Rockwell Software PharmaSuite · Production Management Production Execution Production Review...

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Rockwell Software PharmaSuite®

A Key Ingredient to Build a Connected Enterprise

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.PUBLIC

enhanced by the Internet of Things delivers transformational

value in productivity and global competitiveness

Faster Time to Market

Improved AssetUtilization

$Lower Total Cost

of OwnershipEnterprise Risk Management

THE CONNECTED ENTERPRISE

I n n o v a t i o n

2


The Connected Enterprise…

… is enabled by Integrated Control and Information

Secure NetworkInfrastructure

Mobility &Visualization

Scalable Computing(Control, Edge, Cloud)

Multi-disciplineControl & Information

Information Solutions

Smart Assets

3


Life Sciences – Huge opportunities in operations

Source : Mc Kinsey and Company – Thomas Ebel 2013

Inventory,

days

Pharma

Med devices

Fast-moving

consumer

goods

Obsolescence, %

of sales

Manufacturing lead time,

days

258

153

72

3.1

2.8

0.5

120 - 180

120 - 180

3 - 7

2–4x 6x 30x


Life Sciences – Increased regulatory pressure

Source : FDA

▪ Inspection observations

▪ 2003 – 2012

▪ By quality subsystem


PharmaSuite® Leading MES solution for the Life Sciences Industry

The Connected Enterprise

6


PharmaSuite® - Unique offering

The best platform with a solid track record of scale and stability

The only partner enabled solution for Pharma

The only solution that supports “evergreen”

Unprecedented deployment speed - Pfizer “25 sites in 4 years”


Worldwide Customers

8


API

EBR

1 plant

API / Secondary

W&D, Material track

2 plants

Bio / API / Formulation / Packaging

W&D / EBR / AI

25 plants

W&D / EBR /AI

2 plants

Formulation/Packaging

W&D, EBR

2 plants,

20k / 68k orders

Formulation (Cremes)

W&D / EBR

1 plant

5 k orders

Formulation

W&D

1 plant

W&D / EBR

1 plant

API

Material tracking

1 plant

Serialization

1 line

Qingdao

Formulation (IV solution)

W&D, EBR

1 plant

7000 batch/year

W&D / EBR / AI

1 plant

Formulation

W&D

1 plant

550 orders

Formulation

W&D / EBR

Bio / Formulation, Packaging

EBR, AI

3 plants

Serialization

1 line

Packaging

EBR

1 plant

10k batches

W&D / EBR

Global rollout

1 / 10 / 22 plants

W&D / EBR / AI

1 plant

W&D / EBR /AI

1 plant

API / Formulation

Batch integration

5 plants

Formulation (Solids)

W&D / Material track

1 plant

5 billion tablet/year

Packaging Diagnostic Cards

EBR, Material tracking

1 plant

Connectors for SIM card

chips

EBR / AI

4 plants

Formulation

Docu Mgmnt

1 plant

Formulation (Creme)

W&D / Material track

1 plant

1,500 batch/year

Formulation (Injection)

W&D

1 plant

300 million count/year

9

Fastest Growing Pharma MES

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PharmaSuite® Deployment

EMEA

AP, India

AP, China

NA, EMEA

Global


• Improved compliance reporting

• Improved productivity

• Eliminated paper records

11


Increased production from

7,000 to 11,000 batches

Cut batch review time IN HALF

Increased reactivity

Improved decision making process


PharmaSuite®


Dispense

Blend

Packaging

Master Recipe

Recipe Design

110 10110 10110 10

Pressure 1.000 Pa

Packages 2.000 ea

Temperature 22°C

Batch Record B1

e.g. Packaging

!

Production

Temperature 22°C

Batch Record B1

!

Review by

Exception

Dispense

Blend

Packaging

Control Recipe

Dispatching

PharmaSuite® EBR helps to ensure compliance

and excels productivity


70%less manual

entries

90%less wrong

entries

80%decreased BR

review cycle

50%decrease of

investigations

50%Increase in

stock turnaround

PharmaSuite® EBR benefits across the value chain


EBR Basic Phases

Execution FrameworkDesign FrameworkProduction Management Production Execution Production Review

ProductionCentreSecurity, Infrastructure, Data model, Integration, OS & DB support

Data Manager (Equipment)Recipe & Workflow Designer

Enterprise Integration GatewayPharmaSuite scenarios

Dispense Phases Equipment Tracking Equipment Automation IPC Phases

Upgrade EngineIntelligent upgrade tool

Phase Packages

Softw

are D

eve

lop

me

nt K

it

PharmaSuite®

Modular Architecture


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