
– External WIT valves (optional) for automated in-situ WIT
– Multitasking menu
– Electronic test reports in PDF format
– No thermo printer but dot matrix printer
(longer print preservation)
– SD card reader
– Automatic Test Time Function for intelligent optimization
of test times
– Real-time graphing of tests in progress
Sartocheck® 4 plus
Broad Variety of Test Methods
Filter Tester
– Bubble Point Test (BPT)
– Diffusion Test (DIFF)
– Combined Test (DIFF + BPT)
– Pressure Drop Test | System Leak Test
– Water Intrusion Test (WIT)
– Water Flow Test (WFT)
– Multipoint Diffusion Test
– Customer Specific Tests
Bag Tester
– Leak Test of 2D and 3D bags
Sartocheck® 4 plus –
User Management in Compliance with 21 CFR Part 11
– Individual user access rights assigned by the system administrator
–A
ccess rights assigned for authorized steps and procedures with
definable password length
– Only authorized persons may program tests
–A
ll user action recorded in an audit trail including unauthorized
log-on attempts
– User log-off function
With Service all Down the Line.
Sartocheck® 4 plus
Data Integrity and Security in Compliance with 21 CFR Part 11
–U
p to 250 test programs and 999 test results are saved
in the integrated database
– T est results with user access rights assigned
–U
ser-definable warning limit alerts user when archive
is becoming full
– No data overwriting
– No data loss
– Test reports in PDF format
Sartocheck® 4 plus
Practical Peripherals (as Options)
–A
utonomously performs up to 5 tests in parallel with
one Sartocheck® 4 plus and 4 MultiUnits
– E asily overcomes any pressure drop concerns over a distance
using the flexibility of an external pressure transducer
–R
eliable procedure due to external venting
– E asy automatic remote control of external valves by
Sartocheck® 4 plus during WIT
– Network connection via RJ45 to FTP server
–P
rofibus Interface which allows the integration of
Sartocheck® 4 plus directly into process control systems
World-class Service not Just an Empty Catchphrase,
but Practiced Everyday
–O
n-site applications support through dedicated engineers
– Technical phone support
–H
ighly professional and extensive qualification of Application
and Service Specialists
–O
n-site calibration and maintenance
– F ast delivery times on replacement parts
Sales and Service Contacts
For further contacts, visit www.sartorius-stedim.com
America
Germany
Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 11
37079 Goettingen
Italy
Sartorius Stedim Italy S.p.A.
Via dell’Antella, 76/A
50012 Antella-Bagno a Ripoli (FI)
USA
Sartorius Stedim North America Inc.
5 Orville Drive, Suite 200
Bohemia, NY 11716
Phone +49.551.308.0
Fax +49.551.308.3289
Phone +39.055.63.40.41
Fax +39.055.63.40.526
Toll-Free +1.800.368.7178
Fax +1.631.254.4253
Sartorius Stedim Systems GmbH
Robert-Bosch-Strasse 5 – 7
34302 Guxhagen
Netherlands
Sartorius Stedim Netherlands B.V.
Edisonbaan 24
3439 MN Nieuwegein
Argentina
Sartorius Argentina S.A.
Int. A. Ávalos 4251
B1605ECS Munro
Buenos Aires
Phone +49.5665.407.0
Fax +49.5665.407.2200
Phone +31.30.6025080
Fax +31.30.6025099
France
Sartorius Stedim Biotech S.A.
ZI Les Paluds
Avenue de Jouques – CS 91051
13781 Aubagne Cedex
Poland
Sartorius Stedim Poland Sp. z o.o.
ul. Wrzesinska 70
62-025 Kostrzyn
Phone +33.442.845600
Fax +33.442.845619
Phone +48.61.647.38.40
Fax +48.61.879.25.04
Sartorius Stedim France SAS
ZI Les Paluds
Avenue de Jouques – CS 71058
13781 Aubagne Cedex
Russian Federation
LLC “Sartorius ICR”
Uralskaya str. 4, Lit. B
199155, Saint-Petersburg
Phone +33.442.845600
Fax +33.442.846545
Phone +7.812.327.5.327
Fax +7.812.327.5.323
Austria
Sartorius Stedim Austria GmbH
Franzosengraben 12
1030 Vienna
Scandinavia
Sartorius Stedim Nordic A/S
Hoerskaetten 6D, 1.
2630 Taastrup, Denmark
Phone +43.1.7965763.18
Fax +43.1.796576344
Phone +45.7023.4400
Fax +45.4630.4030
Belgium
Sartorius Stedim Belgium N.V.
Leuvensesteenweg, 248/B
1800 Vilvoorde
Spain
Sartorius Stedim Spain SA
C/Isabel Colbrand 10,
Oficina 70
Polígono Industrial de Fuencarral
28050 Madrid
Phone +32.2.756.06.80
Fax +32.2.756.06.81
Hungary
Sartorius Stedim Hungária Kft.
Kagyló u. 5
2092 Budakeszi
Phone +36.23.457.227
Fax +36.23.457.147
Phone +54.11.4721.0505
Fax +54.11.4762.2333
Brazil
Sartorius do Brasil Ltda
Av. Dom Pedro I, 241
Bairro Vila Pires
Santo André
São Paulo
Cep 09110-001
Phone +55.11.4451.6226
Fax +55.11.4451.4369
Japan
Sartorius Stedim Japan K.K.
Kiba Park Bldg
5-11-13 Kiba
Koto-ku
Tokyo 135-0042
Phone +81.3.5639.9981
Fax +81.3.5639.9983
Malaysia
Sartorius Stedim Malaysia Sdn. Bhd.
Lot L3-E-3B, Enterprise 4
Technology Park Malaysia
Bukit Jalil
57000 Kuala Lumpur, Malaysia
Phone +60.3.8996.0622
Fax +60.3.8996.0755
Singapore
Sartorius Stedim Singapore Pte. Ltd.
1 Science Park Road,
The Capricorn, #05-08A,
Singapore Science Park II
Singapore 117528
Phone +52.5555.62.1102
Fax +52.5555.62.2942
Phone +65.6872.3966
Fax +65.6778.2494
Asia | Pacific
Australia
Sartorius Stedim Australia Pty. Ltd.
Unit 5, 7-11 Rodeo Drive
Dandenong South Vic 3175
Phone +61.3.8762.1800
Fax +61.3.8762.1828
Switzerland
Sartorius Stedim Switzerland AG
Ringstrasse 24 a
8317 Tagelswangen
China
Sartorius Stedim Biotech (Beijing) Co. Ltd.
Airport Industrial Zone B
No. 33 Yu’an Road
Beijing 101300, Shunyi District
Phone +86.10.80426516
Fax +86.10.80426580
U.K.
Sartorius Stedim UK Ltd.
Longmead Business Centre
Blenheim Road, Epsom
Surrey KT19 9 QQ
Sartorius Stedim Biotech (Beijing) Co. Ltd.
Shanghai Branch office
Room 618, Tower 1, German Centre,
Shanghai, PRC., 201203
Phone +44.1372.737159
Fax +44.1372.726171
Phone +86.21.28986393
Fax +86.21.28986392.11
Sartorius Stedim Biotech (Beijing) Co. Ltd.
Guangzhou representative office
Room 704, Broadway Plaza,
No. 233–234 Dong Feng West Road
Guangzhou 510180
Phone +86.20.8351.7921
Fax +86.20.8351.7931
www.sartorius-stedim.com
Phone +91.80.4350.5250
Fax +91.80.4350.5253
Mexico
Sartorius de México S.A. de C.V.
Circuito Circunvalación Poniente
No. 149
Ciudad Satélite
53100, Estado de México
México
Phone +34.90.2110935
Fax +34.91.3589623
Phone +41.52.354.36.36
Fax +41.52.354.36.46
India
Sartorius Stedim India Pvt. Ltd.
#69/2-69/3, NH 48, Jakkasandra
Nelamangala Tq
562 123 Bangalore, India
South Korea
Sartorius Korea Biotech Co., Ltd.
8th Floor, Solid Space B/D,
PanGyoYeok-Ro 220, BunDang-Gu
SeongNam-Si, GyeongGi-Do, 463-400
Phone +82.31.622.5700
Fax +82.31.622.5799
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