6 100419 SCADA_ROK_with Template

8/8/2019 6 100419 SCADA_ROK_with Template

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Room C 203

2nd FloorChemical Eng & Advanced Materials

BioXpert Training

Course

1


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BioXpert Course June 2010

2

BioXpert Overview

Ronan OKennedy


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SCADA Advantages Supervisory Control And Data Acquisition

Continuously collects & stores real time process data Batch to batch comparisons

Real time process diagnostic

Provides higher level process control through sequences Automating phase transitions

Temp Step-Up, Inducer feeding

Bolus nutrient feeds & Fed batch profiles

View process remotely (and make changes!)

More recent systems implement ISA88/95 philosophy Consistent model for process descriptions

Hierarchical & Extensible Process view

Can provide Recipe Management Consistent bioreactor set up and performance

Remote Log Bioreactor configuration


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Phases Additional Sensors

Adapting Configurations : Applications

Batch Fed batch

Continuous

Perfusion 2 stage

Microbial S. cerevisiae

P. pastoris

Mammalian

cell

Benchtop Disposable

SIP

Exit Gas analysis

Cell Density

dCO2

Inducer feeds

Bolus nutrient feeds

Fed batch


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Design Considerations Physical Layout

Unit procedure Metadata needs Unit procedure naming convention, Batch geneology, Raw materials, Unique batch names

Online variables + extras

Offline variables

Formulas & Derived variables

User TrainingConsistent file naming conventions

Procedures for data management (saving) Can procedures be automated ?

Data hygiene & analysis methods How much time will be spent on this ? Can methods be automated ?


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Process design philosophy

Developed initially as

software design standard

Models & terminology for

structuring production

processes

Models for developing

equipment control

ISA88 Design Philosophy

ENTERPRISE

EQUIPMENT MODULE

SITE

AREA

PROCESS CELL

UNIT

CONTROL MODULE

OPERATION

PROCEDURE

UNIT PROCEDURE

PHASE

PHYSICAL MODEL

PROCEDURAL

CONTROL MODEL

May contain

May contain

May contain

May contain

May contain

May contain

Consists of anordered set of



FromMenendez &Tanner(2007)Pharma Eng 27(2) pp 1


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BioExpert 2 with ADI 1030 & 1010

Example SCADA

Not ISA 88 compliant but can be configured to be close analogy

Cannot upload configuration to Controller*

Think

Current & Future uses

Expansion (Multi vessel & lab)

New capabilities

Managing Recipes and Protocols

Backup


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Experimental Cycle

Identify common traits & differences required at dev each stepto simplify subsequent analysis & comparison Config & Templates take into account as many possible

combinations Think of how you will want to analyse data This may take a few iterations !

Planning Setup Execution Analysis

Aims Set up templates Raw materials &

consumables

Probe checks Equipment set up Revival record Inoculum record

Passage record

Offline datarecord

Stored samplesrecord

Passage record Media batch

Run Notes/deviations/problems

Quality samples Compile offline &

Online data Derived

calculations Update overviewrecord & datacheck

Analysis

Record batch to batch traceability (Excel File)


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Process Cell =R101

Units =

B002L01-> B002L08

Process Cell =R201

Units =B002L09->B002L12B005L01,S020L01,

S070L01,D250L01

Physical Arrangement Two areas

Small Scale Pilot Scale

8 bioreactor per area

Folder for each bioreactor

Pilot lab has mixture ofbenchtops,SIP &disposable

Consistent naming code B = Benchtop S = SIP D = Disposable

Back up frequently !!

COM port4

COM port4

\\OFFICE

-Sh

are

\

\R101\

\R201\


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Bioreactor / User Folder Naming

Conventions Consistent Across existing & planned bioreactors

005L01,005L02,005L03 etc

Entensible

Can be expanded without changes

Subfolders are possible

eg "C:\Program Files\BioXpert\FERM.EXE" 005L01\PERFUS -c110905TEMP

Maintain some rules Same # of characters for folder names


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Project & Experiment

Campaign & Batch

Seed Lot/ SF

Seed Lot Bioreactor

Production Lot Bioreactor

Online data Offline Data Quality data

Online Data Offline Data Quality data

Online Data Offline Data Quality data

Annotations

Annotation

Annotation

Harvest

Online Offline Quality data Annotation

Think of the hierarchy !

Project, Experiment

Lot, SF type, incubator, cellline, cell bank, vial, passage,medium, protocol

Lot, Bioreactor, source passage,medium, protocol, recipe

Lot, Bioreactor, source,passage, medium, protocol,recipe

Lot, Harvest Skid, source, Filtertype, area, protocol,recipe

Metadata


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Configuration Steps

Configure Controllers

Configure & Test COMs

Configure Software Acquisition &

Variable Names

Configure Template : Constants,

Formulas, Offlines & Statements

Copy settings to other units in

structured hierarchy

Back up structure & Set up file

backup


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Summary Dont depend default configurations

Define your requirements carefully

Consider metadata requirements

Hierarchical structure

Be consistent with multiple bioreactor configurations

Consistent Data handling operations

Consider data output requirements


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Thank You


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Backup


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BioExpert V2 : Desktop shortcuts

DesktopShortcut

for each vessel

FermX.ini

User Folder

"C:\Program Files\BioXpert\FERM.EXE" B002L01 -c11 TEMP1

UserFolder

StartupFerm11.ini

StartupTemplate. frmfile

Where X = Bioreactor number

Target =

Where User = Bioreactor Name

Defines the online, comm port ,channel, ADDAcard and other serial config

X is the number of the ini file, not thebioreactor channel number.

You can have multiple ini files for a singlebioreactor with different configs

Defines the startup data folder, .ini file &Template file

Template file defines offline, constants,control law profiles & statements

You can have multiple shortcuts to a singlebioreactor for different configs

Use consistent, extensible Names 8 Character maximum for folder, .ini & .frm file

names !! Make a local back up copy of all config files Set up scheduled data backup to network drive

(FolderClone or MS SyncToy)

TEMPxxx.frmTemplate File

Logging frequency Offline variables, constants Substrates & products

characteristics , formulas, Formulas, Control profiles &

Statements Alarms


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Copy Ferm11 and rename

Ferm12,Ferm13,Ferm14 etc

Create folders for each

bioreactor & copy 0905Temp

into each folder

Copy Desktop link and rename

for each bioreactor Update Target in Desktop link to

point to relevant ini & folder

Open each desktop link &

modify device number / COM

port as required

Backup ! Folderclone Standard

Done !

Copy settings to other units in

structured hierarchy

Back up structure & Set up file

backup


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User Steps

Start Bioexpert with desktop link

Set start time & record relevant

metadata Name file (recommend reverse date

with initials)

Start run, sample & analyse Update batch summary sheet

Compile to shared file store / Database


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Tracking & Compiling data flow

COM port4

COM port4

Maintain batch summary list

Metadata

Important measurements (Qp, peak VCC etc)

Use excel autofilter to sift and select

VLOOKUP for more complex searches

Maintain Simple Data store

Unique code for each Bioreactor run

Easily identified batches & main attributes

Master Spreadsheet to summarise genealogy

Batch comparison easily automated

Documents

6 100419 SCADA_ROK_with Template