CT308: Gilead s Greenfield API Pilot Lab Process Control System Uses PlantPAx For Life Sciences

Transcription

1 CT308: Gilead s Greenfield API Pilot Lab Process Control System Uses PlantPAx For Life Sciences Andy Chong Gilead Sciences, Inc., Sr. Automation Engineer Angelo Puglisi Banks Integration Group, Sr. Automation Engineer March 2, 2017 PUBLIC INFORMATION

2 Agenda Project Overview & Scope Project Goals PlantPAx DCS Architecture Components of the System Project Challenges Questions / Discussion

3 Banks Integration Group Background Who is Banks Integration Group? Systems integrator located in Northern California Servicing the West Coast Rockwell Automation Solution Partner Focus on Process Automation, primarily in Life Sciences Life Sciences Automation Provider for over 20 Years

4 Gilead Sciences Background Biopharmaceutical company headquartered at Foster City, California Discovers, develops and commercializes medicines in the area of unmet medical needs. Current portfolio of products includes treatment for: HIV/AIDS Liver Diseases (Hepatitis B and C) Cardiovascular Oncology Inflammation/Respiratory

5 Pilot Lab Building Overview Process Control System (PCS) for new API small molecule Pilot Lab capable of supporting: R&D Clinical Phase-3 Pilot Lab is a new ground-up, 3-story, steel-frame building. Square footage = 23,914 SF / Released for GMP use in June 2016 Built adjacent to a new 191,000 SF R&D Lab building (Building 355) in Foster City Process Suites (GMP ISO 8 area) on 2nd floor Equipment includes the following: 2-Glassline Reactor Suites (50L 500L) / 1-Hastelloy Reactor Suite (50L 200L) Various drying equipment, i.e. filtered dryers, vacuum dryers, centrifuge

6 Business Drivers New API pilot plant is needed to support our future growing pipeline. The old pilot plant only had 2 reactor suites. Gilead had to rely on contract manufacturing to support R&D/clinical batches. The equipment in old pilot plant was old. Difficult to get technical support and parts replacement. The old pilot plant PCS had challenges meeting modern regulatory requirements, i.e. 21 CFR Part 11. The old pilot plant PCS does not have Historian.

7 Project Overview Schedule 2014 Preliminary Design Detailed Design & Build Phase FAT, SAT, Startup, & Qualification Process Reactor Suites Utilities Cooling Towers, TCU s with Hot & Cold Syltherm

8 Project Overview BMS (by others) PCS LIFE SAFETY, FIRE & OTHER SYSTEMS Pilot Lab Automation Overview

9 Banks Scope on the Project Network Design Electrical Design Design Specifications

10 Banks Scope on the Project Instrumentation submittals, procurement Procurement of PLC and control panel hardware

11 Banks Scope on the Project PlantPAx PLC/HMI Design and Programming

12 Banks Scope on the Project Historian, Win-911, FT AssetCentre Design and Programming

13 Banks Scope on the Project Testing Panel FAT, FAT, & SAT Startup & Construction Management Commissioning & Validation Support Management of Instrument Calibration

14 Agenda Project Overview & Scope Project Goals PlantPAx DCS Architecture Components of the System Project Challenges Questions / Discussion

15 Project Goals More robust PLC/HMI backup & restore / disaster recovery features compared to similar, older systems at the site Provide a redundant SCADA architecture Better security for system users compared with similar, older systems at the site 21 CFR Part 11-compliant system Capture historical process data Code standards Reusable, maintainable library of modules that is not owned by a single SI Solution meets the ISA S88 standard Flexible, expandable control system for adding/integrating future systems

16 Agenda Project Overview & Scope Project Goals PlantPAx DCS Architecture Components of the System Project Challenges Questions / Discussion

17 PlantPAx DCS Architecture New API pilot lab for pilot-scale manufacture and R & D I/O count 745 hardwired 85 Profibus

18 PlantPAx PLC Hardware (5) Allen-Bradley CompactLogix PLC 1769-L36ERM (5) Allen-Bradley Stratix 5700 Industrial Managed Switch Network Address Translation (NAT) feature Segregates HMI & PLC networks

19 PlantPAx DCS Architecture Virtualization 2 physical hosts contain View, Historian, & SQL VM s 1 st Host Server VM s: FT View Servers (Primary) HMI, Alarm & Events FT Live Data Interface and Data Server Node (Primary) FT Historian Server (Primary) Terminal Server (Main) FT Directory / Activation Server 2 nd Host Server VM s: FT View Servers (Secondary) HMI, Alarm & Events FT Live Data Interface and Data Server Node (Secondary) FT Historian Server (Secondary) Terminal Server (Cold Standby) SQL Server Databases Audit Trails, Alarms & Events, FT AssetCentre

20 PlantPAx HMI FactoryTalk View SE version 7.0 Redundant SCADA system Primary & Secondary FT View VM s Redundant HMI graphics Redundant Alarm & Events Primary SCADA Secondary SCADA Secondary automatically takes over if Primary fails

21 PlantPAx HMI Thin Client HMI Stations (5) Strongarm Wall Stations with 24 Wide Touchscreen, Track Ball & Keyboard. Located throughout the Pilot Lab. (5) Advantech Thin Clients (one in each station) Remote Desktop Connections to Terminal Server FT HMI client runs in each session

22 PlantPAx HMI Engineering Workstations (EWS) Physical PC s located in the Pilot Lab Control Room EWS #1: FT HMI Client FT View Studio RSLogix 5000 FT AssetCentre Client For asset and disaster recovery schedule configuration Event viewer FT AssetCentre Agent For performing PLC change detect and code compare EWS #2: FT HMI Client FT AssetCentre Client For asset and disaster recovery schedule configuration Event viewer EWS #1 EWS #2

23 PlantPAx DCS Process Objects for Life Sciences Rockwell Automation Library Out of the Box

24 PlantPAx DCS Process Objects for Life Sciences Pre-programmed modules customized for life sciences HMI components integrate with PLC components Motor Module

25 PlantPAx DCS Process Objects for Life Sciences Pre-validated following GAMP Life Cycle Model Design and Test Documentation provided for each module

26 PlantPAx DCS Process Objects for Life Sciences Available Control Modules delivered as Add-On Instructions CM_AIN CM_AOUT CM_DIN CM_DOUT CM_M2S CM_PIDE CM_SCNR CM_Totalizer CM_V2S CM_V3S CM_VFD CM_VMX CM_WS EM_GEN Analog Input Analog Output Discrete Input Discrete Output Motor PIDE Scanner Totalizer Valve (Two State) Valve (Three State) Variable Speed Drive Valve (Mix Proof) Weight Scale Generic Equipment Module

27 PlantPAx DCS Process Objects for Life Sciences Increased visibility PlantPAx built-in displays give operations the ability to more easily troubleshoot abnormal conditions

28 PlantPAx DCS Process Objects for Life Sciences Configuration Control Module Configuration using Excel & RSLinx communications Default Configuration Allows Immediate Use

29 PlantPAx DCS Process Objects for Life Sciences Parameter Download Mass download from Excel configuration spreadsheet to PLC / HMI faceplates

30 PlantPAx DCS Process Objects for Life Sciences Simulation Simulation mode is enabled from an individual module s faceplate or propagated from Area module Device feedback is built into each module Allows programmer to test logic for motors and valves in an office / FAT environment without having to force feedback status inputs in the PLC

31 PlantPAx DCS Process Objects for Life Sciences PIDE Auto Tune Faceplate provides access to PIDE instruction Open loop autotuner loop must be in manual

32 Considerations when using Process Objects for Life Sciences With flexibility comes increased complexity Each module is designed to accommodate several device configurations, which leads to a more complicated configuration Learning curve for configuration spreadsheet Module PLC code is locked Faceplates are more complicated than existing design Process Objects for Life Sciences is licensed per PLC Only available from RA Delivery or from RA Delivery Partners like Banks Integration Group

33 PlantPAx DCS FactoryTalk Historian SE FactoryTalk Historian SE version 4.0 Redundant Historian system Primary & Secondary FT Historian SE Servers Collective Primary & Secondary FT Live Data Interface Nodes Redundant Live Data Interface for Historian Local Data Buffering (Historical trend screens can access data) 264 historian tags

34 PlantPAx DCS FactoryTalk Historian SE FactoryTalk Historian SE version 4.0 Historian provides data for Historical trend screens at HMI Allows users to view data through PI ProcessBook 42 HMI trend screens

35 PlantPAx DCS FactoryTalk AssetCentre Asset Management FT AssetCentre v6.0 PLC file version control Uses SQL database to store and manage PLC files PLC Change Detection Triggered when changes occur on a running processor Disaster Recovery Scheduled (monthly) PLC comparison current master vs running program If desired, can schedule backup and compare running program is promoted to become the master reports PDF reports change detection, compare results

36 PlantPAx DCS FactoryTalk AssetCentre Event Viewer Interface for viewing audit trail data stored in SQL database

37 PlantPAx DCS Win-911 Alarm Notification Win-911 Professional v7.16 with FT Alarm & Events Client notification for pilot lab personnel Communicates with site SMTP mail server Win-911 communicates directly with FT Alarm & Events database Each Win-911 filter links directly to one or more FT A&E tags Configured alarm groups so recipients are only notified about the alarms that apply to them Ex: Pilot Plant Management, Chemists, Maintenance, Automation

38 PlantPAx DCS Win-911 Alarm Notification Win-911 Professional v7.16 with FT Alarm & Events Client Alarm log Downside: No import feature Manually enter Win-911 filters or copy/paste existing filters

39 PlantPAx DCS SQL Server / Domain Controller SQL Server SQL contains ODBC databases to satisfy 21 CFR Part 11 regulation about electronic records Databases FT Alarm and Events FT Diagnostics and user audit trail data FT AssetCentre data

40 PlantPAx DCS SQL Server / Domain Controller Domain Controller FT View SE Security Combination of Microsoft Windows domain security and FactoryTalk View SE security Operators use their normal site login and password FT View Security Groups linked with Windows User Groups Users security is determined by their group membership. To assign security permission to a PCS user, add the user to the appropriate Windows user group. Used the customer s existing domain controller

41 PlantPAx DCS SQL Server / Domain Controller Domain Controller Benefits Operators use their normal site login and password Centralized Administration one place to manage users, groups, and security Note: For applications consisting of more than 10 computers, a domain controller is required.

42 Agenda Project Overview & Scope Project Goals PlantPAx DCS Architecture Components of the System Project Challenges Questions / Discussion

43 Project Challenges Virtual Environment & the IT / Automation divide Original design featured physical servers Worked with customer to gauge comfort level with VM s Worked with customer to convert design from physical to virtual Customer IT maintains ownership of physical hosts / Customer Automation maintains ownership of PCS software

44 Project Challenges Integrate vendor-supplied equipment into PCS (5) Different OEM vendors Remote I/O via Ethernet, Profibus, Ethernet runs to skid PLC s

45 Project Challenges Hazardous Area Classification Process equipment was located in Class 1, Div 1 and Div 2 areas Instruments in these areas are wired to intrinsically-safe I/O modules Control panels were designed to keep IS and non-is wiring segregated HMI stations were located in Class 1, Div 2 area Had to be rated non-incendive

46 Project Challenges Equipment issues during temperature control loop tuning Check valve installed backwards at TCU prevented flow to reactor suite Tape not removed from flanges after construction prevented flow to reactor jacket

47 Agenda Project Overview & Scope Project Goals PlantPAx DCS Architecture Components of the System Project Challenges Questions / Discussion

48 THANK YOU PUBLIC INFORMATION Copyright 2015 Rockwell Automation, Inc. All Rights Reserved.