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How-to → Examples → NovaBio Pharmaceutical AI Designer Example


This example demonstrates the solution NovaBio_Cambridge created by the MCP for Designer.

Solution download: NovaBio_Cambridge.dbsln

Technical Specification PDF: NovaBio_BioProcess_Spec.pdf

OPC-UA I/O Address Sheet: NovaBio_OPC_UA_IO_Addresses.xlsx

Showcases:

  • Build a complete cGMP biopharmaceutical SCADA solution from a PDF specification and an Excel I/O sheet.
  • Connect to an Emerson DeltaV DCS over OPC-UA with certificate-based security and a service account.
  • Organize 23 tags across six manufacturing suites under an ISA-95 Unified Namespace rooted at NovaBio/Cambridge/Mfg/.
  • Configure two-tier alarming with Critical (comment-required acknowledgment) and Warning groups for FDA 21 CFR Part 11 audit trails.
  • Historize 20 analog tags across two tables with engineering-unit deadbands and 365-day retention.
  • Compute rolling statistics through Calculation user-defined types to feed downstream ML pipelines.
  • Visualize all six suites on one process overview screen with color-coded panels, tank visuals, vertical bargraphs, and a 30-minute trend strip.
  • Identify five candidate ML opportunities across bioreactor, chromatography, and utility tags using the built-in ML.NET integration.


This solution was created as a demonstration of FrameworX AI Designer MCP capabilities. It is not intended for production use. Device connections, alarm limits, and process values are illustrative only and have not been validated against real equipment or regulatory requirements.





Summary

This page contains the technical details for the NovaBio Therapeutics AI Designer demo. The AI reads the attached PDF specification and Excel I/O address sheet to build the complete SCADA solution covering all 6 process suites of a cGMP monoclonal antibody manufacturing facility in Cambridge, MA.

Item

Value

Solution Name

NovaBio_Cambridge

Platform

FrameworX fx-10.1 / Enterprise Unlimited

Industry

Biopharmaceutical / Life Sciences

Protocol

OPC-UA (Emerson DeltaV DCS)

UNS Root

NovaBio/Cambridge/Mfg/

Total Tags

23 (21 process + 2 Calculation UDT instances)

Alarm Items

24 (Critical and Warning groups)

Historian Tags

20 analog tags, 365-day retention

Approx. Build Time

~5 minutes (AI-assisted end-to-end)


Demo Prompt

The following prompt was submitted to the AI Designer MCP along with the two attached documents. The AI read both files and built the entire solution autonomously based on this input.

<role> 
You are an automation engineer in life and science business and specialized in FrameworX. 
</role>

<context> 
I have attached 2 files, one is the specification which describes how the project is actually planned in .pdf, it mentions the UNS structure (tags), device information and alarms, and the other one is an excel which defines the address for the device. And my final goal here is to create a FrameworX solution to implement an automation project 
</context>

<instruction> 
1 - Read both files and understand the implementation 
2 - Make the plan to implement the UNS, alarms, historian, 3x2 dashboard displays with 3 gauges, 2 trends, 1 alarmviewer. 
3 - Wait for my approval to start creating the solution  
4 - After creating each module, wait for my confirmation to go to the next one
</instruction>

Attached documents with the prompt

  1. NovaBio_BioProcess_Spec.pdf — cGMP equipment specification with facility suite descriptions, OPC-UA connection parameters, key instrument list with engineering ranges, and critical alarm limits (Warn/Crit Lo/Hi) per FDA/ICH guidelines
  2. NovaBio_OPC_UA_IO_Addresses.xlsx — Two-sheet workbook: full I/O address list with OPC-UA Node IDs and FrameworX UNS paths per tag; plus a connection configuration sheet with endpoint URL, namespace index, security mode, and service account

Approximate creation time = 5 minutes.

Facility Overview

NovaBio Cambridge is a cGMP biopharmaceutical manufacturing site producing monoclonal antibodies for clinical and commercial supply. Two 2,000 L fed-batch bioreactor trains feed an integrated downstream purification and formulation suite. The facility is controlled by an Emerson DeltaV DCS connected to FrameworX SCADA via OPC-UA, organized around an ISA-95 Unified Namespace.

Suite

Name

Description

USP-SEED

Seed Train

20 L and 200 L single-use seed bioreactors

USP-PROD

Production Bioreactors

Two 2,000 L STRs — Trains A and B

DSP-HARV

Harvest & Recovery

Centrifugation and tangential flow filtration

DSP-CHROM

Chromatography

Protein A capture, CEX and AEX polishing columns

DSP-FORM

Formulation & UF/DF

Ultrafiltration, buffer exchange, concentration

UTIL-CIP/WFI

Utilities

CIP/SIP skids, clean steam, and WFI loops

Control System Architecture

DCS Connection

Parameter

Value

Notes

Protocol

OPC-UA

Connection from FrameworX to DeltaV DCS

Device / PLC

Emerson DeltaV v14.3 DCS

Main plant controller

Device IP Address

10.10.1.5

Static IP — plant network segment

OPC-UA Endpoint

opc.tcp://10.10.1.5:4840

Default DeltaV OPC-UA server port

Namespace

ns=2

NovaBio process namespace on DeltaV server

FrameworX Device Name

NovaBio_DeltaV

Node object name in FrameworX solution

FrameworX Channel

NovaBio_OPC_Channel

OPCUA protocol driver instance

UNS Root Path

NovaBio/Cambridge/Mfg/

ISA-95 hierarchy root for all tags

Subscription Rate

1000 ms analog / on-change digital

Matches historian logging rate

Security Mode

SignAndEncrypt / Basic256Sha256

Certificate auth; service account: fxopc_svc

Tag Database by Suite

USP-SEED - Seed Train BR-S20

UNS Path

Instrument

Signal

Range

Units

OPC-UA Node ID

USP_SEED/BR_S20/Temperature

TT-S01

AI

0–100

°C

ns=2;s=NovaBio.USP.Seed.TT_S01.PV

USP_SEED/BR_S20/pH

pHT-S01

AI

0–14

—

ns=2;s=NovaBio.USP.Seed.pHT_S01.PV

USP_SEED/BR_S20/DO

DOT-S01

AI

0–200

%sat

ns=2;s=NovaBio.USP.Seed.DOT_S01.PV

USP-PROD - Production Bioreactors (Train A and B)

UNS Path

Instrument

Signal

Range

Units

OPC-UA Node ID

USP_PROD/BR_PA/Temperature

TT-PA02

AI

0–100

°C

ns=2;s=NovaBio.USP.Prod.TT_PA02.PV

USP_PROD/BR_PA/pH

pHT-PA01

AI

0–14

—

ns=2;s=NovaBio.USP.Prod.pHT_PA01.PV

USP_PROD/BR_PA/DO

DOT-PA01

AI

0–200

%sat

ns=2;s=NovaBio.USP.Prod.DOT_PA01.PV

USP_PROD/BR_PA/AgitatorSpeed

AGT-PA01

AI

0–150

RPM

ns=2;s=NovaBio.USP.Prod.AGT_PA01.PV

USP_PROD/BR_PA/HarvestFlow

FT-PA01

AI

0–500

L/hr

ns=2;s=NovaBio.USP.Prod.FT_PA01.PV

USP_PROD/BR_PB/Temperature

TT-PB02

AI

0–100

°C

ns=2;s=NovaBio.USP.Prod.TT_PB02.PV

USP_PROD/BR_PB/pH

pHT-PB01

AI

0–14

—

ns=2;s=NovaBio.USP.Prod.pHT_PB01.PV

USP_PROD/BR_PA/DOStats

—

Calculation (UDT)

—

—

Computed — no device point

DSP-HARV - Harvest and Recovery

UNS Path

Instrument

Signal

Range

Units

OPC-UA Node ID

DSP_HARV/CF_H01/BackPressure

PT-H01

AI

0–6

bar

ns=2;s=NovaBio.DSP.Harv.PT_H01.PV

DSP_HARV/CF_H01/BowlTemp

TT-H01

AI

0–80

°C

ns=2;s=NovaBio.DSP.Harv.TT_H01.PV

DSP_HARV/TFF_H01/Conductivity

CON-H01

AI

0–200

mS/cm

ns=2;s=NovaBio.DSP.Harv.CON_H01.PV

DSP_HARV/CF_H01/PressureStats

—

Calculation (UDT)

—

—

Computed — no device point

DSP-CHROM - Chromatography

UNS Path

Instrument

Signal

Range

Units

OPC-UA Node ID

DSP_CHROM/UV/Absorbance

UV-C01

AI

0–3

AU

ns=2;s=NovaBio.DSP.Chrom.UV_C01.PV

DSP_CHROM/InletPressure

PT-C01

AI

0–5

bar

ns=2;s=NovaBio.DSP.Chrom.PT_C01.PV

DSP-FORM - Formulation and UF/DF

UNS Path

Instrument

Signal

Range

Units

OPC-UA Node ID

DSP_FORM/TFF_F01/Weight

WT-F01

AI

0–500

kg

ns=2;s=NovaBio.DSP.Form.WT_F01.PV

DSP_FORM/TFF_F01/Temperature

TT-F01

AI

0–25

°C

ns=2;s=NovaBio.DSP.Form.TT_F01.PV

UTIL-CIP/SIP & WFI

UNS Path

Instrument

Signal

Range

Units

OPC-UA Node ID

UTIL_CIP/SteamTemp

TT-U03

AI

0–150

°C

ns=2;s=NovaBio.Util.CIP.TT_U03.PV

UTIL_CIP/CIP_U01/Phase

CIP-U01

DI

—

—

ns=2;s=NovaBio.Util.CIP.CIP_U01.Phase

UTIL_WFI/LoopTemp

TT-U02

AI

0–100

°C

ns=2;s=NovaBio.Util.WFI.TT_U02.PV

UTIL_WFI/Conductivity

CON-U02

AI

0–5

µS/cm

ns=2;s=NovaBio.Util.WFI.CON_U02.PV

Devices and OPC-UA Connection

Field data flows in over OPC-UA from the DeltaV controller. The connection uses one channel feeding one node and 21 read-only points; the two computed Calculation tags do not map to a device address and are populated by server-side scripts.

Layer

Object

Key Parameters

Channel

NovaBio_OPC_Channel

Protocol: OPCUA, ReadGroupMaxSize: 100

Node

NovaBio_DeltaV

opc.tcp://10.10.1.5:4840, Refresh: 1000ms, User: fxopc_svc, Security: SignAndEncrypt/Basic256Sha256

Points

21 mapped tags

All AccessType: Read, Address format: ns=2;s=NovaBio.{Area}.{Tag}.PV


On first Runtime start, the OPC-UA connection requires manual certificate trust exchange between FrameworX and the DeltaV server. Use the OPC-UA Certificate Manager in FrameworX to trust the server certificate, and ensure the fxopc_svc account is configured on the DeltaV side with appropriate read permissions on all ns=2 nodes.

Critical Alarm Limits

Per the NovaBio cGMP process specification (NVBT-MFG-SPEC-2026-003). Train B mirrors Train A limits for all bioreactor parameters.

Parameter

Tag

Warn Lo

Warn Hi

Crit Lo

Crit Hi

Unit

Bioreactor Temperature

BR_PA/Temperature

36.5

37.5

36.0

38.0

°C

Bioreactor pH

BR_PA/pH

6.90

7.10

6.80

7.20

—

Dissolved Oxygen

BR_PA/DO

30

—

20

—

%sat

Centrifuge Back-Pressure

CF_H01/BackPressure

—

4.5

—

5.5

bar

Column Inlet Pressure

DSP_CHROM/InletPressure

—

3.5

—

4.5

bar

Product Temperature

TFF_F01/Temperature

2

8

1

10

°C

WFI Loop Temperature

UTIL_WFI/LoopTemp

72

85

70

88

°C

WFI Conductivity

UTIL_WFI/Conductivity

—

1.3

—

1.5

µS/cm

Alarm Groups

Group

AckRequired

Sound

LogEvents

Purpose

Critical

Comment (operator must type note)

Exclamation

All

cGMP critical parameter breaches — full audit trail

Warning

Yes

Beep

All

Approaching process limits — early warning


The Critical alarm group requires operator comments on acknowledgment (AckRequired: Comment). This ensures every critical alarm acknowledgment generates an audit trail entry — a requirement under FDA 21 CFR Part 11 and EU Annex 11 for electronic records in pharmaceutical manufacturing.

Historian Configuration

The demo records 20 analog process values continuously, organized into two historian tables and kept on disk for 365 days using the built-in tag historian. Deadbands are set in engineering units so logged values reflect process-significant change rather than sensor noise.

Table

Tags

Suites

TimeDeadband

Retention

Process_Tags

17

USP-SEED, USP-PROD, DSP-HARV, DSP-CHROM, DSP-FORM

1000 ms

365 days

Utility_Tags

3

UTIL-CIP, UTIL-WFI

1000 ms

365 days

Deadband Configuration

Tag Type

Deadband

Rationale

Bioreactor pH

0.005

Small pH drift is biologically significant

UV Absorbance 280nm

0.005

Chromatography peak resolution

Bioreactor Temperature

0.05 °C

Process setpoint window is only ±1 °C

Pressure signals

0.05 bar

Alarm limits are 0.5–1.0 bar apart

WFI Conductivity

0.01 µS/cm

USP <1231> requires resolution to 0.1 µS/cm

Steam / Utility temperatures

0.2–0.5 °C

Looser — less regulatory significance


Both historian tables have SaveQuality: true — OPC-UA quality flags (Good/Bad/Uncertain) are stored alongside every value. Bad-quality readings must be excluded from batch records and process capability calculations.

Displays

The demo opens to a single process overview screen that shows all six suites at a glance. Suite panels are color-coded, each suite has tank visuals and vertical bargraphs for every process variable, and a full-width 30-minute trend strip runs across the bottom.

Display Layout

Region

Content

Header bar

Facility title + DCS connection info

Top row — left

USP-SEED: vertical tank (temperature) + bargraphs for pH and DO

Top row — center

USP-PROD: Train A and B tanks + bargraphs for Temp, pH, DO, Agitator RPM, Harvest Flow

Top row — right

DSP-CHROM: bargraphs for UV absorbance 280nm and column inlet pressure

Bottom row — left

DSP-HARV: bargraphs for centrifuge back-pressure, bowl temp, TFF conductivity

Bottom row — center

DSP-FORM: bargraphs for retentate weight and product temperature

Bottom row — right

UTIL: bargraphs for CIP steam temp, WFI loop temp, WFI conductivity

Footer trend strip

30-min TrendChart — Train A Temp (orange), pH (teal), DO (sky blue), Agitator RPM (green)

Symbols Used

Symbol

Used for

Instances

HMI/Tanks/VerticalTank_Scale

Bioreactor vessel visualization — fill level driven by temperature

4

HMI/Linear_Gauge/LinearGauge2

Vertical bargraphs for all process variables across all suites

14

Suite Color Coding

Suite

Panel Header Color

USP-SEED

Dark blue — #1E4976

USP-PROD

Dark green — #1B5E20

DSP-CHROM

Dark purple — #4A148C

DSP-HARV

Dark brown — #4E342E

DSP-FORM

Dark teal — #006064

UTIL-CIP/WFI

Dark indigo — #1A237E

Process Notes for SCADA Configuration

  1. OPC-UA Security: All process tags use SignAndEncrypt / Basic256Sha256. Certificate exchange must be completed on first runtime start. The service account fxopc_svc must have read permissions on all ns=2 nodes in DeltaV.
  2. cGMP Audit Trail: Critical alarms require operator comments on acknowledgment. All alarm events (active, acked, normalized) are logged to historian for regulatory compliance.
  3. Calculation UDT Tags: The DOStats and PressureStats tags have no device points. They will be populated by server-side Script Tasks computing rolling statistics to feed ML.NET pipelines.
  4. Historian Quality Flags: SaveQuality is enabled on both historian tables. OPC-UA Bad quality samples must be excluded from batch record analysis and process capability calculations.
  5. ML Opportunity: Bioreactor DO and temperature, UV absorbance chromatography peaks, centrifuge pressure patterns, and WFI conductivity drift are the primary candidates for ML.NET anomaly detection and forecasting models.

ML Opportunities

Variable

ML Opportunity

Suggested Model

BR_PA/DO — Dissolved Oxygen

Detect oxygen transfer rate deviations — predict sparge/agitation adjustments before DO drops below warning threshold

SSA Spike Anomaly Detection

BR_PA/Temperature — Bioreactor Temp

Thermal drift forecasting during fed-batch — predict cooling demand before critical alarm

Time-Series Forecasting

DSP_CHROM/UV/Absorbance — UV 280nm

Chromatography peak shape classification — distinguish protein peaks from contaminant shoulders

FastTree Binary Classification

CF_H01/BackPressure — Centrifuge Pressure

Pressure trend anomaly before filter breakthrough — PressureStats.Average UDT member supports rolling stats

SSA Spike Anomaly Detection

UTIL_WFI/Conductivity — WFI Conductivity

Predict loop degradation — rising conductivity trend detection before USP limit breach

Time-Series Forecasting


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