FacilityPro Environmental Monitoring Systems Data Processing and System Control

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1 FacilityPro Environmental Monitoring Systems Data Processing and System Control BENEFITS FacilityPro 1010 Designed specifically for pharmaceutical environmental monitoring Integration and control of viable and nonviable sampling High data integrity Ultimate efficiency and reduced error Simple installation and validation Flexible integration FacilityPro 3010 FacilityPro 5010 APPLICATIONS Monitoring of critical environments including: Filling lines Isolators and RABS Blow-Fill-Seal Lyophilizer processes and transfer carts Biosafety cabinets and flow hoods General cleanroom and facility monitoring Viable/Nonviable/Environmental Monitoring The FacilityPro processor provides the central hub for an environmental monitoring system. The processor communicates with cleanroom sensors, including particle and microbial monitors, while buffering data and checking tolerances for alarm activation. Industrial Automation Architecture As a key component of industrial automation architecture, this embedded system offers high reliability as it controls samples and communicates with central software. Three Versions FacilityPro processors are available in three versions, with varying features to support a range of system designs and applications: FacilityPro 5010 FacilityPro 3010 FacilityPro 1010 All three FacilityPro processors are compatible with either the FacilityPro SCADA NG server software or the FacilityPro SMART NG server module. Without measurement there is no control

2 FacilityPro Environmental Monitoring Systems Data Processing and System Control FacilityPro 5010 A fully-integrated solution for system control. Modules housed in a standard 19-inch rack. Processor Module Display Operating Environment Inputs/Outputs 6.5-in TFT LCD with resistive touchscreen 13.5 x 19.0 x 8.75 in (34.3 x 48.3 x 22.3 cm), 5U height 34.5 lb (15.7 kg) VAC, Hz, 600 W Temperature: F (4 40 C); non-condensing Up to 64 particle or microbial sensors Digital (1 standard, 3 optional) 16 relay or digital outputs (configurable) 8 digital inputs Analog (3 optional) 24 analog inputs 0-10 VDC or 4-20 ma *Up to 4 digital or analog boards Pneumatic Module Operating Environment Sensors 8 x 19 x 7.0 in (20 x 48.3 x 17.8 cm), 4U height 26.4 lb (12 kg) VAC, Hz, 240 W Temperature: F (4 40 C); non-condensing 8 sensors, Airnet II or BioCapt Input/Output Module Operating Environment Inputs/Outputs 12.0 x 19.0 x 7.0 in (30.5 x 48.3 x 17.8 cm), 4U height 31.4 lb (14.2 kg) VAC, Hz, 240 W Temperature: F (4 40 C); non-condensing Digital (1 standard, 3 optional) 16 relay or digital outputs (configurable) 8 digital inputs Analog (3 optional) 24 analog inputs 0-10 VDC or 4-20 ma *Up to 4 digital or analog boards Module Operating Environment 14.0 x 19.0 x 5.25 in (35.6 x 48.3 x 13.3 cm), 3U height 22.3 lb (10.1 kg) VAC 3-ph, 50 60Hz and VAC, 50-60Hz Temperature: F (4 40 C); non-condensing

3 FacilityPro Environmental Monitoring Systems Data Processing and System Control FacilityPro 3010 A reliable data and I/O processor designed specifically for smaller systems. Inputs/Outputs 6.2 x 19.0 x 13.2 in (15.8 x 48.3 x 33.5 cm) 27.5 lb (12.5 kg) VAC, Hz, 350 W 16 particle or microbial inputs (configurable) 16 relay or digital outputs (configurable) 8 digital inputs 8 analog inputs, 0 10 VDC or 4-20mA (optional) FacilityPro 1010 Data processor with no built-in I/O, designed to provide a reliable Ethernet interface to viable and nonviable sensors and to upgrade existing ENODE-based systems. Inputs/Outputs 5.7 x 9.0 x 2.6 in (14.5 x 23.0 x 6.5 cm) 2.5 lb (1.14 kg) 120 VDC, 1.5 A 8, 16 or 32 particle or microbial inputs I/O via ENODE interface only. Limited to 6 ENODE modules.

4 FacilityPro Environmental Monitoring Systems Data Processing and System Control Feature Comparison Particle & microbial points per processor Digital ouputs (selectable relay or 24 VDC) FacilityPro 1010 FacilityPro 3010 FacilityPro , 16, 32 (groups of 8) 16 (particle or microbial) - 16 Digital inputs - 8 Analog inputs (optional) (groups of 8) up to 128 in processor (optional I/O module) up to 64 in processor (optional I/O module) up to 192 in processor (optional I/O module) ENODE support y - - Cubic meter algorithms y y y Tolerance checking y y y Recipe-driven sampling y y y Data buffer y y y Real-time microbial monitoring Vacuum and air flow control Microbial monitoring with central vacuum - - y - - y - - y - : not supported y : supported HEADQUARTERS 5475 Airport Blvd Boulder, Colorado USA T: , ENODE and FacilityPro are registered trademarks of Particle Measuring Systems, Inc. Windows is a registered trademark of Microsoft Corporation. All other trademarks are the property of their respective owners. Particle Measuring Systems, Inc. reserves the right to change specifications without notice Particle Measuring Systems, Inc. All rights reserved. GLOBAL OFFICES AUSTRIA T: E: pmsaustria@pmeasuring.com GERMAN T: E: pmsgermany@pmeasuring.com NORDIC T: E: pmsnordic@pmeasuring.com Instrument Service & Support T: Customer Response Center T: E: info@pmeasuring.com BENELUX T: E: pmsbelgium@pmeasuring.com BRAZIL T: E: pmsbrazil@pmeasuring.com ITAL T: E: pmssrl@pmeasuring.com JAPAN T: E: pmsjapan@pmeasuring.com PUERTO RICO T: E: pmspuertorico@pmeasuring.com SINGAPORE T: E: pmssingapore@pmeasuring.com CHINA T: E: pmschina@pmeasuring.com KOREA T: E: pmskorea@pmeasuring.com SWITZERLAND T: E: pmsswitzerland@pmeasuring.com FRANCE T: 33(0) E: pmsfrance@pmeasuring.com MEXICO T: E: pmsmexico@pmeasuring.com TAIWAN T: Ext: 301 E: pmstaiwan@pmeasuring.com

5 FacilityPro Software Data Management, Reporting, and Automation BENEFITS Designed specifically for pharmaceutical environmental monitoring Integration and control of viable and nonviable sampling High data integrity Ultimate efficiency and reduced error Simple installation and validation Flexible integration APPLICATIONS Monitoring of critical environments including: Filling lines Isolators and RABS Blow-Fill-Seal Lyophilizer processes and transfer carts Biosafety cabinets and flow hoods General cleanroom and facility monitoring Viable/Nonviable/Environmental Monitoring FacilityPro software provides the interface, supervisory control, data management, and reporting functionality for an environmental monitoring system. FacilityPro s ability to manage viable, nonviable, and environmental data through a common system improves the efficiency of production operations and quality investigations. Industrial Automation Architecture With the FacilityPro industrial automation architecture, the data processing is performed by the Processor while the data management, display, and storage are performed by the software. This design approach increases system reliability and data integrity. Two Main Versions FacilityPro software is available in two main versions: FacilityPro SCADA NG Server software FacilityPro SMART NG Server module Both software platforms offer a number of intelligent features including data mapping, alarming, reporting, and recipe-driven sampling. Both also offer client software for remote access and viewing of data. The SCADA NG version is built on the GE Proficy ifix SCADA NG platform and Historian database and provides several additional advanced features. Without measurement there is no control

6 FacilityPro Software Data Management, Reporting, and Automation FacilityPro SMART NG Server Module The FacilityPro SMART NG Server is a stand-alone module that interfaces with one FacilityPro Processor per SMART NG module and provides a simple monitoring and reporting tool. By distributing the data processing to the FacilityPro Processor, the FacilityPro SMART NG server delivers high reliability and data integrity. The FacilityPro SMART NG server is 21 CFR Part 11 compliant and provides the user with a number of tools to improve efficiency and reduce error: Map for visual indication of viable, nonviable, and environmental status Configurable display Alarm notification and e-signature acknowledgement Configurable reports including audit, statistics, and trend reports Batch identifiers and data filters Automation of sample collection, driven by recipes Cubic-meter algorithms for nonviable data Volume-based or time-based viable sampling Client software for remote viewing and reporting 12 interface languages supported Specifications Display resolution Minimum requirement client Operating system clients 1280 x 1024 minimum CPU i5 3 GHz, RAM 8 GB, HD GB, 2 Ethernet, 1 DVD/RW, 4 USB Ports Windows 7 Ultimate - 64bit

7 FacilityPro Software Data Management, Reporting, and Automation FacilityPro SCADA NG Server Software The FacilityPro SCADA NG Server software is built on GE s Proficy ifix SCADA NG platform and Historian database. The SCADA NG Server software supports all the same features as the SMART NG Server, with the addition of the following advanced features: Redundant server capability Supports multiple FacilityPro Processors Supports third-party PLC integration Supports SMS and -sending software package Supports FacilityPro WebSpace software, providing remote access to the Server through a web browser or tablet app ios (ipad ) and Android TM app (works in conjunction with WebSpace) Specifications Minimum requirement client Operating Systems CPU i5 3 GHz, RAM 8 GB, HD GB, 3 Ethernet, 1 DVER/RW, 4 USB Ports Windows 7 Professional 64bit English or Operative System, Windows Server Essentials 2012 R2 64bit English

8 FacilityPro Software Data Management, Reporting, and Automation Feature Comparison Viable / nonviable / environmental integration 21 CFR Part 11 compliant Facility map for data and status visualization Configurable display Alarm notification and e-signatures Configurable reports including audit, statistics, and trend reports Batch identifiers and data filters Automated sample collection, recipe-driven Cubic meter algorithms for nonviable data Volume-based or time-based viable sampling Client software for remote viewing and reports Maximum number of FacilityPro Processors Built on GE Proficy ifix SCADA and Historian DB Redundant servers Third-party PLC support software support FacilityPro Webspace support ios (ipad ) and Android app (works in conjunction with Webspace) Language support FacilityPro SMART NG Server (2 max) FacilityPro SCADA NG Server English, Spanish, German, French, Italian, Portuguese, Swedish, Russian, Chinese (simplified and traditional), Korean, Japanese - : not supported y : supported FacilityPro is a registered trademark of Particle Measuring Systems, Inc. GE, ifix and Proficy are all trademarks of General Electric. ipad is a registered trademark of Apple, Inc. ios is a registered trademark of Cisco. Android is a trademark of Google, Inc. Windows is a registered trademark of Microsoft Corporation. All other trademarks are the property of their respective owners. Particle Measuring Systems, Inc. reserves the right to change specifications without notice Particle Measuring Systems, Inc. All rights reserved. HEADQUARTERS 5475 Airport Blvd Boulder, Colorado USA T: , GLOBAL OFFICES AUSTRIA T: E: pmsaustria@pmeasuring.com GERMAN T: E: pmsgermany@pmeasuring.com NORDIC T: E: pmsnordic@pmeasuring.com Instrument Service & Support T: Customer Response Center T: E: info@pmeasuring.com BENELUX T: E: pmsbelgium@pmeasuring.com BRAZIL T: E: pmsbrazil@pmeasuring.com ITAL T: E: pmssrl@pmeasuring.com JAPAN T: E: pmsjapan@pmeasuring.com PUERTO RICO T: E: pmspuertorico@pmeasuring.com SINGAPORE T: E: pmssingapore@pmeasuring.com CHINA T: E: pmschina@pmeasuring.com KOREA T: E: pmskorea@pmeasuring.com SWITZERLAND T: E: pmsswitzerland@pmeasuring.com FRANCE T: 33(0) E: pmsfrance@pmeasuring.com MEXICO T: E: pmsmexico@pmeasuring.com TAIWAN T: Ext: 301 E: pmstaiwan@pmeasuring.com

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