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 temperature-monitoring 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 Pirani Vacuum Gauge

1 Capacitance Manometers 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.

Stop

Back

Play

Alarm Summary

Print

Maintenance

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 comma-

separated 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 pop-up 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

Descriptive Callout Tags

Question Mark Icon

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.