Corning Ascent® Fixed Bed Reactor Process Development System User manual

Brand: Corning

Model: Ascent® Fixed Bed Reactor Process Development System

Type: User manual

Corning® Ascent® Fixed Bed Reactor

Process Development System

Instruction Manual – Addendum 1: Software Updates

Catalog Number: 6970

This Addendum to the Corning Ascent FBR Process Development Instruction Manual (CLS-AN-633DOC)

describes Ascent FBR PD Controller software updates introduced to improve reliability and enhance the

user experience.

Please contact your Corning representative for more information.

The following sections of the Corning Ascent FBR PD Instruction Manual have been updated:

Section 5.3: Updated Pump Speed Range

Section 6.0: Updated Process Overview

Section 6.0: Updated Phase Run Frequency and Constraints

Section 7.2: New Display Symbols Added

Section 7.3: Updated User Access Levels

Section 7.9.1: Updated MCB DO Control Setpoint Input Limits

Section 7.14: New Alarm Types Added and Equipment Module Interlock List Updated

Section 8.1: Updated Calibration Range and Recommended Speed

Section 8.2.6: Media Exchange Phase Corrections

Appendix 2: New Phase Device Permissives Added

Additional Updates: BRX Loop Volume and MCV Volume Change Restrictions

Section 5.3: Updated Pump Speed Range, Table 5-8

In Section 5.3, Table 5-8, Label P2 Description has been updated to:

Pump speed: approximately 10 to 800 mL/min. (calibration-dependent).

Section 6.0: Updated Process Overview, replaces Figure 6-1

Figure 6-1. One owchart example

of a Corning Ascent FBR process

sequence. The Ascent FBR is a exible

system capable of customization to

t the user’s needs.

Section 6.0: Updated Phase Run Frequency and Constraints, replaces Table 6-1

Table 6-1. Phases run frequency and conditions.

Run Frequency Phase Constraints

Once Initialize Cannot be cancelled.

Media Fill/Prime Cannot run after Harvest Preparation or Lysis Preparation has been completed.

Media Conditioning Cannot run after Harvest Preparation or Lysis Preparation has been completed.

Inoculation Cannot run after Harvest Preparation or Lysis Preparation has been completed.

Cannot run until Media Maintenance has run at least once.

Transfection Cannot run after Harvest Preparation or Lysis Preparation has been completed.

Harvest Preparation Cannot run after Lysis Preparation has been completed.

Lysis Preparation Cannot run after Harvest Preparation has been completed.

Shutdown Cannot be cancelled.

Multiple Media Exchange Cannot run after Harvest Preparation or Lysis Preparation has been completed.

For typical in-process media changes, it is recommended to execute the Media Removal

Phase followed by the Media Addition Phase to avoid removing media from the bioreactor.

Media Maintenance Cannot be cancelled.

Cannot run after Harvest Preparation or Lysis Preparation has been completed.

Completed once before inoculation can be initiated and can be performed any time to

set new culture conditions provided no other phases are running.

Harvest Wash, Cell Release,

Cell Removal, Final Rinse

Cannot run after Harvest Preparation or Lysis Preparation has been completed.

Once Harvest Preparation is initiated, these Harvest Phases can run multiple times to

detach cells from the substrate and collect the cells in the harvest collection bottle.

System Drain, Solution 1,

Solution 2, Solution 3

Cannot run after Harvest Preparation or Lysis Preparation has been completed.

Once Lysis Preparation is initiated, these Lysis phases can run multiple times to lyse cells

and harvest product.

System Drain Can only put Solution 1, Solution 2, and Solution 3 phases on Hold.

Auxiliary Phases Cannot be run while a Harvest or Lysis phase is active (Harvest Prep, Harvest Wash, Cell

Release, Cell Removal, Final Rinse, Lysis Prep, System Drain, Solution 1-3).

Sampling Cannot run after Harvest Preparation or Lysis Preparation has been completed.

Section 7.2: New Display Symbols Added to Table 7.2

Table 7-2. Display symbols and colors.

Illustration Symbol Description Meaning

Process status indicators

System displays text on the recirculation pump faceplate

warning the user of the impending interlock with live

timer. The pump is outlined in red and has a red double

exclamation mark.

Low Low Flow alarm is active.

System displays text on the recirculation pump faceplate

warning the user of the impending interlock with live timer.

The pump is outlined in yellow and has an orange single

exclamation mark.

Low Flow Alarm is Active.

Illustration Symbol Description Meaning

Process status indicators

Recirculation pump is outlined in flashing red rectangle

with “Leak Detected” in red text above the pump.

Exclamation mark in a yellow triangle is shown next

to pump.

Recirculation Pump leak is

detected and active.

Recirculation pump is outlined in flashing white rectangle

with “Leak Cleaned” in black text above the pump. A white

bell is shown next to the pump.

Recirculation Pump Leak was

detected and is no longer active but

has not been acknowledged yet.

Red octagon with “Max Flow” in red text shown next to

applicable MFC. MFC is outlined in yellow rectangle.

MFC Overflow alarm is active.

Section 7.3: Updated User Access Levels, replaces Table 7.3

Table 7-3. Login access levels.

Access Levels

Action Default Operator Engineer Admin

Observe process overview screens 

Sys Button (Software Information/Clean Screen) 

Observe historical trends 

Sys Button (Shutdown) 

Initiate and Cancel Phases 

Use of Global Abort Button 

Change Probe Calibration 

Pump Calibration 

Pressure Zero Point Adjustment during Initialize Phase 

Data Button (Data File Entry/Meta-data Entry/Recirc Volume) 

Change Date and Time 

View Alarm History 

Password Admin Button (Reset user passwords)  

USB File Access  

Enable/Disable VPN  

Set EMs into Operator Mode (Start pumps/pinch valves/MFCs manually)  

Diagnostics  

Change Alarm Setpoints  

Advanced control strategy for FBRX DO  

Enable Bypass 

Use Simulated Values 

Configure Advanced Properties 

Exit Application 

Non-Phase Tare Button 

Section 7.9.1: Updated MCV DO Control Setpoint Input Limits

Section 7.9.1 NOTE 2 has been updated to:

Entries in the table will be limited to avoid sending setpoints to the MFC that are unobtainable by the equipment. User will see a range

for allowable total ow values based on the O2%. If these ranges are violated at any point, the row will be highlighted red. If, under certain

circumstances these limits could be violated (e.g., Max CO2 ow is required from pH loop while max. Total Flow is required from MCV DO

loop), the row will highlight yellow. MFC setpoints will be limited to 100% in this case and O2% will be maintained at the expense of the

requested Total Flow.

Section 7.14: New Alarm Types Added to Table 7-20

Table 7-20. Alarm type.

Alarm

Alarm Event How to Clear

Recirculation Pump Low Flow Alarm –

Recirculation pump flow rate is between

10 and 30 mL/min.

If pH loop is active, pH loop output is

limited to ≤50% while this alarm is active.

Increase recirculation pump speed to be

greater than 30 mL/min.

Recirculation Pump Low Low Flow Alarm –

Recirculation pump flow rate is less than

10 mL/min.

All control loops are interlocked. Message

appears on pump faceplate warning the

user to increase recirculation pump speed

for 60 seconds. After 60 seconds the alarm

is activated and message alerts the user of

alarm condition.

Increase recirculation pump speed to be

greater than 10 mL/min.

MFC Over Flow Alarm – MFC setpoint from

MCV DO loop is equal to its maximum flow rate

Graphics appear next to the applicable

MFC alerting user of alarm.

Reconfigure MCV DO control table to not

exceed MFC maximum flow rates.

Recirculation Pump Leak is detected Recirculation pump is interlocked, and

graphics appear next to the recirculation

pump alerting the user of the leak status.

Leak must be cleaned up, and once liquid is no

longer detected, the alarm and interlock must

be reset from the recirculation pump interlock

faceplate or via the refresh button in the

bottom left hand corner of the main screen.

Section 7.14: Updated Equipment Module Interlock List, replaces Table 7-21

Table 7-21. Equipment module interlock list.

Equipment Module (EM) Conditions to Interlock

All EMs

Recirculation pump flow rate is less than 10 mL/min. for 60 seconds.

When Global Abort is initiated.

Pressure HIHI alarm is active.

MCV Temperature EM

After agitator is off for 30 seconds.

Any MCV Heater fault is active.

MCV Temperature sensor failed or out of range.

MCV Temperature Sensor is disconnected.

MCV Temperature HIHI alarm is active.

Pressure HIHI alarm is active.

FBRX Temperature EM

After agitator is off for 30 seconds.

Any FBRX Heater fault is active.

FBRX Temperature sensor failed or out of range.

FBRX Temperature Sensor is disconnected.

FBRX Temperature HIHI alarm is active.

Pressure HIHI alarm is active.

MCV DO EM

MCV DO Sensor failed.

Any MCV DO sensor fault active.

Air MFC Fault.

CO2 MFC Fault.

Valve XV-0117 Fault.

Agitator Fault.

Pressure HIHI alarm is active.

FBRX DO EM

FBRX DO Sensor failed.

Any FBRX DO sensor fault active.

Recirculation pump is interlocked.

Recirculation pump leak detected.

Pressure HIHI Alarm is active.

pH EM

Any pH sensor fault active.

MCV Media HIHI Alarm is active.

Base Pump is interlocked.

CO2 MFC is interlocked.

Valve XV-0117 Fault.

Section 8.1: Updated Calibration Range and Recommended Calibration Speed, replaces Table 8-3

Table 8-3. Pump tubing for calibration.

Pump Tubing Type

Typical Full-scale

Calibration Range

Recommended

Calibration Speed

Media LS17 platinum cured silicone tubing 700 ± 100 mL/min. 25%

Recirculation LS17 PharmaPure® tubing 800 ± 80 mL/min. 25%

Base LS16 platinum cured silicone tubing 90 ± 100 mL/min. 50%

Feed LS16 platinum cured silicone tubing 90 ± 100 mL/min. 50%

Section 8.2.6: Media Exchange Phase Corrections

Step 2, NOTE 2 is updated for this phase to:

Media Exchange creates a media addition setpoint limit based on current conditions (3000 mL – Current MCV Volume + Media Pump

Removal Volume).

Step 5 is updated for this phase to:

In this case, logic is in place to prevent overlling the MCV as follows:

• If MCV Volume is <2.75L, the user is prompted to jog the recirc pump in reverse to drain the BRX to desired level. When prompt is

acknowledged, specified removal volume is automatically removed from MCV via the media pump.

• If MCV Volume is ≥2.75L AND the Media Removal Volume <BRX Loop Volume, then specified volume is automatically removed from

the MCV via the media pump

• If MCV Volume is ≥2.75L AND Media Removal Volume ≥BRX Loop Volume, then the media pump automatically removes the Recirc

Volume (BRX Loop Volume) from the MCV before prompting the operator to jog the recirc pump in reverse to drain the BRX to the

desired level. When prompt is acknowledged, the remaining portion of the specified removal volume is automatically removed from

MCV via the media pump.

Appendix 2: New Phase Device Permissives Added to Table A2-1

Table A2-1. Phase permissives.

Phase Automated Phase Permissive/Devices Put into Program Mode

Lysis Prep All devices and equipment modules.

System Drain Orange valve, red valve, yellow valve, green valve, blue valve, media pump, recirc pump, vent filter heater.

Solution 1 Yellow valve, blue valve, green valve, Air MFC, Agitator, Vent Filter heater, MCV temperature EM, FBRX Temperature EM.

Solution 2 Yellow valve, blue valve, green valve, Air MFC, Agitator, Vent Filter heater, MCV temperature EM, FBRX Temperature EM.

Solution 3 Yellow valve, blue valve, green valve, Air MFC, Agitator, Vent Filter heater, MCV temperature EM, FBRX Temperature EM.

Additional Updates

BRX Loop Volume and MCV Volume Change

Restrictions

During operation of certain phases, the modication

of BRX Loop Volume is disabled with an associated

note in that pop-up window. The BRX Loop Volume

pop-up window is accessed from the Data and then

Recirc Volume buttons on the left button ribbon.

Likewise, during the operation of certain phases the

modication MCV Volume adjustment is disabled with

an associated note on the pop-up window. The MCV

Volume adjustment is accessed from the MCV Vol Adj

button on the Process Overview, Harvest Overview,

and Lysis Overview screens next to the MCV.

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