Sartorius Sartocheck 4 plus Operating Instructions Manual
Operating Instructions | Betriebsanleitung
Sartocheck® 4 plus Filter tester | Filter tester MultiUnit
Filter Integrity Tester | Filterintegritäts-Testgerät
1000025369
2 Contents
Contents | Inhalt
English .............................................. Page 3
Deutsch ............................................. Seite 94
1. Contents
1. Contents ........................................2
1.1 Contents ....................................3
1.2 FCC ......................................5
2. Overview and Proper Use .........................6
2.1 Overview .....................................6
2.2 Proper Use ...................................6
2.3 Technical Specifications ........................7
2.3.1 Dimensions and Weight ..................7
2.3.2 Connection Data .......................7
2.3.3 Pneumatics ............................7
2.3.4 Test Media .............................7
2.3.5 Product-specific Data ...................8
2.3.6 Test Methods ...........................9
2.3.7 General Data ...........................9
3. Safety ..........................................10
3.1 Notes | Warnings | Descriptions .................10
3.1.1 Manufacturer’s ID Label .................10
3.2 Installed Safety Equipment .....................11
3.3 Safety Precautions ............................11
3.4 Operator’s Obligations .........................12
3.5 Safety Tests and Inspections Carried Out by
the Manufacturer at the Facilities ................12
4. General Warnings ................................13
4.1 Hazards ......................................13
4.2 Operating Personnel and Service
and Maintenance Personnel .....................13
4.3 Installation of Replacement Parts ................14
4.4 Shutdown Procedure ..........................14
5. Installation ......................................15
5.1 Equipment Supplied ...........................15
5.2 Receipt of Delivery ............................15
5.3 Installation Instructions ........................16
5.3.1 Ambient Conditions and Conditions
at the Place of Installation ................16
5.3.2 Transport and Unpacking the Equipment ....16
5.4 Connections .................................17
5.4.1 Front Panel and Back Panel ..............17
5.4.2 Left and Right Panels ....................17
5.4.3 Left and Right Panels Sartocheck® 4
MultiUnit ..............................18
5.5 Connections with Internal Pressure Sensor .........18
5.6 Connections with External Pressure Sensor .........20
5.6.1 Inserting Paper Roll and Ribbon Cartridge . . .21
5.6.2 Sartocheck® 4 MultiUnit ..................22
6. Function ........................................23
6.1 General Functional Description .................23
6.2 Test Programs ................................23
6.3 Managing the Test Results .....................24
6.4 Function Test ................................24
6.5 Cleaning ....................................24
6.6 User Interrupt ...............................24
6.7 Self-Test for Broken Conductors and
Short-Circuiting ..............................24
6.8 Calibration ..................................24
6.9 Internal Pressure Sensor .......................24
6.10 Pressure Gauge Function .......................24
6.11 Cleaning | Drying .............................24
6.12 Safety Functions ..............................24
6.13 Software Update .............................25
6.14 Serial Number ................................25
7. Operation .......................................26
7.1 Switching on the Unit .........................26
7.1.1 Operating Elements .....................26
7.2 Switching the Unit ON and OFF .................28
7.2.1 Running a Test .........................29
7.2.2 Switching Off the Unit ..................29
7.2.3 Switching Off the Unit in the Event
of a Power Failure ......................29
7.3 Tests ........................................29
7.3.1 Test Parameters ........................29
7.3.2 Test Methods ..........................30
7.3.3 Programming Tests (F2 – Main Menu) .....30
7.4 Diffusion Test ................................31
7.5 Bubble Point Test .............................35
7.6 Customer-Specific BP .........................36
7.7 Diffusion and Bubble Point Test (Combined Test) . . .36
7.8 Water Intrusion Test | Water Flow Test . . . . . . . . . . .37
7.9 Pressure Drop Test ............................38
7.10 Multipoint Diffusion Test ......................38
7.11 Customer-Specific Multipoint Diffusion Test ......39
7.12 Volume Measurement .........................39
7.13 Plate Holder Test .............................40
7.14 Installed Bag Test .............................41
7.15 Program Database (F4 – Main Menu) ............42
7.15.1 Loading Test Program from Internal
Memory (F1) ...........................43
7.15.2 Uploading Test Program from SD card (F2) . .43
7.15.3 Saving Backup to SD card (F4) ............45
7.15.4 Loading Backup from SD card (F6) .........46
7.15.5 Deleting PLC Programs (F8). . . . . . . . . . . . . . .47
7.16 Visualize (F3 – Main Menu) ....................47
Contents 3
4 Contents
7.17 Results Database (F5 – Main Menu) ...........47
7.18 Special Functions (F6 – Main Menu) ...........49
7.18.1 Function Test MU (F1) ................49
7.18.2 Function Test TU (F2) .................50
7.18.3 Cleaning (F3) . . . . . . . . . . . . . . . . . . . . . . . .50
7.18.4 Drying (F4) .........................52
7.18.5 Pressure Gauge Function (F5) ..........52
7.18.6 Modify Own Password (F6) ............53
7.19 Service (F7 – Main Menu) ....................53
7.19.1 Load Program from TU (F1-Service) .....54
7.19.1.1 External reference volume .....55
7.19.1.2 Network Settings .............56
7.19.1.3 Test Unit Address Allocation ....57
7.19.2 Hardware Configuration (F2-Service) ....58
7.19.3 Calibration|Adjustment (F3-Service) . . . .62
7.19.3.1 Calibration and Adjustment of
the Internal Pressure Sensor . . . .63
7.19.3.2 Calibration and Adjustment
of the External Pressure Sensor
Input .......................65
7.19.4 User Data Management (F4-Service) . . . .66
7.20 Using the Barcode Scanners (optional) .........67
8. Maintenance | Servicing ........................68
8.1 Maintenance ..............................68
8.1.1 Exchanging the Fine-wire Fuses ........68
8.1.2 Sartorius Stedim Biotech Service Menu . .68
8.2 Cleaning .................................68
9. Troubleshooting ................................69
9.1 Disposal and repair instructions ..............69
9.2 Troubleshooting ...........................69
10. Emergencies ...................................80
11. Information and Instructions on Disposal
and Repairs ...................................80
12. Appendix ......................................81
12.1 Detailed Test Description ....................81
12.1.1 Diffusion Test
(Only valid for the
Sartocheck
®
4 plus Filter tester) ........81
12.1.2 Bubble Point Test
(Only valid for the
Sartocheck® 4 plus Filter tester) ........82
12.1.3 Pressure Drop Test ...................83
12.1.4 Plate Holder Test .....................83
13. Electronic Data Transfer via Network Connection ..84
13.1 Network Concept ..........................84
13.2 FTP Server Requirements ....................85
13.2.1 How to Configure Your FTP Server ......85
14. PLC Control ...................................86
14.1 Digital Inputs ..............................86
14.1.1 START Input .........................86
14.1.2 PROG Input .........................86
14.1.3 STOP Input ..........................86
14.2 Digital Output .............................86
14.2.1 POWER on ..........................86
14.2.2 TEST RUNNING ......................86
14.2.3 ERROR .............................86
14.2.4 TEST OK ............................86
14.2.5 TEST not OK .........................86
14.2.6 External Valve 1. . . . . . . . . . . . . . . . . . . . . .86
14.2.7 External Valve 2. . . . . . . . . . . . . . . . . . . . . .86
14.3 Pin Layout ................................87
14.4 Examples .................................88
14.5 Outlets ...................................91
15. Index .........................................92
1.2 FCC Note:
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined
by turning the equipment off and on, the user is encouraged to try to correct the
interference using one or more of the following measures:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
– Connect the equipment to an outlet on a circuit different from that
to which the receiver is connected.
– Consult the dealer or an experienced radio | TV technician for help.
Shielded Cables
Connections between the devices and peripherials must be made using shielded
cables in order to maintain compliance with FCC radio frequency emission limits.
Modifications
Any modifications made to this device that are not approved by Sartorius Stedim
Biotech GmbH may void the authority granted to the user by the FCC to operate
this equipment.
This instruction manual is based on screen shots from software version 3.1.3.
It is also valid for later software versions.
Translation
When the unit is supplied to countries in the EEA, the operating instructions must be
translated into the language or languages of the country of use. If any discrepancies
arise in the translated text, the original German operating instructions shall form the
basis for clearer interpretation or the manufacturer must be contacted.
Copyright
Reproduction, dissemination, transfer by any means and other use is not permitted
without the prior written consent of Sartorius Stedim Biotech GmbH. Offenders will
be liable for damages. All rights reserved.
Contents 5
2. Overview and Proper Use 2. Overview and Proper Use
2.1 Overview: Sartocheck® 4 plus
Filter tester
Fig. 2-1 | Overview
Picture of Sartocheck® 4 plus Filter tester
1 Housing
2 Printer
3 Touch screen
4 Keypad
5 Indicator lights
Overview: Sartocheck® 4 plus Filter tester MultiUnit
Fig. 2-2 | Overview
2.2 Proper Use Sartocheck® 4 plus Filter tester is a filter integrity tester. It was exclusively developed,
constructed and built for the industrial and commercial purpose of conducting filter
tests in pharmaceutical and biotechnological production and laboratory operations.
The unit is not intended for use in or with explosive atmospheres!
The system is exclusively designed for the purpose defined above. Any other
application above or beyond this or any modifications to the unit without the
written permission of the manufacturer is not considered proper use.
12
3
4
5
6 Overview and Proper Use
Sartorius Stedim Biotech GmbH cannot assume liability if Sartocheck® 4 plus test
units are subjected to improper use or improper operation. Sartorius Stedim Biotech
is not liable for any damages resulting therefrom. The operator bears the sole risk.
Proper use also includes compliance with operating, inspection and maintenance
conditions prescribed by the manufacturer. Non-compliance with the warnings in
the operating instructions and installation instructions, in particular, constitutes
improper use of the equipment. Only EMC-tested control leads and accessories may
be used. Units may only be returned in their original boxes or appropriate secure
packaging. No liability can be accepted for transport damage.
2.3 Technical Specifications
2.3.1 Dimensions and Weight Sartocheck
®
4 plus Filter tester
Length: 460 mm
Width: 390 mm
Height: 245 mm
Weight: 15 kg
Packing Weight: 2.7 kg
Sartocheck
®
4 plus Filter tester MultiUnit
Length: 460 mm
Width: 390 mm
Height: 150 mm
Weight: 13 kg
Packing Weight: 2.7 kg
2.3.2 Connection Data Sartocheck
®
4 plus Filter tester | Sartocheck® 4 plus Filter tester MultiUnit
Power requirements
Operating voltage: 100-240 V/±10%
Number of phases: 1 Ph/N
Neutral conductor: Loadable N (in the Appendix)
Grounding conductor: Separate SL (yellow-green) (in the Appendix)
Frequency: 47-63 Hz
Protection rating: IP 44
Installation: According to VDE regulations
Permissible voltage fluctuation: ± 10% from normal value
Maximum operating pressure: 10 bar g
Operating pressure: min. 4 bar g
Maximum power input: 74 Watt
Internal limit pressure: 10 bar g
2.3.3 Pneumatics Sartocheck
®
4 plus Filter tester | Sartocheck® 4 plus Filter tester MultiUnit
Required compressed air 4–9 bar g
Water, oil and particle free
2.3.4 Test Media Sartocheck
®
4 plus Filter tester | Sartocheck® 4 plus Filter tester MultiUnit
Test gas: Compressed air, dehydrated and deoiled
Wetting fluid: Water or as described with the process validation
documents for the filter cartridge to be tested
Overview and Proper Use 7
8 Overview and Proper Use
2.3.5 Product-specific Data Manual input range upstream system volume 01) –150000 ml
Measuring Ranges
– Test pressure: 100–8000 mbar g
– Pressure drop: 1–2000 mbar
– Max. measurable volume: 150 L
– Diffusion: 0.1–3000 ml/min
– Water intrusion: 0.1–999 ml/10 min
– Water flow: 0.01–99.9 ml/min
– Bubble point: 100–8000 mbar
Measuring Accuracy
– Pressure ± 0.1% | ± 9.5 mbar full scale
– Pressure drop ± 1 mbar
– Net volume measurement ± 4%
– Diffusion ± 5%
– Water intrusion ± 5%
– Bubble point ± 50 mbar
Operating Conditions
– Room temperature +15°C to +35°C
– Rel. humidity 10-80%
Touch screen (Sartocheck
®
4 plus Filter tester only)
– Size 10.4“
– Color 256 colors
Interface Port for Data Output
– Serial port TU RS232| RS485
– Serial port MU RS232 (Sartocheck® 4 plus
Filter tester only)
– PLC port binary signals 12 pins
– Network Connection RJ45
Selectable languages:
English, German, French, Spanish, Italian
1)
When 0 is input, the upstream system volume is measured. Volume input and volume measurement are
not applicable for bag testing.
Overview and Proper Use 9
2.3.6 Test Methods Test method Without ext. ref. tank With ext. ref. tank
Press. drop test All filter systems up to Not applicable
net volume of 150 L
Diffusion test
Cartridge systems up to Cartridge systems up
net volume of 14 L net volume of 150 L
Bubble point test Small systems and cartridge Small systems and cartridge
systems up to net volume systems up to net volume
of 14 L of 150 L
Multipoint diffusion Cartridge systems up to –
test net volume of 14 L
Diffusion and Cartridge systems up to Cartridge systems up to
bubble point test net volume of 14 L net volume of 150 L
(complete test)
Intrusion test, Cartridge systems up to –
water flow test net volume of 14 L
2.3.7 General Data Ambient conditions
Ambient temperature: +5 up to +35°C
Noise level: < 70 dB (A)
Humidity: 95% at 25°C
The unit should be set up under ambient conditions that produce no negative
effects during operation and processing, e.g. from contaminated airflows,
metallic dust or fluids from leaks, condensation, aerosols or widely changing
temperature conditions.
3. Safety 3. Safety
Operating instructions are binding;
designated by a “book”.
Warnings
are designated by a “Hazard” triangle.
Electrical Hazards
are designated by the symbol to the left.
Notes
are designated by a “Hand”.
Grounding Conductor Connection
is designated by this symbol at the connection sites.
Mandatory Instructions
for handling electrical plug connections.
3.1.1 Manufacturer’s ID Label
Fig. 3-1 | Manufacturer’s ID Label Sartocheck® 4 plus Filter tester
Fig. 3-2 | Manufacturer’s ID Label Sartocheck
®
4 Filter tester MultiUnit
10 Safety
3.1 Notes | Warnings |
Descriptions
The information given in these operating instructions applies to Sartocheck® 4 plus
Filter tester, Order no. 26288---FT and Sartocheck® 4 Filter tester MultiUnit,
Order no. 26288---FM.
The manufacturer’s label is affixed to the rear panel of the unit.
Important: if you have any questions
Always have the following information ready:
– Model
– Version
– Serial number
Having the right information readily available will ensure correct and quick
processing.
3.2 Installed Safety Equipment The installed safety equipment must be inspected at regular test intervals
(d = daily, w = weekly, m = monthly). The test methods used are: S = sight inspection,
F = functional testing.
The unit has the following safety equipment installed:
Line Disconnector
The unit is disconnected from the mains voltage by switching off the unit or when
the unit is unplugged from the wall outlet (mains supply).
Housing
All unit-specific components are shielded against external influences by a plastic
housing. It is strictly forbidden to disengage or dismantle the safety equipment.
The function of this safety equipment must be inspected and tested according to the
instructions given in the Chapter “Maintenance”.
The operator is responsible for instructing the operating personnel and
service and maintenance personnel about the meaning and the function
of the safety equipment.
These operating instructions are an integral part of the unit and must be available to
operating personnel and service and maintenance personnel at all times.
The safety precautions and warnings contained herein must be observed.
3.3 Safety Precautions The operator must
(to be carried out by – instruct their operating and servicing personnel in the use of the filter cartridge
the operator) housing’s safety devices and
– ensure that the safety precautions are complied with.
– prevent unauthorized persons (not operating and servicing personnel) from
accessing the filter cartridge housing danger zone.
These operating instructions must be kept in a safe place for future reference.
The frequency of inspections and checks must be observed.
The work described in these operating instructions is explained in such a way that it
can be understood by trained workers and qualified technicians.
Safety 11
Test
Interval Method
m S/F
Test
Interval Method
m S
12 Safety
Definitions Adapted from EN 60204-1:
Trained Worker
A person familiarized with and, if applicable, trained in their particular duties by
a qualified technician and instructed about the potential dangers in the event of
improper conduct and on the necessary safety devices and safety precautions.
Qualified Technician
A person who, by virtue of their technical training, know-how, experience and
knowledge of relevant standards, is able to assess the work assigned to them
and identify potential dangers.
3.4 Operator’s Obligations
In the European Economic Area (EEA), the laws to nationally implement Council
Directive (89/391/EEC), as well as the corresponding individual Directives and specifically including Council Directive (89/655/EEC) concerning the minimum safety and
health requirements for the use of work equipment by workers during labor, must be
observed and complied with in their respectively valid versions.
In Germany, the Operational Safety Regulation dated October 2002 must be
observed (regulation transposing the above-mentioned Directives into national law).
The operator must obtain a local operating permit and follow the regulations and
restrictions set forth therein.
Additionally, the operator must comply with the local rules and
regulations for:
– The safety of the personnel (accident prevention regulations)
– The safety of the work equipment (protective gear and equipment and
maintenance)
– Product disposal (Waste Management Act)
– Material disposal (Waste Management Act)
– Cleaning (cleaning agents and disposal) and the environmental rules
and regulations.
3.5 Safety Tests and Inspections 1. Measurement of airborne noise
Carried Out by the 2. Testing and inspection according to DIN EN 61010-1
Manufacturer at the Facilities
General Warnings 13
4. General Warnings 4. General Warnings
4.1 Hazards The safety systems and safety notes described in these operating instructions should
be complied with accordingly.
Keep the work area of the Bag tester free of objects during operation so that
unimpeded access is possible at all times.
Before any installation, servicing or repair work is carried out, make sure you
are aware of the electrical hazards!
Unplug the equipment from the wall outlet (mains supply) before opening it!
Observe the required operating conditions, especially with regard to the temperature
of the medium. It is transmitted to the components. Touching components or contact
with the medium can result in burns or scalding.
In order for the Sartocheck® 4 plus Filter tester to be EMC compliant, the original
Ethernet cable must be used.
4.2 Operating Personnel and Operating personnel and service and maintenance personnel are persons who are
Service and Maintenance responsible for the transport, installation, operation, equipping, maintenance and
Personnel cleaning as well as troubleshooting on the unit.
1. The unit may only be operated by trained and authorized persons in accordance
with operating instructions that have been issued by the operator.
2. The responsibilities for operation of the unit must be clearly set down and
observed so that no ambiguities arise with respect to safety.
3. The safety precautions and warnings given in the operating instructions must be
complied with when carrying out any work (operation, maintenance, repairs etc.).
4. The operator shall never work in any way that could impair the safety of the
unit or him | herself or others.
5. It is the responsibility of the operator to ensure that only authorized persons
work on the unit.
6. It is the responsibility of the operator to report immediately any changes
occurring on or to the unit to the operating company.
7. It is the responsibility of the operator to ensure that the unit is only operated
in perfect working condition.
4.3 Installation of Please note that replacement parts and Replacement Parts accessories that not have
been supplied by Sartorius Stedim Biotech GmbH have not been tested and approved
by Sartorius Stedim Biotech GmbH. The installation of and|or the use of such
products can therefore have a negative effect on the design properties of the unit as
constructed.
Sartorius Stedim Biotech GmbH is not liable for any damages resulting from the use
of non-original parts or non-original accessory parts.
Standard parts can be purchased from specialized dealers.
4.4 Shutdown Procedure
The following shutdown procedure must be followed before any cleaning,
servicing or repair work is carried out.
1. Line disconnect
Turn off the main switch by pulling out the AC adapter of the mains supply.
2. Compressed air supply
Turn off the compressed air supply and vent system.
Personnel may suffer physical injuries or fatalities if this procedure is not followed!
14 General Warnings
5. Installation 5. Installation
5.1 Equipment Supplied
Fig. 5-1 | Sartocheck® 4 plus Filter tester
The equipment supplied with the Sartocheck® 4 plus Filter tester includes:
1. Sartocheck® 4 plus Filter tester, Order no. 26288---FT
2. Operating instructions and technical documents
3. Accessories (not shown in the picture)
– Tubing “Inlet” with compressed air filter (I.D. = 6 mm) Order no.: 18104
– Tubing “Outlet” (I.D. = 4 mm) Order no.: 18103
– Spare ink ribbon cartridge Order no.: 6982141
– Spare roll of printer paper Order no.: 6982142
– Country-specific power cord
The equipment supplied with the Sartocheck® 4 Filter tester MultiUnit includes:
1. Sartocheck® 4 Filter tester MultiUnit, Order no. 26288---FM
2. Operating instructions and technical documents
3. Accessories (not shown in the picture)
– Tubing “Inlet” with compressed air filter (I.D. = 6 mm) Order no.: 18104
– Tubing “Outlet” (I.D. = 4 mm) Order no.: 18103
– Country-specific power cord
– Connecting cable Sartocheck
®
4 plus Filter tester MultiUnit and
Sartocheck® 4 plus Bag tester MultiUnit, Order no.: 1ZE---0010
5.2 Receipt of Delivery Incoming inspection:
– Check the shipment for damage!
– Check the shipment against the delivery note to ensure that it is complete!
Complaints
If the shipment was damaged during transit:
– Immediately contact the carrier!
– Keep the packaging material (in case the carrier wants to inspect it or
the shipment has to be returned to us)
If the shipment is not complete:
– Immediately contact Sartorius Stedim Biotech GmbH or the Customer Service
Department in your country!
If the delivery has other defects:
– Immediately contact Sartorius Stedim Biotech GmbH or the Customer Service
Department in your country!
Operating Instructions | Betriebsanleitung
Sartocheck® 4 plus Filter tester | Filter tester MultiUnit
Filter Integrity Tester | Filterintegritäts-Testgerät
85032-536-78
1 2
Installation 15
Packaging for Return Shipment
Use the original packaging and original packaging material as far as possible.
If the original packaging and original packaging material are
no longer available:
– Commission a packaging company with specialized technicians.
– Pack the unit in a shipping container in such a way that mechanical
damage is prevented.
If you have any questions about packaging and transport securing devices,
please contact Sartorius Stedim Biotech GmbH.
Check the equipment supplied against the delivery note. Please report incomplete
deliveries immediately to the shipping carrier or the supplier.
Interim Storage
The external packaging of the unit and its spare and replacement parts is designed
for a storage period of three months from delivery.
Units kept in interim storage must be stored in a closed, dry room at temperatures
from +5°C to max. +50°C.
5.3 Installation Instructions
5.3.1 Ambient Conditions Select a place of installation that meets the following conditions:
and Conditions at the Place t No relatively high temperature or exposure to heat or sun
of Installation t No strong drafts
t No aggressive chemical environments
t No strong vibrations
t No dust
t No major humidity effects
5.3.2 Transporting and The unit and its accessories are packaged according to the national custom and
Unpacking the Equipment protected against impacts. To avoid damaging the equipment, please comply with
the following notes and instructions:
t Please observe the Technical Specifications in Chapter 3!
t Please observe the weight. For transport to the unpacking site, use a floor
truck if appropriate.
t
To prevent the unit from slipping, it should always be carried or lifted by two people.
t To open the packaging, remove the unit and place it on a workbench
or table intended for that purpose.
t The workbench or table must be level and able to bear the appropriate load.
Allow sufficient space around the workbench or table for the operator to work.
t Unpack the accessories and technical documents and put them in a safe place.
t Moisture in the air can condense on the surfaces of a cold unit whenever it is
brought into a substantially warmer place. If you transfer the unit to a warmer
area, make sure to condition it for about 2 hours at room temperature, leaving it
plugged into AC power. The positive temperature differential between the inside
of the unit and the ambient environment essentially protects the unit against
humidity and moisture.
Open the packaging carefully. It is a good idea to save the packaging material
(in case the carrier wants to inspect it or the shipment has to be returned).
Dispose of packaging materials in compliance with prevailing environmental
safety regulations.
16 Installation
5.4 Connections Before starting up the unit; make sure that the unit is stable and secure.
Check all pneumatic and electrical connections on the unit.
5.4.1 Front Panel and Back Panel The following displays are located on the front panel:
1 Standby
Is lit up when Sartocheck
®
4 plus Filter tester is ready for operations, but not
currently running any test program. (Blinking LED)
2 Ready
Lights up when the result of the filter test is ready. (LED lit)
3 Running
Is lit up when a test is currently running. (LED lit)
4 Error
Lights up when the test unit has identified an error and cancelled the test.
(LED lit)
The following connection ports are located on the back panel:
1 Housing ventilator
The unit is equipped with a ventilator that ensures that Sartocheck® 4 plus
Filter tester is kept at a constant temperature.
2 Serial port MU (Management Unit)
This port is used for connecting accessories (e.g. barcode scanner).
3 AC adapter
Power plug for connecting the power cord to mains supply.
4 Fuses
Fine-wire fuses between unit and mains supply.
5 Network Connection
RJ45
5.4.2 Left and Right Panels
Sartocheck® 4 plus Filter tester Located on the left panel:
1 Main power switch
Switch on the power with the main power switch.
2 SD Card Reader
The SD card reader is designed for standard SD cards for inputting and
storing data.
3 Serial port TU (test unit)
Port for connecting additional test units (Multiunits).
4 PLC Port
Port for connecting PLC controller signal input and output.
1 2 3 4
Fig. 5-2 | Front Panel
14
3
2
5
Fig. 5-3 | Back Panel
1 2 3 4
Fig. 5-4 | Left panel
Installation 17
Located on the right panel:
1 Ext. sensors
Port for connecting an external pressure sensor.
2 Ext. valves
Port for connecting external valves.
3 Ext. reference tank
Quick connector for external reference tank.
4 Venting 1
Quick connector for Venting 1.
5 OUT
Quick connector for test tubing.
6 Venting 2
Quick connector for Venting 2.
7 IN
Quick connector for compressed air supply.
5.4.3 Left and Right Panels
Sartocheck
®
4 Filter tester MultiUnit
5.5 Pneumatic Connections Sartocheck® 4 plus can be operated with an internal pressure sensor and with
different ports for connecting tubing. The ports for connecting tubing, for both
the Sartocheck® 4 plus and Sartocheck® 4 MultiUnit, are illustrated in Fig. 5-8,
Fig. 5-9 and Fig. 5-10.
Do not connect Sartocheck® 4 plus Bag tester to pressurized or high temperature systems! Wait until the whole system is at room pressure and temperature!
Inlet Pressure During Operation with Internal Pressure Sensor
The minimum operating pressure required depends on the test method selected,
but should be at least:
> 4000 mbar and > 500 mbar above the test pressure or above the max. B.P. entered.
Sartocheck® 4 plus automatically detects the operating pressure during the function
test before starting each test and during the whole test sequence.
Check to make sure that all inlet and outlet pressure tubing is connected properly,
that all electrical connections have been correctly installed, and that the paper roll
as well as the ribbon cartridge have been inserted.
1 2 3 4 5 6 7
Fig. 5-5 | Right panel
Fig. 5-6 | Left panel Fig. 5-7 | Right panel
18 Installation
Installation 19
Fig. 5-8 | Connection with internal pressure sensor
Fig. 5-9 | Connection with internal pressure sensor and external vent
Fig. 5-10 | Connection with internal pressure sensor and external volume reference tank
Sartocheck 4 plus
Sartocheck 4 plus
Sartocheck 4 plus
5.6 Connections with Sartocheck® 4 plus can be operated with an external pressure sensor and with
External Pressure Sensor different ports for connecting tubing. The ports for connecting tubing, for both the
Sartocheck
®
4 plus and Sartocheck® 4 MultiUnit, are illustrated in Fig. 5-11, Fig. 5-12
and Fig. 5-13.
Check to make sure that all inlet and outlet pressure tubing is connected properly,
that all electrical connections have been correctly installed, and that the paper roll
as well as the ribbon cartridge have been inserted.
Fig. 5-11 | Connection with external pressure sensor and manual valves
Fig. 5-12 | Connection with external pressure sensor and external valves
Sartocheck 4 plus
Sartocheck 4 plus
20 Installation
Installation 21
Fig. 5-13 | Connection with external pressure sensor for WIT
5.6.1 Inserting Paper Roll To insert or change the paper roll, lift the cover off the paper feed. Pull the feed
Ribbon Cartridge mechanism out of the assembly and push the cover to the left and lift it out
of its attachments. Now lift the paper feed mechanism out of the Sartocheck® 4 plus
housing.
Insert a new paper roll into the paper slot and slide the paper feed mechanism back
into the housing. Thread the end of the paper through the slot of the paper feed.
Make a final check to ensure that the feed mechanism is locked in place.
Close the printer cover and secure the splashguard. Check to make sure that the
splashguard is locked in place.
To change the ribbon cartridge (when the feed mechanism is pulled outwards)
lift the previously installed cartridge out of the paper feed and insert a new one.
Apply slight pressure to lock the cartridge in.
Sartocheck 4 plus
22 Installation
5.6.2 Sartocheck® 4 plus Sartocheck® 4 Bag tester MultiUnits are connected to the Sartocheck® 4 plus Filter
Filter tester MultiUnits tester MultiUnit or to the Sartocheck® 4 plus Bag tester via the serial port TU
connection ports. Different ways of connecting are shown below in Fig. 5-14 to 5-17.
The location of the Sartocheck
®
4 Bag tester MultiUnits, relative to the Sartocheck®
4 plus Filter tester or to the Sartocheck® 4 plus Filter tester MultiUnit, will determine
which method is best suited for the application.
Fig. 5-14 | Serial connection to a Bag tester
Fig. 5-15 | Serial connection to a Filter tester
Function 23
6. Function 6. Function
Fig. 6-1 | Overview
Picture of Sartocheck® 4 plus Filter tester
1 Housing
2 Printer
3 Touch screen
4 Keypad
5 Indicator lights
6.1 General Functional Description Sartocheck® 4 plus Filter tester is a qualifiable filter integrity testing unit, consisting
of a data management unit, a test unit and up to four additional Filter tester
MultiUnits or Bag tester MultiUnits.
The test unit is a mechanically, pneumatically and electrically closed functional unit.
A test unit cannot be operated directly by the user, but is 100% controlled by the
data management unit via an internal RS 485 interface. With the help of its electrical
and pneumatic peripheral devices, the data management unit performs the actual
filter tests along with a series of other additional functions.
Bag Test
The main purpose of Sartocheck® 4 plus Bag tester is to test single use bags and
single use bioreactors according to the pressure drop method.
Filter Integrity Test
The main purpose of Sartocheck® 4 plus Filter tester is to test the integrity
of membrane filters according to various methods.
6.2 Test Programs In the test program, the procedural steps and the parameters are set down for either
the bag test or for the filter integrity test.
A programmed test program can be loaded into the test unit and the test will be run
independently.
– Load a test program
– Run a test program
The test unit runs through the previously loaded test program, in other words,
it carries out the test and saves the result in non-volatile memory. The data management unit monitors the progress of the bag test or the filter integrity test, i.e. it reads
in the current data in order to present them to the user.
12
3
4
5
24 Function
6.3 Managing the Test Results Sartocheck® 4 plus Filter tester processes the measured raw data (the test results),
which means that the unit values are converted and numbers transformed into text.
6.4 Function Test With the function test, the user is able to interactively test the functionality
of pneumatic components. The proportional valves are not explicitly, but rather
implicitly tested in this context.
6.5 Cleaning Sartocheck
®
4 plus Filter tester starts the procedure for cleaning and flushing the
internal lines and the volume reference tank.
6.6 User Interrupt The user can interrupt any test on Sartocheck
®
4 plus Filter tester by pressing the
[STOP] button. Pressing the [arrow upwards] and [STOP] buttons simultaneously
will interrupt tests on all Sartocheck® 4 plus Filter tester MultiUnits or
Sartocheck® 4 Bag tester MultiUnits connected to the Sartocheck® 4 plus Filter tester,
as well as any test running on the Sartocheck
®
4 plus Filter tester unit.
6.7 Self-Test for Broken While controlling the valves and sensors, the Sartocheck® 4 plus Filter tester
Conductors and Short-Circuiting hardware can check whether there are any broken conductors or short-circuits.
6.8 Calibration The calibration function is designed to calibrate the internal pressure sensor with
the help of more accurate reference measuring equipment, and if necessary, adjust it.
The sensor has a monitored calibration date.
An adjustment routine automatically follows the test. The test can also be activated
separately. Sartocheck® 4 plus Filter tester saves the raw data for the calibration
record in permanent memory.
The operator can use the following sensor type for determining the reference
pressure:
t Relative pressure sensor:
The measured reference pressures relate to the ambient pressure. The ambient
pressure must be known or measured with additional reference measuring
equipment.
6.9 Internal Pressure Sensor Sartocheck® 4 plus Filter tester sets 8 pressure values and compares them with
the internal pressure sensor and the pressure values measured on the reference
measuring instrument (connected to the “OUT” connector) to calculate scale
and linearization.
6.10 Pressure Gauge Function When in the pressure gauge function, Sartocheck
®
4 plus Filter tester acts like
a digital pressure measuring device.
6.11 Cleaning | Drying Through the pneumatic connectors, Sartocheck
®
4 plus Filter tester is able to
flush almost all internal volumes. It is the responsibility of the user to use original
Sartocheck® equipment only (Cleaning Kit type 26288---CK”).
6.12 Safety Functions t As one of its technical options, Sartocheck® 4 plus Filter tester runs the test step
Initialization | Security Status in the event of a power failure. Basically, what this
step does is close the compressed air supply and the block valve to the test set-up.
t Sartocheck® 4 plus Filter tester is not responsible for ensuring whether the
pressure supplied to the system being tested is too high. This means that the
user must make sure that the programmed pressure cannot damage the system
being tested.
Function 25
6.13 Software Update The operating software on Sartocheck® 4 plus Filter tester is updated with a
corresponding program run with an external PC|laptop. The Management Unit
may be updated with an SD card. Since the configuration data are localized in
a battery-backed RAM, they remain unchanged during any software update.
6.14 Serial Number Every unit bears its own unique serial number. The serial number may not be changed
during a software update.
t The serial number is entered for the first time during production of the unit.
t If the PCB has to be replaced during repairs that may arise later,
the unit must be assigned the exact same serial number that is imprinted
on the manufacturer’s label.
26 Function
7. Operation 7. Operation
7.1 Switching On the Unit
Fig. 7-1 | Overview
Picture of Sartocheck
®
4 plus Filter tester
1 Housing
2 Printer
3 Touch screen
4 Keypad
5 Indicator lights
7.1.1 Operating Elements
Fig. 7-2 | Display and control panel
The display and control panel features the following operating elements:
1 Esc
Press this key to cancel the current procedure.
2 F1-F 10
Function keys F1-F10 correspond to the function types displayed on touch screen.
3 Log on
Press this key to switch on the log-on screen.
4 Log off
Press this key to log the current user off.
12
3
4
5
8 109 12
11
13
7
654321
Function 27
5 Start
Press this key to start a test.
6 Stop
Press this key to stop a running test.
7 Paper
This key advances the paper in the internal printer.
8 PC keypad
Is used for inputting and starting processes.
9 Home
When this key is pressed, programming is cancelled without saving. The former
test is reinstated and the user is automatically taken back to the Main Menu.
10 End
Press this key to jump to the end of the input line when entering parameters
and data.
11 Page up
Press this key to scroll a page back in the service menu guidance.
12 Page down (toggle key)
Press this key to scroll to the next service menu window.
13 All Test Stop
Pressing the [Ç] and [STOP] buttons simultaneously will stop all running tests
on all MultiUnits, as well as any running test on the Sartocheck
®
4 plus Filter
tester unit.
Both the keypad and the touch screen can be used to operate Switching Sartocheck®
4 plus Filter tester. These two options can also be combined.
Individual menu items can be selected Sartocheck® 4 plus Filter tester with function
keys, on the keypad or by pressing the touch screen. Selection from lists is done by
entering the line number or by direct selection on the touch screen.
All dialog boxes are set up so that the operator can tell by the color which part
of the touch screen can be operated, which are the input boxes and which areas are
for information only. Function keys and other keys that can be pressed on the
screen and on the keypad are highlighted in yellow.
Input boxes are white. Non-changeable information boxes or function keys
that have already been activated are highlighted in gray. Selected dialog boxes are
colored blue. Warnings and error messages appear in red.
28 Operation
7.2 Switching the Unit If you want to switch the unit on, proceed as follows:
ON and OFF
Before you switch on the power supply and the compressed air, compare the
connection data for the unit (see the Chapter 01 Technical Specifications) with
the data for the mains current and the compressed air supply.
Connect Sartocheck® 4 plus Filter tester to the mains supply by plugging the power
cord into the wall outlet, install all tubing connections. The unit is now ready for
operation.
Login menu
User ID: Enter operator’s name
Password: Enter operator’s password
OK: Confirm correct entry
Cancel: Delete entry
Important Note: When Sartocheck® 4 plus Filter tester is delivered it is factory
set for the following user:
Name: mentor
Password: mentor
Operators must log-in before activating the Main Menu.
The operator logs in by pressing the “Login” key on the keypad. After pressing the
“Login” key, the user will be asked for their name and password. When both are
entered correctly, the keypad and touch screen are released for use. When the operator stops working with Sartocheck
®
4 plus Filter tester, they must always log out by
pressing the “Logout” key. Sartocheck® 4 plus Filter tester is then blocked for further
operation until another operator logs in.
Information line with model, version, system number and user name.
Menu display: Main Menu
F1-F8: Select the function menus with the function keys
Selects the function menus
Functional unit selected and operational status.
The Main Menu appears.
t Before starting a test, allow the unit to warm up for about 20–30 min.
For shut-down times < 30 min and constant ambient temperatures, the warm-up
phase can be shortened accordingly. For more information about the tests, see
Chapter 7.3 ff.
t Program the data for the test routine.
t The Sartocheck® 4 plus Filter tester ready for operation (by the logged-in user).
t Start the test.
Only service technicians or trained personal may install connections and start up
the unit!
Fig. 7-3 | Login menu
Fig. 7-4 | Main Menu
Operation 29
7.2.1 Running a Test Run the test according to the test procedure that you selected and programmed.
7.2.2 Switching Off the Unit When switching off the unit, proceed as follows:
t Run the test to the end.
t Close the compressed air supply at the compressed air supply port.
t Run the log-off function.
t Turn off the main power switch.
7.2.3 Switching Off the Unit in In the event of a power failure, all valves will be switched to a secure state.
the Event of a Power Failure This guarantees that the system being tested is vented. The ongoing test is cancelled.
No test result will be available.
Loss of Compressed Air
In the event that the compressed air supply stops, the test is automatically
cancelled and an error message appears. “Target pressure not reached”. The system
is vented automatically. When the supply of compressed air resumes, the unit must
be restarted and the test repeated.
7.3 Tests
7.3.1 Test Parameters To obtain reliable and reproducible test results, observe the following:
t Run the test at room temperature (approx. 15–30°C), whenever possible.
t During a test run, always avoid any temperature changes.
t The upstream side of the system must be absolutely leak-free
t Do not connect the tester to pressurized systems.
t For filter testing: If you wish to use other types of compressed gas and| or wet-
ting fluids not specified by Sartorius Stedim Biotech, consult your local Sartorius
Stedim Biotech office or Sartorius Stedim Biotech GmbH in Germany.)
t For the Water Intrusion Test, the surface tension of the water must be
> 70 dyn/cm.
t Always enter correct test parameters. Incorrect test parameters will lead to
incorrect test results or erroneous evaluations.
Calibration
The Sartocheck 4 plus Filter tester should be re-calibrated at least once a year,
twice being preferable.
30 Operation
7.3.2 Test Methods With the Sartocheck® 4 plus Filter tester, you can directly select a particular test
method. This greatly simplifies programming the data for a test, since only the
parameters that are relevant for the selected test are displayed.
You can select any of the following test methods:
Test methods
1 Diffusion test
2 Bubble point test (Standard and Customer specific)
3 Diffusion and bubble point test
4 Water intrusion test
5 Pressure drop test
6 Multipoint diffusion test (Standard and Customer specific)
7 Volume measurement
8 Plate holder test
9 Installed bag test
System Venting
At the end of each test, after a power failure or after switching off the unit during
a test, the system is automatically vented.
7.3.3 Programming Tests The Sartocheck® 4 plus Filter tester cannot perform bag tests.
(F2 – Main Menu) Nevertheless it is possible to program bag tests due to the fact that additional Bag
tester MultiUnits may be connected to the Filer tester. The test parameters for the
individual tests are entered and selected on Sartocheck
®
4 plus Filter tester by using
the keypad or the touch screen. The Main Menu is the starting point for programming. The following example uses a diffusion test to illustrate how to program
data for tests and run test sequences (F2 – Main Menu). The programming and test
sequences are identical for the other test types.
Before we start programming, we would like to explain a few important keys
and|or touch commands.
The Sartocheck® displays are set up with yellow buttons located on the right side
of the screen. These buttons always have the same functions:
Main Menu: The program jumps back to the Main Menu (see Fig. 7-5)
Page Up: the program scrolls to the previous page of the screen
Page Down: the program scrolls to the next page of the screen
List Up: Whenever a list is displayed on the screen, use LIST UP
to scroll up the list
List Down: Whenever a list is displayed on the screen, use LIST DOWN
to scroll down the list
Enter: Confirms the selected function, action or entry.
Following confirmation, the yellow key turns gray
Fig. 7-5 | Main Menu
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