Global Medical Cures™ | US Senate Letter to Apotex (GENERICS PRICING)
AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process
-
Upload
rockwell-automation -
Category
Technology
-
view
366 -
download
6
Transcript of AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process
![Page 1: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/1.jpg)
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED
PUBLIC INFORMATION
Apotex: Pharma Controls Retrofit Improves Process
![Page 2: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/2.jpg)
Pharma Controls Retrofit Improves Process
Dwight Trotter, P. Eng. Director, Capital Engineering
![Page 3: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/3.jpg)
Agenda
• Who is Apotex?
• Introduction to Fluid Bed and Granulator
• Motivation for controls upgrade
• Technical Details
• Benefits
• Questions / Discussion
![Page 4: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/4.jpg)
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
![Page 5: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/5.jpg)
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.
![Page 6: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/6.jpg)
Partner Integrator Grantek Systems Integration Inc. “Grantek is dedicated to delivering thought leadership, customer
centric thinking, and passion for your success.“
Safety
![Page 7: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/7.jpg)
Fluid Bed / Granulator
![Page 8: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/8.jpg)
Fluid Bed / Granulator
![Page 9: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/9.jpg)
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
![Page 10: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/10.jpg)
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
![Page 11: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/11.jpg)
Reasons for Doing Project
• Unscheduled Downtime
–Computer crashes caused downtime
– Lost batches = Lost Product = Lost $$$
– Production equipment causing customer service problems
![Page 12: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/12.jpg)
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
![Page 13: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/13.jpg)
Technical Details – Architecture
• Upgraded to ControlLogix® PLC from Opto 22 control
• Upgraded to Ethernet Festo Valve Bank to simplify installation and reduce commissioning
![Page 14: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/14.jpg)
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
![Page 15: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/15.jpg)
Technical Details – ControlLogix
• Apotex standardized on ControlLogix® PLC
• Leverages existing Rockwell Automation investment
• Flexible platform to meet current project needs and future requirements
![Page 16: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/16.jpg)
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
![Page 17: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/17.jpg)
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
![Page 18: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/18.jpg)
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
![Page 19: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/19.jpg)
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
![Page 20: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/20.jpg)
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
![Page 21: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/21.jpg)
HMI Application Before
![Page 22: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/22.jpg)
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
![Page 23: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/23.jpg)
Apotex Graphic Standards
• Tab navigation
• Device with unsatisfied interlocks
• Numeral display (process values)
• Numeric input fields
![Page 24: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/24.jpg)
HMI Application After
![Page 25: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/25.jpg)
Recipe Editing
![Page 26: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/26.jpg)
Reporting
![Page 27: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/27.jpg)
Benefits
• Fluid Bed Service calls down by 68%
![Page 28: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/28.jpg)
Benefits
• Granulator Service calls down by 50%
![Page 29: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/29.jpg)
Benefits
• Replacement Allen-Bradley® hardware readily available from local distributors
• Common components with other Apotex systems, reducing spare parts inventory requirements
![Page 30: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/30.jpg)
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!
![Page 31: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/31.jpg)
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
![Page 32: AP02 - Apotex: Pharmaceutical Controls Retrofit Improves Process](https://reader030.fdocuments.in/reader030/viewer/2022032618/55b3f8f3bb61eb24488b45b6/html5/thumbnails/32.jpg)
www.rockwellautomationteched.com
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
PUBLIC INFORMATION
Rockwell Automation TechED 2015 @ROKTechED #ROKTechED
Questions?... Thank You!