ez control for in situ sterilizable bioreactors · 3.3 alarm limits ... 5.2.1 full sterilization...

ez-Control for

In Situ sterilizable Bioreactors

SOFTWARE REFERENCE MANUAL

Software version 1.8X

Document Version 1.0


CONTENTS ez-Control for In Situ sterilizable Bioreactors Software Version 1.8X, Document Version 1.0

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TABLE OF CONTENTS 1 GENERAL ................................................................................................................................................ 4

1.1 Introduction ...................................................................................................................................... 4 1.2 Example of an In Situ Sterilizable Bioreactor System ..................................................................... 4 1.3 Home Screen .................................................................................................................................... 5 1.4 Icons ................................................................................................................................................. 7 1.5 Keypad and Keyboard ...................................................................................................................... 8 1.6 Bar Graph and Trend View Screens ................................................................................................. 9 1.7 Set-Points ....................................................................................................................................... 10 1.8 Configurable Outputs ..................................................................................................................... 11 1.9 Related Manuals ............................................................................................................................. 11

2 AUTHORIZATION ................................................................................................................................ 12 2.1 Login Levels .................................................................................................................................. 12 2.2 Login Procedure ............................................................................................................................. 12 2.3 Changing a Password ..................................................................................................................... 13

3 PROCESS PARAMETERS .................................................................................................................... 14 3.1 Example of the List of pH Settings (Controller Off) ..................................................................... 15 3.2 Start / Stop Individual Controller ................................................................................................... 15 3.3 Alarm Limits .................................................................................................................................. 16 3.4 Show Controller Output ................................................................................................................. 16 3.5 Calibrate Sensors ............................................................................................................................ 16

3.5.1 Pressure Calibration ......................................................................................................... 17 3.5.2 pH Calibration .................................................................................................................. 17 3.5.3 Temperature Calibration ................................................................................................... 18 3.5.4 DO Calibration ................................................................................................................. 19

3.6 Manual Control .............................................................................................................................. 23 3.6.1 Force Actuator On / Off ................................................................................................... 23 3.6.2 Actuator Activity Range ................................................................................................... 23

3.7 Dose Monitor ................................................................................................................................. 24 3.8 Controller Setup ............................................................................................................................. 24 3.9 Set-point ......................................................................................................................................... 25 3.10 Cascade Speed Limits (stirrer speed only) ..................................................................................... 25 3.11 PID Settings SIP ............................................................................................................................. 25 3.12 Additional Foam / Level Controller Settings ................................................................................. 25 3.13 Synoptic Screen (all controllers started) ........................................................................................ 26

4 MENU OPTIONS ................................................................................................................................... 27 4.1 Control Options .............................................................................................................................. 28

4.1.1 Manual Control................................................................................................................. 28 4.1.2 Tubing Pump Control ....................................................................................................... 29 4.1.3 Start / Stop All Controllers ............................................................................................... 29 4.1.4 Sterilization ...................................................................................................................... 29

4.2 View Options ................................................................................................................................. 30 4.2.1 Show Bar Graph Screen ................................................................................................... 30 4.2.2 Output Value Monitor ...................................................................................................... 30 4.2.3 Alarm Overview ............................................................................................................... 30 4.2.4 Dose Monitor .................................................................................................................... 31

4.3 System Configuration..................................................................................................................... 34 4.3.1 Configuration Options ...................................................................................................... 34 4.3.2 Bioreactor Customization ................................................................................................. 39


ez-Control for In Situ sterilizable Bioreactors CONTENTS Software Version 1.8X, Document Version 1.0

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4.3.3 Extended I/O..................................................................................................................... 40 4.3.4 Status Bar ......................................................................................................................... 40 4.3.5 Input (Sensor) and Output (Actuator) Names .................................................................. 41 4.3.6 File Handling .................................................................................................................... 42 4.3.7 Utilities ............................................................................................................................. 47

5 STERILIZATION ................................................................................................................................... 50 5.1 Preparation ..................................................................................................................................... 50 5.2 Configure Sterilization ................................................................................................................... 50

5.2.1 Full Sterilization Parameters ............................................................................................ 51 5.2.2 Empty Sterilization Parameters ........................................................................................ 51 5.2.3 Sterilization Outputs ......................................................................................................... 52 5.2.4 Actuator Activity Matrix during the Sterilization Routine ............................................... 54

5.3 Phases in the Sterilization Routine ................................................................................................. 57 5.3.1 Start .................................................................................................................................. 58 5.3.2 Initialization...................................................................................................................... 58 5.3.3 Pressure Hold Test............................................................................................................ 58 5.3.4 Phase 1 .............................................................................................................................. 59 5.3.5 Preheating ......................................................................................................................... 59 5.3.6 Phase 2 .............................................................................................................................. 59 5.3.7 Sterilization ...................................................................................................................... 60 5.3.8 Natural Cooling ................................................................................................................ 60 5.3.9 Cooling 2 .......................................................................................................................... 61 5.3.10 Cooling 3 .......................................................................................................................... 61 5.3.11 End ................................................................................................................................... 61

5.4 Manual Control .............................................................................................................................. 62 6 REMOTE ACCESS ................................................................................................................................. 63

6.1 Setting on the PC ............................................................................................................................ 63 6.2 Starting the Security Certification .................................................................................................. 64 6.3 Starting the Remote Access login procedure ................................................................................. 66 6.4 Changing the Remote access level ................................................................................................. 68 6.5 Logging off .................................................................................................................................... 68

7 SYSTEM WARNINGS ........................................................................................................................... 69 7.1 Power Failure During Operation .................................................................................................... 69 7.2 Emergency Stop During Operation ................................................................................................ 70


GENERAL ez-Control for In Situ sterilizable Bioreactors Software Version 1.8X, Document Version 1.0

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1 GENERAL 1.1 INTRODUCTION The Applikon In Situ sterilizable Bioreactor Systems basically consist of the following parts: • An In Situ sterilizable Bioreactor with the appropriate auxiliaries, like a stirrer assembly, baffles, sensors,

an aeration assembly, etc. • A wet part for temperature control and steam sterilization. • An ez-Control for measurement and control of process variables (pH, temperature, DO, level, pressure,

and stirrer speed) with corresponding controller outputs in order to keep process conditions on set-point. The ez-Control combines and supports actuators like pumps and valves in order to optimize the use of limited bench space.

1.2 EXAMPLE OF AN IN SITU STERILIZABLE BIOREACTOR SYSTEM Below the ez-Control is shown in combination with an In Situ sterilizable 30L bioreactor.

Depending on the type / size of the reactor, the stirrer speed controller may be installed in an additional Power Box. Refer to the Hardware Manual.


ez-Control for In Situ sterilizable Bioreactors GENERAL Software Version 1.8X, Document Version 1.0

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Pumps Set-points

Gas Actuators

Process Value Buttons Parameter Buttons

Temperature Actuators

Login Level

Application / Project Name

Scroll Button

Illumination Button

Upper Alarm Limit

Menu Button

Controller Output

Lower Alarm Limit

Actual Value

Lower Range Value

Upper Range Value

Set-Point

1.3 HOME SCREEN After switching on the power of the ez-Control, it presents itself (after initialization) on the touch screen display with its Home Screen.This will be either the Synoptic Screen or the Bar Graph Screen. The Synoptic Screen shows the actuator activity and measured sensor values (on Process Value buttons). To view an additional Process parameter (like Pressure for Steam-In-Place applications) in this and other screens, repeatedly press the Scroll button (which is present in the Synoptic Screen only). The Bar Graph screen shows Set-points, Alarm Limits, and actual measured values.



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Control loop The combination of a bar, a Process Value button and a Parameter button represent a single control loop. Depending on the parameter value and the status of the control loop, the buttons and bars have different colours.

*) If a control loop has no actuator allocated to it, its deviation alarms will be shown on a red background. Control buttons Functional (control) buttons are presented as rectangles with rounded corners. Process information Rectangles with straight corners represent process information (not a button) or a button without access. Colours of buttons Depending on the status of the ez-Control, the specific control loop and the actual screen and on the login level, the Parameter buttons and other functional (control) buttons have different colours.

Project name The Project Name / Application Name can be edited after pressing the top-left button of any screen: the alphanumeric keyboard that is presented, is discussed in Section 1.5. At least Operator authorization is required (see Chapter 2).

Colour of Process Value button / Bar Control loop Deviation alarm

Grey Off No alarm

Green On No alarm

Yellow Off *) Alarm

Red On Alarm

Colour of Control / Parameter button Remark

Blue Parameter button or selection button

White The Home button

Brown Option is selected / Device is active

Dark Grey Indicates the path from Home screen to the current screen

Grey Passive button



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1.4 ICONS The various buttons and screens show various icons, depending on the actual screen and the control loop status.

ICON DESCRIPTION

Home: returns to the Home screen (Synoptic or Bar Graph)

Trend: opens the Trend View screen of the corresponding parameter

Trend: opens the percentage-oriented Trend View screen

Synoptic: opens the Synoptic screen

Set-point

High Alarm Limit

Low Alarm Limit

Upper Range Value

Lower Range Value

Applikon logo: enables changing the Project name / Application name

Login (Access Control)

Logout (returns to the View level)

Upper Limit of the Actuator action < 100 % (default = 100 %)

Low Limit of the Actuator action > 0 % (default = 0 %)

Low Limit of the Actuator action > 0 % and Upper Limit of the Actuator action < 100 %

Actuator has a Timer function with defined On and Off times

Illumination: switches on the lamp in the reactor for a predefined period



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1.5 KEYPAD AND KEYBOARD The ez-Control presents a numeric keypad when data like Set-points and parameter values must be edited. Follow the instructions shown above the edit field. The current value of the parameter is shown in a blue edit field. During editing, this field has a white background. The minimum and maximum values for the specific parameter are shown to the right of the edit field. Notice the current raw value of the parameter as shown near the Cancel button. Press the ENTER button in order to confirm the new parameter value. The <=BS button means Back-Space. The +/- , . , ENTER and EXP buttons are only active when their functions are valid. The +/- button is a toggle. For entering texts (like a password), an alphanumeric keyboard is used.

Password recognition in the ez-Control is case-sensitive!



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Upper Range Value

Lower Range Value

ParameterButtons

Actual Value

Upper Alarm Limit

Set-Point Value

Process Value

Buttons

Lower Alarm Limit

Menu Button

1.6 BAR GRAPH AND TREND VIEW SCREENS The Bar Graph screen is an overview of the various parameters of the ez-Control. Each Set-point value that is shown on a blue Set-point Value button can be edited (see Section 1.7). The Bar Graph screen gives access to the Parameter Settings screen of a parameter via the corresponding blue Parameter button (see Chapter 3). The Process Value button toggles between the Trend View screen(s) of the specific parameter and the Home screen. Example of a Temperature Trend View screen (press the Temperature Process Value button):



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Set-point Values

The Trend View screen shows the following information as a function of time: • Two red lines represent the alarm limits. • A black line shows the measured process value. • A blue line represents the Set-point value (only presented for the time periods when the control loop has

been active). Only values between the current Range Values will be visible. In the Trend View screen you can: • Press on the Lower Range Value or Upper Range Value button, and use the numeric keypad to set a

new view range value. • Press the Hour Scale button and select a time scale: this time scale applies to all Trend View screens. • Press the Home button to return to the Home screen.

The alarm limits are defined as part of the control loop settings: press the blue parameter button and select the Alarm limits option. The parameter Level has no Trend View screen (therefore, pressing its Process Value button returns to the Home screen). The Stirrer parameter has two subsequent Trend View screens: one for the output power (in %) and one for the stirrer speed (in rpm).

1.7 SET-POINTS Changing Set-points requires at least Operator authorization (see Chapter 2). Each Set-point value that is shown on a blue Set-point Value button in the Bar Graph screen or Synoptic screen can be edited after pressing that button: the numeric keypad will pop up. The Set-point values can also be changed after pressing the parameter button to display the parameter Setting screen and then pressing the button Set point (see Section 3.10). In case stirrer speed control is configured in a cascade as part of the DO (dissolved oxygen) control loop, the stirrer speed Set-point will not be shown (example above).



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1.8 CONFIGURABLE OUTPUTS The default assignment of actuators to control loops can be edited. This means that the available actuators can be re-assigned according to specific demands. The actuators can be renamed to the current assignment. The lay-out of the parameter status bar can be edited according to specific demands. The free assignment of actuators (controller outputs), renaming actuators and redefining the parameter status bar is described in section 4.3 (System Configuration) of this manual!

1.9 RELATED MANUALS • ez-Control Hardware Manual for In Situ sterilizable Bioreactors, • ez-Control Operator Manual for In Situ sterilizable Bioreactors, • ez-Control PID Control Manual for In Situ sterilizable Bioreactors, • ez-Control Additional Sensor and I/O Hardware Manual.


AUTHORIZATION ez-Control for In Situ sterilizable Bioreactors Software Version 1.8X, Document Version 1.0

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2 AUTHORIZATION 2.1 LOGIN LEVELS The ez-Control has four authorization (login) levels: • View level (initial level; no password required) • Operator level (operator password required) • System engineer level (system engineer password required) • Service engineer level (service password required; for Applikon service engineers only!)

After logging in as Operator or System engineer, the ez-Control will automatically return to the View level after a predefined period of time without any operation at the touch screen display. This interval is initially set to 15 minutes but can be adjusted (see Section 4.3.7.2).

2.2 LOGIN PROCEDURE 1. Press the button at the top of the

screen. The list with the various login levels is presented.

2. Press the button or the button to login. The button is used by the Applikon

service engineer. 3. Press one of the buttons or

(see Section 2.3). 4. Use the alphanumeric keyboard to enter the

corresponding password(s).

The password verification of the ez-Control is case-sensitive! The default password for the Operator and System engineer levels is: 0000

The table on next page lists the login levels that are required for the various functions of the ez-Control.

Login Button


ez-Control for In Situ sterilizable Bioreactors AUTHORIZATION Software Version 1.8X, Document Version 1.0

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FUNCTION VIEW OPERATOR SYSTEM ENGINEER

Login (access control) X X X View Device Information X X X View Trends X X X Edit Time Scale of Trend Views X X X Edit Range Values of Trend Views X X X View Output Value Monitor X X X Sensor Calibration - X X Edit Set-points - X X Edit Alarm Limits - X X Manual Control Actuators - X X Dose Monitor Calibration - X X Reset Dose Monitor Values - X X Start / Stop Controllers - X X Controller Output Limits / Timer Function - X X Level Control Timing - X X Tubing Pump Control - X X Edit Project Name - X X Execute Sterilization Routine - X X Enable Remote access - X X Change password and Logout time Remote Access - - X Edit Sterilization Parameters - - X Edit Controller Settings - - X Edit Actuator Configuration and Name - - X Edit Communication Settings - - X Enable 2-point DO Calibration - - X Export / Import Configuration and Process Value Files - - X Restart Controllers after Power Failure - - X Restart Controllers after Emergency Stop - - X

2.3 CHANGING A PASSWORD To change a password, the following steps must be performed: 1. Log in as either Operator or System engineer.

2. In the Operator screen or System engineer screen, press the button. 3. Type the current password of the current login level. 4. Type the new password. 5. Type the new password again for verification purposes.

The new password for this login level is now active.


PROCESS PARAMETERS ez-Control for In Situ sterilizable Bioreactors Software Version 1.8X, Document Version 1.0

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Process Parameter Buttons

3 PROCESS PARAMETERS The Process Parameter buttons are always shown at the bottom of each screen. The table below shows the options that are presented when the Parameter button of a specific control loop is pressed.

Controller Pressure Level pH Temperature DO Stirrer

Start / stop controller X X X X X X Alarm limits X X X X X Show controller output X X X X X Calibrate sensor X X X X Manual control X X X X X Dose monitor X X X Controller setup X X X X Set-point X X X X X Pump timing X Display pump activation X Sensitivity Foam X*) Cascade Speed Limits X**) PID settings SIP X

*) Only when a Foam sensor is configured (selection between low and high sensitivity). In case a Level

sensor is configured, this calibration option is not available (sensitivity is low); See section 3.13. **) Only available when the stirrer is included in the DO cascade . When no actuator for a control loop is configured, only the sensor options (calibration, alarm limits) are available in the parameter menu.


ez-Control for In Situ sterilizable Bioreactors PROCESS PARAMETERS Software Version 1.8X, Document Version 1.0

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3.1 EXAMPLE OF THE LIST OF PH SETTINGS (CONTROLLER OFF) In this example, the grey colour of the pH Process Value button shows that the pH controller is not running. In this state, the button Manual control is enabled (blue). The option Show controller output has been switched on, as can be seen from the brown colour of the corresponding button. As a result, the current actuator output value (%) is presented above the pH bar graph in the Bar Graph screen. Most of the controller settings that are discussed in the following paragraphs are available in the settings screens of the other controllers too. The top of each screen shows the path to the current screen. Press one of these white / dark grey buttons to return to a previous screen.

3.2 START / STOP INDIVIDUAL CONTROLLER This button, as part of the control settings, is used start or stop the currently selected controller.

In case the stirrer speed controller is configured as actuator in DO control, the status of the stirrer speed controller is given in the table below:

DO Controller is Off DO Controller is On

Stirrer speed controller acts as stand alone controller (manual set-point) Stirrer speed controller is slave of the DO controller

In case DO control is switched-off (as individual controller), the stirrer speed controller becomes independent again!



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3.3 ALARM LIMITS This setting is available for: • Pressure • pH • Temperature • DO • Stirrer speed For editing the alarm limits of a process parameter, at least Operator authorisation is required. Press the Upper alarm limit button or Lower alarm limit button in order to edit the corresponding value, using the numeric keypad. The new upper alarm limit must have a value between the Set-point and the upper range value. The new lower alarm limit must have a value between the lower range value and the Set-point.

If you set an alarm limit outside the current view range, the range is automatically enlarged. For example, if the low range value =3 and you set the lower alarm limit to 2, the low range value will automatically be lowered into 1.

3.4 SHOW CONTROLLER OUTPUT This option can be enabled or disabled for each individual control loop: In case the option is enabled, the actual controller output is presented at the top of the bar graph

( ). The arrow with the green background represents the active actuator.

3.5 CALIBRATE SENSORS A sensor can only be calibrated when the corresponding controller is switched off. This option is available for the sensors: • Pressure • pH • Temperature • DO In case of a Foam sensor, its sensitivity can be selected (High Sensitivity or Low Sensitivity); see Section 3.12. A Level sensor has no sensitivity selection!



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3.5.1 PRESSURE CALIBRATION Like the temperature sensor, the pressure sensor has a predefined sensitivity. Sensor output Sensitivity 4 mA –1 barg (vacuum 8 mA 0 barg (environment pressure) 20 mA 3 barg

If a pressure sensor needs to be calibrated: 1. Press the Pressure Parameter button 2. Use the option Calibrate pressure to perform a 1-point or 2-point calibration.

3.5.2 pH CALIBRATION In the pH Settings screen, press the button Calibrate pH to start the Calibration menu. Numerical data Slope

Edit this value in the numeric keypad. Offset

Edit this value in the numeric keypad. Control Buttons

Correct an on-line pH value with data from off-

line pH measurements in samples. Only the current offset is corrected by entering the off-line measured value.

Off-line measurement of the acidity of a sample of the culture must be carried out under strict conditions: • pH measurement in the sample must be carried out directly after sampling: any CO2 or NH3 that is

stripped off the sample will change the current pH value of the sample. • off-line pH measurement must be carried out at process temperature: changes in temperature of the

sample introduce measuring errors (by causing a shift in the equilibrium between H3O+ and its salt form).

: toggle button (Show raw / standard values) Calibration data will be presented as raw or standard values.

: Calibration of offset only.

: Calibration of slope and offset; standard procedure for the pH sensor.

: Reset to slope = 1.00 and offset = 0.00 (standard values).



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Calibration procedure

1. Press the button. 2. Specify the temperature of the buffer solutions

via the numeric keypad (the temperature value that is displayed on the Process Value button is measured by the Pt-100 sensor in the bioreactor, not in the buffer solution).

3. The numeric keypad prompts for the pH value of the first buffer solution. Wait until the shown process value stabilizes. Enter the corresponding pH value (i.e. the first calibration point).

4. Repeat step 3 for the pH value of the second buffer solution. Again, wait for the shown process value to stabilize and enter the corresponding pH value (i.e. the second calibration point).

5. The calculated calibration data (slope and offset) are presented in the Calibration screen. In case a 1-point calibration is selected, the calibration routine is finished after the first buffer value is entered.

3.5.3 TEMPERATURE CALIBRATION In the Temperature Settings screen, press the button Calibrate temperature to start the Temperature Calibration screen. Numerical data Slope

Edit this value in the numeric keypad. Offset

Edit this value in the numeric keypad. Control buttons

Basically, the Temperature calibration routine consists of a 1-point calibration or a 2-point calibration. But since temperature measurements are carried out with a Pt-100 sensor, a 1-point calibration will be sufficient for most applications with In Situ stetrilizable reactors.

The calibrated offset value can be reset by pressing this button.

Since the Pt-100 sensor does not show any decrease in sensitivity during its lifetime, it needs only be calibrated once!

Calibration procedure 1. Insert the Pt-100 sensor in a solution with a known temperature (e.g. ice-water). 2. Wait until the temperature (as shown on the temperature Process Value button) is stable.

3. Press the button. 4. In the numeric keypad, enter the known temperature value in °C (e.g. 0.00 for the ice-water). 5. The offset value of the sensor is now calibrated and presented in the Temperature Calibration screen.



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In case a 2-point calibration is required however, it can be achieved with help of two different solutions with a known temperature (e.g. ice-water and boiling water). Immerse the Pt-100 sensor in the first liquid and enter the corresponding temperature value in °C. After having processed this first calibration point, the ez-Control will request you to condition the Pt-100 sensor in a liquid with a second temperature and to enter the corresponding value in °C. The calibration data (slope and offset) are now calculated by connection the two calibration points though a straight line.

3.5.4 DO CALIBRATION Before the DO calibration procedure is started, the bioreactor should be sterilized. After sterilization, the DO sensor must be polarized for six hours. During this interval, the medium can be saturated with air or oxygen.

Per default the DO calibration procedure is a 1-point calibration on air / oxygen saturation. The 0-value can be used to check the performance of the DO sensor. See the manual of the respective DO sensor. For special applications (anaerobic cultivations with set-points near 0% DO), the System Engineer can enable a 2-point calibration. In the DO Settings screen, press the Calibrate DO button to start the DO Calibration screen. Standard 1-point calibration procedure: Numerical data Slope This value may be edited by pressing it. Offset This value may be edited by pressing it.

Control buttons Show raw / standard values

The button toggles the presentation of values on the Slope and Offset buttons between raw values and standard

values. Raw values are presented in nA. Set measurement range

Press the button for Measurement range selection; two ranges are available: • Range for saturation with oxygen • Range for saturation with air The active range is presented as a brown button. Press this button to maintain the current measurement range or press the blue button to select the other measurement range. Now control returns to the DO calibration screen.



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Temperature compensation This button toggles between On and Off. Since DO calibration is usually performed at process Temperature; this compensation is normally switched off.

Reset calibration values

The button will reset the calibration data to default values: • Slope: 1.00 (standard) = 680.00 nA (raw) • Offset: 0.00 (standard) = 0.00 nA (raw)

Calibrate

Press the button to start execution of the DO calibration. The next screen is presented:

Press the button to open the aeration valve. Continue the aeration until DO reading is stable.

Press the button to close the aeration valve.

Press the button to proceed.

Note: The button cancels the calibration and returns to the main DO calibration screen. In case the calibration routine was continued, the numeric keypad is opened to enter the current DO-percentage (100% air saturation or 100% oxygen saturation). Press the Enter key to confirm.



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The calculated calibration results (slope and offset) are presented:

Press the button to return to the Home screen.

Additional Notes:

• In case the measuring range is set to saturation with air, the air valve will be operated before the DO calibration is executed.

• In case the measuring range is set to saturation with oxygen, the oxygen valve will be operated before the DO calibration is executed.

Calibration Procedure • Aeration of the medium with air or oxygen may

be omitted (skip pressing the valve). In this case, the medium must be aerated manually!

• When logged-in as System Engineer, a 2-point calibration may be enabled (press the

.button). • The 1-point or 2-point calibration option will

now also be presented in the Operator level of the DO-calibration!

• When the 2-point DO calibration is enabled, the

blue button will turn brown/red:

Press this button to disable the 2-point calibration!

• In case a 2-point calibration is enabled, the medium can be aerated in two phases (also see example below): Step 1 (before the first calibration point) aeration with air or oxygen to reach 100% air or oxygen saturation, Step 2 (before the second calibration point) aeration with nitrogen to reach 0% air or oxygen saturation.

• In case aeration is realized through Mass Flow Controllers, the air-, oxygen- and nitrogen-MFC’s are used instead of valves!

• In case an aeration actuator has been given a new name, its action will be excluded from the DO-calibration routine!



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Example of a 2-point DO Calibration: In the table below, the actions for a 2-point calibration with oxygen and nitrogen are described. For a 2-point calibration with air and nitrogen, instead of the oxygen valve / MFC, the air valve / MFC must be used. Note: Make sure that the 2-point calibration option is enabled by the System Engineer. Calibration Step Operator Action Display Remark

1 Press the parameter button

followed by the button

Calibration display with default calibration parameters

2

Press the button

Press the button to start aeration with oxygen.

When saturation is

completed, press the button

3

Press the button

and enter the value 100

The measured value is scanned until stable and the

calibration routine is continued

4

Press the button to start aeration with nitrogen.

When saturation is

completed, press the button

5

Press the button

and enter the value 0

The measured value is scanned until stable and the

calibration routine is continued

6

The obtained calibration parameters are displayed.

Press the button to return



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3.6 MANUAL CONTROL This option is available for: • Pressure • Level • pH • Temperature • DO The corresponding controller must be switched off. The example shows actuators in pH control.

3.6.1 FORCE ACTUATOR ON / OFF

• Press a button (activity button) to activate

the corresponding actuator (i.e. pump). The button turns into a brown button.

• Press this button to stop the actuator.

3.6.2 ACTUATOR ACTIVITY RANGE The actuator buttons in the Manual Control screen (in above example the Alkali pump and Acid pump buttons) can be pressed to edit the activity ranges of the corresponding actuators. The default actuator activity range of the alkali pump is 0 % to 100 %. Refer to the ez-Control PID Control Manual for the effect of these range settings on the relation between the controller output and the actuator output. Press a blue limit button to edit its value in the numeric keypad: 0 % ≤ Low limit < High limit ≤ 100 %

The changed limits are enabled only when the corresponding controller is switched on.

In case one (or both) limit(s) is (are) changed, this is indicated by an icon on the respective actuator button in the Manual Control screen. In this example, the low limit of the alkali pump has been set to a value above 0 %:

Activity

ButtonActuatorButton



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3.7 DOSE MONITOR This option is available for: • Level • pH • DO The example shows the dose monitors for actuators in pH control. The corresponding controller is switched off. In case the controller is on, the dose monitor is read-only. By pressing a blue dose monitor value button, the corresponding dose monitor function can be calibrated or reset via the numeric keypad. For information concerning dose monitors, see Section 4.2.4.

3.8 CONTROLLER SETUP This option is available for: • Pressure • pH • Temperature • DO The example shows a pH Controller Setup screen. A controller can be set to: • Automatic mode:

The control parameter values are optimized during the fermentation / cultivation process (self-tuning). In this case all value buttons are disabled.

• Preset mode: fixed PID parameter values (see table below).

The brown button (Preset / Automatic) indicates the current status. Press the blue button to switch to the other mode.

The use of either Automatic or Preset setup parameters is discussed in the PID Control Manual of the ez-Control!

In Preset mode, the PID control parameters can be set for the following controllers.

Controller Pressure pH Temperature DO Fermentation Sterilization

P-Gain X X X X X I-Interval (seconds) X X X X X D-Interval (seconds) X X X X X Cycle time (seconds) X X X - X Dead zone - X*) - - -

*) The dead zone in pH control is only enabled when both the I- and D-intervals are set to 0 seconds.



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3.9 SET-POINT Use the numeric keypad to edit the Set-point for the control loop (see Section 1.7).

3.10 CASCADE SPEED LIMITS (STIRRER SPEED ONLY) This option is available for Stirrer and only when the stirrer is included in the DO cascade.

In this case, the parameter button is added to the list of stirrer speed control parameter settings. Press the limit you want to edit and use the numeric keypad for entering the value:

3.11 PID SETTINGS SIP This option is available for Temperature only (System Engineer rights are required to edit the PID-settings). The P-gain, I-time and D-time values that can be set via the numeric keypad will be used by the Temperature controller during the sterilization process.

3.12 ADDITIONAL FOAM / LEVEL CONTROLLER SETTINGS The Level or Foam controller differs from the other controllers. It only acts on the signals contact or no contact; there is no PID control functionality. For more information concerning control, see the ez-Control PID manual, section “Level Control”. Level / Foam settings screen Display actuator activation

This button equals the effect of the button Show controller output of the other control loops (pH, Temp. and DO).



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Level Control Foam Control

Level controller setup After pressing this button, the setup of the Level or Foam control loop is displayed (see below).

Level control When Level control is selected, the Activation mode can be selected (Contact or No contact).

In case the activation mode is set to Contact, the Level Pump is started on Contact. In case the activation mode is set to No contact, the Level Pump is started on No contact.

When using Level control, the sensitivity selection is disabled. Foam control

When Foam control is selected, the foam control pump is active on Contact. The Sensitivity can be selected. High sensitivity is recommended for foam that contains much air. Low sensitivity is recommended for highly conductive foam.

Actuator timing a Dead time and a Pulse time can be entered through the numeric keypad. In case of detected foam / level, the defined intervals elapse in a sequence until contact is disabled.

3.13 SYNOPTIC SCREEN (ALL CONTROLLERS STARTED) When all control loops are started, the Synoptic view of the ez-Control (press the Home button) shows the reactor overview with the status of the actuators:


ez-Control for Autoclavable and Single Use Applications MENU OPTIONS Software Version 1.8X, Document Version 1.0

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Menu Button

4 MENU OPTIONS The Menu button is located at the upper right-hand corner of the touch screen display. When the Menu button is pressed, the following options are displayed: • Control

• View

• System These options of the Menu screen are discussed in the following sections, but since the sterilization is a comprehensive process, it is described separately (see Chapter 5).

Light icon ( ) After pressing the Light icon, the illumination inside the reactor will switch on. It will stay on for a period of time that is defined by a setting in hardware (between 0.01 and 100 minutes).


MENU OPTIONS ez-Control for Autoclavable and Single Use Applications Software Version 1.8X, Document Version 1.0

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4.1 CONTROL OPTIONS

4.1.1 MANUAL CONTROL This option lists the status of all actuators of the control loops (except the stirrer speed actuator) that are currently switched off. The option has multiple pages that are selectable via the tabs Basic and SIP at the right-hand side of the screen.

4.1.1.1 ACTUATORS IN A CONTROL LOOP

Actuators that are configured in a control loop are presented as brown Actuator buttons. Actuators not part of a control loop have blue Actuator buttons. There are two types of Activity buttons:

• or for digital actuators, used to manually switch the corresponding actuator on or off • Activity buttons for analog activators (like Air MFC), show the controller activity in the actual

engineering unit. The calibration factor for the analog activator is entered during the Dose Monitor

calibration routine. Activator control is achieved by pressing the button and entering a new value by using the numeric keypad.

Starting the control loop will reset the corresponding activity button(s): digital actuators to Off and analog ones to 0 (ml or L/min).

In the Manual control screen, all Actuator buttons (except the rectangular ones) can be pressed to edit the actuator control limits (activity range) of corresponding actuator. Press a blue limit button to edit its value in the numeric keypad: 0 % ≤ Low limit < High limit ≤ 100 % Refer to the ez-Control PID Control Manual for the effect of these range settings on the relation between the controller output and the actuator output.

The changed limits are enabled only when (and as long as) the corresponding controller is switched on.

In case one (or both) limit(s) is (are) changed, this is indicated by an icon on the respective actuator button in the Manual Control screen: . In this example, the low limit of the alkali pump has been set to a value above 0 %.

Actuator Buttons Activity Buttons



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4.1.1.2 TIMER FUNCTION OF FREE DIGITAL ACTUATORS

Digital actuators that are not configured in a control loop are presented as a blue actuator button. They can, however, be programmed as a stand-alone timer function, defined by a Delay time, an Off time and an On time. The Delay time will elapse only once. When both the Off time and the On time are > 0 sec., the manual timer is defined. Now the actuator button in the Manual Control screen is marked with a timer icon: To stop the timer, reset the Off and On times to 0 sec. (or start the control loop).

4.1.2 TUBING PUMP CONTROL The manual Tubing pump control option is used for priming purposes (e.g. after replacing the pump tubing). When the pH and/or Level control loops are active, the corresponding tubing pumps can not be operated manually. Control buttons

Press this button and keep it pressed until the new tubing is filled completely.

/ This button toggles between Enable and Disable (disabled pumps cannot be operated). This option can be used when replacing pump tubes. A disabled pump is shown in grey colour here and in the Synoptic screen. Press enable to enable the pump again.

4.1.3 START / STOP ALL CONTROLLERS This menu option is used to stop all active controllers or start all controllers that have been switched off, with a single command. Individual controllers may be started or stopped by using parameter settings options (see Section 3.2).

Both buttons may be blue: this indicates that some controllers are on and others are off.

4.1.4 STERILIZATION The Sterilization menu is described in chapter 6.



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4.2 VIEW OPTIONS

4.2.1 SHOW BAR GRAPH SCREEN Press this button to display the Bar Graph screen. After viewing the Bar Graph screen, press the Menu button to return to the Menu screen. This option only temporarily changes the process presentation. The type of Home screen can be selected in the Main Menu > Utilities screen

4.2.2 OUTPUT VALUE MONITOR The Output value monitor is used to monitor the controller output percentage during the fermentation process. Per individual control loop, the controller output and the actuator output are presented (even if they are manually controlled).

In case of a mass flow controller, the output value is presented in the format: “Current Set-Point (Actual Value)”.

4.2.3 ALARM OVERVIEW The Alarm overview shows a list of all active System alarms. In case no System alarm is active, the message No alarms detected is displayed.

Note the difference between a System alarm and a Deviation alarm. A Deviation (or Sensor Value) alarm is

detected by a control loop and is presented by the red colour of the related Process Value button.



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4.2.4 DOSE MONITOR The Dose Monitor screen is used to view, calibrate and reset the dose monitor values. The displayed values show the volumes that have been supplied to the bioreactor since the latest reset of the respective dose monitor(s), including volumes for calibrating and priming, and those added via manual control.

Dose monitor values can also be seen in the parameter screens (see Section 3.8 for an example of the pH controller).

Control buttons

Press this button to reset all integrated dose monitor values to 0 ml, including those of the active controllers. Resetting a single dose monitor can be done in the respective calibration screen (see following sections).

/ In case the Extended I/O module is installed, an extra button with Extended I/O actuators becomes available. Refer to the Additional Sensor and I/O Hardware manual.

4.2.4.1 DOSE MONITOR CALIBRATION

The configured actuators (pumps, valves or mass flow controllers) that are used for dose monitoring need to be calibrated in order to convert their “on time” or “flow” into volume. Per default, a calibration factor of 1ml/min is in place. A dose monitor can only be calibrated when the corresponding controller is switched off.

Manually defined timers must also be calibrated. Their names are shown in black text in the Dose Monitor screen. Dosed volumes depend on the applied tube diameter: differences of ±10 % between batches of tubing are not unusual.

4.2.4.2 CALIBRATING DOSE MONITORS FOR PUMPS AND AERATION VALVES

This procedure can also be used to calibrate other pumps and aeration valves. Calibration procedure for the Alkali pump 1. In the Dose Monitor screen, press the blue alkali

pump dose monitor button ( ). 2. Select the appropriate engineering unit for the

dosed volume. Per default, the volume is

expressed in ml/min (the brown button presents the selected engineering unit). Press the

button to change (System Engineer rights are required).

3. Prepare a calibrated cylinder or beaker to collect



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the dosed volume. Make sure that the pump tubing is filled with liquid.

Press the button. The timer starts counting and the pump starts pumping. The function of the Start output button toggles with Stop output.

4. When the dosed volume can be measured

accurately, press the button to stop the pump.

5. Measure the dosed volume.

6. Press the button and use the numeric keypad to enter the measured dosed volume.

7. The entered volume and the calculated

calibration factor are shown. Confirm these values by pressing the button.

8. The dose monitor for the pump is reset to 0 ml.

Control now returns to the Dose Monitor screen.

The calculated Dose Monitor Calibration Factor is presented in the Dose Monitor screen (press the

button). Reset procedure

The dose monitor can be reset without calibrating it in the calibration screen ( button) and

in the dose monitor screen ( button).



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Dose monitor values for a gas valve relates to the integrated On-time of the valve. The actual gas flow during the On-time of the valve depends on the setting of its rotameter tuning valve.

4.2.4.3 CALIBRATING DOSE MONITORS FOR MASS FLOW CONTROLLERS

The Mass Flow Controllers used in the ez-Control are already accurately calibrated by the manufacturer. Consequently, this calibration factor (gas flow per 100% actuator output) is used for calibrating the Dose Monitor function. Calibration procedure 1. In the Dose Monitor screen, press the blue

MFC dose monitor button ( ). 2. Select the appropriate engineering unit for the

dosed gas volume. Per default, the volume is expressed in ml/min (the brown button presents the selected engineering unit). Press the button to change (System Engineer rights are required).

3. Press the button. 4. Enter the given flow rate for 100 % Actuator Output using the numeric keypad. 5. The Dose Monitor calibration for the mass flow controller is now completed. Reset procedure Reset the dose monitor by pressing the button. The dose monitor value will return to 0.



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4.3 SYSTEM CONFIGURATION The System Options are divided in Configuration and Utilities: In the next sections, the options are described.

4.3.1 CONFIGURATION OPTIONS Pressing the Configuration button will present the different configuration options: • Control loop Configuration • Bioreactor Customization • Additional (AD/DA) I/O Customization • Status Bar Configuration • Input names Customization • Output names Customization • Export/Import Parameter and Configuration files

4.3.1.1 DEFAULT LOOP CONFIGURATION

In the basic lay-out of the ez-Control (configured for SIP reactors), per default four control loops are present: Control Loop Actuator below

Set-point Actuator above

Set-point pH Alkali pump Acid pump Temperature* Heater Cooling Valve

Diss. Oxygen Air Valve N2 Valve Level or Foam Level or Anti Foam Pump The Temperature control loop configuration is fixed and cannot be edited. Consequently, it is greyed out in this screen. In case the reactor is equipped with a pressure sensor in the head space and a back pressure control valve in the off-gas line, the Pressure control loop may also be configured or added. Press the button to view or edit additional control loops. The stirrer speed control loop is either a fixed speed control loop or part of the DO control cascade (variable stirrer speed, based on the DO-tension). The level/foam control loop is either defined as Level or as Anti-Foam (refer to section 3.12).

In case Additional I/O is installed (through the Extended I/O Module or USB), refer to the Additional Sensor and I/O Hardware manual.

In combination with the Extended I/O module, an (extra) external stirrer controller can be configured (including adjusted lower and upper limits). The external stirrer can be added to an existing cascade of actuators that is configured in a control loop!



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0-400 -300 -200 -100 100 200 300 400ControllerOutput %

ActuatorOutput %

Actuator 1

Actuator 4

Actuator 2

Actuator 3

100

50

Actuator -1Actuator -2

Actuator -3Actuator -4

Maximum Actuator Configuration for pH or DO Control

4.3.1.2 EDITING THE DEFAULT ACTUATOR CONFIGURATION

Basic rules for configuring actuator hardware • A number of actuator outputs are available to be assigned to the control loops. • The controller output for pH and DO may vary between -400 to +400% (max. four actuators at each side

of the set-point). • The controller output for Temperature varies between -100 to +100% (max. one actuator at each side of

the set-point) • The Level or Foam controller only has one actuator (actuator output is either 0 or 100%) • The Stirrer Speed and Pressure controllers only have one actuator (stirrer motor or back pressure control

valve; actuator output varies from 0 – 100%) Graphical presentation of the maximum actuator configuration of the pH or DO Control loop: Graphical presentation of the actuator configuration of the Temperature and Pressure control loop:

0-100 100ControllerOutput %

Maximum Actuator Configurationfor Temperature Control

Actuator 1Heater

100

50

Actuator -1CoolingVaklve

ActuatorOutput %

0-100 100ControllerOutput %

Maximum Actuator Configurationfor Pressure Control

Actuator 1Back PressureControl Valve

100

50

ActuatorOutput %



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Reconfiguring a Control Loop A control loop is reconfigured by removing existing actuators and adding new ones. The procedure that is described below describes reconfiguring the DO control loop. This procedure is also valid for the pH control loop. Step 1: Login as System Engineer and go to Menu > Configuration > Control loop.

Step 2: Press the button. The DO Loop configuration screen is now presented. Step 3: Remove the currently configured actuators by pressing the

and the button.

Step 4: Now press one of the two buttons in order to add a new actuator (in this example an actuator below set-point). The currently present actuators are presented. The actuators that are greyed out are already assigned (not free anymore). The actuator with its name in white letters is the “preferred” one. Press one of the free actuators to add it to the control loop.

Press the button to address the additional I/O hardware (refer to the Additional Sensor and I/O Hardware manual).

Press the button to address the SIP hardware (back pressure control valve).



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Step 5: In this example, the Air valve is added as actuator below set-point for the DO Control loop. Step 6: Now the N2 valve is added to the DO Control loop to act above set-point (same procedure as for adding the Air valve). Step 7: The Stirrer control loop is now added as a cascade actuator (press the blue Add button below set-point). The N2 valve and Air valve actuators are already assigned. Now press the blue Stirrer button. Step 8: The stirrer control actuator is now added to the cascade of the DO Control loop.

When the stirrer speed is configured as second actuator in the DO Control loop cascade, the stirrer speed will be increased as soon as the DO Controller

Output rises above +100%. It will reach its maximum speed at a DO Controller Output of +200%. The minimum and maximum stirrer speed is defined in the Parameter List of the Stirrer (press the blue Stirrer button; the parameter button Cascade speed limits is used to define the minimum (CO = +100%) and maximum (CO = +200%) speed.



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Step 9: Press the button to return to the Control Loop overview screen. Reconfiguring the actuators must be finished by pressing

the button (otherwise the configuration is not saved)!

The button that is presented in this screen is used to view additional control loops. For more information concerning these additional loops, refer to the Additional Sensor and I/O Hardware manual. In case no additional overview screen is available, this is changed into a grey rectangle.

The button is used to interrupt the actuator configuration process and to return to the previous menu without saving any changes.

Press the button to restore the default actuator configuration of the control loops. A confirmation is requested first. Press the Yes button to proceed. Pressing the No button will return to the previous screen. This example of configuring actuators in a control loop is now finished. Additional actuators may be added using the same procedure. For more information concerning control loops in cascade, refer to the PID Control manual of the ez-Control.

4.3.1.3 REMOVING A CONTROL LOOP

A complete control loop can be removed from the

configuration by pressing the button. The corresponding control loop will be removed (after confirmation) and the corresponding parameter button at the bottom of the screen together with the process value will be removed. In case a control loop was removed, the free space in the list of controllers can be filled with an additional control loop (refer to the Additional Sensor and I/O Hardware manual) or the removed control loop can be redefined.



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4.3.2 BIOREACTOR CUSTOMIZATION The Bioreactor Customization option is used for three purposes: • Selecting the proper Operation Mode (SIP or autoclavable / single use) and options, • Selecting the proper Stirrer type and • Selecting the proper Synoptic Display.

4.3.2.1 STEAM IN PLACE BIOREACTOR

The Bioreactor Customization screen contains three columns: • Bioreactor type, • Synoptic (visualization of the reactor system)

and • Stirrer type. Bioreactor Type: The reactor type depends on the application of the ez-Control. In case hardware for Steam-in-Place actions is mounted, the Bioreactor type is fixed to . Synoptic: The Synoptic type normally corresponds with the reactor type. However, it is allowed to select a different Synoptic (e.g. a Steam-in-Place reactor type with the Synoptic of an autoclavable reactor). Stirrer Type: In case of Steam-in-Place applications, a selection can be made between: • No stirrer, • Internal Stirrer (only for cell culture applications) and • External Stirrer (for microbial or other applications). The Pressure switch activation button is disabled in case of Steam-in-Place applications.

The button is used to save any changes. The button is used to return to the previous page in the menu. Standard Synoptic for a Steam-in-Place configuration:



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4.3.3 EXTENDED I/O In case an Extended I/O module is used for extra sensor and I/O hardware (biomass monitor, CO2 and/or O2 gas sensors or other external transmitters, extra analog and digital in- and outputs), these hardware modules can be configured by:

• Extended I/O installation and • Renaming and configuring the extra connected hardware and control loops

Refer to the Additional Sensor and I/O Hardware manual of the ez-Control.

4.3.4 STATUS BAR The Status Bar of the ez-Control has a default lay-out:

Depending on the use of the scroll button, the Level / Foam parameter button may be replaced by Pressure or other(s).

The three middle positions of the status bar may be configured according to user requirements. Press the blue Status Bar button in the System Configuration Menu list. The next screen will be presented: The parameter buttons at positions 2, 3 and 4 can now be reconfigured. Press the button at the position to be edited (in this example, position 2). The screen now shows the available options for the selected parameter position. Select one of the blue parameter buttons (in this example the Temperature button). The screen will now show the reconfigured Status Bar:



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4.3.5 INPUT (SENSOR) AND OUTPUT (ACTUATOR) NAMES The last two options in the System Configuration Menu are editing the Input Names and the Output Names. Below the screens are presented of the standard input names; since these names are dedicated to the input function, they cannot be edited.

Press the button to return to the previous page. Editing Output Names: The screens with lists of output names are presented below:

The list of names of basic outputs has a second page. Press the button. The Output Names of the default or edited actuators can be redefined. Press one of the blue buttons with the Actuator name and edit it. Editing the output names of the Extended I/O module for additional outputs is described in the Additional Sensor and I/O Hardware manual.



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4.3.6 FILE HANDLING The file handling action consists of the option of: • Exporting the ez-Control Parameter File and/or Configuration File • Importing the ez-Control Parameter File and/or Configuration File The Export- and Import-function can be used to • rapidly and accurately switch between types of process • synchronize with other ez-Controls running the same application.

4.3.6.1 EXPORTING FILES

Press the button in the Configuration screen. The File Handling screen is opened:

Press the button to export files (mount an USB memory stick at the rear of the ez-Control). Now the following options are presented: Export File Export File Export Files Make sure that an USB memory stick is mounted at the rear of the ez-Control. Press one of the export buttons to proceed.



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The Export file name can be entered using the alpha-numeric keyboard. The export file name is used to identify the set of data!

Press the button to proceed. The export process is now started. The export result is reported:

Press the button to proceed and return to the Export screen. Note: In case the export file name already exists, the following message is reported:

Press the button to overwrite the existing file.

Press the button to cancel the export operation. The export files are transferred to the memory stick in the following manner: \Applikon\Configurations\CFFilename (Configuration File) \Applikon\Configurations\PFFilename (Process value File)



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The files have a .txt format and can be opened with a text editor like Notepad. Example of a fragment of the Configuration file in Notepad:

Data like input and output names, alarm limits, etc. may be edited using the text editer.

4.3.6.2 CONTENTS OF EXPORT FILES

The Configuration File basically contains the following data (alphabetical order):

AD/DA Actuators (optional) Analog Outputs Yes / No, Range Digital Outputs Yes / No

Agitation Int. / External, Name

Bioreactor Pressure Switch Yes / No Synoptic Type Reactor Type

Common Creation Date ######## (date) Software Version ######## (version) System ID ######## (system ID)

Input Names Analog_X Input name Loop X Actuator(s) and ID

Output Names Basic Outputs Output name AD/DA Outputs (opt.) Output name

AD/DA Sensors (inputs) Analog_X Yes / No The Process value File basically contains the following data (in alphabetical order):

Actuator Setting for Basic and AD/DA Outputs (assigned)

Control Limits ### , ### (limits) ID Output Name Output Type ###### , ### , #### , EU Flow

Actuator Setting for Basic and AD/DA Outputs (not assigned)

ID Output Name Output Type ###### , ### , #### , EU Flow Timing ### , ### , ###

Calibration

DO Slope , Offset , Range , T comp pH Slope , Offset , pH Corr. Temperature Slope , Offset Other Inputs Slope , Offset

Common See Configuration File

Loop Setup Alarm Limits ####.## , ####.## Algorithm Type ID Loop name

Set Points Par. name ###.### (set point value)



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4.3.6.3 IMPORTING FILES

Exported files can be used to save the experiment setup and or to be able to upload files at any time at any ez-Control in order to synchronize the configuration and parameters of different ez-Controls that run the same application.

Consideration: In case exported files are used for import at another ez-Control, the hardware configurations of both devices must be identical!

For importing files, press the button in the File Handling screen. Again a selection can be made: Import File Import File Import Files Press one of the blue buttons. In this example, the button is used to import both configuration and parameter value files.



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The importable files from the USB device (memory stick) are now listed. In case the number of files exceeds the space on the screen, the grayed out

buttons and become alive! Select one of the files by pressing the corresponding blue button. The import routine is executed. The result of this routine is presented (no warnings or errors are expected):

Press the button to store the new configuration and restart the ez-Control.

Press the button to interrupt the import process and to return the Import screen.



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4.3.7 UTILITIES The Utilities screen offers the following options: • Device Information, • Set Delay Timers, • Communication Settings and • Screen Cleaning. At the bottom of the screen, the type of Home screen can be selected: • Synoptic screen or • Bar Graph screen.

4.3.7.1 DEVICE INFORMATION

The Device information screen presents the relevant versions of hardware and software, the configuration date and the amount of up-time hours of the specific ez-Control. The MAC address identifies an individual ez-Control. This address is required to obtain software updates.

The button is only present in case hardware is installed that comes with a specific license (e.g. a fluorescent amplifier or biomass monitor). When this button is presented, pressing it will show the list of licensed modules. Example:



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4.3.7.2 DELAY TIMERS

The option Delay Timers offers two different parameter settings: • Automatic Log-out Delay and • Set Backlight Saving Delay. Both delay times can be set in minutes between 1 and 600 minutes (10 hours). The setting to 0 minutes disables the delay timer. Example of the Automatic Log-out Delay screen: After the delay time has elapsed, the ez-Control switches to the View-mode (automatic log-off) or switches off the Human Interface (backlight saving). The user can login at the human interface as Operator or System Engineer at any time (however, remote access to the Web-Interface disable access to the Human Interface). When in backlight saving mode, the Human Interface will be recalled after touching the screen!

4.3.7.3 COMMUNICATION SETTINGS FOR REMOTE ACCESS (WEB-INTERFACE)

The ez-Control can be remotely accessed by a host in a network using the TCP/IP protocol (using the Web-Interface of the ez-Control). As a result, the ez-Control is accessed through a web browser and control through the touch screen display is disabled! Control of the ez-Control is taken over by a PC. Refer to section 5.3 and 5.4 of this manual

Remote access allows easy access to the ez-Control from a PC in the office!

The communication settings and remote access settings must be configured accordingly. Communication Settings: The System Engineer can either obtain the communication settings from the network server (Automatically; DHCP) or define them manually. Set the IP addresses of the host to the same range as the IP address of the ez-Control. Example: • ez-Control: 192.168.1.201 • host: 192.168.1.200 If the IP address is obtained from the network, contact the System Administrator.



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Remote Access settings: The Yes / No button toggles between Remote Access and No Remote Access (Yes (brown) enable remote access, No (blue) disables remote access).

Remote Access concerns the use of the “Web-Interface” of the ez-Control.

SCADA programs like BioXpert have access to control functions and data of the ez-Control at any time, even when no access is allowed! The password of the ez-Control can be entered using the alpha-numeric keyboard. This password is required in order to enable remote access to the Web-Interface. The Time-out interval can be set in minutes (press the value-button and use the numeric keypad to enter a new value). Once remote access is established, a timer starts counting down (being reset by any new remote command). When the timer reaches 0 min., remote access is disabled automatically.

4.3.7.4 SCREEN CLEANING

This Menu option is used to clean the touch screen without any interference with the controller software. Clean the screen with a soft cloth (dampened with a mild glass cleaner). 10 seconds after last touching the screen, it will return to the Menu options.


STERILIZATION ez-Control for In Situ sterilizable Bioreactors Software Version 1.8X, Document Version 1.0

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5 STERILIZATION 5.1 PREPARATION

During sterilization of (parts of) the Bioreactor system, the steam supply and drain piping will be very hot! Take precautions to prevent burns!

Prior to starting the sterilization process, various parameters must be set. The parameters and the process differ slightly between the sterilization of a full bioreactor and an empty one. In the Menu screen, press the Sterilization button to switch to the Sterilization screen. Control buttons

Press this button to select the type of parameter and output series you want to edit for the next sterilization process (see Section 5.2).

/ Press one of the buttons to start the sterilization process (see Section 5.3).

Press this button if you need to operate some actuators manually (see Section 5.4).

5.2 CONFIGURE STERILIZATION

In the Menu – Sterilization screen, press the button to display the Configure Sterilization screen. • The color of the button

means that the Preparation prompts for manual operator actions between the steps of the sterilization process are enabled. In case this button is blue, the prompts are disabled.

• Press the button and the button to edit the

respective limits using the numeric keypad. • Press (one of) the other buttons to select the

parameters or outputs for editing.


ez-Control for In Situ sterilizable Bioreactors STERILIZATION Software Version 1.8X, Document Version 1.0

51

5.2.1 FULL STERILIZATION PARAMETERS In case no pressure control is configured (no Pressure sensor or no Back Pressure Control valve), the Pressure Test and pressure values are excluded from the Sterilization routine!!

Example of parameters for sterilization of a full 140L bioreactor: Recipe Step Duration Temp. Press. Airflow Pressure Test 30 min - 1.20 barg 100 % Preheat Filter 2 min 95 oC - - Sterilization 20 min 122 oC 1.15 barg - Cooling 2 - 85 oC 0.80 barg 100 % Cooling 3 - 40 oC 0.50 barg 100 % End Position - 37 oC 0.20 barg 100 % More Parameters Value Stirrer Speed 100 rpm Minimum Sterilization Temperature 121 oC Max. Time under Sterilization Temp. 10 min Min. Cooling Pressure 0.10 barg Max. Pressure Drop during pressure test 0.10 barg Press any blue value button to edit the value via the numeric keypad.

5.2.2 EMPTY STERILIZATION PARAMETERS In case no pressure control is configured (no Pressure sensor or no Back Pressure Control valve), the Pressure Test and pressure values are excluded from the Sterilization routine!!

Example of parameters for sterilization of an empty 140L bioreactor: Recipe Step Duration Temp. Press. Airflow Pressure Test 30 min - 1.20 barg 100 % Preheat Filter 2 min 40 oC - - Sterilization 20 min 122 oC 1.15 barg - Nat. Cooling - 115 oC 1.00 barg 100 % Cooling 2 - 85 oC 0.80 barg 100 % Cooling 3 - 40 oC 0.50 barg 100 % End Position - 37 oC 0.20 barg 100 % More Parameters Value Stirrer Speed 0 rpm Minimum Sterilization Temperature 121 oC Max. Time under Sterilization Temp. 10 min Min. Cooling Pressure 0.10 barg Max. Pressure Drop during pressure test 0.10 barg

Press any blue value button to edit the value via the numeric keypad. The differences with the full sterilization are: • The Stirrer Speed is set to zero since a rotating shaft in a empty reactor will damage the ball bearings. • The gas inlet filter is heated at a lower temperature than for full sterilization. • An extra cooling step (Natural Cooling) is introduced immediately after finishing the sterilization time.

During this step, gas is introduced into the reactor while the jacket of the reactor is not filled with cooling water. This is necessary to prevent a vacuum in the reactor.



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5.2.3 STERILIZATION OUTPUTS The ez-Control comes with a default valve configuration. Only in case of changing the sterilization conditions or hardware configuration, these output settings must be edited by a System Engineer. Control screens Empty Sterilization Outputs

Each of the buttons represents a single step of the sterilization process. Full Sterilization Outputs

This screen equals the Empty Sterilization Outputs screen except for the Natural cooling step, which is absent in the Full version (see Section 5.3.8).

Control buttons Phase button

Press a phase button to switch to the screen in which the corresponding actuator settings for that specific step can be changed.

Section button

Select the section 1, 2, 3 or 4 by pressing the corresponding

button.

Actuator Activity button

Press a blue ( ) or brown ( ) actuator activity button to toggle its status.

View tags / View names

With this button you can toggle between displaying the names or tag numbers of the actuators.

On next page, the actuators per SIP Board Section are listed.

Important Note:

The sterilization actuators can be manually operated through the Menu > Sterilization > Configure > Empty / Full sterilization outputs > Fermentation screen (see screen above).

Select the proper section and press a blue ( ) or brown ( ) actuator activity button to toggle its current status. However, before leaving this screen, make sure to set the status of all actuators back to their original status!



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The tables below list the actuators on the different SIP Board Sections: SIP Board Section 1 SIP Board Section 2 V-2.04 Circulation Valve #1 V-10.05 Valve Clean Steam Overlay Filter V-2.08 Circulation Valve #2 V-10.06 Valve Biowaste Overlay Filter V-2.12 Drain Valve V-10.07 Block Valve Overlay V-2.13 Clean Steam Supply Valve V-10.09 Gas Supply Valve Overlay V-10.15 Valve Clean Steam Sparger Filter V-14.02 Clean Steam Supply Cont. Addition 1 V-10.16 Valve Biowaste Sparger Filter V-14.03 Inlet Valve Contained Addition 1 V-10.08 Block Valve Sparger V-14.04 Biowaste Valve Contained Addition 1 V-10.19 Gas Supply Valve Sparger V-11.02 Off-gas Block Valve V-20.10/ HE-2.51 Filter Heater

SIP Board Section 3 SIP Board Section 4 V-11.01 Valve Biowaste Offgas Filter V-2.07 Water Outlet Valve V-14.12 Clean Steam Supply Cont. Addition 2 V-2.14 Chilled Water Valve V-14.13 Inlet Valve Contained Addition 2 V-2.15 Cooling Water Valve V-14.14 Biowaste Valve Contained Addition 2 BV-12.01 Bottom Valve V-14.22 Clean Steam Supply Cont. Addition 3 V-12.02 Valve Bottom Valve to Biowaste V-14.23 Inlet Valve Contained Addition 3 V-20.03 Clean Steam to Bottom Valve V-14.24 Biowaste Valve Contained Addition 3 V-17.02 Valve Sample Valve to Biowaste V-3.82/ V-3.81 Solenoid Valve Air or N2 Overlay V-20.02 Clean Steam to Sample Valve

V-3.83/ V-1.81 Solenoid Valve O2 or CO2 Overlay



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V-2.04

SteamTrap

V-2.09

WaterSupply

WaterReturn

CondensateDrain

P-2.41

Heater

Steam to gas inlet filterV-10.15

V-11.02

V-10.07

V-10.08V-10.16

V-10.19

Gas SupplyLine

Condenser

Bioreactor

To Biowaste

(Clean)SteamSupply

V-2.06

V-2.13

V-2.12

V-14.02

Gas InletFilter

Steam other auxiliaries

Pump

Exhaust

Off-gasFilter

(Plant)SteamSupply

V-2.08

V-14.04

V-14.03

5.2.4 ACTUATOR ACTIVITY MATRIX DURING THE STERILIZATION ROUTINE In the tables below, examples of the actuator activity matrices are given. System Configuration: • Common Gas Inlet Filter for Sparging and Overlay • Off-gas Filter on top of the Condenser • Manually operated Contained Addition Line 1 • Manually operated Contained Bottom Valve • Manually operated Contained Sample Valve The Actuator Activity Tables are listed on next pages. Both tables use the following abbreviations:

O = OPEN C = CLOSED X = 1, 2, 3 NA = NOT APPLICABLE



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Actuator Activity Table for Empty Sterilization:

Tag Description Ferm

ent.

Init

Pre

ss. t

est

Pha

se 1

Pre

heat

f.

Pha

se 2

Ste

riliz

e

Nat

ural

C.

Coo

ling

2

Coo

ling

3

End

SIP Board Section 1 V-2.04 Circulation valve #1 O O O C C C C C O O C V-2.08 Circulation valve #2 O O O C C C C C C O C V-2.12 Drain valve C C C O O O O C C C C V-2.13 Clean steam supply valve O O O O O O O O O O O V-10.15 Steam to filter valve C C C C O O O C C C C V-10.16 Filter condensate valve C C C C O O O C C C C V-10.08 Sparger block valve O O C C C O O O O O C V-10.19 Gas supply valve O O C C C C C O O O O V-11.02 Offgas block valve (n.o.) O O C O O O O O O O O HE-2.51 Filter Heater O C C C C C C O O O O SIP Board Section 2 V-10.07 Block valve overlay O O C C C O O O O O O V-14.02 Clean steam supply cont. add. 1 C C C C C C C C C C C V-14.03 Inlet valve contained addition 1 C C O O O O O O O O C V-14.04 Biowaste valve cont. addition 1 C C C C C O O C C C C SIP Board Section 3 V-3.82 Solenoid Air valve overlay O O C C C C C O O O O V-3.83 Solenoid O2 valve overlay O C C C C C C C C C C SIP Board Section 4 BV-12.01 Bottom Valve C C C C C O O C C C C V-12.02 Valve bottom valve to biowaste C C C C C O O C C C C V-20.03 Clean steam to bottom valve C C C C C O O C C C C V-17.02 Valve sample valve to biowaste C C C C C O O C C C C V-20.02 Clean steam to sample valve C C C C C O O C C C C



56

Actuator Activity Table for Full Sterilization:

Tag Description Ferm

ent.

Init

Pre

ss. t

est

Pha

se 1

Pre

heat

f.

Pha

se 2

Ste

riliz

e

Nat

ural

C.

Coo

ling

2

Coo

ling

3

End

SIP Board Section 1 V-2.04 Circulation valve #1 O O O C C C C NA O O O V-2.08 Circulation valve #2 O O O C C C C NA C O O V-2.12 Drain valve C C C O O O O NA C C C V-2.13 Clean steam supply valve O O O O O O O NA O O O V-10.15 Steam to filter valve C C C C O O O NA C C C V-10.16 Filter condensate valve C C C C O O O NA C C C V-10.08 Sparger block valve O O C C C O O NA O O C V-10.19 Gas supply valve O O C C C C C NA O O O V-11.02 Offgas block valve (n.o.) O O C O O O O NA O O O HE-2.51 Filter Heater O C C C C C C NA O O O SIP Board Section 2 V-10.07 Block valve overlay O O C C C O O NA O O O V-14.02 Clean steam supply cont. add. 1 C C C C C C C NA C C C V-14.03 Inlet valve contained addition 1 C C O O O O O NA O O C V-14.04 Biowaste valve cont. addition 1 C C C C C O O NA C C C SIP Board Section 3 V-3.82 Solenoid Air valve overlay O O C C C C C NA O O O V-3.83 Solenoid O2 valve overlay O C C C C C C NA C C C SIP Board Section 4 BV-12.01 Bottom Valve C C C C C C C NA C C C V-12.02 Valve bottom valve to biowaste C C C C C O O NA C C C V-20.03 Clean steam to bottom valve C C C C C O O NA C C C V-17.02 Valve sample valve to biowaste C C C C C O O NA C C C V-20.02 Clean steam to sample valve C C C C C O O NA C C C



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5.3 PHASES IN THE STERILIZATION ROUTINE The sterilization of an In-Situ sterilizable bioreactor consists of the following discrete phases, which are executed in a fixed order. The sterilization process as described in detail in the following sections is based on a specific configuration of manually and automatically operated valves (see Section 5.2.3). In between sterilization steps the operator is prompted to carry out actions with manually operated valves. The prompts for manual operator actions can be disabled (see Section 5.2). 1. Start (full or empty) sterilization.

At this point in the procedure, the operator needs to confirm that the pH-sensor is calibrated. The states of the valves and other related actuators are kept as they were during fermentation / cultivation. When the prompt is confirmed, the next step is started.

2. Initialization. Conditions for the pressure hold test are created (reactor pressure > 1.2 barg). If the off-gas valve behind the exhaust filter is manually operated, this valve must be closed. As soon as the Pressure Hold Test conditions are met, the next step is started.

3. Pressure Hold Test. During this interval the reactor pressure is monitored. If the pressure does not drop more than the set criterion (e.g. 0.1 barg), the test is completed successfully and the first sterilization phase will be started.

4. Sterilization phase 1. The temperature set-point is set to sterilization temperature (e.g. 121 °C). Steam valves are opened. Steam is introduced in the reactor jacket. Water (and condensate) from the jacket of the reactor is drained. This step is completed when the Pre-heat temperature is reached.

5. Preheating. The Steam-to-filter valve is opened. As a result, the gas inlet filter is preheated with steam. Condensate is removed from the filter to the drain or biowaste. When the Preheating interval has elapsed, the next step is started.

6. Sterilization phase 2. Steam is now injected in the reactor through the gas inlet filter. This sterilization step is finished as soon as the sterilization temperature is reached.

7. Sterilization. The temperature is maintained at sterilization set-point during the sterilization interval (e.g. 20 minutes). When the temperature in the reactor drops below the minimum sterilization temperature, the sterilization timer is interrupted until the sterilization temperature is reached again.

8. Natural cooling (for Empty Sterilization only). Steam inlet valves are closed. The Gas inlet valve is opened in order to prevent vacuum in the reactor. Cooling water is not yet introduced into the jacket of the reactor. This step is completed when the Natural cooling temperature (e.g. 115 °C) is reached.

9. Cooling 2. Water is introduced into the jacket of the reactor (forced cooling). This step is completed as soon as the cooling 2 temperature (e.g. 80 °C) is reached.

10. Cooling 3. This cooling step is a continuation of cooling 2. This step is completed as soon as the cooling 3 temperature (e.g. 40 °C) is reached.

11. End. The sterilization is finished. Press the OK button to return to the Home screen.



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5.3.1 START In the Menu – Sterilization screen, press the Start full sterilization button or the Start empty sterilization button, depending on the status of the bioreactor (full or empty).

Before starting the sterilization routine, the operator has to confirm that the pH and temperature calibrations are performed or still

functioning ok. If both are calibrated, press the blue Check button: it will turn brown now to indicate that the calibration has been verified. Press the blue Continue button.

5.3.2 INITIALIZATION The sterilization routine is initialized: the conditions are set for the next step (the pressure hold test). From this moment on, you can abort the sterilization process by pressing the Stop sterilization button. The illumination inside the bioreactor can be switched on (for a predefined period of time) by pressing the Light icon. During the sterilization process, the screen will show the current step (or phase) on a green background. Finished steps are shown in brown.

5.3.3 PRESSURE HOLD TEST As soon as the pressure hold test condition (i.e. the finish condition of the initial phase, as shown to the right of the Init field) is met, the pressure hold test is started. A timer is started, of which the remaining time (in seconds) is shown at the right-hand side of the screen.



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5.3.4 PHASE 1 If the pressure hold test completes successfully, the first heating phase is started. The rector is now heated up. Phase 1 is completed as soon as the preheat filter temperature is reached.

If you stop the sterilization process during this or coming steps, the controller will turn to an idle state until the reactor is cooled down to process temperature. As soon as this condition is met, new commands can be entered.

5.3.5 PREHEATING The predefined interval of heating the reactor is started. The timer counts down the preset time period.

5.3.6 PHASE 2 In Phase 2, steam is injected in the reactor through the gas inlet filter. This step completes as soon as the sterilization temperature in the reactor is reached.



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5.3.7 STERILIZATION The reactor is kept at sterilization temperature until the sterilization interval has elapsed: the timer counts down. If during the sterilization interval the reactor temperature drops below sterilization set-point, the timer stops counting. If the sterilization temperature stays too low for 10 minutes, the sterilization routine is interrupted: the message “Sterilization Failed, Temperature too Low” is shown. Check the situation of the reactor and the actuators. Press the blue Restart sterilization button to continue.

From this moment on, the sterilization process cannot be stopped anymore.

5.3.8 NATURAL COOLING For empty sterilization only! During Natural Cooling, the empty reactor is aerated before cooling water enters the jacket, in order to prevent a vacuum in the reactor. During full sterilization, this first cooling step is omitted because, due to the relatively low headspace volume, cooling water can be introduced without risking an undesired vacuum. This step ends when the temperature has dropped below set-point (i.e. enough to start forced cooling).



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5.3.9 COOLING 2 After the sterilization interval (during full sterilization) or the natural cooling (during empty sterilization), step Cooling 2 starts. The steam valves are closed, the gas inlet valve is opened, and cooling water is introduced into the reactor jacket. Cooling 2 ends when the reactor temperature has dropped below the set-point for this cooling step (pressure is controlled at set-point for this step).

5.3.10 COOLING 3 Forced cooling is continued during step Cooling 3. Cooling 3 ends when the reactor temperature has dropped below the set-point for this cooling step (pressure is controlled at set-point for this step).

5.3.11 END The sterilization routine is now completed. Press the OK button in order to return to the Home screen.



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5.4 MANUAL CONTROL

Actuators that are not listed in this screen can be manually operated through the Sterilization Configurations screens. Refer to chapter 5.2.3!

This option enables manual control of actuators during cultivation or idle status. If an analog actuator is configured, its blue activity button shows its activity percentage. Press this button if you want to edit this value in the numeric keypad. The other activity buttons toggle between Open and Closed or On and Off. Press the View tags button to display the (valve) numbers of the shown actuators. Press the View names button to return to displaying the actuator’s names.

Per default, the Clean Steam supply valve is always open except when the Emergency Stop button is pressed or the ez-Control is switched off. As a result, the sample and bottom valves and any addition valves can be sterilized at any time during fermentation or idle status.


ez-Control for In Situ sterilizable Bioreactors REMOTE ACCESS Software Version 1.8X, Document Version 1.0

63

6 REMOTE ACCESS Remote Access to the Web-Interface of the ez-Control can be enabled through a remote PC-connection (network or peer-to-peer). Make sure that remote access to the ez-Control is enabled (refer to section 4.3.4.3).

6.1 SETTING ON THE PC 1. Set the IP address in the same range as the

ez-Control. Example: 192.168.1.x. Where x = 0 … 255 and x is different than the IP address of the ez-Control.

2. Set the Subnet mask. Example: 255.255.255.0

How to go to the IP address screen? (contact the System Administrator for assistance). Windows Start \ Control panel \ Network- connections \ Local Area Connection (double click) \ Properties \ Internet Protocol (TCP/IP) (double click) / Use the following IP address: 3. Check the Internet security settings, especially the

setting of “Use TLS 1.0”. How to go to the Internet security setting screen? (contact the System Administrator for assistance).

Open Internet Explorer \ Tools \ Internet options \ Advanced \ Security settings option:


REMOTE ACCESS ez-Control for In Situ sterilizable Bioreactors Software Version 1.8X, Document Version 1.0

64

6.2 STARTING THE SECURITY CERTIFICATION This certification procedure needs to executed the first time the Remote access is established on your computer. The next time you start the Internet Explorer, the “Certification error” that is described below, is omitted. 1. Start your computer at System Administrator level to allow this security certification.

2. Open the Windows Internet Explorer (version 6.0 or higher).

Other web browsers can also be used, e.g. Firefox.

3. Insert the IP address of the ez-Control on the address bar: https://192.168.1.x and Enter.

4. Ignore the message about a Security problem:

”There is a problem with this web site’s security certificate”. Select the option for “Continue to this website”.

5. The Login screen is displayed. Click on the red rectangle in the address bar.

6. The warning is displayed.

Select the option . 7. The Certificate screen is displayed.


https://192.168.1.xx/



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8. The Certificate Import Wizard (welcome)

screen is displayed.


9. The Certificate Import Wizard Certificate (store) screen is displayed. Press the button to proceed.

10. The Certificate Import Wizard Certificate (completing) screen is displayed. Press the button to proceed.

11. The Security Warning screen is displayed.




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12. Press the button to finish the Certificate Import Wizard.

Remark: Now the certification procedure has been completed. Now you can continue the login procedure.

6.3 STARTING THE REMOTE ACCESS LOGIN PROCEDURE

1. Open the Windows Internet Explorer (version 6.0 or higher). Other web browsers can also be used, e.g. Firefox.

2. Insert the IP address of the ez-Control on the address bar. Example: https://192.168.1.11 and Enter.

3. The Security Alert screen is displayed.

Press the button. 4. The second security Alert screen is displayed.


https://192.168.1.11/



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5. The Login screen is displayed.

Enter the password of the ez-Control and press button Login. If the ez-Control is not in the View mode, then the message is displayed:

ACCES DENIED System not in View mode Go to Login screen

6. The ez-Control home screen is displayed.

It takes several seconds to download a screen.

During Remote Access, the Human Interface of the ez-Control is locked. The login field is blinking (straight corners):

/ The remote user is automatically logged off after the entered time-out interval (refer to section 4.3.4.3) Maximum time-out interval = 60 min.

Now you can use the mouse pointer of your PC to click on buttons in order to navigate through the ez-Control screens. When logged in as Operator or System Engineer, all available functions at that level are now available for the remote user. Any button that is clicked on is directly sent to the ez-Control. However, it takes several seconds before the new screen is downloaded in the web browser. When inserting a set-point, it is possible to enter all numbers on the screen before the screen is updated in the web browser. When entering multiple numbers, it is advised to enter numbers only after the update of the screen such that the operator can verify the entered number before accepting it on the ez-Control. *The password for remote access is defined in the Remote access settings screen. Press: Menu > Utilities > Communication > Remote access setting to access this screen and to view the current password.



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6.4 CHANGING THE REMOTE ACCESS LEVEL You can change the remote access level on the PC screen.

Depending on the login level (View, Operator or System Engineer), access at different levels of the ez-Control is allowed. Refer to section 2 of this Software Reference manual.

1. Click on at the left bottom corner of the screen. 2. Now the Access level screen is displayed. 3. Select the required Access level (Operator or

System Engineer; Service Engineer level is for Applikon personnel only).

4. Enter the password as used on the ez-Control itself to login on this access level.

5. Click on the button.

6.5 LOGGING OFF Click on the to discontinue remote access. After logging off, the Login screen is displayed again.

When the web browser on the PC is closed without clicking on , keyboard accessibility will be available again in less than 30 seconds.


ez-Control for In Situ sterilizable Bioreactors SYSTEM WARNINGS Software Version 1.8X, Document Version 1.0

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7 SYSTEM WARNINGS

7.1 POWER FAILURE DURING OPERATION In case a power failure occurs that takes longer than the brown out time during operation (running controllers), the ez-Control will detect this event. It will restart with a Power Fail message. The user is logged out (returned to View mode). Restart after power failure 1. Log in as System Engineer. 2. The options Resume and Halt are now

enabled. 3. Before pressing the Resume button, make sure

that the bioreactor is in a safe condition to restart the process.

4. Pressing the Halt button will turn the ez-Control into an idle mode (no running control loops).


SYSTEM WARNINGS ez-Control for In Situ sterilizable Bioreactors Software Version 1.8X, Document Version 1.0

70

7.2 EMERGENCY STOP DURING OPERATION In case during operation the Emergency Stop button was pressed, control is stopped immediately. However, measuring will be continued. The Emergency Stop screen will be presented. Restart after emergency stop 1. Remove the cause of the Emergency Stop in

order to return to a stable process. 2. Now turn the Emergency Stop button clockwise

until it resets itself to the normal position. 3. Log in as System Engineer. 4. The options Resume and Halt are now

enabled. 5. Before pressing the Resume button, make sure

that the bioreactor is in a safe condition to restart the process.

6. Pressing the Halt button will turn the ez-Control into an idle mode (no running control loops).

ez control for in situ sterilizable bioreactors · 3.3 alarm limits ... 5.2.1 full sterilization...

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