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Millipore Sigma Steritest User Manual

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

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Do you have a question about the Steritest and is the answer not in the manual?

Questions and answers

Nina Ruban
May 2, 2025

what model steritest pump can clean by hydrogen peroxide (in isolator)

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1 comments:
Mr. Anderson
May 16, 2025

The Steritest® Symbio pump model can be cleaned with hydrogen peroxide in an isolator.

This answer is automatically generated

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Summary of Contents for Millipore Sigma Steritest

  • Page 1 ® User Guide Steritest Symbio Pumps ® The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the US and Canada. SigmaAldrich.com...
  • Page 2 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: Table Of Contents

    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 ........
  • Page 4 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 ..................

  • Page 5: Introduction

    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,...

  • Page 6: Steritest ® Symbio Pump Versions

    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.
  • Page 7 This pump is integrated in an isolator equipped with a standard round cutout. ECHELLE 1:5 ECHELLE 1:5 ECHELLE 1:5 ECHELLE 1:5 NOTE ECHELLE 1:5 ECHELLE 1:5 This pump is not compatible with the oval cutout used for the Steritest ® ECHELLE 1:5 ECHELLE 1:5 Equinox Isofit pump. Page 7 of 113...
  • Page 8 Steritest Symbio FLEX Pump ® This pump can be used in multiple configurations: In an isolator - low integration on round or oval cutouts Page 8 of 113...
  • Page 9 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.
  • Page 10 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.
  • Page 11 In a vertical laminar flow environment, on feet NOTE Use the optional carrying handles to facilitate pump handling (see Accessories and Replacement Parts). FLEX sur pieds FLEX sur pieds sur pieds Page 11 of 113...

  • Page 12: Additional Features

    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: •...
  • Page 13 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. •...

  • Page 14: Specifications And Operating Requirements

    Specifications and Operating Requirements Parameter Value/Range Width 633 mm (24.9 in.) Depth 372 mm (14.6 in.) Dimensions and Height 410 mm (16.1 in.) weight: LFH version, 15.8 kg (34.8 lb) equipped pump Weight 14.2 kg (31.3 lb) (without accessories) Pump head height 158 mm (6.2 in.) Width 588 mm (23.1 in.)
  • Page 15 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...
  • Page 16 Sterisolutest, Steridilutor and liquid transfer kits Protection type (IEC 60529-2004) IP64 for the pump Sound intensity <70 dB Millipore SAS certifies that the Steritest Symbio Pump is designed and ® manufactured in application of: • The following European Council directives:...

  • Page 17: Overview Of The Pump Assembly

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

  • Page 19: Overview Of The Pump Control Panel

    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.

  • Page 20: Installing The Pump

    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.
  • Page 21 Silicone (FLEX version) support rod cable cord* (ISL and FLEX versions) drain tubing *The power cord is not included in the Steritest Symbio FLEX BQ Pump kit, 2 ® media (see Accessories and Replacement Parts). NOTE The Steritest Symbio Pumps User Guide, the Steritest Symbio ISL ®...

  • Page 22: Installing The Pump In The Work Environment

    · One T 6.3A L 250V fuse at the front · Two T 3.15A L 250V fuses at the rear To order spare fuses for the Steritest Symbio communication hub, see ® Accessories and Replacement Parts.
  • Page 23 Connect the end of the pump connection cord to the pump power inlet. Pump power inlet NOTE For the LFH pump, place the pump on the side to connect the pump connection cord to the pump power inlet. Connect one end of the power cord to the communication hub power inlet. Communication hub power inlet T 3.15A L 250V...
  • Page 24 To transfer test methods to the pump using a USB flash drive (see Configuring the Pump, Method Transfer, Transfer Using a USB Flash Drive), connect a USB flash drive to the dedicated USB port of the communication hub If using the optional footswitch, connect the footswitch to the dedicated port of the communication hub (see Overview of Optional Accessories).

  • Page 25: Installing The Bottle Holder

    Installing the Bottle Holder Insert the bottle holder support rod into its dedicated support on the left side of the pump. Secure the support rod by placing the lug into the dedicated slot located on the support. Loosen the fastening screw on the bottle holder basket, but do not unscrew it all the way.
  • Page 26 Insert the bottle holder basket on the bottle holder support rod. Adjust the height and orientation of the basket. Secure the position of the bottle holder basket by tightening the screw. Page 26 of 113...

  • Page 27: Installing The Drain Tray

    The drain tray supports are not the same for all pump versions. To optimize working comfort when using the Steritest Symbio FLEX Pump ® on feet or in an isolator in high integration configuration, use the Steritest ® Symbio drain tray support for 2 canisters, FLEX pump, high integration. This Accessories...
  • Page 28 NOTE On the LFH version, a intermediate position exists for use when the pump must be carried without removing the drain tray. Connect the silicone drain tubing to the drain tray. Drain tubing Place the other end of the drain tubing directly into a waste container (for LFH version) or connect it to the isolator table drain (for ISL and FLEX versions).

  • Page 29: Overview Of Optional Accessories

    ® Operating the pump with the footswitch frees hands for easier handling of samples and the Steritest filtration device. ® The footswitch is compatible with Steritest Symbio Pumps and with Steritest ® ® Equinox pumps. The footswitch is connected to the pump through a dedicated port on the communication hub.
  • Page 30 ® The glass parts are collected inside the container. The glass ampoule breaker is independent from the Steritest Symbio pump. ® Choose a location in the testing environment to accommodate either right- or left- handed technicians.
  • Page 31 Steritest Pumps Syringe Support ® Use the Steritest Pumps syringe support together with the Steritest device for ® ® prefilled syringes to test most prefilled syringes (with or without needle) produced by the pharmaceutical industry. The syringe support holds the syringe. The distribution of sterile fluid to dilute the content of the syringe is controlled by an electrovalve, eliminating the necessity to turn the dilution bottle between each syringe testing.
  • Page 32 Symbio bottle holder during liquid sampling ® • The vent of the Steridilutor expansion chamber (an accessory used to dissolve and/or dilute powder samples in small vials before filtration on a Steritest ® device) This accessory is autoclavable and resistant to vaporized hydrogen peroxide (VHP) and peracetic acid decontamination cycles in isolators.
  • Page 33 This accessory prevents the liquid waste container from overflowing, and is especially helpful when the waste container is placed out of the operator’s view. When the liquid reaches the maximum filling level, an alert appears on the Steritest Symbio Pump display (see Using the Waste Overfill Sensor in Standard ®...
  • Page 34 Press the button. The main screen appears. The blue waste overfill sensor icon is displayed. If the icon is red, empty or replace the waste liquid container. Page 34 of 113...
  • Page 35 There are many different installation possibilities. NOTE For more information about this accessory, refer to the Steritest Symbio ® ISL Pump Installation Guide, Document PF16599 or Steritest Symbio ®...
  • Page 36 • During intermediate and final readings of the sterility test, all 5 canisters can be visually inspected at by gently swirling the Steritest carrying tray. ® The tray and rack are autoclavable and resistant to vaporized hydrogen peroxide (VHP) and peracetic acid decontamination cycles within an isolator.

  • Page 37: Using The Steritest Symbio Pump

    Using the Steritest Symbio Pump ® Making Selections Using the Control Knob Turn the control knob to highlight selections. Push the control knob in to confirm the selection. NOTE symbol indicates a currently activated value. symbols indicate that the list continues below or above.
  • Page 38 Press the pump on/off button . The screen displays the range of Steritest devices. This is followed by the welcome screen: ® The first time the pump is started, and until the pump certificate is activated, the following screen also displays: To activate the pump certificate, turn and press the control knob to select Yes.
  • Page 39 To use a language other than English, turn and press the control knob to select Yes. The Language screen displays: Turn and press the control knob to select a language. NOTE The language can also be changed later using the Configuration menu. Configuring the Steritest Symbio Pump. ® Press the button to continue.
  • Page 40 The Steritest Symbio Pump Press the ® Certificate screen displays: Do one of the following: • To confirm activation of the certificate of conformity: Turn and press the control knob to select Yes. The countdown • to the next calibration is set to 12 months, and the following screen displays: •...
  • Page 41 The Autotest screen displays. The autotest procedure starts, and the pump head opens. The screen also displays the serial number of the pump and the number of days before the next scheduled calibration. When the autotest is complete, the following screen displays. A symbol in a check box indicates that an accessory or data source is connected to the communication hub.

  • Page 42: Starting The Pump After Initial Startup

    Starting the Pump after Initial Startup Switch on the communication hub by pressing the on/off switch (position I ). Press the button on the pump control panel. The screen displays the range of Steritest devices. This is followed by the welcome screen: ® NOTE The Steritest products image can be replaced by another image.

  • Page 43: Using The Main Screen

    Use the pump in the Standard Mode (see Using the Pump in Standard • Mode) • Use the pump in the Test Method Mode (see Using the Pump in Test Method Mode) Configuring the Steritest Symbio Pump) • Configure the pump (see ® Page 43 of 113...
  • Page 44 The following information is visible at the top of this screen: The date and time • • A calibration reminder if the calibration is scheduled in less than 45 days or is overdue Status and configuration of the pump and accessories •...

  • Page 45: Starting The Filtration Of A Sample

    Starting the Filtration of a Sample From the main screen, turn and press the control knob to select either Standard Mode or Test Method Mode. Installing the Steritest Device ® Remove the Steritest device from its packaging and place the two canisters ®...
  • Page 46 Slide the tubing from left to right and right to left to ensure that it is correctly positioned. NOTE If the tubing does not slide freely, repeat the operation. Ensure that the tubing connected to the canister is not under tension. If necessary, slide the tubing to the right in the pump head.

  • Page 47: Using The Standard Mode And Test Method Mode Screens

    To remove the tubing from the pump head, press the button to open the pump head. Pull the tubing gently to release it. Using the Standard Mode and Test Method Mode Screens Both the Standard Mode screen and the Test Method Mode screen are composed of 4 main areas: Standard Mode Screen: Pump head and...
  • Page 48 Date and Time (Standard Mode Screen only) This area displays the current date and time. Back and Next Buttons (Test Method Screen only) Use these buttons to navigate through the screens Pump Head and Accessories Status The following table explains the symbols that indicate the status and configuration of the pump and accessories: Status Icon...
  • Page 49 Speed The pump speed value can vary from 1 to 150. NOTE The default speed value is 75. Pressure The Steritest Symbio Pump constantly monitors the pressure inside each ® Steritest canister and indicates when pressure goes above normal working ®...
  • Page 50 • As soon as the pressure returns to the normal operating range, the color bar returns to green. NOTE This pressure alarm works with but does not replace the Steritest red plugs ® safety function. Operation of the Steritest device should never prevent the ®...

  • Page 51: Using The Pump In Standard Mode

    Adjustment of the speed Using the Pump in Standard Mode ccess the main screen: Turn and press the control knob to select Standard Mode. The Standard Mode screen displays: Install the Steritest device (see Using the Steritest Symbio Pump, ® ®...
  • Page 52 When test is complete, press the button on the pump control panel to open the pump head. When the pump head is open, remove the Steritest Device. ® Do one of the following: To run more tests in Standard Mode, go back to step 3 of this section.
  • Page 53 Turn the control knob clockwise to increase the speed. Turn the control knob counterclockwise to reduce the speed. Using the Timer in Standard Mode To adjust the value of the timer: Press and hold the control knob until the value of the timer is blinking. NOTE The timer value cannot be adjusted when the pump is running.
  • Page 54 NOTE To stop the pump before the end of the timer value, press the control knob. A message asking if filtration should resume with remaining time displays. To stop the pump, turn and press the control knob to select No. Using the Waste Overfill Sensor in Standard Mode In Standard Mode, when the maximum liquid waste level is reached, the waste overfill sensor icon changes from blue to red.

  • Page 55: Using The Pump In Test Method Mode

    LED no longer lights up on the waste overfill sensor. Using the Pump in Test Method Mode The Test Method Mode is available only if test methods have been loaded in the pump. Test methods are created and transferred to the Steritest Symbio Pump ® using the Steritest Symbio Software.
  • Page 56 Turn and press the control knob to select the Test Method Mode. The Methods sorting options screen displays: Turn and press the control knob to select the preferred test methods sorting option. The list of the test methods stored in the pump displays: Turn and press the control knob to select a test method.
  • Page 57 NOTE Use the buttons to browse through the steps of the test method. Using the Steritest Symbio Pump, Install the Steritest device (see ® ®...
  • Page 58 NOTE In steps in which the pump is supposed to run, if the button is pressed when the pump has not begun to run, the following message displays: “No pumping performed in this step. Switch to next step?” Turn and press the control knob to select Yes to go to the next step.
  • Page 59 The pump runs at the new speed. This speed is valid only for the current step of the test method; in the next sequence in the test method, the pump operates at the predefined speed. Changing the Timer Setting While Running a Test Method The filtration parameters for each step are predefined in the test method, and the preset timer value cannot be changed.
  • Page 60 When the waste overfill container is full, the red waste overfill sensor icon displays on the screen below the pump head icon. An alert beep sounds from the pump. An orange LED lights up on the waste overfill sensor. The pump continues to run.

  • Page 61: Entering Standby Mode

    To switch off the pump: Press and hold the button on the control panel for a few seconds. The following screen displays, followed by the screen with the view of the Steritest ® devices range or the custom image if one has been added:...

  • Page 62: Safety Mechanisms

    Safety Mechanisms Steritest Red Plugs ® Two red safety plugs are delivered with the Steritest devices. They are installed ® on the vents on the tops of the canisters, and they pop off if overpressure occurs in the canisters. The pressure measurement system of the Steritest Symbio Pump works with ®...
  • Page 63 When the pump can resume testing operations, the following message displays and a beep sounds intermittently for ten seconds. • If the maximum operating temperature is reached during the test in progress, the pump automatically stops and the following screen displays: The test cannot be completed.

  • Page 64: Configuring The Steritest Symbio Pump

    Configuring the Steritest Symbio Pump ® To configure the pump: Access the main screen. Turn and press the control knob to select Configuration. The Configuration menu displays. NOTE The Configuration menu can also be reached directly from the Standard Mode by pressing the button when the pump head is closed and the pump not running.

  • Page 65: Pressure Mode

    Use the Pressure Mode menu to choose the pressure measurement mode used in Standard Mode. The two options are pressure monitoring and pressure regulation. NOTE In the Test Method Mode, the pressure mode is predefined for each step during the creation of the test method using the Steritest Symbio ® Software.
  • Page 66 To select the pressure measurement mode used in the Standard Mode: NOTE Using the Standard Mode and Test See details on the pressure modes in Method Mode Screens, Filtration Parameters. In the Configuration menu, turn and press the control knob to select Pressure Mode.

  • Page 67: Footswitch

    Footswitch he footswitch is an optional accessory (see Installing the Pump, Overview of Optional Accessories). Use the footswitch menu to select the operating mode of the footswitch. To select the operating mode of the footswitch: In the Configuration menu, turn and press the control knob to select Footswitch.

  • Page 68: Syringe Support

    Two operating modes are available: Footswitch Mode Symbol Start/Stop Press the footswitch once to start the pump. Press again to stop the pump. Press it a third time to restart the pump. If the timer is activated (the timer value is set to anything but off) and the footswitch is pressed to stop the pump before the end of the set value, a confirmation screen asks if the filtration should resume with remaining time or if the timer value should be canceled and the...
  • Page 69 If the syringe support is connected to the communication hub, the following screen displays: Turn and press the control knob to select Yes to activate the syringe support, or No to deactivate the syringe support. The syringe support is not compatible with the pressure regulation mode. If the pressure regulation mode is activated when activating the syringe support, a confirmation screen displays that provides the opportunity to deactivate the pressure regulation mode:...

  • Page 70: Date And Time

    Date and Time To set the date and time: In the Configuration menu, turn the control knob to select Date and Time. The Date and Time screen displays. Turn the control knob to go from a field to another. To modify a value, press the control knob to enter the value field, then turn the control knob to change the value of the field.

  • Page 71: Pump Information

    Pump Information To access the Pump Information screen: In the Configuration menu, turn and press the control knob to select Pump Information. The Pump Information screen displays. This screen provides information about the pump: • Serial number Firmware version installed on the pump •...

  • Page 72: Alarm Volume

    When the calibration alerts are deactivated, the question regarding the activation of the pump certificate no longer appears, and the calibration countdown and alerts are hidden. • Turn and press the control knob to activate or deactivate the calibration alerts and countdown. To modify the calibration frequency, turn the control knob to select the •...

  • Page 73: Methods Transfer

    Methods Transfer 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. Use this menu to transfer Test Methods from the Steritest ®...
  • Page 74 USB flash drive, the following Methods Transfer screen displays: Transfer Using a Network Cable To transfer test methods from the Steritest Symbio Software to the pump using ® a network cable: Ensure that the communication hub is connected to an active network or directly to the computer (see Network Configuration).
  • Page 75 Network connection between pump and computer: To ensure that test methods are not modified during pump use, the pump must be in one of the two following states when it is receiving test methods: Pump is ON in Configuration / Methods Transfer / Network / File •...
  • Page 76 Press the button to continue. The File Transfer screen displays. The pump is ready to receive test methods from the Steritest Symbio Software. ® In the Steritest Symbio Software, click the Connect command to connect ® the software to the pump. From the drop-down list, select the pump to be updated.
  • Page 77 Transfer Using a USB Flash Drive To transfer test methods from the Steritest Symbio Software to the pump using ® a USB flash drive: Transfer the transfer file containing the test methods to a USB flash drive using the Steritest...

  • Page 78: Network Configuration

    Turn and press the control knob to select the transfer file to be transferred from the USB flash drive to the pump. NOTE Transferring test methods to the pump erases its current content. Press the button to start the transfer. The file transfer screen displays, and the transfer starts.

  • Page 79: Pressure Sensors Test

    NOTE Refer to the Steritest Symbio Software User Guide and contact your ® local network administrator to perform network configuration. Do one of the following: • Turn and press the control knob to select Automatic (DHCP). No other action is required.
  • Page 80 The materials needed to perform the verification of the pressure sensors are listed on the screen. Gather these materials. Press the button to continue. The following screen displays: Unpack a Steritest device. ® Place the two yellow plugs on the canister outlets, and place the canisters on the drain tray.
  • Page 81 Press the button to continue. The following screen displays: Install the tubing in the pump head (see Using the Steritest Symbio Pump, ® Installing the Steritest Device). ® Press the button to continue. The following screen displays: Slide the tubing from left to right and right to left, to ensure that it is correctly positioned.
  • Page 82 Press the button to continue. The following screen displays: Insert Steritest needle adapter into a sterile water bottle (volume > 500 ® ml). NOTE Keep the bottle upright on the workbench. Press the button to continue. The following screen displays.
  • Page 83 Steritest tubing in the pump head. Install the pressure ® control kit for Steritest Pumps (See Accessories and Replacement Parts) ® on the corresponding canister. Pressure control kit Press the button to continue. The following screen displays:...
  • Page 84 Press the button. The following screen displays: The pump head closes, and the pump starts at a fixed speed of 30. After the pump has started, do not handle the tubing for 30 seconds. This allows the air to be transferred and the pressure measurement to stabilize. NOTE Keep the bottle on the workbench.
  • Page 85 The liquid is transferred to the tested canister, and the pressure on the pressure gauge increases. 316 SS TUBE AND CONNECTION MILLIPORE CAUTION If the pressure reaches 53 psi (3.6 bar) and the pump does not Pressure automatically stop, press the control knob to abort the test. See Sensors Test Issues, Overpressure.
  • Page 86 Press the button. The following screen displays: Remove the pressure control kit for Steritest Pumps to release the pressure ® in the canister. Remove the bottle from the bottle holder basket and place it upright on the workbench. Open the clamp on the bottle side.
  • Page 87 Press the button. The following screen displays: Turn and press the control knob to select Sensor number 2 (upper tubing). The following screen displays: Identify the upper Steritest tubing in the pump head. Install the pressure ® control kit for Steritest Pumps on the corresponding canister.
  • Page 88 Press the button. The following screen displays: On the bottle side, clamp the lower tubing to prevent transferring liquid to the canister from the untested tubing. Click! Press the button. The following screen displays: The pump head closes, and the pump starts up at a fixed speed of 30. Page 88 of 113...
  • Page 89 NOTE After the pump has started, do not handle the tubing for 30 seconds. This allows the air to be transferred and the pressure measurement to stabilize. Keep the bottle on the workbench. The instructions on the pump screen indicate when to move to next step. The following screen displays: Turn the bottle upside down and place it in the bottle holder.
  • Page 90 Pressure Sensors Test Issues, Pressure Outside the Acceptable Range. Press the button. The following screen displays: Remove the pressure control kit for Steritest Pumps to release the pressure ® in the canister. Remove the bottle from the bottle holder basket and place it on the workbench.
  • Page 91 Press the button. The following screen displays: Place the red plugs on the canister vents. Remove the canisters from the drain tray, remove the yellow plugs from the canister outlets, and put the canisters back into the drain tray. Ensure that the drain tray waste tubing is connected to a waste container Press the button.
  • Page 92 During the pressure sensors test, if the pressure in the canister exceeds 53 psi, manually stop the pump by pressing the control knob. The following screen displays: Remove the pressure control kit for Steritest Pumps from the tested ® canister.
  • Page 93 If the tubing is damaged: Turn and press the control knob to select Yes. The following screen • displays: • Discard the Steritest device and install a new one. Press the ® button. • Restart the pressure sensor test procedure as explained in Configuring the Pump, Pressure Sensors Test.
  • Page 94 If the pump must be stopped manually again during the test, the following message displays. The verification procedure cannot be completed. If this happens: • Remove the pressure control kit for Steritest Pumps from the tested ® canister. •...
  • Page 95 No Pressure Increase Detected During the pressure sensors test, if no pressure increase is detected after about 30 seconds in the tested canister, the test stops and the following screen displays: Remove the bottle from the bottle holder and place it upright on the workbench.
  • Page 96 If the tubing is damaged: • • Turn and press the control knob to select Yes. The following screen displays: • Discard the Steritest device and unpack a new one. Press the ® button. • Restart the pressure sensor test procedure as explained in...
  • Page 97 37 psi or higher than 53 psi, do the following: Pumps is calibrated. • Ensure that the pressure control kit for Steritest ® • Repeat the test. If the problem persists, contact technical service and have a certified technician calibrate the pressure sensors.

  • Page 98: Maintenance

    Pressure • Perform the pressure sensor verification every six months. See Sensors Test. The Steritest Symbio Pump should be serviced by a certified technician • ® annually. This servicing includes a check of the operating performances and calibration of the pressure sensors. Contact our sales representative or Technical Service for more information about the service agreements.
  • Page 99 Turn the pump display to its transportation position (horizontal). Retrieve the original pump box and protective foam or the optional Steritest ® Accessories and Replacement Parts). Symbio pumps shipment case (see Place the pump and the communication hub in the box or shipment case using the protective foam.

  • Page 100: Cleaning The Pump

    Cleaning the Pump Recommended Cleaning Agents The compatibility of the following cleaning agents with the Steritest Symbio ® Pump has been verified. Cleaning Product Validated dilution Ethanol (<30%) Didecyldimethylammonium chloride (<1%) Ready to use Propanol (<1%) N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine (<1,5%) Isopropyl alcohol 70%...
  • Page 101 Turn the drain tray to the removal position. Remove the drain tray from the pump. Disassemble the two parts of the drain tray. Remove the bottle holder basket from the bottle holder support rod. Page 101 of 113...
  • Page 102 Remove the bottle holder support rod from the pump. To disassemble the bottle holder fastening system, completely unscrew and remove the screw: emove the plastic screw clip from the screw. Page 102 of 113...
  • Page 103 Remove the pump head cover by pulling it off with both hands. SB04b If necessary, remove the rotor mounting screw from the pump head using a 4mm hex wrench, and remove the rotor from the pump head. NOTE It is not necessary to remove the pump head rotor unless there has been an accidental spill.

  • Page 104: Cleaning The Pump

    Cleaning the Pump To clean the pump: Disassembling the Pump). Disassemble the pump components (see Switch off the communication hub using the on/off switch (position Ο) and disconnect the hub from the power source. NOTE It is not necessary to remove the pump head rotor unless there has been an accidental spill.
  • Page 105 Rinse with clean water. Optional: Autoclave the bottle holder parts (disassembled) at 121 °C for 30 minutes or 134 °C for 10 minutes. Clean the optional Steritest holder for sterile bags and the Steridilutor vent ®...

  • Page 106: Decontamination Procedure In An Isolator

    Decontamination Procedure in an Isolator Remove the bottle holder from the pump. Disconnect the drain tubing from the isolator table. Remove the drain tray from the pump. Remove the protective cover from the pump head (see Disassembling the Pump). Remove these parts from the isolator. Disassemble the bottle holder and the drain tray (see Disassembling the Pump).

  • Page 107: Reassembling The Pump

    Reassembling the Pump o reassemble the pump: Ensure that the communication hub is disconnected from the power source. Reattach the control knob by pushing it onto the post. If the pump head rotor has been removed, reinstall it by aligning the notch in the rotor with the guide part.
  • Page 108 • Adjust the cover position to align the pump rotor with its housing, and then push on the cover. NOTE The cover can be installed only when the equipment is switched off. Clamp rotation spindle housing Clamp rotation spindle Ensure that the cover is firmly seated on the pump. NOTE The gap between the pump and the protective cover is about 2 mm (.079 in.).

  • Page 109: Troubleshooting

    Troubleshooting If a pump error occurs, a message displays on the pump screen with the name of the problem, the error code, and the procedure to solve it. Follow the instructions on the screen. It may be necessary to restart the pump. If the error persists, contact Technical Service and provide the error code.
  • Page 110 Reinstall tubing The liquid is not pinched or clamped following the procedure described in evenly distributed or damaged. Installing the Steritest Device. between the two ® canisters. Filtration speed is Reduce the filtration speed.

  • Page 111: Accessories And Replacement Parts

    ® Steritest pumps syringe support SYMBSYS01 ® Steritest Symbio waste overfill sensor for solid containers SYMBWFS01 ® Pressure control kit for Steritest pumps TQ00PSI01 ® Steritest holder for sterile bags and Steridilutor vent chamber SYMBSVB01 ® Steritest Symbio communication hub holder for isolators SYMBCHI01 ®...
  • Page 112 Symbio communication hub fuses kit, 6.3A SYMBHFK6A ® Steritest Symbio communication hub fuses kit, 3.15A SYMBHFK3A ® Pump head cover for Steritest Symbio 2 media SYMBHEC01 ® Power cord for North America, Central America, Mexico FTPF02471 Power cord for Europe...

  • Page 113: Symbols Referenced

    400 Summit Drive Burlington, MA 01803 © 2021 Merck KGaA, Darmstadt, Germany, and/or its affiliates. All rights reserved. MilliporeSigma, the Vibrant M, Millipore, and Steritest are Lit. No. MS_UG7737EN trademarks of Merck KGaA, Darmstadt, Germany, or its affiliates. All other trademarks are the property of their respective owners. Detailed 04/2021 information on trademarks is available via publicly accessible resources.

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