Millipore Sigma Steritest Bedienungsanleitung
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
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ECHELLE 1:5
ECHELLE 1:5
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ECHELLE 1:5
ECHELLE 1:5
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ECHELLE 1:5
ECHELLE 1:5
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ECHELLE 1:5
ECHELLE 1:5
Page 7 of 113
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
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ECHELLE 1:5 ECHELLE 1:5
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ECHELLE 1:5 ECHELLE 1:5
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ECHELLE 1:5 ECHELLE 1:5
Page 8 of 113
Steritest®Symbio FLEX Pump
This pump can be used in multiple configurations:
In an isolator - low integration on round or oval cutouts
33
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361 355
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361 355
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361 355
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361 355
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Page 9 of 113
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
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289
106
459
645
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361
11
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645
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11
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10
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289
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459
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326
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11
Page 10 of 113
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
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361
119
301
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456
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