Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

PUBLIC INFORMATION

Apotex: Pharma Controls Retrofit Improves Process

Pharma Controls Retrofit Improves Process

Dwight Trotter, P. Eng. Director, Capital Engineering

Agenda

• Who is Apotex?

• Introduction to Fluid Bed and Granulator

• Motivation for controls upgrade

• Technical Details

• Benefits

• Questions / Discussion

Who is Apotex

• Largest Canadian-owned pharmaceutical company

• Founded in 1974

• Grown from 2 employees, 5000 sq. ft. to 10,000 employees worldwide

• Exports to 115 countries

• Worldwide sales exceeding $2 billion

Who is Apotex

• Dwight Trotter – Director of Capital Engineering

• Responsible for capital projects across Canada and the USA, supporting affiliates worldwide

• Partnered with Rockwell Automation® Solution Partner – Grantek Systems Integration Inc.

Partner Integrator Grantek Systems Integration Inc. “Grantek is dedicated to delivering thought leadership, customer

centric thinking, and passion for your success.“

Safety

Fluid Bed / Granulator

Fluid Bed / Granulator

Reasons for Doing Project

• Obsolete hardware platform, business risk

– Opto 22 controller with obsolete firmware

– Obsolete Windows 2000 HMI, with obsolete PC hardware

– Obsolete Solenoids

• Limited functionality

– Could not add new product recipes

Reasons for Doing Project

• Locked proprietary software

– Harder to troubleshoot

– Tied to original vendor for modifications

• HMI didn’t match Apotex / Grantek standard look and feel of other systems in facility

• Apotex non-standard software, vs. FactoryTalk® View from Rockwell Automation

Reasons for Doing Project

• Unscheduled Downtime

–Computer crashes caused downtime

– Lost batches = Lost Product = Lost $$$

– Production equipment causing customer service problems

Technical Details – Architecture

• Upgraded PC’s

– RAID / Redundant Power Supplies

– PC’s on corporate domain to support domain level authentication and corporate password policy

– FactoryTalk® View

• Virtualized database server

Technical Details – Architecture

• Upgraded to ControlLogix® PLC from Opto 22 control

• Upgraded to Ethernet Festo Valve Bank to simplify installation and reduce commissioning

New Architecture

Corporate Ethernet

Granulator PLC (ControlLogix)

Granulator HMI Server

Granulator Database Server (Virtual)

DCM PLC (SLC 5/05)

Fluid Bed Dryer PLC (ControlLogix)

Fluid Bed Dryer HMI Server

Fluid Bed Dryer Database Server (Virtual)

DCM HMI PC

Technical Details – ControlLogix

• Apotex standardized on ControlLogix® PLC

• Leverages existing Rockwell Automation investment

• Flexible platform to meet current project needs and future requirements

Technical Detail – FactoryTalk View SE

• Leveraged existing investment in 10+ FactoryTalk View SE systems at Apotex

• Leverages Apotex domain authentication, including Windows Linked User Groups

• VBA Scripting supports custom Apotex database audit trail and advanced batch tracking and recipe control

Technical Details – FactoryTalk Transaction Manager

• Logs system event data and batch records. Critical for audit trail to meet 21 CFR Part 11 requirements

• Allows for customized Apotex batch database and use of custom Apotex db stored procedures

• Runs on high availability virtual server, logging even if FactoryTalk View SE application is offline or disabled

Technical Details – Virtualization

• Apotex has a strong in-house IS department

• Automation servers have successfully been virtualized since 2005

• Virtualization provides protection from hardware failure, centralized management, sharing of resources at central data centre site

• Ensures greater longevity of system

Technical Details – 21 CFR Part 11

• Upgraded from serial RS232 to Ethernet datalogging

• Supports future electronic record keeping and batch reporting

• Apotex architecture allows:

– Full audit trail on all system actions and operator actions

– Full revision control, change control and time based tracking of recipes

Technical Details – Mechanical

• Utilized existing mechanical components to reduce cost, and validation.

• Controls needed upgrade, mechanical did not

• Upgrade electrical to meet higher safety standard and isolation requirements

HMI Application Before

Apotex Graphic Standards

• ISA101 Human Machine Interfaces

– Use gray colours for backgrounds

– Bright colours for status changes

– Ensures operator can quickly, see device status and detect faults

Apotex Graphic Standards

• Tab navigation

• Device with unsatisfied interlocks

• Numeral display (process values)

• Numeric input fields

HMI Application After

Recipe Editing

Reporting

Benefits

• Fluid Bed Service calls down by 68%

Benefits

• Granulator Service calls down by 50%

Benefits

• Replacement Allen-Bradley® hardware readily available from local distributors

• Common components with other Apotex systems, reducing spare parts inventory requirements

Benefits

• Flexible Solution

– Meets current needs without calling in integrator, all setpoints and recipe values can be configured by Apotex

• Foundation for future upgrades

– Production requested adding a new recipe parameter, flexible platform supports this!

Benefits

• Remote recipe editing, reduces GMP gown-degowning

• Recipes can be edited by second HMI, while running – previously unavailable

• HMI update includes custom calibration and PM screens to accelerate regular maintenance

www.rockwellautomationteched.com

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

PUBLIC INFORMATION

Rockwell Automation TechED 2015 @ROKTechED #ROKTechED

Questions?... Thank You!