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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.

Содержание Steritest

Страница 1: ...The life science business of Merck KGaA Darmstadt Germany operates as MilliporeSigma in the US and Canada SigmaAldrich com User Guide Steritest Symbio Pumps...

Страница 2: ...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...

Страница 3: ...alling 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...

Страница 4: ...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 Procedu...

Страница 5: ...vices 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...

Страница 6: ...t 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...

Страница 7: ...is not compatible with the oval cutout used for the Steritest Equinox Isofit pump 355 325 276 32 81 588 293 234 ECHELLE 1 5 ECHELLE 1 5 355 354 325 276 103 101 185 588 293 234 313 ECHELLE 1 5 ECHELLE...

Страница 8: ...p This pump can be used in multiple configurations In an isolator low integration on round or oval cutouts 33 82 355 611 326 276 361 33 355 611 356 186 106 326 276 361 355 97 33 82 355 611 326 276 361...

Страница 9: ...ccessories 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 e...

Страница 10: ...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...

Страница 11: ...Use the optional carrying handles to facilitate pump handling see Accessories and Replacement Parts FLEX sur pieds 191 142 355 361 276 4 645 355 361 276 295 112 465 456 645 sur pieds 191 142 355 361...

Страница 12: ...tch 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 syrin...

Страница 13: ...o 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 acc...

Страница 14: ...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 i...

Страница 15: ...ump 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 prop...

Страница 16: ...uipment 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 El...

Страница 17: ...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...

Страница 18: ...munication 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...

Страница 19: ...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 rotat...

Страница 20: ...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 sta...

Страница 21: ...ories and Replacement Parts 9 Remove the 2 Steritest canisters carrying trays and deliver them to the user of the pump 10 Open the smaller box that contains the accessories 11 Remove the accessories T...

Страница 22: ...used inside an isolator using the Steritest Symbio connection cable extension with Tri Clover clamp and the Steritest Symbio feet for use in isolator see Accessories and Replacement Parts ISL version...

Страница 23: ...e communication hub power inlet 3 Connect the other end of the power cord to a properly grounded power outlet 4 To transfer test methods to the pump using the company network or using direct connectio...

Страница 24: ...the dedicated port of the communication hub see Overview of Optional Accessories 7 If using the optional syringe support connect the syringe support to the dedicated port of communication hub see Ove...

Страница 25: ...older support rod into its dedicated support on the left side of the pump 2 Secure the support rod by placing the lug into the dedicated slot located on the support 3 Loosen the fastening screw on the...

Страница 26: ...e 26 of 113 4 Insert the bottle holder basket on the bottle holder support rod 5 Adjust the height and orientation of the basket 6 Secure the position of the bottle holder basket by tightening the scr...

Страница 27: ...t or in an isolator in high integration configuration use the Steritest Symbio drain tray support for 2 canisters FLEX pump high integration This drain tray support is not delivered with the FLEX pump...

Страница 28: ...d and reverse pressure into the drain tray ensure that the tubing does not touch the liquid in the waste container and that the waste container is open or correctly vented Also ensure that the drain t...

Страница 29: ...bio Pumps and with Steritest Equinox pumps The footswitch is connected to the pump through a dedicated port on the communication hub The footswitch operates in two modes Start Stop and Continuous Set...

Страница 30: ...p Choose a location in the testing environment to accommodate either right or left handed technicians An optional cutting file is available for use with ampoules without a prescored neck The glass amp...

Страница 31: ...ent of the syringe is controlled by an electrovalve eliminating the necessity to turn the dilution bottle between each syringe testing The syringe support valve is connected to the pump through a dedi...

Страница 32: ...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 T...

Страница 33: ...laced To use the overfill sensor 1 Place the sensor around the waste container Use the belt to secure the position NOTE Keep enough space at the top of the container so that the filtration in progress...

Страница 34: ...Page 34 of 113 4 Press the button The main screen appears The blue waste overfill sensor icon is displayed 5 If the icon is red empty or replace the waste liquid container...

Страница 35: ...he Steritest Symbio ISL or FLEX pump after it is installed inside the isolator table cutout The multiple fastening options make this optional accessory compatible with many isolators configurations th...

Страница 36: ...ted at one time The Steritest carrying tray and Steritest rack can remain in the incubator firmly holding the canisters During intermediate and final readings of the sterility test all 5 canisters can...

Страница 37: ...on to 12 months It is possible to activate the pump certificate within one year after the date of factory calibration After this period the countdown can be reset only during a standard maintenance pe...

Страница 38: ...pump is started and until the pump certificate is activated the following screen also displays 3 To activate the pump certificate turn and press the control knob to select Yes NOTE If No is selected t...

Страница 39: ...e control knob to select a language NOTE The language can also be changed later using the Configuration menu See Configuring the Steritest Symbio Pump 5 Press the button to continue The following scre...

Страница 40: ...nd the following screen displays Fill out the activation date on the certificate of quality that was delivered with the Steritest Symbio Pump Press the button to move to next step autotest sequence To...

Страница 41: ...er 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 sour...

Страница 42: ...bio Software User Guide After a few seconds 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...

Страница 43: ...t an accessory or data source is connected to the communication hub 3 Press the button to continue The main screen displays Using the Main Screen Use the Main screen to Use the pump in the Standard Mo...

Страница 44: ...tion hub is connected to an active network or directly to the computer using a network cable USB flash drive A USB flash drive is connected to the communication hub Footswitch optional The footswitch...

Страница 45: ...nstalling the Steritest Device 1 Remove the Steritest device from its packaging and place the two canisters on the drain tray 2 Install the tubing in the pump head At the same time gently pull the tub...

Страница 46: ...tubing does not slide freely repeat the operation 5 Ensure that the tubing connected to the canister is not under tension If necessary slide the tubing to the right in the pump head 6 Close the pump h...

Страница 47: ...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 Test Method Mode Screen Pump head and accessories sta...

Страница 48: ...itch The footswitch is connected to the communication hub and Start Stop mode is selected The footswitch is connected to the communication hub and Continuous mode is selected Syringe support The syrin...

Страница 49: ...r a preset filtration time The timer value can vary from off not used to 999 see Using the Pump in Standard Mode NOTE The timer default value is off Speed The pump speed value can vary from 1 to 150 N...

Страница 50: ...alarm works with but does not replace the Steritest red plugs safety function Operation of the Steritest device should never prevent the red safety plugs from popping off in the event of overpressure...

Страница 51: ...s until the pump speed returns to the set value Using the Pump in Standard Mode 1 Access the main screen 2 Turn and press the control knob to select Standard Mode The Standard Mode screen displays 3 I...

Страница 52: ...starting pump displays on the information area of the screen The pump starts and the icon with the a moving dot displays 6 To stop the pump press the control knob or use the footswitch if connected 7...

Страница 53: ...e Pressure Measurement System from Regulation to Monitoring Turn and press the control knob to select Continue 2 Turn the control knob clockwise to increase the timer value Turn the control knob count...

Страница 54: ...the maximum liquid waste level is reached the waste overfill sensor icon changes from blue to red An alert beep sounds from the pump An orange LED lights up on the waste overfill sensor The pump conti...

Страница 55: ...hts 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 t...

Страница 56: ...s 3 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 4 Turn and press the control knob to select a test meth...

Страница 57: ...eritest device see Using the Steritest Symbio Pump Installing the Steritest Device 7 Press the button to close the pump head NOTE During the locking procedure of the pump head the icon blinks When the...

Страница 58: ...tration parameters for each step are predefined in the test method however it is possible to change the speed of the pump Speed can be changed if the pump is running or not running To change the pump...

Страница 59: ...he end of the timer value To stop the pump before the end of the timer value 1 When the pump is running press the control knob The pump and the timer countdown stop and the following screen displays 2...

Страница 60: ...ds from the pump An orange LED lights up on the waste overfill sensor The pump continues to run When the pump is stopped the overfilling alert screen displays The red waste overfill sensor icon remain...

Страница 61: ...ware User Guide To exit standby mode press the control knob NOTE If no action is performed for 60 minutes while the pump head is open the pump switches off automatically Switching Off the Pump To swit...

Страница 62: ...h Pressure alert level Put both red plugs back on the canister vents and continue pump operations If the red plugs have not popped off when the High Pressure alert is displayed reduce speed or stop th...

Страница 63: ...est in progress the pump automatically stops and the following screen displays The test cannot be completed No action on the pump is possible until the temperature returns to an acceptable value excep...

Страница 64: ...ndard Mode by pressing the button when the pump head is closed and the pump not running From the configuration menu the following functions can be configured Pressure Mode select the pressure measurem...

Страница 65: ...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...

Страница 66: ...trol knob to select a pressure mode A symbol indicates the enabled mode The pressure regulation mode is not compatible with the timer function or with the optional syringe support accessory If the tim...

Страница 67: ...he footswitch To select the operating mode of the footswitch 1 In the Configuration menu turn and press the control knob to select Footswitch If the footswitch is not connected to the communication hu...

Страница 68: ...footswitch is pressed again To stop the pump before the end of the timer value press the control knob A confirmation screen asks if the filtration should resume with the remaining time or if the timer...

Страница 69: ...on 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 The sta...

Страница 70: ...ange the value of the field Press the control knob to confirm the value 3 Press the button to return to the Configuration menu Language To set the language 1 In the Configuration menu turn and press t...

Страница 71: ...pump Serial number Firmware version installed on the pump Date of the last update of the test methods contained in the pump If no test method has been loaded to the pump the message is No test method...

Страница 72: ...firm the value NOTE The calibration frequency can be modified only if the calibration alerts and countdown are activated It can be changed to between 6 and 12 months Press the button to return to the...

Страница 73: ...mbio Software is not intended to replace the user s quality management system QMS which should be in place to comply with good manufacturing practices The software helps users to create and modify tes...

Страница 74: ...plays If the communication hub is connected to an active network or directly to the computer using the network cable or to a USB flash drive the following Methods Transfer screen displays Transfer Usi...

Страница 75: ...p is OFF but the communication hub is ON 2 Do one of the following If the pump is ON continue to step 3 If the pump is OFF and the communication hub is ON go to step 6 3 Access the Configuration menu...

Страница 76: ...the drop down list select the pump to be updated 7 Select the transfer file to be transferred and confirm the transfer see the Steritest Symbio Software User Guide NOTE Transferring test methods to th...

Страница 77: ...see the Steritest Symbio Software User Guide 2 Connect a USB flash drive to the USB port on the communication hub 1 2 3 Access the Configuration menu from the main screen 4 In the Configuration menu...

Страница 78: ...the following screen displays 9 Press the button to return to the Configuration menu Network Configuration Use this menu to configure the network to ensure proper communication between the pump and th...

Страница 79: ...he values shown are the default values Modifications should be made by the local network administrator 4 Turn the control knob to go from one field to the next To modify a value push the control knob...

Страница 80: ...rs Test screen displays The materials needed to perform the verification of the pressure sensors are listed on the screen Gather these materials 3 Press the button to continue The following screen dis...

Страница 81: ...he pump head see Using the Steritest Symbio Pump Installing the Steritest Device 5 Press the button to continue The following screen displays Slide the tubing from left to right and right to left to e...

Страница 82: ...rt Steritest needle adapter into a sterile water bottle volume 500 ml NOTE Keep the bottle upright on the workbench 7 Press the button to continue The following screen displays 8 Turn and press the co...

Страница 83: ...ntrol kit for Steritest Pumps See Accessories and Replacement Parts on the corresponding canister 9 Press the button to continue The following screen displays On the bottle side clamp the upper tubing...

Страница 84: ...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 The instructions on the...

Страница 85: ...he test stops See Pressure Sensors Test Issues No Pressure Increase Detected 11 As soon as the pump stops read the pressure on the pressure gauge The pressure should be between 37 psi 2 5 bar and 53 p...

Страница 86: ...bottle from the bottle holder basket and place it upright on the workbench Open the clamp on the bottle side 13 Press the button The pump head opens and the following screen displays Slide the tubing...

Страница 87: ...een displays 15 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 k...

Страница 88: ...reen displays On the bottle side clamp the lower tubing to prevent transferring liquid to the canister from the untested tubing 17 Press the button The following screen displays The pump head closes a...

Страница 89: ...bottle on the workbench The instructions on the pump screen indicate when to move to next step 18 The following screen displays Turn the bottle upside down and place it in the bottle holder The liquid...

Страница 90: ...pressure gauge The pressure should be between 37 psi 2 5 bar and 53 psi 3 6 bar NOTE If the pressure is not between 37 psi 2 5 bar and 53 psi 3 6 bar refer to Pressure Sensors Test Issues Pressure Out...

Страница 91: ...sters 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 22...

Страница 92: ...utton to return to the configuration menu Pressure Sensor Test Issues Overpressure 1 During the pressure sensors test if the pressure in the canister exceeds 53 psi manually stop the pump by pressing...

Страница 93: ...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 C...

Страница 94: ...topped 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...

Страница 95: ...wing screen displays Remove the bottle from the bottle holder and place it upright on the workbench Ensure that the tubing of the tested canister is not clamped at the bottle end 1 Press the button Th...

Страница 96: ...Configuring the Pump Pressure Sensor Test If the tubing is not damaged Turn and press the control knob to select No The following screen displays Re install the tubing in the pump head Press the butt...

Страница 97: ...Configuration menu Contact Technical Service NOTE Until the pressure sensors issue has been resolved the pressure level in the canisters should be assessed exclusively through the use of the red plug...

Страница 98: ...is 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 agreeme...

Страница 99: ...al 8 Retrieve the original pump box and protective foam or the optional Steritest Symbio pumps shipment case see Accessories and Replacement Parts 9 Place the pump and the communication hub in the box...

Страница 100: ...hlorite 250 ppm 5 Peracetic acid at 5 to 15 Acetic acid at 5 to 15 Hydrogen peroxide 15 to 30 2 5 6 Ethanol 25 to 50 Polyhexamethylene biguanide hydrochloride 2 5 N 3 aminopropyl N dodecylpropane 1 3...

Страница 101: ...of 113 4 Turn the drain tray to the removal position 5 Remove the drain tray from the pump 6 Disassemble the two parts of the drain tray 7 Remove the bottle holder basket from the bottle holder suppor...

Страница 102: ...113 8 Remove the bottle holder support rod from the pump 9 To disassemble the bottle holder fastening system completely unscrew and remove the screw 10 Remove the plastic screw clip from the screw 1b...

Страница 103: ...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 accide...

Страница 104: ...tective cover of the pump head with a nonwoven wipe moistened with one of the recommended cleaning agents listed in this section Optional Autoclave the protective cover at 121 C for 30 minutes or 134...

Страница 105: ...this operation daily Spare drain trays are available see Accessories and Replacement Parts 10 Clean the bottle holder parts using a nonwoven wipe moistened with one of the recommended cleaning agents...

Страница 106: ...C for 10 minutes NOTE The drain tray and bottle holder should be completely disassembled for autoclaving 9 Return these parts to the isolator Hang them or place them on a shelf in the isolator NOTE Th...

Страница 107: ...nto the post 3 If the pump head rotor has been removed reinstall it by aligning the notch in the rotor with the guide part 4 Insert the pump head rotor mounting screw and tighten using a 4mm hex wrenc...

Страница 108: ...tween the pump and the protective cover is about 2 mm 079 in 7 Connect the communication hub to power source and switch it on using the on off switch position l 8 Press the button to switch the pump o...

Страница 109: ...do the test NOTE For very small volumes performing a pre wetting step is highly recommended For other issues refer to the following table If any issue persists contact Technical Service Symptom Possib...

Страница 110: ...rain tray higher than the waste container The tubing between the drain tray and the waste container is bent or looped Ensure that the tubing between the drain tray and the waste container is straight...

Страница 111: ...Tri Clover clamp 1 SYMBXTC01 Steritest Symbio drain tray support for 2 canisters FLEX pump high integration 1 SYMBDSF02 Steritest carrying trays for 5 canisters 8 SYMBCAN08 Steritest rack to hold up t...

Страница 112: ...BLE11 Steritest Symbio flat seal for ISL pump 1 SYMBFSI01 Steritest Symbio flat seal for FLEX pump 1 SYMBFSF01 Software Available at www millipore com steritest software Steritest Symbio Software Cons...

Страница 113: ...of Sale applicable to your purchase transaction The presence of this logo on the product testifies the compliance of the Steritest Symbio Pump with the following European Union directives Electromagne...

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