Infors HT Minifors 2 Operating Manual Download

Page: 126 / 217

Minifors 2 - Benchtop Bioreactor

Operation

Page

124

214

07 February 2019

This means that the

Sample information

dialogue appears and dis-

plays how long the batch has been running since inoculation

(

Batch Time….)

, and how many samples have been taken (

Sam-

ple Nr.….

), or how many times

SAMPLE NOW

has been pressed

since

START BATCH

was pressed.

closes the dialogue.

10.2 Menus for System Settings

There are eight menus for system settings, of which six are availa-

ble for the operator.



VESSEL TYPE

: Selection of the culture vessel used



APPEARANCE

: Display settings, including language and

time



NETWORK SETTINGS

: Network configuration



eve COMMUNICATION

: Configuration of the OPC UA

server for communication with the bioprocess platform soft-

ware eve® by the equipment manufacturer.



CHANGE PIN CODE

: Password settings



USB

: Export files on a USB stick or load updates and addi-

tional packages from a USB stick.



SYSTEM INFO

: Information about system versions and up-

time



SERVICE MENU

: Functions for authorised service partners

of the equipment manufacturer, only accessible with the rele-

vant password

Summary of Contents for Minifors 2

Page 1: ...Operating Manual 2019 02 07 Minifors 2 Benchtop Bioreactor Dok ID 75623 V 03 00 Original...

Page 2: ...SA Inc 9070 Junction Drive Suite D Annapolis Junction MD20701 T 1 301 362 3710 T 1 855 520 7277 toll free USA F 1 301 362 3570 infors usa infors ht com www infors ht us Infors Canada 8350 rue Bombardi...

Page 3: ...2 4 Responsibility of the Provider 15 2 5 General Hazards 15 2 5 1 Electrical Current 16 2 5 2 Unauthorised Spare Parts and Accessories 16 2 6 Particular Hazards 16 2 6 1 Hot Surfaces 17 2 6 2 Danger...

Page 4: ...System 33 3 5 Stirrer 34 3 6 Gassing System 35 3 6 1 Gas Entry 36 3 6 2 Exit Gas 36 3 7 pH Control 36 3 7 1 Measurement System 36 3 8 pO2 Control 37 3 8 1 Measurement System 38 3 9 Antifoam Control 39...

Page 5: ...5 20 Starter Kit 62 5 21 Service Sets 62 5 22 Auxiliary Supplies 62 6 Transport and Storage 63 6 1 Transport 63 6 2 Storage 64 7 Installation and Initial Operation 65 7 1 General Location Requirements...

Page 6: ...Mounting a Sensor into a 12 mm Port 86 8 1 18 Mounting Sensors with Electrode Holder 87 8 1 19 Mounting the Antifoam Sensor 89 8 1 20 Preparing the Super Safe Sampler 91 8 1 21 Mounting the Sparger Ho...

Page 7: ...ivation 116 10 Operation 118 10 1 Screen Areas Menu Navigation and Control Elements 118 10 1 1 Main Screen 120 10 1 2 EDIT VIEW 121 10 1 3 START BATCH INOCULATE STOP BATCH 122 10 1 4 SAMPLE NOW 123 10...

Page 8: ...TY Automatically Filling Emptying Pump Hoses 158 10 8 Calibration 159 10 8 1 Calibrating the pH Sensor General Information 159 10 8 2 Calibrating the pH Sensor Procedure 160 10 8 3 pH Sensor Product C...

Page 9: ...er 191 11 8 Cleaning the Exit Gas Cooler 191 11 9 Cleaning the Basic Unit and Operating Panel 192 11 10 Maintenance Plan 192 11 11 Decalcifying the Equipment 193 12 Interferences 195 12 1 Interference...

Page 10: ...14 4 4 Gas Air O2 or N2 208 14 5 Specifications 208 14 5 1 Operating Panel 208 14 5 2 Culture Vessels 208 14 5 3 Stirrer 209 14 5 4 Temperature 210 14 5 5 Gassing 211 14 5 6 pH 211 14 5 7 pO2 212 14...

Page 11: ...roughly and fully un derstand its contents before beginning any work Adhering to all the safety and operating instructions in this manual is essential to ensure that work is carried out safely The sco...

Page 12: ...at may result in significant damage to property if not avoided INFORMATION Texts located below a grey bar bearing the notice INFOR MATION provide useful tips and recommendations for ensuring efficient...

Page 13: ...at your disposal for technical advice and specialist enquiries For contact information see page 2 Due to their familiarity with the potential applications of the equip ment the Customer Service team i...

Page 14: ...wareness of the associated risks 2 1 Intended Use Incorrect Use and Misuse The bench top bioreactor Minifors 2 from INFORS HT is de signed especially for research and development and for the cultivati...

Page 15: ...ecessary infrastructure available These persons may also be included in the group of people known as users though this is not always the case Irrespective of whether a provider is a member of the comp...

Page 16: ...have been trained for working in a biotech nology laboratory can be considered for the role of operator These include Process technicians in the fields of biotechnology and chemis try Biotechnologists...

Page 17: ...rements relating to occupational health and safety in a biotechnology laboratory In particular The provider is responsible for ensuring that the work and en vironmental regulations applicable in a bio...

Page 18: ...cuit 2 5 2 Unauthorised Spare Parts and Accessories Incorrect or imitated spare parts and accessories as well as spare parts or accessories that have not been authorised by the manu facturer represent...

Page 19: ...ces In order to prevent high emissions of dangerous gases the follow ing measures must be taken The gas connections on the equipment must be checked be fore any cultivation processes using dangerous g...

Page 20: ...nce the equipment is used deliberately for such applications it is the responsibility of the users to ensure that they have sufficient protection 2 6 6 Overpressure or Vacuum Glass vessels may break o...

Page 21: ...econtaminated before sending to the manufacturer The provider is therefore required to completely and truthfully fill out a declaration of decontamination and have it signed by the person responsible...

Page 22: ...s 2 Thermal block and adapter 3 Connections for sparger and exit gas cooler 4 Operating panel 5 LED signal strip 6 Main switch 7 Connections for sensors 8 Hooks for vessel holder All of the measuremen...

Page 23: ...p green as soon as it is switched on 3 1 2 LED Strip The LED strip is located on the front of the basic unit When the LED strip Lights up green as soon as the equipment is switched on The equipment is...

Page 24: ...e pumps This is numbered 1 to 4 from bottom to top and labelled to indicate the standard factory settings Pump 1 Acid digital Alternative setting FEED analogue Pump 2 Base digital Alternative setting...

Page 25: ...6 Water Connections The water connections are located on the rear of the basic unit at the bottom right They are marked with the following symbols H2O IN water inlet H2O OUT water outlet 3 1 7 Gas Co...

Page 26: ...located on the rear of the basic unit at the bottom left SERVICE 9 pin RS232 for connecting a diagnostic com puter for maintenance BALANCE 9 pin RS232 for connecting a balance LAN port for connecting...

Page 27: ...and the connecting cables for the pH pO2 and antifoam sensors are always present The matching sensors for pH pO2 and anti foam are included in the standard package 1 pO2 2 Temperature Pt100 3 Antifoam...

Page 28: ...cooler are located on the front of the basic unit at the bottom left They are marked with the corresponding symbols 1 Exit gas cooler water outlet 2 Exit gas cooler water inlet The water supply and re...

Page 29: ...ve can be fixed in the required position using a lock nut 3 2 Operating Panel The operating panel on the top right of the basic unit has a 7 TFT colour touch screen On the right hand side of the panel...

Page 30: ...6 Reagent bottle holder 7 Vessel holder 8 Top plate The illustration shows a culture vessel with a total volume of 1 5 L and a nominal width of 90 mm There are three vessel sizes availa ble each with...

Page 31: ...O ring 5 Damping ring spacer ring 6 Flange The top plate is attached to the vessel using four knurled screws and a flange The knurled screws also hold the vessel in place in the vessel holder An O ri...

Page 32: ...etc The number of ports in the top plate and its configuration de pends on the diameter nominal inner diameter of the culture vessel 3 3 3 Vessel Top Plate Nominal Width 90 1 12 mm Pg13 5 pH sensor 2...

Page 33: ...12 mm Pg13 5 Exit gas cooler 3 12 mm Pg13 5 Additional sensor 4 7 5 mm Addition port adaptors 4x 5 10 mm Sparger 6 12 mm Pg13 5 pO2 sensor 7 12 mm Pg13 5 Additional sensor 8 10 mm Temperature sensor P...

Page 34: ...Additional sensor 3 7 5 mm Addition port adaptors 4x 4 10 mm Sparger 5 10 mm Dip tube for sampling 6 12 mm Pg13 5 pH sensor 7 12 mm Pg13 5 pO2 sensor 8 10 mm Temperature sensor Pt100 9 Antifoam sensor...

Page 35: ...thermal block The temperature in the culture vessel is measured using a plati num resistor temperature sensor Pt100 The temperature is transmitted from the thermal block to the adapter and from the a...

Page 36: ...rrer The stirrer shaft is driven from above and turns anti clockwise left when viewing vessel from above 1 Drive hub 2 Stirrer shaft 3 Mechanical seal The stirrer shaft is sealed using a mechanical se...

Page 37: ...els with nominal widths 115 and 145 The motor is connected by pushing it onto the drive hub on the top plate 3 6 Gassing System The following gases can be used Air Oxygen O2 or nitrogen N2 The basic u...

Page 38: ...exit gas filter from becoming clogged with moisture At the same time it also prevents liquid loss in the culture medium INFORMATION If heavy foaming is expected a bottle of antifoam agent can be inst...

Page 39: ...Operation chapter Cali brating the pH Sensor INFORMATION If the pH sensor has already been calibrated before connection to the system the bioreactor will use this data and calibration on the operatin...

Page 40: ...the following applies Unlike measurements such as pH which are calibrated to absolute measurement values the oxygen measurement is always calibrated to a relative refer ence point For this purpose th...

Page 41: ...ent bottle that is connected to the antifoam sensor and the antifoam pump via a hose The sensor also acts as a dosing needle When the sensor comes in contact with foam the antifoam pump is activated a...

Page 42: ...at is integrated into the bioreactor basic unit Type ASD12 N with OPL05 optical path length for higher cell densities Manufacturer Optek Measures the absorption in the 0 4 CU range The ASD12 N sensors...

Page 43: ...contact with the media are made of electrolytically polished steel Main components 1 LED light source 2 Sapphire window 3 Optical path length OPL 4 Daylight filter 5 Silicon photodiode detector A defi...

Page 44: ...an O ring fit an O ring if necessary Mount the sensor by hand do not use any tools If the mounting depth of the sensor is adjustable mounting with electrode holder make sure the mounting depth is set...

Page 45: ...suring system automatically switches off if the temper ature of the sensor in the medium exceeds 50 C during opera tion thermal shutdown Once the medium has cooled down measurement automatically conti...

Page 46: ...0 25 INFORMATION Both sensor types are only suitable for use in aerobic bopro cesses For details on the safety technical data usage and maintenance requirements for the gas sensors see the separate do...

Page 47: ...ow on the gas sensor s flow adapter and fasten in place with the clamp 3 Push the open end of the hose onto the exit gas filter on the exit gas cooler INFORMATION Do NOT use a clamp here as the hose m...

Page 48: ...t 1 1 1 Addition port adaptor for 7 5 mm port 4 4 4 Clamping adapter for 10 mm port 3 3 3 Antifoam sensor for 10 mm port 1 1 1 Blanking plug for 12 mm Pg13 5 port 4 6 7 Blanking plug for 10 mm port 2...

Page 49: ...rectly into the medium via a ring sparger 6 mm The sparger is mounted in a 10 mm port in the vessel top plate using a clamping adaptor and connected to the gassing sys tem on the basic unit via a sili...

Page 50: ...ing Adaptors and Fastening Screws section Blanking plug 12 mm Must be fitted with an O ring before being mounted in the 12 mm Pg13 5 port Mounted using a thread 5 5 Clamping Adapters and Fastening Scr...

Page 51: ...ping adapter Fastening screw M5 The fastening screws are used to hold components in place in the 10 mm ports in the vessel top plate 5 6 Electrode Holder Electrode holders are used for mounting sensor...

Page 52: ...diameter 2 mm Hose connection outside diame ter 4 mm Installation depth 17 mm Addition port adapters protrude as far as the head space of the vessel and have very sharp ends with slanted points Each c...

Page 53: ...culture vessel after autoclaving Using a dip tube prevents foaming For adding inoculum For sampling The aseptic Super Safe Sampler system can be used for sampling For harvesting For siphoning off med...

Page 54: ...perature Sensor Pt100 The pocket is a pipe with a sealed bottom end and is used to in sert the temperature sensor Pocket 10 mm Fitted with fixed O ring A fastening screw is used to fasten it in the 10...

Page 55: ...The hose connections and the exit gas filter are secured with hose clamps The hose clamp securing the exit gas filter is equipped with a screw that can be used to loosen or tight it manually 1 Pressur...

Page 56: ...addition port adapter in the culture vessel and to a pump head 1 Filter 2 Silicone hose 2 x 6 mm 3 Cable tie INFORMATION 250 mL reagent bottles are supplied as standard in the unit package These fit...

Page 57: ...s connected via silicone hose with a dip tube Valve assembly 1 Sterile filter 2 Check valve 3 Luer activated sample valve 4 T piece 5 Hose The valve assembly consists of a T piece two check valves a L...

Page 58: ...line this sampling system can save culture volume which is particularly important with small vessels and or frequent sampling The dead volume of the culture remaining in the group of valves after flu...

Page 59: ...inge disinfect the sample valve Fort this spray a commercially available disinfectant onto the valve After spraying and after each sampling close the the sample valve with a sterile Luer Lock cap Dead...

Page 60: ...are placed in the two holders and the mount ing plate with the pump heads is simply pushed onto the pump holder The culture vessel can this be transported and autoclaved as a sin gle unit together wi...

Page 61: ...dry at all times and should thus ideally be replaced after each use 37 mm marked red Application Inlet air sparger 1 5 lit culture vessels Retention rate 0 2 m 50 mm Type ACro50 TF no label Usage Inl...

Page 62: ...n sparger for 3 0 and 6 0 L TV culture vessels Silicone hose 5 x 8 mm Gassing sparger Pressure hose trans parent 4 x 8 mm Water supply and return exit gas cooler Silicone hose transpar ent 2 x 6 mm Re...

Page 63: ...ring 120 x 105 Damping ring between glass vessel and vessel holder NW90 PTFE ring 145 x 130 Damping ring between glass vessel and vessel holder NW115 PTFE ring 175 x 160 Damping ring between glass ves...

Page 64: ...ntents list is included in each starter kit 5 21 Service Sets Service sets with O rings gaskets sterile filters hoses etc to fit each vessel size are available separately A detailed contents list is i...

Page 65: ...e The following points must be observed when transporting the equipment internally relocation Always work in pairs and use suitable auxiliary equipment when transporting the equipment The entire equip...

Page 66: ...d its components clean dry and pro tected against dust dirt and liquids Store the equipment and its components in a cool place with low air humidity but protected against frost Storage temperature 5 C...

Page 67: ...nges specified in the chapters Technical Data Connection Values and Technical Data Operating Conditions must be observed The equipment must only be installed inside a laboratory or a laboratory like e...

Page 68: ...wer supply 7 3 2 Water Supply and Return Connection conditions The in house water supply to the unit as well as the drainage of the water must meet the following requirements Very soft or soft water q...

Page 69: ...bar Gas es is are dry clean and free of oil and dust Recommended compressed air quality as per DIN ISO 8573 1 Class 1 2 3 4 ATTENTION The use of impure gases can lead to blockage of the sterile filter...

Page 70: ...he laboratory laboratory like facility is equipped with a sufficient ventilation system de pending on the application 7 4 Connecting the Motor Cable The motor is controlled directly via the basic unit...

Page 71: ...To avoid calcium deposits demineralised water is recommended for filling the vessel The following description of the test run does not detail handling of individual components e g exit gas cooler sti...

Page 72: ...to this end follow the symbols on the basic unit water inlet on bottom of exit gas cooler water outlet at top of exit gas cooler 7 Close all remaining open ports with blanking plugs 8 Hang the culture...

Page 73: ...t of the procedure allow the Batch to run with the tem perature switched on 7 5 3 Stirring Batch process is running with temperature switched on To test the stirrer proceed as follows Procedure 1 On t...

Page 74: ...m airflow depends on the size of the culture vessel and the correct setting in the Vessel Type menu 3 Ensure that all other gas parameters Gas2Flow TotalFlow GasMix are switched off If the gassing is...

Page 75: ...Bioreactor Installation and Initial Operation 07 February 2019 Page 73 of 214 When the motor has cooled down 5 Uncouple the motor from the vessel and place it on a clean and dry work surface 6 Empty...

Page 76: ...sel if necessary Preparing sensors and other accessories 8 1 Preparing and Autoclaving the Culture Vessel All accessories required for later cultivation must be prepared and mounted accordingly and au...

Page 77: ...ecessary reposition or replace If component parts are fitted into other component parts clamping adap tor there must also be an O ring between them INFORMATION Septum collars are sealed with a septum...

Page 78: ...late is described here This means that the vessel top plate is still removed During mounting ensure that the sparger or the dip tube does not come into contact with other component parts stirrer The s...

Page 79: ...ten the slotted head screw 8 1 4 Inserting the Vessel into the Vessel Holder To insert the glass vessel into the vessel holder proceed as fol lows Procedure 1 Place the flange onto the ring of the ves...

Page 80: ...Benchtop Bioreactor Before Cultivation Page 78 of 214 07 February 2019 3 Insert the vessel carefully 8 1 5 Inserting the Baffles Proceed as follows Procedure 1 Insert the baffles carefully into the gl...

Page 81: ...oss of volume and thus to increased salt concentration in the medium If nec essary top up with sterile water INFORMATION Development of steam is not possible when autoclaving an empty and dry culture...

Page 82: ...hich can result in failure of the equipment The screws may not be tightened with a tool under any circumstances This applies to all screw connections where the instructions specify that they must be t...

Page 83: ...nsert the O ring and blanking plug into all unused ports 2 Tighten by hand 3 Use the hexagon socket spanner to make it hand tight 8 1 9 Mounting Addition Port Adapters Proceed as follows Procedure 1 I...

Page 84: ...the chapter Mounting Addition Port Adapters 8 1 11 Mounting the Pocket for Temperature Sensor Pt100 Proceed as follows Procedure 1 Insert the pocket with the fixed O ring into the 10 mm port 2 Fix it...

Page 85: ...ep tum collar and screw it tight by hand If necessary use the hexagon socket spanner to make it hand tight 8 1 13 Preparing the Dip Tube Addition Port Adapter for Inoculation If later inoculation is t...

Page 86: ...her com ponent parts is impaired as little as possible 4 Check to ensure that the exit gas filter is fitted securely 5 Cap the exit gas filter loosely with a little aluminium foil INFORMATION A humidi...

Page 87: ...he operating panel before mount ing and autoclaving pO2 sensor Mount the pO2 sensor in such a way that it has good access to the flow and there is no risk of bubbles collecting Calibra tion is carried...

Page 88: ...ng panel is switched on automatically and the sys tem is started 3 Calibrate the pH sensor in accordance with the detailed de scription in the main chapter Operation chapter Calibrating the pH Sensor...

Page 89: ...of a sensor in a 12 mm Pg13 5 port for culture vessels with a nominal width of 115 an electrode holder must be used To do so proceed as follows Procedure 1 On the electrode holder lightly loosen the g...

Page 90: ...ad pointing in the downward direction 5 Fit the fork of the guide bar into the groove of the hollow screw 6 Push the hollow screw and the guide bar together upwards and insert the guide bar into the h...

Page 91: ...nting The antifoam sensor is equipped with transparent insulation that must be intact as otherwise a continuous signal Foam liquid detected may be generated The sensor head must not touch the clamping...

Page 92: ...lotted head screw at the clamping adaptor 5 Set the desired mounting depth of the sensor carefully 6 Tighten the slotted head screw carefully ATTENTION If the sensor is fixed too tightly in the clampi...

Page 93: ...l purposes of comprehen sion In order to prepare the Super Safe Sampler sampling system for autoclaving proceed as follows Procedure 1 Attach the hose of the valve group on the dip tube 2 Secure the h...

Page 94: ...21 Mounting the Sparger Hose and the Inlet Air Filter The sparger must be equipped with the hose and inlet air filter be fore autoclaving To do so proceed as follows Procedure 1 Cut a short piece of...

Page 95: ...2 Preparing the Reagent Bottles Pumps and Hoses 250 mL reagent bottles are supplied as standard in the equipment package These fit in the reagent bottle holder that is built into the vessel holder Bef...

Page 96: ...cone hoses must be selected to ensure that the hose connections between the reagent bottles pumps and culture vessel do not have any tensions or kinks 2 Thoroughly rinse the silicone hoses with distil...

Page 97: ...s not touch the bottom of the bot tle otherwise the hose may get sucked against the bot tom and no longer be able to pump liquid b the end of the hose is cut diagonally In this case the hose end can t...

Page 98: ...el 7 Ensure that each reagent bottle is connected with the appropriate pump according to its contents Base to base pump etc filters are clean and dry short hose line is open 8 Cap the filter loosely w...

Page 99: ...process started To this end the diameter of the hose used must be selected For details on the pumps and the setting options see the main chapter Operation the PUMPS parameter group chapter and the as...

Page 100: ...nto the opening of the drive hub 8 1 27 Checklist Before Autoclaving Check and ensure the following items before autoclaving Culture vessel All necessary O rings are fitted All unused ports are closed...

Page 101: ...to prevent them from slipping Hoses on the reagent bottles for sampling and the gassing system sparger are clamped off with hose clamps The exit gas hose is NOT clamped off The hoses are undamaged th...

Page 102: ...vessel to from the autoclave note the following Always transport the culture vessel in the vessel holder Always transport the culture vessel to from the autoclave in pairs and use suitable auxiliary e...

Page 103: ...in Place and Fit the Pump Heads Proceed as follows Procedure 1 Hang the vessel holder into place on the two hooks on the thermal block adapter 2 Pull off the mounting plate with the pump heads from th...

Page 104: ...l if possible For details on filling see the main chapter Operation chapter Parameter Group PUMPS 8 2 3 Connecting the Gassing To connect the sparger to the gassing proceed as follows Procedure 1 Remo...

Page 105: ...unit onto the upper connection nozzle on the exit gas cooler INFORMATION The exit gas cooler only works when the temperature control system is switched on Temperature ON parameter 8 2 5 Coupling the...

Page 106: ...e To do so proceed as follows Procedure 1 Sterilise the medium separately 2 If necessary pump off any water that remains in the culture vessel 3 Establish a sterile hose connection between the culture...

Page 107: ...is not in direct contact with the medium Procedure 1 Insert the sensor into the pocket in the vessel top plate as far as it will go 8 2 8 Connecting the Antifoam Sensor To connect the antifoam sensor...

Page 108: ...r To connect the pH sensor proceed as follows Procedure 1 Remove the red protective cap from the sensor cable 2 Place the connector of the sensor cable onto the sensor head and screw into place Ensure...

Page 109: ...O2 sen sor is calibrated either before the vessel is filled with medium or afterwards in the prepared medium For more details on the calibration refer to main chapter Opera tion chapter Calibrating th...

Page 110: ...bottles are present pump heads are mounted and the reagent hoses are filled Depending on the user specifications the pO2 sensor is already calibrated 9 1 Preparing the Medium Before the first samplin...

Page 111: ...the operating panel the sampling can be logged in the electronic logbook and assigned a sample ID For more details see main chapter Operation The method of sampling can vary due to the different analy...

Page 112: ...erile syringe and sterile closing caps For details see the main chapter Accessories chapter Sampling System Super Safe Sampler section Aseptic Sampling Proceed as follows Procedure 1 Check that all sc...

Page 113: ...ng hose can be filled with sterile air af ter taking a sample INFORMATION Only use a clean and dry syringe to avoid blocking the sterile fil ter This syringe can be reused as often as desired since ai...

Page 114: ...ample 9 3 Inoculation Check and ensure the following items before inoculation Medium has been filled Heat labile separately sterilised substances are present The reagent bottles are connected with the...

Page 115: ...rticularly suitable for all vessel sizes of the equipment 9 3 1 Inoculation with a Syringe Proceed as follows for the inoculation Procedure 1 Fill the syringe with the required amount of inoculum 2 Un...

Page 116: ...down via a sterile hose connection To do so proceed as follows Procedure 1 Make a sterile connection between the hose at the dip tube for harvest and the new vessel 2 Connect the hose to one of the pu...

Page 117: ...o the local regulations 9 6 Emptying the Reagent Hoses Before autoclaving the culture vessel with accessories all reagent hoses must be completely emptied using the corresponding pump This can either...

Page 118: ...r the user specific specifications and then clean them 9 8 Autoclaving the Culture Vessel After Cultivation After emptying the culture vessel and before cleaning the culture vessel must be autoclaved...

Page 119: ...all filters with aluminium foil ATTENTION Do not cover the pH and pO2 sensors with aluminium foil 5 Fit the cone plug into the opening of the drive hub ATTENTION Risk of loss of property du penetrati...

Page 120: ...displays 3 Main screen 4 Display of the Batch time since inoculation and possible alarms 5 Buttons for the selection of the parameter dis play and time stamp for sampling 6 Buttons with changing func...

Page 121: ...nnection to SCADA software Display for an active wireless connection Alarm display If alarms occur equipment alarm or parameter alarm they are signalled by a red exclamation mark highlighted in white...

Page 122: ...VESSEL TYPE menu for setting the vessel size Depending on the menu selected the CANCEL and OK but tons or only the OK button are available in the menu footer OK saves the changes and closes the menu...

Page 123: ...ed to show or hide parts of the menu and display The figure to the left shows the example of the menu with parame ter options which becomes visible after pressing the arrow button on the right hand ed...

Page 124: ...urrent parameter settings are simultaneously logged in a log file and re cording of the actual values begins INFORMATION Log files can be exported on a USB stick The button now changes function to INO...

Page 125: ...removed from the culture vessel by hand this can be signalled to the bioreactor by pressing SAMPLE NOW This logs the sampling and is visible in the log files for the batch For details see the USB Dat...

Page 126: ...h six are availa ble for the operator VESSEL TYPE Selection of the culture vessel used APPEARANCE Display settings including language and time NETWORK SETTINGS Network configuration eve COMMUNICATION...

Page 127: ...e available in the menu footer 10 2 1 VESSEL TYPE Selecting a Culture Vessel The culture vessel used is set in the VESSEL TYPE menu There are three culture vessel sizes ATTENTION With the selection of...

Page 128: ...display language The desired display language can be selected using the pull down menu The languages in the pull down menu are always displayed in English INFORMATION Additional languages can be down...

Page 129: ...ay of the info buttons for the on screen help for the vari ous parameters is switched on YES or off NO using the switch If the display is switched on the info buttons also appear in the main screen Af...

Page 130: ...e date and the time of the bioreactor cannot be set manually SET DATE AND TIME SET DATE AND TIME Manually enter the date and time Can only be done provided AC CEPT DATE AND TIME FROM OPC is not switch...

Page 131: ...igura tion with the DHCP protocol Please consult your network adminis trator IP ADDRESS Displays the allocated IP address during automatic configuration Auto DHCP or can be used to enter the IP addres...

Page 132: ...ss IP configuration under NETWORK SETTINGS This infor mation is required for configuration of the connection in eve equipment manufacturer s bioprocess platform software SERVER ACCESS Determine whethe...

Page 133: ...USB Stick In the USB menu a USB stick connected with the equipment s USB port can be used to import or export data EXPORT DATA TO USB Opens the menu for data export The selection menu in the left han...

Page 134: ...CSV format In combination with the initial state at batch start parameters json the current configuration can be determined at any time The columns of the CSV file are DateTime Absolute date and time...

Page 135: ...data import from a USB stick for the data im port of the parameter configuration This also contains the cas cades and the PID settings UPDATE FIRMWARE Carries out an update of the controller firmware...

Page 136: ...ation In the SYSTEM INFO menu the currently installed version of the firmware and the operating hours since start up are displayed 10 3 Parameter Parameter Groups On the main screen up to eight parame...

Page 137: ...d Turbidity if avail able EXIT GAS Contains the Exit GasO2 and Exit GasCO2 param eters provided the exit gas analysis option is available PUMPS Contains the Pump1 to Pump4 parameters and also offers t...

Page 138: ...ters Operation is described in the Calibration section Editing opens the editor menu with the various settings for the selected pa rameter Not all parameters have an editor menu Amongst other options...

Page 139: ...tarted using START BATCH and the correspond ing parameter has been activated using ON OFF After pressing the input field in the SETPOINT column of the de sired parameter the key pad appears for typing...

Page 140: ...arms If a parameter is activated and the Batch inoculated parameter alarms are generated after a predefined waiting time if there are unexpected deviations from the actual values and setpoints Alarm g...

Page 141: ...A red exclamation mark highlighted in white on a red back ground appears in the footer Pressing the symbol or swiping upwards opens the Equipment Alarm menu For details see the Alarms Equipment Alarm...

Page 142: ...below the prescribed setpoint the Gasmix is in creased by the controller until the desired setpoint is reached for the pO2 The cascades can be configured using the editor menu of the pa rameter The p...

Page 143: ...Temperature Measures and controls the temperature in the culture vessel 10 4 2 Stirrer Measures and controls the speed of the stirrer Rotation speed de pends on factors such as the size of the motor v...

Page 144: ...ttings for the cascade are carried out in the editor menu of the parameter At the CASCADE menu item the pull down menu is used to call up the list of pre defined cascades for pH control The following...

Page 145: ...For this purpose the calibration is set to 100 relative oxygen saturation usually with air at max stirring speed and maximum gas flow rate The actual concentration of dissolved oxygen in mmol L 1 may...

Page 146: ...ing GasMix Serial cascades Stirrer TotalFlow pO2 is first controlled by Stirrer and after reaching its maximum it is controlled by TotalFlow Stirrer Gasmix pO2 is first controlled by Stirrer and after...

Page 147: ...ssociated subchapters If necessary the value ranges used for the cascaded parameter s can be adjusted here In the example below the cascaded parameter Stirrer is selected for this purpose in the visua...

Page 148: ...mposition or the gas composition to be kept constant in the event of a changing volume flow The measurement value is displayed in L min 1 The sum of the volume flows TotalFlow is often used in a casca...

Page 149: ...ion entry is confirmed using OK The gas composition Gasmix is often used in a cascade for pO2 control Cascades for pO2 control can be configured in the editor menu of the pO2 parameters 10 4 7 Foam In...

Page 150: ...on of anti foaming agent to reduce foam before more antifoaming agent is added ALARM TIME Time in seconds after which a parameter alarm is triggered if foam is still detected despite the addition of a...

Page 151: ...ment 10 5 2 Balance Optional Measures a weight e g a bottle with feed solution Can be coupled with Pump4 feed to carry out gravimetric feeding See the Pump4 feed solution section for details The balan...

Page 152: ...low can only be controlled individually when TotalFlow and Gasmix are deactivated 10 5 4 Gas2Flow Measures and controls the flow rate of the optional second gas into the culture vessel using a mass fl...

Page 153: ...al exit gas analysis Details on technical data usage and maintenance requirements for the gas sensors can be found in separate documentation provided by the manufacturer ATTENTION Risk of damage to th...

Page 154: ...parameter group the delivery rate of the pumps can be set or monitored and the function mode of the pumps can be configured In addition the pump hoses can be manually filled or emptied by pressing an...

Page 155: ...e Foam parameter Pump 4 FEED Addition of feed solution analogue with vari able speed controlled by the user The figure below shows the pumps with the factory configuration In digital operation pumping...

Page 156: ...tor menu of Pump 1 as an ex ample TUBE TYPE Select the pump hose used The following pump hoses are available 0 5 mm 1 0 mm stand ard or 2 5 mm On the basis of the selected hose diameter the pumped vol...

Page 157: ...stimated on the basis of the hose diameter selected under TUBE TYPE If a balance Balance is connected and linked with Pump4 g measured pumped weight is also available at Pump4 RESET COUNT Here the tot...

Page 158: ...ntries in the editor menu of the pH parameter 10 7 4 Pump3 Antifoam Level or Additional Feed Solution Pump3 can be configured for the AntiFoam function mode factory setting Level or Feed AntiFoam The...

Page 159: ...alance Feed Feed Pump operation is analogue and is used for the addi tion of feed solution Balance Feed Pump operation is analogue and is used for the addition of feed solution The delivery rate is co...

Page 160: ...he sub menu for automatic filling and emptying of the pump hoses is opened For each pump an individual filling duration FILLING DURATION as well as an individual emptying duration EMPTYING DURA TION c...

Page 161: ...required or a 1 point calibration and a zero point adjustment is sufficient The various calibrations are described in the following sections 10 8 1 Calibrating the pH Sensor General Information In gen...

Page 162: ...o calibrate the pH sensor at the operating panel Procedure 1 Connect the sensor cable For details see the Before Cultiva tion section and the Connecting the pH Sensor sub section 2 Carefully remove th...

Page 163: ...produced by the firmware of the sensor manufacturer that is integrated in the sensor 4 Select 2 point calibration The menu display changes and displays the following Left hand side First Calibration...

Page 164: ...of the desired reference value INFORMATION The pH sensors are calibrated with the following standard set tings ex works Buffer pH 4 calibration point 1 buffer pH 7 cali bration point 2 at room tempera...

Page 165: ...ted the cur rent pH measured value appears and CALIBRATE POINT 1 is activated i e the button turns orange 7 Press CALIBRATE POINT 1 to begin calibration CONFIRM NOW creates a visual representation of...

Page 166: ...en the desired reference value has been selected the cur rent pH measured value appears and CALIBRATE POINT 2 is activated i e the button turns orange 11 Press CALIBRATE POINT 2 to begin calibration C...

Page 167: ...only effective if the externally measured and entered pH value does not deviate from the original pH value by more than 2 pH units Proceed as follows for a product calibration Procedure 1 Call up the...

Page 168: ...firm Sample was taken at Display of date and time of the sampling 2 Measure the pH of the sample and enter the value Measure the pH of the sample and enter the value 3 Start the calibration Start the...

Page 169: ...tion OR b Confirm the sampling generate a time stamp leave the calibration menu and carry out the product calibration with an external measured value at a later time Variant a Procedure 1 Press CONFIR...

Page 170: ...bora tory measurement of the pH value for the sample at a later time of your choosing In the calibration menu Sample Taken is displayed under PRODUCT CALIBRATION to show that sampling was carried out...

Page 171: ...er the following conditions in medium at operating temperature at the maximum expected stirrer speed at the maximum expected gas flow rate for air or the oxygen containing gas ses provided for the cul...

Page 172: ...connec tion In the process leave the gas supply closed INFORMATION If necessary enter setpoints for temperature and pH activate parameters and press START BATCH and wait until the desired operating te...

Page 173: ...bration 1 POINT CALIBRATION Select 1 point calibration 2 POINT CALIBRATION Select 2 point calibration SHOW SENSOR STATUS Shows data and values produced by the firmware of the sensor manufacturer integ...

Page 174: ...the reference value of the first calibration point 2 Optionally set setpoints for XX pO2 If necessary enter the setpoint for XX pO2 corresponding gassing and stirrer are activated by this 3 Evaluate...

Page 175: ...play CALIBRATE POINT1 Start the calibration procedure for the 1st calibration point CONFIRM NOW Confirm the calibration and continue with the 2nd calibration point 4 Slowly open the nitrogen supply 5...

Page 176: ...n has been displaced from the medium i e wait until the measured value display via CALIBRATE POINT 1 is stable 9 Press CALIBRATE POINT 1 to begin calibration Gassing and the stirrer are stopped CONFIR...

Page 177: ...not calibrated one after the other in 1 point calibration mode is activated i e the but ton turns orange INFORMATION This facilitates a calibration of the sensor outside of the medium i e without acti...

Page 178: ...Turbidity Sensor General Information Optek turbidity sensors optional are pre calibrated in the factory Inserts are available for reference measurement Due to the different light absorption of differ...

Page 179: ...il measurement is stable Wait until the measured value is stable 2 Perform zero point calibration Carry out zero point calibra tion 3 Wait until the measured value is stable display via CALI BRATE 4 P...

Page 180: ...actor is 0 05 D differential quotient derivative of the error set in seconds mostly to 0 Be aware of the following relating to the individual factors Proportional factor The change of the proportional...

Page 181: ...as it exceeds the time minimum for which the control is required This causes fluctu ations in the control circuit Example of calculation of the integral factor The cycle duration of system oscillatio...

Page 182: ...band If a dead band is entered no control is implemented within this value at either side of the setpoint value symmetrically I e the con troller output is 0 The dead band is used for pH control I Lim...

Page 183: ...menu of the corresponding parameter and therefore described there 10 10 Alarms Equipment Alarm Menu There are two types of alarm that appear in the Equipment Alarm menu Parameter alarms Display of de...

Page 184: ...quip ment Alarm menu DESCRIPTION Display of the type of alarm STATE Status display of the alarm open or resolved Open alarms are displayed in red and with the word Open Resolved alarms are displayed i...

Page 185: ...washing agent for industry and lab use Cleaning agent for dena turation of proteins e g exit gas cooler 0 1 N NaOH Cleaning agent for smaller component parts e g exit gas cooler dip tube Ultrasonic ba...

Page 186: ...e vessel top plate ports and place them to the side for separate cleaning according to the manu facturer guidelines 2 Completely fill the culture vessel with 0 1 N NaOH 3 Fit the top plate on the vess...

Page 187: ...essel top plate port by hand Ensure that the O ring does not get lost 2 Gently release the hose clamp with the hand wheel pull off the exit gas filter and dispose of it 3 Remove the pressure hose piec...

Page 188: ...avoid damage never dismantle the pump heads Always re place a damaged pump head along with the pump hose and vice versa Proceed as follows Procedure 1 Remove cable ties e g with a side cutter so that...

Page 189: ...cedure 1 Loosen the blanking plug with a hexagon socket spanner in the septum collar and remove it by hand Ensure that the O ring does not get lost 2 Unscrew the septum collar out of the port by hand...

Page 190: ...remove the stirrer shaft 5 Check the glass vessel for damage cracks fissures scratches and replace if necessary 11 3 8 Removing the Sparger and the Dip Tube s Straight spargers and dip tubes can be re...

Page 191: ...11 4 Cleaning and Storing Individual Parts The procedure described here applies to the following individual parts Vessel Accessories such as blanking plugs spargers dip tubes addi tion port adapters...

Page 192: ...cannot be physically dam aged e g by falling or prepare them for the next cultivation 11 5 Cleaning the Sensors Apart from antifoam and level sensor all sensors are cleaned and maintained according to...

Page 193: ...m When using a soap solution 3 Then rinse the sampling system thoroughly with water INFORMATION If the test record requires that the culture is killed off after culti vation by autoclaving the culture...

Page 194: ...a damp cloth Clean with an appropriate disinfectant as necessary 4 Clean the screen with a wipe suitable for computer or laptop screens 11 10 Maintenance Plan WARNING Non compliance of this maintenanc...

Page 195: ...To be carried out by qualified personnel Interval Maintenance work Every 6 months Check and calibrate measuring sections temperature pH etc with a sim ulator 11 11 Decalcifying the Equipment Calcifica...

Page 196: ...ier 4 Connect the chiller or water bath to the water inlet and outlet on the basic unit using hoses 5 To open the corresponding valves in the basic unit set the temperature on the operating panel to 5...

Page 197: ...wn Check the fuses of the mains connection and the basic unit Qualified elec trician Power connection interrupted Check the plug and cable at the basic unit and mains socket Check mains cable for dama...

Page 198: ...is activated and set to oxygen control via the stirrer cascade Switch cascade off and test operation via the Stirrer parameter Operator Interference Motor control is volatile irregular or stops Possi...

Page 199: ...cause Remedy By The on site gas supply has been in terrupted Stop the Batch process Check the on site gas supply and switch it on if nec essary Operator The AirFlow and or Gas2Flow pa rameter s is are...

Page 200: ...Check the water supply to the exit gas cooler re store it if necessary The exit gas cooler or basic unit is calcified Decal cify the equipment if necessary Operator The exit gas cooler does not cool T...

Page 201: ...d the vessel Connect properly if necessary Remove clamps if necessary Operator Pump base acid does not operate properly Check the pump acid base functionality on the op erating panel Operator Pump hos...

Page 202: ...e No pO2 control Possible cause Remedy Remedied by The pO2 parameter and or cascaded parameter is are not activated Activate parameters Operator The cascade settings are incorrect Check the cascade se...

Page 203: ...By The Foam parameter is not acti vated Activate the Foam parameter Operator Pump 3 antifoam is not switched on Switch on pump 3 antifoam Operator Remedy No antifoam agent or medium supply or inadequ...

Page 204: ...ck the function of the feed pump on the operat ing panel Operator The pump hose is damaged Replace pump head Operator Pump head does not rotate Defec tive pump head Replace pump head Operator Incorrec...

Page 205: ...to disassembly Switch off the equipment and lock any isolation switch in the off position Physically disconnect the main energy supply from the equip ment and wait for components to fully discharge R...

Page 206: ...firms For disposal the system units are to be disassembled and disman tled into individual material groups These materials are to be dis posed of according to the applicable national and local legisla...

Page 207: ...rs 2 Benchtop Bioreactor Technical Data 07 February 2019 Page 205 of 214 14 Technical Data 14 1 Equipment Dimensions 565 400 631 740 NW115 145 691 NW 90 418 375 Dimensions in mm 400 455 Front view Top...

Page 208: ...2 Benchtop Bioreactor Technical Data Page 206 of 214 07 February 2019 14 2 Dimensions of Culture Vessel The two dimension drawings show a fully equipped culture vessel ready for autoclaving Dimension...

Page 209: ...1 Electrical Description Value Unit Voltage 120 230 VAC Frequency range 50 60 Hz Max Current 8 A Max power consumption 1 800 W 1 During heating phase vessel with max 4 L working volume at max rotatio...

Page 210: ...cifications 14 5 1 Operating Panel Description Value HMI 7 colour touch screen Operating system Embedded Linux OPC server OPC UA Splash and dust pro tection IP 22 14 5 2 Culture Vessels Vessel Descrip...

Page 211: ...Borosilicate glass Top plate Stainless steel AISI 316L electrolyti cally polished Components Stainless steel AISI 316L electrolyti cally polished Impellers At NW 90 PEEK At NW115 and 145 Stainless ste...

Page 212: ...nd NW 115 Vessel size NW 90 2 Rushton impellers with 6 blades Stainless steel 316L electrolytically polished PEEK Vessel A B C 6 l TV NW 145 54 mm 11 mm 11 mm 3 0 l TV NW 115 46 mm 11 mm 11 mm 1 5 L T...

Page 213: ...led even for gassing using air only Vessel Control range of gas flow l min 1 TV 2 Max AV 3 1 5 L 1 0 L 0 05 to 2 3 0 L 2 0 L 0 05 to 4 6 0 L 4 0 L 0 05 to 8 2 Total volume 3 Working volume 14 5 6 pH C...

Page 214: ...pO2 sensor with built in opto electronics Type Visiferm DO ARC Manufacturer HAMILTON Measuring range 0 05 300 air saturation INFORMATION The pO2 sensors are preconfigured by unit manufacturer IN FORS...

Page 215: ...p 4 FEED analogue BALANCED ana logue Hoses Standard Option 1 Option 2 Inside diameter 1 0 mm 0 5 mm 2 5 mm Delivery rate 1 3 5 ml min 1 1 1 ml min 1 16 1 ml min 1 Material PharMed BPT 1 Typical figure...

Page 216: ...Minifors 2 Benchtop Bioreactor Technical Data Page 214 of 214 07 February 2019 14 8 Auxiliary Supplies pH buffers Intended use pH 4 0 pH 7 0 For calibrating the pH sensor...

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