w SYSTEM DESCRIPTION The Hu//Lyophi/izer System (LP-0106) performs the freeze-drying of liquid pharmaceutical product. It has a 300 ft2 shelf area

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1 w SYSTEM DESCRIPTION The Hu//Lyophi/izer System (LP-0106) performs the freeze-drying of liquid pharmaceutical product. It has a 300 ft2 shelf area which will accommodate the processing of not less than 50,000 5mL vials (22ram diameter and 40ram height) in one batch. The lyophilizer includes a stainless steel chamber with a single full-opening door and sub-door for the loading of shelves with vials. The system includes an internal condenser system, heat transfer system, refrigeration system, vacuum system, internal stoppering system, clean-in-place system, steam sterilization system, and a process automation package for controlling the freeze-drying, sterilization, defrosting, vacuum integrity testing, and clean-in-place process sequencing. The overall system control is performed by an Allen-Bradley PLC-5/25 programmable logic controller. The refrigeration unit is controlled locally by an Allen-Bradley SLC-5/02 programmable logic controller, which operates as a slave to the =main" PLC-5/25 controller. The system provides a personal-computer-based operator interface for operator interaction with the process, as well as trending of critical process variables and tuning of control loops. Process variable data is also logged by a stand-alone data-logging and trending unit (Digilink 4S Plus); this unit is connected to a local printer for hard-copies of data trends. 2.1 Operational Requirements Please refer to the following system documentation for detailed functional requirements: 1. Engineering Document No SM, VOL. 1, Section 2: System Functional Specification. 2. Engineering Document No SM, VOL. 1, Section 3: Freeze Drying System Enhancements Summary. 2.2 Modes of Operation The following modes of operation are supported by the Huff Lyophi/izer System (LP-0106): Product Freeze Drying and Vial Stoppering Vacuum LeakTest Chamber and Condenser Plate Steam Sterilization (SIP) Condenser Plate Defrost Chamber Condenser Plate Clean-In-Place (CIP) For detailed specifications of each operation mode, please refer to Engineering Document No SM, VOL. 1, Section 2: System Functional Specification, section System Sequence Flowchart For a logic flow-chart of the Product Freeze Drying and Vial Stoppering sequence, please refer to Engineering Document No M, VOL. 1 of 12, Section 8: Freeze Drying Operation. For a logic flow-chart of the Vacuum Leak Test sequence, please refer to Engineering Document No M, VOL. 1 of 12, Section 7: Leak Testing. For a logic flow-chart of the Chamber and Condenser Plate Steam Sterilization (CIP) sequence, please refer to Engineering Document No M, VOL. 1 of 12, Section 10.0: Clean-In-Place (CIP) System. For a logic flow-chart of the Condenser Plate Defrost sequence, please refer to Engineering Document No M, VOL. 1 of 12, Section 9: Defrosting The Condenser Plates. 2.4 System Safety Requirements The Hull Lyophilizer System (LP-0106) system contains various safety features. These safety features include the following: Safety Interlocks- Please refer to Engineering Document No SM, VOL. 1,

2 Section 2: Model 300FS250-SS20C Freeze Drying System, section Uninterruptable Power Supply (UPS) for maintaining system power during power failures - Please refer to Engineering Document No SM, VOL 1, Section 2: Model 300FS250-SS20C Freeze Drying System, section Automatic Alarm Handling System - Refer to Section 4.4 of this document. All safety codes and practices as per the industry associations and agencies listed in Engineering Document No SM, VOL. 1, Section 2: Model 300FS250-SS20C Freeze Drying System, section MACHINE CONTROL SYSTEM ARCHITECTURE 3.1 PLC System The main (host) controller for the Hull Lyophilizer System (LP-0106) system is an Allen- Bradley PLC-5/25 series industrial controller. This PLC is mounted in a standard 16-slot PLC rack (Local Rack #0-3). The addressing mode for this PLC system is configured for 1-Slot addressing, allowing the use of 16-point I/O cards. There are no remote racks (I/O or controllers) connected to this system; all I/O on this machine is connected to the local rack, and is Allen-Bradley Series I/O. All machine sequencing and control is dictated by the PLC-5/25 controller; however, several =slave" control functions are performed by smaller controllers. For detailed PLC system requirements, please refer to Engineering Document No SM, VOL. 1, Section 4: Allen-Bradley PLC 5/25. A complete listing of the PLC hardware components used will be included in the Controls As- Built Documents section of the Software Documentation Binder for this system. All I/O points will be defined and listed in the Controls As-Built Documents section as well. 3.2 Operator Interface The operator interface for this system consist of the following components: Paragon 550 MMI station - Please refer to Engineering Document No SM, VOL. 1, Section 2: System Functional Specification, section 2.4, and Engineering Document No.... " " Li.. ",....,.... i. "..." ~... " SM, VOL. 1, Section 3: Freeze Drying System Enhancement Summary, sedion Digilink 4S Plus analog signal recorder with printer - for data logging, charting, and batch record printing. Refer to Engineering Document No SM, VOL. 1, Section 2: Model 300FS250-SS20C Freeze Drying System, section Manual control switches, dials, and indicator lamps - refer to Engineering Document No M, VOL. 1 of 12, Section 2: Control System. 3.3 Other Control Components several control-related tasks are performed with components other than the Allen-Bradley PLC- 5/25 controller. These components are each described in this section of this document. 1. The refrigeration unit is controlled locally by an Allen-Bradley SLC-5/02 programmable logic controller, which operates as a slave to the "main" PLC-5/25 controller. The SLC-5/02 controller controls the refrigeration unit when it is running in AUTO mode 2. The refrigeration unit shelf temperature control is performed using a Yokogawa UP25 temperature controller unit. When the refrigerator unit is running in AUTO mode, the Yokogawa UP25 controller receives it s setpoint signa!s from the SLC-5/02 PLC; when in MANUAL, it receives it s setpoints from the local refrigeration unit control panel. For more information regarding the requirement specifications for the Yokogawa controller, please refer to Engineering Document No M, VOL. 1 of 12, Section 3.0: Sample Programs.

3 3. MKS vacuum controller - used to control vacuum pressure in the freeze dry unit. 4. LOGIC AND SOFTWARE 4.1 PLC-5/25 Software Description The PLC-5/25 system is programmed with a personal computer (not supplied) running ICOM AIseries PLC-5 programming software. All programming is done in standard "ladder-logic" format, no Sequential Function Chart or Structured Text programming is used for this system. The PLC s user-configured memory is utilized for the following two functions: PLC Program Files PLC Data Files (Input, Output, Bit, Integer, Floating Point, Control, Timer, Counter, ect) The following two sections of this document define the layout for both the PLC s Program Files, and Data Files. L Program File Listing 0 System File 1 Function Chart File 2 (section 1) Analog PID s 2 (section 2) Freeze Dry Cycle Sequencer section 3 section 4 section 5 section 6 2 (section 7) section 8 section 9 Freeze Down Profile Prima D Profile ~ Pmfile SterilizerC cle Se uencer Leak Test Cycle Sequencer Defrost Cycle Sequencer CIP C cle Profile Lo In utjout ut Control Not used Not used --~ontrols Shelf Fluid Temperature PID, Drain Temperature PID, Shelf Heat SCR Setpoint, and Refrigeration Controller Setpoint Control logic for Freeze Dry cycle sequencing Control logic for Freeze Down step Control Io ic for D ste Control logic for Seconda~ DW ste~ Control logic for Sterilization step Control logic for Leak Test step Control logic for Defrost Step Control logic for CIP step Controls all PLC I/O Data File Listing 0 (O) Output 1 (I) Input

4 2 (S) Status 3 (B) Bit 4 ( 1") Timer 5 (C) Counter 6 (R) Control 7 (N) Integer 8 (F) Floating Point 9 Unused 10 Unused 11 (B) Bit 12 Unused 13 Unused 14 (N) Integer 15 (N) Integer Output Registers - for all discrete outputs Input Registers - from all discrete inputs System status registers - used by PLC for overhead/background tasks Individual bit-level registers for general program usage Timer registers - for all program timer functions Counter registers - for all program counter functions Control registers - used by specialty/advanced programming functions (e.g. SQO, FAL, ect) Integer registers - used for general program usage Floating Point registers - used for general prograrh usage Unused Unused Individual bit-level registers for shelf position sequencing Unused Unused Integer registers - used for general program usage Integer registers - used for general program usag~ 4.2 Operator lnterface Software Description The main operator interface component for this system is a Paragon 550 Man-Machine Interface (MMI) package running on a personal computer. The MMI system components, display screens, tune screens, and features are described in Engineering Document No SM, VOL. 1, Section 2: System Functional Specification, section 2.4, and Engineering Document No SM, VOL. 1, Section 3: Freeze Drying System Enhancement Summary, section Control Loops There are several functions on this system which are controlled by multiple components of the system. Each of these functions (control loops) are listed in this section. Each control loop has been defined in a system drawing, in Engineering Document No M, VOL. 7. SCR Shelf Heat Loop C UPS Power Loop CIP System Loop Steam S~,stem Loop

5 Vacuum S~,stem Loop PSIA Pressure Loop Shelf Position Loop Refrigeration Loop Condenser Plate Loop Chamber TIC Loop Chamber TIC Loop Chamber TIC Loop Subcooled Liquid Loop Suction Pressure Loop Refrigeration Exchanger Loop C C C C C C C C C C C C C C Fault Detection and Handling The PLC system is capable of detecting various fault conditions while running, and responding to them in an appropriate manner. For more information on alarms, please refer to Engineering Document No SM, VOL. 1, Section 2: Model 300FS250-SS20C Freeze Drying System, section Recovery From Power Loss and Process Fault Conditions The machine has an appropriate recovery sequence for bringing the system back on-line after either: A machine malfunction alarm A system power failure If the machine has stopped due to a critical fault condition or an E-Stop activation, the system sequence may be restored by following this sequence: 1. Rectify the fault condition 2. Insure that all safety guards are closed and in place 3. If recovering from an E-Stop alarm, pull the E-Stop button out from it s activated position 4. Acknowledge the fault on the MMI display 5. Restart machine per the process SOP If the machine has stopped due to a power failure, the system is capable of powering up in the following state: Machine sequence stopped and in an idle state Machine controllers (sequence control, motor controls, and refrigeration control) all in their default states System ready to start using the normal starting procedure (as defined in the process SOP) 5. DATA

6 5.1 Critical Parameters and Control Ranges Critical parameters are defined as those parameters which are critical to the control of the process. Critical parameters for this system include, but are not limited to, those listed in the following table. CHAMBER PSIA psia COOLING WATER TEMP C COND. PLATE #1 TEMP C COND. PLATE #2 TEMP o C COND. PLATE #3 TEMP o C COND. PLATE #4 TEMP C COND. PLATE #5 TEMP C COND. PLATE #6 TEMP C SHELF tnlet TEMP o C CHAMBER VACUUM MICRONS VACUUM PULLDOWN TIME FREEZE DOWN PROFILE SETPOINT #1 C FREEZE DOWN PROFILE SETPOINT #2 C FREEZE DOWN PROFILE RAMP RATE #1 C/HOUR FREEZE DOWN SEGMENT #2 G.SOAK TIME FREEZE DOWN PROFILE SETPOINT #.3 C FREEZE DOWN PROFILE SETPOINT #4 C FREEZE DOWN PROFILE RAMP RATE #2 C/HOUR FREEZE DOWN SEGMENT #4 G.SOAK TIME FREEZE DOWN PROFILE SETPO~NT #5 C FREEZE DOWN PROFILE SETPOINT #6 C FREEZE DOWN PROFILE RAMP RATE #3 C/HOUR FREEZE DOWN SEGMENT #6 G,SOAK TIME FREEZE DOWN PROFILE SETPOINT #7 o C FREEZE DOWN PROFILE SETPOINT #5 C FREEZE DOWN PROFILE RAMP RATE #4 C/HOUR FREEZE DOWN SEGMENT #8 G,SOAK TIME PRIMARY DRY PROFILE SETPOINT #1 C PRIMARY DRY PROFILE SETPOINT #2 C PRIMARY DRY PROFILE RAMP RATE #1 o C PRIMARY DRY SEGMENT #2 G.SOAK TIME PRIMARY DRY PROFILE SETPOINT #2 C PRIMARY DRY PROFILE SETPOINT #4 C PRIMARY DRY PROFILE RAMP RATE #2 C/HOUR PRIMARY DRY SEGMENT #4 G.SOAK TIME PRIMARY DRY PROFILE SETPOINT #5 C PRIMARY DRY PROFILE SETPOINT #6 C PRIMARY DRY PROFILE RAMP RATE #3 C/HOUR PRIMARY DRY SEGMENT #6 G.SOAK TIME PRIMARY DRY PROFILE SETPOINT #7 C PRIMARY DRY PROFILE SETPOINT #8 C PRIMARY DRY PROFILE RAMP RATE #4 C/HOUR PRIMARY DRY SEGMENT #5 G.SOAK TIME SECONDARY DRY PROFILE SETPOINT #1 C SECONDARY DRY PROFILE SETPOINT #2 C SECONDARY DRY PROFILE RAMP RATE #1 C/HOUR SECONDARY DRY SEG. #2 G,SOAK TIME SECONDARY DRY PROFILE SETPOINT #3 C SECONDARY DRY PROFILE SETPOINT #4 C SECONDARY DRY PROFILE RAMP RATE #2 C/HOUR SECONDARY DRY SEG. #4 G.SOAK TIME SECONDARY DRY PROFILE SETPOINT #5 C SECONDARY DRY PROFILE SETPOINT #6 C SECONDARY DRY PROFILE RAMP RATE #3 o C/HOUR SECONDARY DRY SEG. #6 G.SOAK TIME SECONDARY DRY PROFILE SETPOINT #7 C SECONDARY DRY PROFILE SETPOINT #5 C SECONDARY DRY PROFILE RAMP RATE #4 C/HOUR SECONDARY DRY SEG. #8 G,SOAK TIME STERILIZE CYCLE STEAM SOAK TIME STERILIZE CYCLE PREVAC COUNTS COUNTS STERILIZE CYCLE RAM DOWN SOAK TIME 5.2 Data Logging, Trending, and Archiving The data logging, trending, and archiving on this system is performed by the DigiLink 4S Plus data legging unit. The DigiLink 4S Plus unit receives and records data from 28 thermocouples, 2 controlling RTD s, and 2 pressure transducers. The signals are printed on a local dot-matrix printer for monitoring and manual archiving. The recorded signals are listed in the following table, 101 TIC #1, chamber #1 temperature

7 102 TIC #2, chamber #2 temperature 103 TIC #3, chamber #3 temperature 104 TIC #4, chamber #4 temperature TIC #5, chamber #5 temperature T/C #6, chamber #6 temperature 107 TIC #7, chamber #7 temperature 108 TIC #8, chamber #8 temperature 109 TIC #9, chamber #9 temperature 110 TIC #10, chamber #10 temperature 111 TIC #11, chamber #11 temperature 112 TIC #12, chamber #12 temperature 113 TIC #13, chamber #13 terpperature 114 TIC #14, chamber #14 temperature 115 TIC #15, chamber #15 temperature 116 TIC #30, shelf outlet temperature 201 Chamber Vacuum 202 2O3 2O4 Measured vacuum from vacuum pumps TIC #16, condenser plate #1 temperature TIC #17. condenser plate #2 temperature 205 TIC #18, condenser plate #3 temperature 206 TIC #27, condenser plate #4 temperature 207 TIC #28, condenser plate #5 temperature 208 TIC #29, condenser plate #6 temperature 209 RTDIB, shelf inlet temperature 210 RTD2B, system drain temperature 211 TIC #25, cooling water temperature 212 SUB CL4 (spare T/C) 213 SUB CL5 (spare T/C) 214 SUB CL1 (spare T/C) 215 SUB CL2 (spare T/C) 216 SUB CL3 (spare T/C) o C o C o C Microns Microns Microns o C o C

8 N/A C N/A C N/A C N/A o C N/A C 5.3 Batch Record The Paragon 550 operator interface system will be capable of providing a printed batch record at the end of each freeze-drying batch. Please refer to Engineering Document No SM, VOL. 1, Section 2: Model 300FS250-SS20C Freeze Drying System, section for a listing of all data to be included in the batch record printout. 5.4 Recipe Management The Paragon 550 operator interface system will be capable of providing recipe management tools for the system. It will provide the following recipe management functions: Recipe parameter configuration screens Abilityto name/create new recipes Ability to save recipes to the computer s hard disk Ability to recall saved recipes Recipe parameter download to PLC-5/25 Programmable Logic Controller The following is a recipe template for the system. CHIRON RECIPE TEMPLATE PRODUCT # xxx DATE : xx~,x~x TIME : xx:xx DESCRIPTION VALUE UNITS CHAMBER PSIA HIGH ALARM VALUE SETPT \000 COOLING WATER HIGH TEMP ALARM SETPT \001 COND. PLATE #1 HIGH TEMP ALARM SETPT \002 COND. PLATE #2 HIGH TEMP ALARM SETPT \003 COND. PLATE #3 HIGH TEMP ALARM SETPT \004 COND. PLATE #4 HIGH TEMP ALARM SETPT \005 COND. PLATE #5 HIGH TEMP ALARM SETPT \006 COND. PLATE #6 HIGH TEMP ALARM SETPT \007 SHELF INLET HIGH TEMP ALARM SETPOINT \008 CHAMBER VACUUM BREAK WITH AIR ENABLE \009 CHAMBER VACUUM BREAK WITH N2 ENABLE \010 VACUUM CONTROL SETPOINT \011 VACUUM ALARM SETPOINT \012 VACUUM PULLDOWN TIME ALARM SETPOINT \013 VACUUM PULLDOWN TIME \014 CHAMBER BREAK TO PSIA SETPOINT \015 FREEZE DOWN PROFILE SETPOINT #1 \016 FREEZE DOWN PROFILE SETPOINT #2 \017 FREEZE DOWN PROFILE RAMP RATE #1 \018 FREEZE DOWN SEGMENT #2 G.SOAK TIME \019 FREEZE DOWN PROFILE SETPOINT #3 \020 FREEZE DOWN PROFILE SETPOINT #4 \021 FREEZE DOWN PROFILE RAMP RATE #2 \022 FREEZE DOWN SEGMENT #4 G.SOAK TIME \023 FREEZE DOWN PROFILE SETPOINT #5 \024 FREEZE DOWN PROFILE SETPOINT #6 \025 FREEZE DOWN PROFILE RAMP RATE #3 \026 FREEZE DOWN SEGMENT #6 G.SOAK TIME \027 FREEZE DOWN PROFILE SETPOINT #7 \028 FREEZE DOWN PROFILE SETPOINT #8 \029 FREEZE DOWN PROFILE RAMP RATE #4 \030 FREEZE DOWN SEGMENT #6 G.SOAK TIME \031 PRIMARY DRY PROFILE SETPOINT #1 PSIA

9 NONE NONE MICRONS MICRONS MICRONS PSIA /HOUR /HOUR /HOUR /HOUR \032 CHIRON RECIPE TEMPLATE (Continued) DESCRIPTION VALUE UNITS PRIMARY DRY PROFILE SETPOINT #2 \033 PRIMARY DRY PROFILE RAMP RATE #1 \034 /HOUR PRIMARY DRY SEGMENT #2 G.SOAK TIME \035 PRIMARY DRY PROFILE SETPOINT #3 \036 PRIMARY DRY PROFILE SETPOINT #4 \037 PRIMARY DRY PROFILE RAMP RATE #2 \038 /HOUR PRIMARY DRY SEGMENT #4 G.SOAK TIME \039 PRIMARY DRY PROFILE SETPOINT #5 \040 PRIMARY DRY PROFILE SETPOINT #6 \041 PRIMARY DRY PROFILE RAMP RATE #3 \042 /HOUR PRIMARY DRY SEGMENT #6 G.SOAK TIME \043 PRIMARY DRY PROFILE SETPOINT #7 \044 PRIMARY DRY PROFILE SETPOINT #8 \045 PRIMARY DRY PROFILE RAMP RATE #4 \046 /HOUR PRIMARY DRY SEGMENT #8 G.SOAK TIME \047 SECONDARY DRY PROFILE SETPOINT #1 \048 SECONDARY DRY PROFILE SETPOINT #2 \049 SECONDARY DRY PROFILE RAMP RATE #1 \050 SECONDARY DRY SEG. #2 G.SOAK TIME \051 SECONDARY DRY PROFILE SETPOINT #3 \052 SECONDARY DRY PROFILE SETPOINT #4 \053 SECONDARY DRY PROFILE RAMP RATE #2 \054

10 SECONDARY DRY SEG. #4 G.SOAK TIME \055 SECONDARY DRY PROFILE SETPOINT #5 \056 SECONDARY DRY PROFILE SETPOINT #6 \057 SECONDARY DRY PROFILE RAMP RATE #3 \058 SECONDARY DRY SEG. #6 G.SOAK TIME \059 SECONDARY DRY PROFILE SETPOINT #7 \060 SECONDARY DRY PROFILE SETPOINT #8 \061 SECONDARY DRY PROFILE RAMP RATE #4 \062 SECONDARY DRY SEG. #8 G.SOAK TIME \063 STERILIZE CYCLE STEAM SOAK TIME STERILIZE CYCLE PREVAC COUNTS /HOUR /HOUR /HOUR /HOUR \076 \077 COUNTS STERILIZE CYCLE RAM DOWN SOAK TIME \078 L 6. SECURITY The Hull Lyophilizer System (LP-0106) system contains several security measures to insure the integrity of the system s operational functions, power distribution, and controller programming. Each of the security measures are listed and described in this section of this document. Allen-Bradley PLC-5/25 Controller Security Features Run/Remote Prog/Remote Run key switch on PLC faceplate - This switch may be locked into the "Run" position to prevent un-authorized personnel from being able to tamper with the software program running in the PLC controller. A password may be enabled in the PLC programming application which would not allow a user to change, upload, or download a program without the proper security clearance. Please refer to Engineering Document No SM, VOL. 1, Section 4: Allen- Bradley PLC-5/25, section for more information regarding security of the PLC system. Allen-Bradley SLC-5/02 Controfler Security Features None. Operator Interface Security Features The Paragon 550 MMI package has password protection for it s various features. Please refer to Engineering Document No SM, VOL. 1, Section 3: Freeze Drying System Enhancement Summary, section and section for more information on this system s levels of password protection. Digilink 4 Plus Security Features

11 Programming mode security ~ A programming mode password may be configured to restrict access to the system s programming mode. If enabled, the password will prevent unauthorized access to the following parameters: function codes, decimal codes, configuration codes, and the system clock. Refer to the Digilink 4 Plus system manual for detailed secudty configuration instructions. CTX access security - A password may be enabled to restdct access to the Digilink 4 Plus system when used with a computer. Refer to,the Digilink 4 Plus system manual for detailed security configuration instructions.

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