Sartocheck® 4 plusFilter 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 surround-ed 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 comple-mentary factors as we do on the product itself.

A global team of Applications Specialists are in place ready to provide immediate assis-tance with filter and bag test

questions and troubleshooting. A dedicated service group en-sures maximum system uptime to enhance productivity and equipment longevity. Compre-hensive documentation in the form of manuals, validation guides, and applications notes provide the user with up-to-date 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.

Documentation

Expanded Capabilities

On-Site Validation

Applications Expertise

World-Class Service Support

Continual Research & Development

Sartocheck® 4 plus – Benefits that Count

GMP Production ProvenFull compliance with GAMP 5 and 21 CFR Part 11, individual user access rights and audit trail traceability of unauthor-ized log-on attempts, intuitive programming and opera-tion, 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-OwnershipThe extraordinary benefits that come with features such as the automated cleaning func-tion, 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 in-vest in the industry leader for filter integrity test and bag leak test equipment is continu-ously rewarded.

World-Class SupportSartorius’ commitment to fully support the Sartocheck® prod-uct line – by providing on-site and factory Applications exper-tise, 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 cus-tomers require to achieve their primary objectives.

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 auto-matically generate the information if it was fulfilled or not

The Sartocheck® 4 plus thus gives the most comprehensive traceability there is.

User and Program ManagementAs the same users are likely to use several different Sartocheck® 4 plus units the user accounts may be trans-fered from one unit to the other, using the SD card or the ethernet connection. Programs may also be trans-fered 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.

Designed to Minimize Service CostsThe patented cleaning function of Sartocheck® 4 plus allows the user to easily perform clean-ing 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 SafetyThe 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 appre-ciate 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 EntryUsing 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 OperationA 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 immedi-ate knowledge and comfort in programming and running the unit, ultimately resulting in enhanced productivity and error-free operation.

Parallel Filter and Bag TestingIn order to maximize produc-tivity 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 TraceabilityThe 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.

Sartocheck® 4 plus – Precision Down to the Last Detail. With Service all Down the Line.

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– Access rights assigned for authorized steps and procedures with

definable password length– Only authorized persons may program tests– All user action recorded in an audit trail including unauthorized

log-on attempts– User log-off function

Sartocheck® 4 plus – Precision Down to the Last Detail. With Service all Down the Line.

Sartocheck® 4 plus Data Integrity and Security in Compliance with 21 CFR Part 11

– Up to 250 test programs and 999 test results are saved in the integrated database

– Test results with user access rights assigned– User-definable warning limit alerts user when archive

is becoming full– No data overwriting– No data loss– Test reports in PDF format

World-class Service not Just an Empty Catchphrase, but Practiced Everyday

– On-site applications support through dedicated engineers– Technical phone support– Highly professional and extensive qualification of Application

and Service Specialists– On-site calibration and maintenance– Fast delivery times on replacement parts

Sartocheck® 4 plus Practical Peripherals (as Options)

– Autonomously performs up to 5 tests in parallel with one Sartocheck® 4 plus and 4 MultiUnits

– Easily overcomes any pressure drop concerns over a distance using the flexibility of an external pressure transducer

– Reliable procedure due to external venting– Easy automatic remote control of external valves by

Sartocheck® 4 plus during WIT – Network connection via RJ45 to FTP server – Profibus Interface which allows the integration of

Sartocheck® 4 plus directly into process control systems

Sales and Service ContactsFor further contacts, visit www.sartorius-stedim.com

EuropeGermanySartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen

Phone +49.551.308.0Fax +49.551.308.3289

Sartorius Stedim Systems GmbHRobert-Bosch-Strasse 5 – 7 34302 Guxhagen

Phone +49.5665.407.0Fax +49.5665.407.2200

FranceSartorius Stedim Biotech S.A.ZI Les PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex

Phone +33.442.845600Fax +33.442.845619

Sartorius Stedim France SASZI Les PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex

Phone +33.442.845600Fax +33.442.846545

AustriaSartorius Stedim Austria GmbHFranzosengraben 121030 Vienna

Phone +43.1.7965763.18Fax +43.1.796576344

BelgiumSartorius Stedim Belgium N.V.Leuvensesteenweg, 248/B1800 Vilvoorde

Phone +32.2.756.06.80Fax +32.2.756.06.81

HungarySartorius Stedim Hungária Kft.Kagyló u. 52092 Budakeszi

Phone +36.23.457.227Fax +36.23.457.147

ItalySartorius Stedim Italy S.p.A.Via dell’Antella, 76/A50012 Antella-Bagno a Ripoli (FI)

Phone +39.055.63.40.41Fax +39.055.63.40.526

NetherlandsSartorius Stedim Netherlands B.V.Edisonbaan 243439 MN Nieuwegein

Phone +31.30.6025080Fax +31.30.6025099

PolandSartorius Stedim Poland Sp. z o.o.ul. Wrzesinska 7062-025 Kostrzyn

Phone +48.61.647.38.40Fax +48.61.879.25.04

Russian FederationLLC “Sartorius ICR”Uralskaya str. 4, Lit. B199155, Saint-Petersburg

Phone +7.812.327.5.327Fax +7.812.327.5.323

ScandinaviaSartorius Stedim Nordic A/SHoerskaetten 6D, 1.2630 Taastrup, Denmark

Phone +45.7023.4400Fax +45.4630.4030

SpainSartorius Stedim Spain SAC/Isabel Colbrand 10, Oficina 70Polígono Industrial de Fuencarral28050 Madrid

Phone +34.90.2110935Fax +34.91.3589623

SwitzerlandSartorius Stedim Switzerland AGRingstrasse 24 a8317 Tagelswangen

Phone +41.52.354.36.36Fax +41.52.354.36.46

U.K.Sartorius Stedim UK Ltd.Longmead Business CentreBlenheim Road, EpsomSurrey KT19 9 QQ

Phone +44.1372.737159Fax +44.1372.726171

AmericaUSASartorius Stedim North America Inc.5 Orville Drive, Suite 200Bohemia, NY 11716

Toll-Free +1.800.368.7178Fax +1.631.254.4253

ArgentinaSartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires

Phone +54.11.4721.0505 Fax +54.11.4762.2333

BrazilSartorius do Brasil LtdaAv. Dom Pedro I, 241Bairro Vila Pires Santo André São PauloCep 09110-001

Phone +55.11.4451.6226Fax +55.11.4451.4369

MexicoSartorius de México S.A. de C.V.Circuito Circunvalación Poniente No. 149Ciudad Satélite53100, Estado de MéxicoMéxico

Phone +52.5555.62.1102Fax +52.5555.62.2942

Asia|PacificAustraliaSartorius Stedim Australia Pty. Ltd.Unit 5, 7-11 Rodeo DriveDandenong South Vic 3175

Phone +61.3.8762.1800Fax +61.3.8762.1828

ChinaSartorius Stedim Biotech (Beijing) Co. Ltd.Airport Industrial Zone BNo. 33 Yu’an RoadBeijing 101300, Shunyi District

Phone +86.10.80426516Fax +86.10.80426580

Sartorius Stedim Biotech (Beijing) Co. Ltd.Shanghai Branch officeRoom 618, Tower 1, German Centre,Shanghai, PRC., 201203

Phone +86.21.28986393Fax +86.21.28986392.11

Sartorius Stedim Biotech (Beijing) Co. Ltd.Guangzhou representative officeRoom 704, Broadway Plaza,No. 233–234 Dong Feng West RoadGuangzhou 510180

Phone +86.20.8351.7921Fax +86.20.8351.7931

IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, NH 48, JakkasandraNelamangala Tq562 123 Bangalore, India

Phone +91.80.4350.5250Fax +91.80.4350.5253

JapanSartorius Stedim Japan K.K.Kiba Park Bldg5-11-13 KibaKoto-kuTokyo 135-0042

Phone +81.3.5639.9981Fax +81.3.5639.9983

MalaysiaSartorius Stedim Malaysia Sdn. Bhd.Lot L3-E-3B, Enterprise 4Technology Park MalaysiaBukit Jalil57000 Kuala Lumpur, Malaysia

Phone +60.3.8996.0622Fax +60.3.8996.0755

SingaporeSartorius Stedim Singapore Pte. Ltd.1 Science Park Road, The Capricorn, #05-08A,Singapore Science Park IISingapore 117528

Phone +65.6872.3966Fax +65.6778.2494

South KoreaSartorius Korea Biotech Co., Ltd.8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-GuSeongNam-Si, GyeongGi-Do, 463-400

Phone +82.31.622.5700Fax +82.31.622.5799

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