The LyoS™ Control System FOR LYOSTAR™ 3 LYOPHILIZERS Welcome to LyoS™ Welcome to LyoS™ • • • • Pronounced \‘lī-,ōs\. Windows®-based platform. Leverages GE Proficy HMI/SCADA iFIX. Provides visualization, data acquisition and supervisory capabilities directly to an Allen-Bradley CompactLogix PLC. Key Features • • • • Automated Leak and Function Testing Automatic Backfill / Automatic Stoppering Barometric Endpoint Testing (PRISE) Pirani vs. Capacitance Manometer differential testing (PRCM) Sophisticated Instrumentation Set • Sixteen (16), Type T product temperaturemonitoring thermocouples. • Two (2) Capacitance Manometers (product and condenser chambers). • Pirani vacuum transducer (product chamber). Optional Cycle Optimization Tools • SMART™ Freeze Dryer Technology (optional). • ControLyo™ Nucleation On-Demand Technology (optional). Fully Validateable • Fully configurable and fully validatable for regulated pharmaceutical and biotechnology applications. • SP Scientific offers onsite control system IQ/OQ validation support and a more comprehensive factory-initiated System Integration Testing (SIT) program. Documentation and Support • All original software is provided with the LyoS™ control system. • A backup copy of the LyoS™ control system is provided. • PLC source code is available. Requires a signed Confidentiality Disclosure Agreement (CDA). Control System Hardware / Software Comparison Control System Feature LyoStar™ 3 LyoStar™ II Praxair ControLyo™ Nucleation Technology Optional Not Available SMART™ Freeze Dryer Technology Optional (Available June 2011) Optional Programmable Logic Controller (PLC) Allen-Bradley CompactLogix Opto 22 Vacuum Sensor Configuration (Standard) 2 Capacitance Manometers 1 Capacitance Manometers 1 Pirani Vacuum Gauge 2 Pirani Vacuum Gauge Control System Software Feature Comparison Control System Feature LyoStar™ 3 LyoStar™ II PVG/CM Differential Feedback Testing Standard Offering. Not Available. Barometric Endpoint / Pressure Rise Testing Standard Offering. Not Available. Vacuum Ramping During Primary Drying Standard Offering. Not Available. Vacuum Preseal Standard Offering. Not Available. Product Driven Mode Standard Offering. Not Available. Vacuum Control Using Secondary Gauge Standard Offering. Not Available. Basic Navigation (Buttons) The circular icons located at the top middle and top right corner of the screen provide access to additional screens and functions. Play Stop Back Alarm Summary Maintenance Print Data Export Trend Basic Navigation (Buttons) • Play. Start or continue an automatic cycle. • Stop. Terminate an automatic cycle. • Back. Return to the previous screen. Basic Navigation (Alarm Summary Button) • The Alarm Summary button provides access to a detailed list of all active alarms. • The button displays the current number of unacknowledged alarms. • Alarms are automatically saved to the computer’s hard drive. The Alarm Summary Page The Alarm Summary Page (Alarm Print) • Select the Alarm Print button to print saved alarms. • The Alarm Print dialog appears with a list of dates. • Alarms are printed by date. Dates are formatted as yy/mm/dd. The Alarm Print Dialog • To print the Alarm Summary, select a date and click Print Alarm. • To close the Alarm Print dialog, click Cancel. Basic Navigation (Maintenance Button) The Maintenance button opens the Maintenance menu dialog. • Enable Component Mode. • Open the Configuration page. • Open the Calibration page. The Maintenance Menu (Component Mode) • Component Mode allows you to manually control system components listed on the Synoptic page such as the heater, fluid pump, vacuum pump, compressors, and associated valves. • Click the Component button to enable. The Synoptic page will open. The Maintenance Menu (Configuration) • Select the Configuration button to open the Configuration page. • Configure settings used by the software to determine how the system will operate, as well react to certain conditions. • PLC version and system serial number are displayed at the top of the page. The Configuration Page The Configuration Page (ControLyo™) • Systems configured with ControLyo™ Nucleation Technology will include additional settings. The Maintenance Menu (Calibration) • Select the Calibration button to open the Calibration page. • Calibrate the lyophilizer’s temperature sensors (i.e., shelf, condenser, ambient, interstage and product probes). The Calibration Page Basic Navigation (Trend Button) Use the Trend button to launch the Historical Trend screen. • Monitor real-time and historical cycle data. • Customize active charts. • Create new charts. The Historical Trend Screen Basic Navigation (Data Export Button) Use the Data Export button to open the Historical Data Export page. • Export historical data into a commaseparated value (.CSV) file that can be viewed in any spreadsheet application. The Historical Export Page Basic Navigation (Print Button) • Print. Prints the current full-screen view to the available printer. Print Basic Navigation (Cycle Status) The Cycle Status pull-down is accessible from the top left corner of the screen. Cycle Status Pull-Down Basic Navigation (Cycle Status) The Cycle Status pull-down displays the real-time status of critical system parameters. Basic Navigation (Cycle Status) Select the Probe Avg button to open the Product Probes popup window. Basic Navigation (Tabs) The LyoS™ control system includes a series of navigation tabs located across the bottom of the screen. To navigate to a particular page, simply click the tab of the page you wish to access. The Synoptic Page • A process flow diagram of the complete lyophilization system. • Individual components may be monitored and/or controlled from this screen. • Critical system parameters are displayed. • Activate or deactivate individual components with a click of the mouse. The Synoptic Page The Synoptic Page (ControLyo™) • Systems configured with ControLyo™ Technology include additional process flow items. The Freeze-Dry Page • The Freeze-Dry Recipe page allows you to view and edit current recipe parameters, and load a previously saved recipe. • This page provides access to the Recipe Manager function, which allows you to create and save recipes. The Freeze-Dry Page The Freeze-Dry Page (ControLyo™) Systems configured with ControLyo™ Technology include additional fields below the Freezing/Thermal Treatment steps. The SMART™ Page • SMART™ technology utilizes manometric temperature measurement (MTM). • Automated measurements of the product temperature at the sublimation interface are used to determine ideal parameters for preventing product collapse or meltback during primary drying. The SMART™ Page Coming June 2011. The Leak Test Page • The Leak Test page is intended to be used when verifying the vacuum integrity of the system. • Leak Test results are stated in terms of the system’s Rate of Rise, as well as its Volume–Based Leak Rate (VBLR). The Leak Test Page The Function Test Page • Verify the system’s performance against specifications or previous test data. • Test results include cold and warm probe test data; shelf, condenser and vacuum pull-down rates; lowest shelf and condenser temps, lowest vacuum temps., and shelf heat-up rate. The Function Test Page The Semi-Auto Page • The Semi-Auto page may be accessed to activate or deactivate the semi-auto functions, including Shelf (Shelf Control to setpoint or Heat Only to setpoint), Condenser, Vacuum Control to setpoint, Isolation Valve, Backfill, Vacuum Release and Defrost. The Semi-Auto Page The Semi-Auto Page (ControLyo™) • Systems configured with ControLyo™ Nucleation Technology will include the following Semi-Auto functions. Additional Layout Items From left to right, the top of the page layout also includes the following: • SP Scientific logo. • Current security access level. • Question Mark and Information icons. • Date and time. Security Access Levels • The control system contains a multi-level, password-protected security system. • The standard security access levels are identified as Guest, Operator and Supervisor. Question Mark Icon • The Question Mark icon indicates a Help entry point. • When selected with the Synoptic page active, illustrated components are tagged with descriptive callouts. This feature may be particularly useful when operating your lyophilizer in Component Mode. Question Mark Icon Question Mark Icon Descriptive Callout Tags Information Icon Selecting the Information icon opens a window displaying a Vapor Pressure over Ice table. Date and Time The current date and time, according to the Windows® operating system clock, is displayed at the top right corner of the control system layout.