Millipore Sigma Steritest User manual

The life science business of Merck KGaA,
Darmstadt, Germany operates
as MilliporeSigma in the
US and Canada.
SigmaAldrich.com
®
User Guide
Steritest®Symbio Pumps

Page 2 of 113
Notice
The information in this document is subject to change without notice and should
not be construed as a commitment by Millipore SAS, Molsheim, France. Millipore
SAS assumes no responsibility for any errors that may appear in this document.
This manual is believed to be complete and accurate at the time of publication. In
no event shall Millipore SAS be liable for incidental or consequential damages in
connection with or arising from the use of this manual.

Page 3 of 113
Contents
Introduction .........................................................................................................................5
System overview.................................................................................................................5
About this Manual ...............................................................................................................5
Steritest®Symbio Pump Versions ..........................................................................................6
Additional Features............................................................................................................ 12
Operator and Equipment Safety .......................................................................................... 12
Specifications and Operating Requirements ............................................................................. 14
Overview of the Pump Assembly............................................................................................ 17
Overview of the Pump Control Panel..................................................................................... 19
Installing the Pump .......................................................................................................... 20
Unpacking the Equipment .................................................................................................. 20
Installing the Pump in the Work Environment........................................................................ 22
Installing the Communication Hub ....................................................................................... 22
Installing the Bottle Holder ................................................................................................. 25
Installing the Drain Tray..................................................................................................... 27
Overview of Optional Accessories ........................................................................................ 29
Using the Steritest®Symbio Pump ........................................................................................ 37
Making Selections Using the Control Knob ............................................................................ 37
Starting the Pump for the First Time and Activating the Pump Certificate .................................. 37
Starting the Pump after Initial Startup ................................................................................. 42
Using the Main Screen ....................................................................................................... 43
Starting the Filtration of a Sample ....................................................................................... 45
Installing the Steritest®Device ........................................................................................... 45
Using the Standard Mode and Test Method Mode Screens ....................................................... 47
Using the Pump in Standard Mode ....................................................................................... 51
Using the Pump in Test Method Mode ................................................................................... 55
Entering Standby Mode ...................................................................................................... 61
Switching Off the Pump...................................................................................................... 61
Safety Mechanisms............................................................................................................ 62
Configuring the Steritest®Symbio Pump ................................................................................ 64
Pressure Mode .................................................................................................................. 65
Footswitch........................................................................................................................ 67
Syringe Support................................................................................................................ 68

Page 4 of 113
Date and Time.................................................................................................................. 70
Language......................................................................................................................... 70
Pump Information ............................................................................................................. 71
Alarm Volume................................................................................................................... 72
Brightness........................................................................................................................ 72
Methods Transfer .............................................................................................................. 73
Network Configuration ....................................................................................................... 78
Pressure Sensors Test........................................................................................................ 79
Maintenance ...................................................................................................................... 98
Safety Precautions ............................................................................................................ 98
Ongoing Maintenance ........................................................................................................ 98
Preparing the Pump for Shipment........................................................................................ 98
Cleaning the Pump............................................................................................................ 100
Recommended Cleaning Agents ........................................................................................ 100
Disassembling the Pump .................................................................................................. 100
Cleaning the Pump .......................................................................................................... 104
Decontamination Procedure in an Isolator........................................................................... 106
Reassembling the Pump ................................................................................................... 107
Troubleshooting................................................................................................................. 109
Accessories and Replacement Parts ...................................................................................... 111
Symbols Referenced .......................................................................................................... 113
Standard Product Warranty ................................................................................................. 113
Technical Assistance........................................................................................................... 113

Page 5 of 113
Introduction
System overview
The Steritest®Symbio peristaltic pumps are used for sterility testing and are
available in three versions. Combined with optional accessories, the pumps
provide a wide range of installation possibilities (see Steritest®Symbio Pump
Versions), enabling integration in all testing environments (laminar flow hood,
biosafety cabinet, clean room, and isolator), including existing isolators without
table rework.
The Steritest®Symbio pumps have been designed to be used with Steritest®
devices. Many types of sterile products can be tested with the Steritest®system,
including:
• Large- and small-volume parenteral solutions in glass or plastic bottles,
collapsible bags, ampoules, and vials
• Pre-filled syringes
• Lyophilized and other soluble products in ampoules or vials
• Antibiotics in ampoules or vials
• Medical devices
• Difficult-to-dissolve powders
The easy-load automatic pump head facilitates the Steritest®tubing placement in
an isolator configuration and protects the user from the rotor.
A timer coupled with a rotor position compensation provides repeatability of
small-volume sampling.
A pressure control system constantly monitors the pressure inside both canisters.
An alarm signals pressure increases above the specifications. In regulation mode,
the pump decreases the pumping speed automatically until the pressure returns
to normal.
The microorganisms present in the sample are captured on the microporous
membrane in the Steritest®canisters . Appropriate medium is pumped into
each canister separately to promote the growth of the captured organisms. The
canisters are incubated and examined for contamination in accordance with the
relevant pharmacopoeia.
About this Manual
All screen shots and drawings in this manual are examples and may vary
depending on the pump version. All dimensions indicated in the illustrations are in
millimeters.

Page 6 of 113
Steritest®Symbio Pump Versions
Steritest®Symbio LFH Pump
This pump is used, on feet, in a laminar flow hood, a biosafety cabinet, or in a
clean room. It can also be used in an isolator, using special feet.
NOTE
To use this pump in an isolator, on feet, replace the standard feet with
special feet for use in isolator, and use the optional connection cable
extension with Tri-Clover clamp for the connection of the pump to the
communication hub (see Accessories and Replacement Parts).
372
335
633
166
282
421
ECHELLE 1:5
ECHELLE 1:5
372
335
633
166
282
421
ECHELLE 1:5
ECHELLE 1:5
372
335
633
166
282
421
ECHELLE 1:5
ECHELLE 1:5
372
335
633
166
282
421
ECHELLE 1:5
ECHELLE 1:5

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Steritest®Symbio ISL Pump
This pump is integrated in an isolator equipped with a standard round cutout.
NOTE
This pump is not compatible with the oval cutout used for the Steritest®
Equinox Isofit pump.
355
354
325
276
103
101
185
32
81
588
293
234
313
ECHELLE 1:5 ECHELLE 1:5
355
354
325
276
103
101
185
32
81
588
293
234
313
ECHELLE 1:5 ECHELLE 1:5
355
354
325
276
103
101
185
32
81
588
293
234
313
ECHELLE 1:5 ECHELLE 1:5
355
354
325
276
103
101
185
32
81
588
293
234
313
ECHELLE 1:5 ECHELLE 1:5

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Steritest®Symbio FLEX Pump
This pump can be used in multiple configurations:
In an isolator - low integration on round or oval cutouts
33
82
355
611
356
186
106
326
276
361 355
97
33
82
355
611
356
186
106
326
276
361 355
97
33
82
355
611
356
186
106
326
276
361 355
97
33
82
355
611
356
186
106
326
276
361 355
97

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In an isolator - high integration on round or oval cutouts
NOTE
To install the pump in an isolator in high integration configuration, a special
integration kit (sold separately) is required (see Accessories and
Replacement Parts). There are two integration kits, one for a round
cutout and one for an oval cutout. The following drawings show the
dimensions of the pump when installed in an isolator equipped with the
standard round cutout.
136
185
10
355
361
276
289
106
459
645
326
361
11
136
185
10
355
361
276
289
106
459
645
326
361
11
136
185
10
355
361
276
289
106
459
645
326
361
11
136
185
10
355
361
276
289
106
459
645
326
361
11

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In an isolator without table cutout, using special feet
NOTE
To install the pump in an isolator, on feet, replace the standard feet with
special feet for use in isolator. Use the optional connection cable extension
with tri-clover clamp for the connection of the pump to the communication
hub. Use the optional carrying handles to facilitate pump handling (see
Accessories and Replacement Parts).
148
197
355
645
361
119
301
472
456
276
148
197
355
645
361
119
301
472
456
276
148
197
355
645
361
119
301
472
456
276
148
197
355
645
361
119
301
472
456
276

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In a vertical laminar ow environment, on feet
NOTE
Use the optional carrying handles to facilitate pump handling (see
Accessories and Replacement Parts).
FLEX sur pieds
191
142
355
361
276
295
112
465
456
645
FLEX sur pieds
191
142
355
361
276
295
112
465
456
645
FLEX sur pieds
191
142
355
361
276
295
112
465
456
645
FLEX sur pieds
191
142
355
361
276
295
112
465
456
645

Page 12 of 113
Additional Features
Tests can be run in either the Standard Mode, in which filtration parameters
are chosen manually, or in the Test Method Mode, in which every step of the
method appears on the screen with preloaded parameters for speed and time
to ensure there is no deviation from the approved test protocol. The test
methods are created with the Steritest®Symbio Software and transferred to
the Steritest®Symbio Pump through a network cable or with USB flash drive.
The software (from version 1.1.0.0) can be used in ten languages (German,
English, Spanish, French, Italian, Portuguese, Japanese, Simplified Chinese,
Turkish, and Russian).
The drain tray and bottle holder are ergonomically positioned around the pump
head for easy access in limited-space environments.
A wide range of optional accessories are available to improve the sterility testing
workflow:
• A footswitch with two operation modes
• A glass ampoule breaker
• A support rod extension for hanging sterile bags or the Steridilutor vent
chamber
• A syringe support that facilites the handling of pre-filled syringes (with or
without needles), and provides an automatic rinsing function
• A liquid waste overfill sensor that signals an alarm on the pump screen
• A communication hub holder to fix the communication hub to one of the
four legs of the laminar flow hood
• A communication hub holder to fix the communication hub below the
isolator
• A tray that carries up to 5 Steritest®canisters and an optional rack to hold
up to 4 carrying trays.
NOTE
Go to www.millipore.com/steritest-symbio to check the latest version
of this document and get information about Steritest®Symbio Pump
optional accessories.
Operator and Equipment Safety
All employees who will operate and/or be near the Steritest®Symbio Pump must
comply with the following:
• Read and understand this user guide before using the pump. Failure to follow
operating instructions could result in user injury or damage to the instrument.

Page 13 of 113
• Read and understand all maintenance instructions in this user guide before
performing maintenance on the pump. Failure to follow instructions could result
in user injury or damage to the instrument.
• Any alteration of the pump from factory specification may cause unsafe
conditions, and will void the product warranty.
• Any attempt to use the pump in a manner not specified in this user guide may
result in damage to the instrument, operator injury, and will void the product
warranty.
• Do not attempt to open and repair the pump. Service should be performed by
trained and authorized personnel only.
• Place the pump on a clean, flat, stable, horizontal surface, away from any
source of excessive heat and close to an easily accessible, properly grounded
power supply outlet.
• Do not expose the pump or the communication hub to liquid. If this happens,
immediately switch off and disconnect the pump from the power outlet, and
then decontaminate the pump and communication hub surfaces using a wipe
moistened with one of the recommended cleaning agents listed in Cleaning
the Pump.
• Never expose the equipment to extreme temperatures. Operating temperature
must be between 15 °C and 40 °C (59 and 104 °F).
• Use only accessories and replacement parts designed for the pump. See
Accessories and Replacement Parts. Using accessories not designed for the
pump could result in user injury or damage to the instrument.
• The Steritest®Symbio Pump has been designed to be used with the Steritest®
devices and accessories.
• When filtrating hazardous liquids, wear and use proper protective clothing and
equipment for the handling and the disposal of the liquid to be filtrated.
• In case of skin contact with the filtrated liquid, refer to the safety datasheet of
the filtrated liquid for first aid measures.
• Dispose the filtrated liquids according to local regulations.
• Do not use the Steritest®Symbio Pump to filtrate flammable products.
• Never touch the display or control panel with a sharp object.
• Before cleaning, shut down the the Steritest®Symbio Pump and switch off and
disconnect the communication hub from power source.
• The power supply must be protected by a fuse below the main connection.
• The electrical installation must comply with local standards.
• Use an electrical surge protector to prevent damage to the system.
• The communication hub is a specific component of the Steritest®Symbio Pump
and should not be used for any other purpose.

Page 14 of 113
Specications and Operating Requirements
Parameter Value/Range
Dimensions and
weight:
LFH version,
equipped pump
Width 633 mm (24.9 in.)
Depth 372 mm (14.6 in.)
Height 410 mm (16.1 in.)
Weight 15.8 kg (34.8 lb)
14.2 kg (31.3 lb) (without accessories)
Pump head height 158 mm (6.2 in.)
Dimensions and
weight:
ISL version,
equipped pump
Width 588 mm (23.1 in.)
Depth 313 mm (12.3 in.)
Height 354 mm (13.9 in.)
Weight 17.6 kg (38.8 lb)
16.0 kg (35.3 lb) (without accessories)
Pump head height 81 mm (3.2 in.)
Dimensions and
weight:
FLEX version,
equipped pump
On feet in a
laminar flow
hood
Width 645 mm (25.4 in.)
Depth 355 mm (14.0 in.)
Height 464 mm (18.3 in.)
Pump head
height 189 mm (7.4 in.)
On feet in an
isolator
Width 645 mm (25.4 in.)
Depth 355 mm (14.0 in.)
Height 472 mm (18.6 in.)
Pump head
height 197 mm (7.8 in.)
Low integration
in an isolator
Width 611 mm (24.1 in.)
Depth 361 mm (14.2 in.)
Height 356 mm (14.0 in.)
Pump head
height 82 mm (3.2 in.)
High Integration
in an isolator
Width 645 mm (25.4 in.)
Depth 361 mm (14.2 in.)
Height 459 mm (18.1 in.)
Pump head
height 185 mm (7.3 in.)
Weight 19.6 kg (43.2 lb)
17.9 kg (39.5 lb)
Performance
specifications
Rotation speed up to 240 rpm
Timer from 0.5 to 999

Page 15 of 113
Materials of
construction
Pump housing 316L Stainless steel
Pump housing seal (LFH version) Silicone foam
Pump housing flat seal (ISL
version) Silicone foam
Pump housing fastening screws A2 Stainless steel
Pump head protective cover
housing 316L Stainless steel
Pump head protective cover
tubing guide Polyphenylsulfone (PPSU)
Pump head 316L Stainless steel
Seal plate (closing system seal) Polyoxymethylene (POM)
Pump handles / pump supports
for drain tray and bottle holder 316L Stainless steel
Screen pane/window Toughened glass
Screen housing 316L Stainless steel
Screen housing seals Ethylene propylene diene monomer
(EPDM)
Screen seal Silicone
Pump control panel / key pad Polyester
Rotary control knob 316L Stainless steel
Rotary control knob seals Ethylene propylene diene monomer
(EPDM)
Pump power inlet Chrome-plated brass
Pump feet Polyvinyl chloride (PVC)
Pump feet screws A2 Stainless steel
Drain tray
Drain tray container Polyphenylsulfone (PPSU)
Drain tray support 316L Stainless steel
Drain tray support seal Ethylene propylene diene monomer
(EPDM)
Steritest®canisters carrying trays Polyphenylsulfone (PPSU)
Bottle holder
Bottle holder support rod 316L Stainless steel
Bottle holder basket 316L Stainless steel
Bottle holder fastening system
screw clip Polyphenylsulfone (PPSU)
Communication hub
Housing 316L Stainless steel with epoxy paint
Feet Nylon and ethylene vinyl acetate (EVA)
USB port Nickel-plated brass and polybutylene
terephthalate (PBT)
Fuse holder Thermoplastic+tin-plated copper alloy
Ethernet port Nickel-plated brass and polybutylene
terephthalate (PBT)
Communication ports (for
footswitch, etc.)
Nickel-plated brass and polybutylene
terephthalate (PBT)
Power inlet Polyamide 6.6 and nickel-plated steel
Pump connection cable Polyvinyl chloride (PVC)
Pump connection cable grommet Nickel-plated brass
Pump connection cable connector Chrome-plated brass

Page 16 of 113
Electrical
Specifications
Power supply voltage 100 to 240 Volt AC, 50/60 Hz
Input to pump 24 Volt DC
Power
LFH version: maximum 120 W
ISL version: maximum 140 W
FLEX version: maximum 150 W
Operating
Requirements
Ambient temperature 15 to 40 °C (59 to 104 °F)
Relative humidity < 90%
Altitude < 2000 meters (6561 feet)
Filtration units
Compatible with all Steritest®,
Sterisolutest, Steridilutor and liquid
transfer kits
Protection type (IEC 60529-2004) IP64 for the pump
Sound intensity <70 dB
Regulatory
Information
Millipore SAS certifies that the Steritest®Symbio Pump is designed and
manufactured in application of:
• The following European Council directives:
-Electromagnetic compatibility 2014/30/EU
-Low voltage directive 2014/35/EU
-Restriction of the use of certain Hazardous Substances in electrical
equipment (RoHS) 2011/65/EU
• The following standards:
-IEC 61010-1(Ed. 3) Safety requirements for electrical equipment
for measurement, control and laboratory use – Part 1: General
requirements
-IEC 61326-1 (Ed. 2) Electrical equipment for measurement, control
and laboratory use -EMC requirements – Part 1: General requirements.
These standards include the national deviations as appropriate for the
relevant countries: USA, Canada, Australia, Argentina, Brazil, China, India,
Japan, Mexico, Russia, Saudi Arabia, South Africa, South Korea, Singapore
• The Federal Communications Commission (FCC) standard and test method:
-Standard:
FCC part 15: 2014 Code of federal regulations
Title 47 – Telecommunication chapter 1- Federal Communication
Commission.
Part 15 - Radio frequency devices Subpart B - Unintentional Radiators
Limits and Methods of measurement of radio disturbance.
-Test method:
Section 15 .107 - Information to the user
Section 15 .109 - Conducted limits
• The European Union Directive 2012/19/EU on Waste Electrical and
Electronic Equipment (WEEE)

Page 17 of 113
Overview of the Pump Assembly
The Steritest®Symbio Pump assembly consists of the following components:
• The pump, including:
• A control panel on the front
• An adjustable color display at the back
• A pump head located below a protective cover on the top
• Carrying handles (standard on LFH version; optional on FLEX version)
• A bottle holder (mounted on the left side of the pump)
• A drain tray (mounted on the right side of the pump)
• A communication hub equipped with the cable dedicated to connect it to the
pump
• A power cord
Documentation and some accessories are also delivered with the pump:
• A network cable (for connection of the pump to a network or directly to a
computer) for the transfer of test methods from a computer to the pump
• A USB flash drive for the transfer of test methods from a computer to the pump
• Silicone drain tubing for the liquid disposal
• 2 threaded stems (ISL and FLEX versions only)
• A flat seal (FLEX version only)
• Quick guides (in German, English, Spanish, French, Italian, Portuguese,
Japanese, Simplified Chinese , Turkish, and Russian):
• Steritest®Symbio Pump Startup Quick Guide
• Steritest®Symbio Pump User Interface Quick Guide
• Steritest®Symbio Software Quick Guide
• Safety instructions (in German, English, Spanish, French, Italian, Portuguese,
Japanese, Simplified Chinese, Turkish, and Russian)
• Steritest®Symbio 2 media pumps EAC request
• 2 Steritest®canisters carrying trays with user quick guide
WARNING
Do not discard the Steritest®canisters carrying trays. Deliver them to the
final user of the pump.

Page 18 of 113
Communication hub ― front view:
Drain tray
Bottle holder
Color display
Pump head
Handle
Handle
Control panel
Drain tray
On/off switch
Overfill
system port
Footswitch port
Syringe
support port
Ethernet port
USB port
Fuse slot

Page 19 of 113
Communication hub ― rear view:
NOTE
To use the pump in Test Method Mode, it is necessary to previously create
test methods and transfer them from the computer to the pump using the
Steritest®Symbio Software.
To access this software and the software user guide, go to
www.millipore.com/steritest-software.
Overview of the Pump Control Panel
Use the control panel to start, operate, and stop the pump. The control panel
consists of the following components:
• An on/off button that is used to switch the pump on and off.
• A control knob that can be rotated and pressed to perform various operations.
• An open/close button that is used to open and close the pump head.
• A next button that is used to perform various operations.
• A back button that is used to perform various operations.
Fuse slot
Power inlet
Pump connection
cable
T 3.15A L 250V
Open/close button
On/off button
Next button
Back button
Control knob

Page 20 of 113
Installing the Pump
Unpacking the Equipment
The Steritest®Symbio Pump is delivered in two boxes that are strapped together.
The larger box contains:
• The Steritest®Symbio Pump
• The communication hub
• 2 Steritest®canisters carrying trays
• The pump Certificate of Quality
• The safety instructions
• Steritest®Symbio 2 media pumps EAC request
• Steritest®cannisters carrying tray and rack user quick guide
WARNING
Do not discard the Steritest®canisters carrying trays. Deliver them to the
final user of the pump.
The smaller box contains the pump accessories and the quick guides.
To unpack the boxes:
1. Using the carrying handles on the larger box, place the package on a flat,
stable, and horizontal surface.
2. Cut the plastic straps to separate the two boxes.
3. Put the smaller box aside.
4. Open the larger box.
5. Retrieve the pump documentation (an envelope containing the Certificate
of Quality and a plastic file folder containing the safety instructions, the
EAC request, and the Steritest®canisters carrying tray and rack user quick
guide).
STERITEST
TM
SYMBIO LFH
2MEDIA
CatNb: SYMBLFH01
LotNb: F4PN01234
S/N LFH1
MilliporeS.A.S67120 Molsheim - Made in France