Environmental Monitoring System (EMS) Architectures

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1 Summary Invensys tailored EMS Environmental Monitoring System (EMS) Architectures meets demanding SCALABILITY requirements for: Invensys understands the critical nature and the challenges of a Life Sciences Environmental Monitoring System (EMS). Each facility, or area within a facility, has different requirements. Critical process parameters can range from temperature and humidity to more complex airborne particle counts and room air changes. Industry regulations and guidelines are substantial and require much of an EMS. Invensys offers tailored solutions that help manufacturing and distribution be more efficient and flexible in meeting the new Pharma 3.0 challenges. Security Advanced reporting Smart alarm management Scalability Available Architectures High Availability Object-oriented, SQLbased, reusable, modular and open Redundant Mid-size, report-centric and peaceof-mind validation ENHANCEMENT CAPABILITIES Simplex PAC-based, The Invensys EMS embeds built-in expansion capability to easily allow additional monitoring points. This is achieved when sensors are connected to Invensys Foxboro PAC (Process Automation Controller) control units: InTouch, report-enabled, modular and easily expandable Entry Recorder-based and cost-effective Monitoring strategy is based on parameterized modules developed according to TickIT guidance (ISO 9001:2000). GAMP1 Category 5 configurations are no longer required. A devolved EMS block builds up logic for sensors, rooms, and areas, including calibration adjustment and alarm management. Configuration building blocks are available for displays, data collection, security management and system health diagnostics. Single but distributed project database and inter-processor peer-to-peer communication secures system upgrades with minimum validation effort. Templates for project lifecycle documents optimize testing and validation efforts, even for first-time users. 1 GAMP (Good Automated Manufacturing Practice) is a trademark of the International Society for Pharmaceutical Engineering.

2 STORE AND FORWARD Invensys innovative Store and Forward is a self-healing 21 CFR Part 11 data archiving system that automatically stores data during a communications failure and then forwards it to the server once communications have been reinstated. The result is secure electronic recording with total data integrity, protecting valuable production records and eliminating the need to scrap/re-work batches due to data loss. Customer Success An Invensys customer requires all environmental data to be stored in a central historian database. In the event of a communications break between the local data acquisition system and the central historian, all 21 CFR Part 11 data is logged locally. On reestablishing communication, Store and Forward automatically backfills the central historian from the locally stored data. Without the environment data, manufactured batches cannot be released. The EMS solution is designed to ensure valuable batches are saved, and production data is not lost. Normal Operation Process value and audit trail sent directly to central historian Missing Data in Historian caused by: Communications failure PC failure Historian failure Store and Forward and Backfill Identify missing data period Retrieve data from temporary local audit trail file Backfill the central historian with missing data Data integrity is achieved by collecting the data locally via Eurotherm S6000 Series Recorders and Foxboro PACs and storing it in multiple locations. Following a communications loss and recovery between the central historian and local data acquisition units, the unique Store and Forward utility identifies the duration of missing data and then backfills the central historian automatically, resulting in no historian data gap.

3 EMS OBJECT Invensys has designed an EMS control block as part of our standard solution. It is essentially a point interface with alarm functions and a calibration facility and has been designed specifically to work with Foxboro PAC universal analogue and digital inputs. Benefits of the EMS object include: Minimum effort System software falls in GAMP Category 3, decreasing validation documentation requirements, project execution time and risk Easily upgraded Sensors are conveniently added, leveraging the modular architecture and software library Enhanced reliability Powerful diagnostics and alarm management are standard Alarm functions Grouped Alarms: Critical, Warning and three separate New Alarms System Alarms: Calibration Warning, Bad Calibration, PV Input Held, and Hardware Process Alarms: HiHi, Hi, Lo, LoLo with on-delay and common hysteresis Digital Alarms: For door alarm or communications failure to a sensor device Fifteen priority levels are available. Each alarm can be masked. Alarms can also be subject to a suppression condition. Calibration This block provides the following functions: Calibration Checking to verify the calibration and assure it is correct Calibration Adjusting to change the calibration constants and make readings compliant to calibration standards 2-point adjustment 3-point adjustment with four point-pairs (up-down) median-fit method User manually determines slope and offset factors for maximum flexibility In a typical system, the calibration state normally resides in the OK state. The state changes automatically to Warning when a Calibration Warning is flagged. The Adjusting, Checking and Bad states are all selected by the user as part of the calibration process. Specifically included in the calibration checking and adjustment process are routes to ensure the user leaves the system in a suitably auditable condition.

4 HIGH AVAILABILITY ARCHITECTURE This architecture is designed for highend performance and flexibility and is particularly applicable where zero downtime, multi-plant integration is required. Corporate object libraries, operator best practices, standard maintenance procedures, tailored reporting and intelligence are all easily achieved and maintained. High Availability Architecture is easily integrated with Wonderware Facility Management System (FMS) and Corporate Energy Management (CEM) applications. Virtualization and web collaboration are possible leveraging the latest Microsoft technologies. Wonderware System Platform Terminal Server with fail-over for network segregation and validation ease Dedicated Galaxy Database with object-oriented capability for easy configuration Dedicated Redundant Data Servers with local Store and Forward to the Historian Server Historian Server with TIER capability for (remote) data redundancy, disconnected from the data network Information Server for web support Control network Fully redundant mesh Foxboro PAC Controllers Hot redundant central processing units (CPUs) with removable firmware and configuration (GAMP Category 4) memory card with security code Store and Forward capability to locally store tamper proof data, events, alarms and timestamps Local alarm management with priority and strategies Calibration checking and adjustment services

5 REDUNDANT ARCHITECTURE An EMS may need to manage an entire sterile manufacturing building. Critical data cannot be lost. In this case, redundancy is needed, but not all the standard capability and power of the High Availability Architecture. Instead, the Redundant Architecture takes full advantage of redundant servers for InTouch connected to cost-effective redundant Foxboro PAC units. One Historian Server will meet reporting requirements, with data safe thanks to Store and Forward self-healing data archiving. This integrated solution balances the need to meet demanding requirements while controlling maintenance costs and validation efforts. Wonderware InTouch Hot Redundant Servers for InTouch Historian Server with TIER capability for (remote) data redundancy, disconnected from the data network HMI Reports and/or Historian Clients for advanced trending and reporting with web capabilities Impressive 21 CFR Part 11 Audit Trail capabilities and Security Manager for electronic signatures Remote alarming via text messaging or FTP (File Transfer Protocol) server and OPC (Object Linking and Embedding for Process Control) server via FS Gateway Control network Fully redundant mesh Foxboro PAC Controllers Hot redundant CPUs with removable firmware and configuration (GAMP Category 4) memory card with security code Store and Forward capability to locally store tamper proof data, events, alarms and timestamps Local alarm management with priority and strategies Calibration checking and adjustment services

6 SIMPLEX ARCHITECTURE This PC-based architecture is designed for cost-effectiveness and expandability and is an excellent solution for warehouses, critical equipment and small production areas where a manual data recording backup system might be considered. If you are looking for step-by-step, fully automatic, paperless electronic data recording, this is a great starting point. Historian offers the most sophisticated data analysis and reporting, while InTouch provides operators with confidence. A mix of local recorders and blind distributed I/O devices can easily be integrated on the same network. Servers can be simplex or redundant. InTouch Operator Client Wonderware HMI Reports Domain Controller Ethernet Data Network (with firewall) Server for Wonderware InTouch Optional Redundant Server for InTouch Foxboro PAC Controller Foxboro PAC Controller Engineering Station + PAC configuration tools Redundant Ethernet Control Network Eurotherm Recorders Smart I/O Wonderware InTouch Server for InTouch (can be redundant) HMI Reports for web reporting capabilities Impressive 21 CFR Part 11 Audit Trail capabilities and Security Manager for electronic signatures Cost-effective solution with flexible scalability Remote alarming via text messaging or FTP server and OPC server via FS Gateway Foxboro PAC Controllers Redundant CPUs with removable firmware and configuration (GAMP Category 4) memory card (with optional security code) Local alarm management with priority and strategies Calibration checking and adjustment services Easily validated GAMP Category 5 with foolproof controllers and configuration Store and Forward capability can be added at any time

7 ENTRY ARCHITECTURE This architecture is designed for point systems where a PC-based, networked solution is not practical. Eurotherm S6000 Recorders are 21 CFR Part 11 compliant, self-contained devices capable of satisfying all EMS requirements. Operators will appreciate the user-friendly touch interface provided by the S6000. The high-quality input boards are designed for high precision, repeatability and stability. Data can be easily accessed by Quality and used for complex calculations such as Mean Kinetic Temperature (MKT). The Eurotherm Review application allows remote viewing of all recorded data, and the embedded FTP push technology allows critical records to be stored in up to three backup databases. Reports can be structured by time, by event or by batch and back-annotated, all while fully complying with 21 CFR Part 11. Wonderware HMI Reports and Eurotherm Review or Eyris Flexible reporting with web capabilities Tamper proof historian, fully 21 CFR Part 11 with annotation and batch-oriented capabilities Out-of-the-box solution, GAMP Category 3 Remote alarming via text messaging or FTP server and OPC server via FS Gateway Remote on-line data analysis Eurotherm S6000 Data Management and nanodac Reduced validation cost 21 CFR Part 11 fully compliant hardware Uses unique tamper proof file for process data, events and alarms SNTP (Simple Network Time Protocol) support, bar code readers, printer, key-protected, secure USB for data backup Local powerful operator touch screen interface

8 NEW CONCEPT: SOFTWARE MARSHALING As stated in the International Society for Pharmaceutical Engineering (ISPE) Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) Appendix 2, Section 1.6.7: It is common practice to qualify monitoring systems (sensors, transmitters,...) for those parameters defined as critical and to use GEP [good engineering practice] to ensure the development and maintenance of a robust control system. A common alternative approach is to employ an independent system for alarming and managing critical data. The HVAC control system is limited to control and maintenance information. Leveraging the unique features embedded in the Foxboro PAC system, Invensys is introducing the innovative software marshaling concept. The GAMP Category 1 peer-to-peer communication protocol used by each Foxboro PAC unit is used to move critical data from the EMS donor to the Building Management System (BMS) receiver. Benefits Reduced validation effort. No double indication and reading. No errors. No offsets. No linearization issues. Less maintenance. No need for sensor duplication or wiring. Industrial-grade quality and precision of the EMS can be leveraged to drive effective energy saving strategies at no cost via the BMS system. Integrated diagnostics and alarm management, including calibration. EMS sensor parameters are all fully available to the receiver BMS. One way communication to achieve proper EMS/BMS segregation. Network independent. EMS could be made fully redundant to guarantee high availability. Easier commissioning for reduced time to market. Invensys Operations Management 5601 Granite Parkway III, #1000, Plano, TX Tel: (469) Fax: (469) iom.invensys.com Invensys, the Invensys logo, ArchestrA, Avantis, Eurotherm, Foxboro, IMServ, InFusion, SimSci-Esscor, Skelta, Triconex, and Wonderware are trademarks of Invensys plc, its subsidiaries or affiliates. All other brands and product names may be the trademarks or service marks of their representative owners Invensys Systems, Inc. All rights reserved. No part of the material protected by this copyright may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, broadcasting, or by any information storage and retrieval system, without permission in writing from Invensys Systems, Inc. Rel. 09/11 PN IN-0189

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