FTS LYOSTAR 3 User manual

LYOPHILIZER OPERATOR’S MANUAL
FTS S YSTEMS L YO S TAR ™ 3
R ESEARCH & D EVELOPMENT / P ILOT -S CALE F REEZE D RYER

Rev 006, 01/14 i
© SP Scientific 2014
Copyright © 2014 SP Scientific. All marks herein are used under license.
All brand or product names mentioned may be trademarks or registered trademarks of their respective
companies.
Part Number 100004448
Rev 006, 01/14
Original Instructions
The U.S. English version of this document is the original instructions.
All other languages are a translation of the original instructions.
SP Scientific
3538 Main Street
935 Mearns Road
815 State Route 208
Stone Ridge, NY 12484
USA
Warminster, PA 18974
USA
Gardiner, NY 12525
USA
[phone]
[phone]
[phone]
[phone]
[phone]
[phone]
SP Service
[phone]
SP Service Fax
[phone]
Website
http://www.spscientific.com
This Lyophilizer Operator’s Manual contains confidential and proprietary information of SP Scientific and
may be used only by a recipient designated by and for purposes specified by SP Scientific.
Reproduction of, dissemination of, modifications to, or the creation of derivative works from this Lyophilizer
Operator’s Manual, by any means and in any form or manner, is expressly prohibited, except with the prior
written permission of SP Scientific. Permitted copies of this document must retain all proprietary notices
contained in the original.
The information in this document is subject to change without prior notice. Always confirm with SP Scientific
that you are using the most current version of this document. SP Scientific is free to modify any of its
products and services, in any manner and at any time, notwithstanding the information contained in this
document.
THE CONTENTS OF THIS DOCUMENT SHALL NOT CONSTITUTE ANY WARRANTY OF ANY KIND,
EITHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES
OF MERCHANTABILITY AND/OR FITNESS FOR A PARTICULAR PURPOSE OR GIVE RISE TO ANY
LIABILITY OF SP SCIENTIFIC, ITS AFFILIATES OR ITS SUPPLIERS.
The terms and conditions governing the use of this Lyophilizer Operator’s Manual shall consist of those set
forth in written agreements with SP Scientific.

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Important Symbols
WARNING! INJURY OR EVEN DEATH
MAY RESULT IF RECOMMENDATION
MARKED WITH THIS SYMBOL IS NOT
HEEDED.
CRUSH HAZARD. KEEP HANDS
CLEAR WHEN OPERATING DOOR.
ELECTRIC SHOCK DANGER! USE
APPROPRIATE CAUTION TO AVOID
INJURY OR DEATH.
CORROSIVE CHEMICAL. WEAR
SUITABLE GLOVES, SAFETY
GLASSES, AND PROTECTIVE
CLOTHING.
BURN DANGER! POTENTIALLY HOT
SURFACE. USE APPROPRIATE
CAUTION.
PROPERTY CAUTION! TO PREVENT
DAMAGE TO CHAMBER EQUIPMENT
AND/OR LOAD, ADHERE TO
PROCEDURES MARKED BY THIS
SYMBOL.
DO NOT STORE FLAMMABLE
MATERIALS IN CHAMBER. PRACTICAL OPERATING TIP. THESE
RECOMMENDATIONS STREAMLINE
UNIT OPERATION AND PREVENT
COMMON OPERATOR ERRORS.
ALWAYS WEAR APPROPRIATE
PERSONAL PROTECTIVE
EQUIPMENT (PPE) SUITED FOR THE
TASK YOU ARE PERFORMING.
EXPLOSIVE MATERIALS HAZARD!
KEEP OBJECTS AWAY FROM HEAT.
Freeze Dryer Safety Warnings
Do not freeze-dry explosive or highly flammable substances.
Always assume that shelf, condenser and internal parts may be very cold or very hot. Wear protective equipmentto avoid burns.
Always ensure that only an authorized technician services the refrigeration, heat transfer, vacuum and electricalsystems.
Always ensure that refrigeration air intake is clear and clean.
Always ensure vacuum pump exhaust is properly ventilated and/or contained.
Always practice team lifting when moving heavy equipment.
Always regulate maximum pressure to 1 psig when backfilling from an inert gas.
Always wear appropriate personal protective equipment (PPE) suited for the task you are performing.
Be sure to carefully read the entire instruction manual before attempting to operate the freeze dryer.
Be sure to verify that the electric service and other utilities match the unit’s requirements before connecting topower.
Never allow hand or body contact with open vacuum ports.
Never clean with solvents. Use mild detergent and water only.
Never operate the unit without all covers in place.
Never pressurize a freeze-drying chamber unless it has been specially designed and coded as a pressure vessel(e.g., displays an ASME-coded certificate).
Never stopper vials unless the chamber door is tightly closed.
Never use acrylic closures if they are cracked or crazed.
Never use with toxic, corrosive, flammable or organic materials unless special precautions are in place toprevent injury to personnel or damage to equipment.

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Warranty Information
FTS Systems LyoStar™ 3 Lyophilizers are warranted by SP Scientific to be free of defects in material and
workmanship when operated under normal conditions as specified in the instructions provided in this manual. Please
take this opportunity to locate the serial tag on your new FTS Systems LyoStar™ 3 and record the information below
for future reference. SP Scientific also recommends that you complete and return your unit’s warranty registration card.
Model Number
Serial Number
Part Number
Limited Warranty
SP Scientific (the “Company”) shall warrant each of its products against defects in material or workmanship for a period
of 12 months from the date of installation or 15 months from the date of shipment (whichever comes first) provided that
the product is used in a reasonable manner under appropriate conditions and consistent with the applicable operating
instructions. In addition, the Company shall warrant the refrigeration system for a period of 24 months provided that the
system is used in a reasonable manner under appropriate conditions and consistent with the applicable operating
instructions.
The obligation of the Company shall be, at its option, to repair or replace, without charge any parts that prove to be
defective within the warranty period, if the purchaser notifies the Company promptly in writing of such defect. No
product shall be returned to the Company without prior approval of the Company.
This limited warranty shall cover the costs of parts and labor to repair or replace all defective product(s) at the Seller’s
factory. For all products installed by the Company and located within the Company service travel areas, this warranty
shall cover transportation charges to ship the product to and from the Company’s factory and/or the costs of travel,
room and board if the Company’s employees conduct repair at the Buyer’s location. In lieu of repair or replacement at
the Company’s factory, the Company may, in its discretion, authorize a third party to perform the repair or replacement
at the Buyer’s location, and at the Company’s sole expense.
The Company shall not be responsible for labor charges payable with respect to persons other than Company
employees. Replacement or repair of parts pursuant to this warranty shall not in any way extend the original warranty
period. The Company shall not be responsible for any unauthorized repairs, replacements or product modifications, nor
will it be responsible for any product failures resulting from such unauthorized repairs, replacements or product
modifications negligently or otherwise made by persons other than Company employees or authorized representatives
of the Company. The buyer shall assume transportation charges to ship the product to and from the Company’s factory
and the costs of travel, room and board if the Company’s employees conduct repair at the Buyer’s location within the
warranty period if the product was not installed by the Company’s and/or is not located within the Company’s service
travel areas.
THE COMPANY DOES NOT MAKE AND EXPRESSLY DISCLA
IMS ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, WITH
RESPECT TO THE SALE, INSTALLATION, DESIGN OR USE OF ITS PRODUCTS. ADDITIONALLY, THE
COMPANY SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OF OR
ANY DEFECTS IN ITS PRODUCTS.
The Company’s employees are available to provide general advice to customers concerning the use of the Company’s
products; however, oral representations are not warranties with respect to particular products or their uses and may not
be relied upon if they are inconsistent with the relevant product specifications for the items set forth herein.
Notwithstanding the above, the terms and conditions set forth in the Company’s formal sales contracts shall be
controlling and supersede any inconsistent terms contained herein, and any changes to such contracts must be made
in writing and signed by an authorized executive of the Company.
WARNING! THE DISPOSAL AND/OR EMISSION OF SUBSTANCES USED IN CONNECTION WITH
THIS EQUIPMENT MAY BE GOVERNED BY VARIOUS FEDERAL, STATE OR LOCAL
REGULATIONS. ALL USERS OF THIS EQUIPMENT ARE URGED TO BECOME FAMILIAR WITH
ANY REGULATIONS THAT APPLY IN THE USERS AREA CONCERNING THE DUMPING OF
WASTE MATERIALS IN OR UPON WATER, LAND OR AIR AND TO COMPLY WITH SUCH
REGULATIONS.

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Contents
Important Symbols...............................................................................................................................................ii
Freeze Dryer Safety Warnings.............................................................................................................................ii
Warranty Information .......................................................................................................................................... iii
Introduction.................................................................................................................1
Standard Features...............................................................................................................................................1
Equipment Options ..............................................................................................................................................2
Getting Started............................................................................................................3
Initial Inspection...................................................................................................................................................3
Setup Procedure..................................................................................................................................................3
The Freeze-Drying System .........................................................................................9
Components and Subsystems.............................................................................................................................9
Product Drying Chamber....................................................................................................................................10
Standard Chamber........................................................................................................................................10
ControLyo™ Chamber...................................................................................................................................10
Standard Chamber Door...............................................................................................................................10
ControLyo™ / Stainless Steel Chamber Door...............................................................................................10
Stainless Steel Chamber Door......................................................................................................................10
Product Shelves.................................................................................................................................................11
Shelf Stack and Latching...............................................................................................................................11
Stoppering.....................................................................................................................................................11
Product Trays................................................................................................................................................11
Shelf Heat-Transfer System..........................................................................................................................12
TDLAS Spool Piece...........................................................................................................................................12
Isolation Valve....................................................................................................................................................12
Isolation Valve Utility Requirements..............................................................................................................12
Condenser System ............................................................................................................................................13
Condenser Cooling........................................................................................................................................13
Standard Condenser Door.............................................................................................................................13
Defrost...........................................................................................................................................................13
Refrigeration System .........................................................................................................................................13
Refrigeration System Utility Requirements....................................................................................................13
Aeration and Vacuum Level Control ..................................................................................................................14
Vacuum System.................................................................................................................................................14
Vacuum Pump Exhaust.................................................................................................................................14

Contents
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LyoS™ Control System......................................................................................................................................14
Programmable Logic Controller (PLC) ..........................................................................................................14
Operating your Lyophilizer ........................................................................................15
Leak Rate and Function Testing........................................................................................................................15
Preparation and Pretreatment............................................................................................................................15
Product Temperature-Monitoring Probes ......................................................................................................16
Pre-Freezing..................................................................................................................................................17
Stoppers........................................................................................................................................................17
Freeze Drying................................................................................................................................................17
Freezing / Thermal Treatment.......................................................................................................................18
Drying Steps 1-16..........................................................................................................................................18
Drying Step 17...............................................................................................................................................19
Completing the Cycle.........................................................................................................................................19
Defrost...............................................................................................................................................................19
Liquid Nitrogen Trap..................................................................................................21
Operation.......................................................................................................................................................22
Cleaning........................................................................................................................................................24
Sample Extractor Assemblies...................................................................................27
Standard Sample Extractor Assembly (Acrylic)..................................................................................................27
Sample Extractor Assembly Components.....................................................................................................27
Sample Extractor...........................................................................................................................................28
Installation.....................................................................................................................................................28
Sample Extractor Operation..........................................................................................................................29
ASME-Coded Stainless Steel Sample Extractor Assembly................................................................................33
Sample Extractor Assembly Components.....................................................................................................33
Sample Extractor Operation..........................................................................................................................34
Shelf Spacing.....................................................................................................................................................37
Stoppering.................................................................................................................39
Main Components..............................................................................................................................................39
Stoppering..........................................................................................................................................................40
Inert Gas Backfill................................................................................................................................................41
Shelf-Latching...........................................................................................................43
Praxair’s ControLyo™ Nucleation On-Demand Technology ....................................47
The Praxair ControLyo™ Nucleation On-Demand Technology Process............................................................48
Pressurization................................................................................................................................................48
Depressurization ...........................................................................................................................................48
Purging..........................................................................................................................................................48
Importance of Controlled Nucleation..................................................................................................................49
Key Steps...........................................................................................................................................................50
Mechanism.........................................................................................................................................................52

FTS Systems LyoStar™ 3
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Guidelines and Performance Expectations....................................................................................................52
General Maintenance................................................................................................55
Vacuum System.................................................................................................................................................55
Vacuum Pump...............................................................................................................................................55
Changing Vacuum Pump Oil.........................................................................................................................55
Gas Ballast Valve on the Vacuum Pump.......................................................................................................56
Vacuum Tubing and Gaskets........................................................................................................................56
Refrigeration System .........................................................................................................................................57
Air-Cooled Condenser...................................................................................................................................57
Water-Cooled Condenser..............................................................................................................................57
Condenser Chamber..........................................................................................................................................57
Acrylic Parts.......................................................................................................................................................58
Chemical Resistance Chart...........................................................................................................................58
Routine Maintenance Schedules .......................................................................................................................59
Recommended Monthly Maintenance Schedule...........................................................................................60
Recommended Quarterly Maintenance Schedule.........................................................................................60
Recommended Annual Maintenance Schedule.............................................................................................61
Recommended Five-Year Maintenance Schedule........................................................................................62
Appendix A: Sample Recipe .....................................................................................63
Appendix B: Troubleshooting....................................................................................65
Troubleshooting Chart .......................................................................................................................................65
Additional Troubleshooting: Vacuum System.....................................................................................................67
Vacuum Pump Test.......................................................................................................................................67
Product Chamber and Condenser Vacuum Leak Check...............................................................................68
Appendix C: Stainless Steel Cleaners.......................................................................69

Contents
FTS Systems LyoStar™ 3
viii Rev 006, 01/14
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© SP Scientific 2014
Chapter
1
Introduction
Introducing the LyoStar™ 3—the pinnacle of freeze dryer engineering. Designed and
built like a full-scale production freeze dryer, this pilot-scale lyophilizer offers superior
shelf mapping, rapid shelf freezing, a robust 5.5 hp cascade refrigeration system,
unmatched process accuracy and reliability, and a sophisticated instrumentation set.
In short, the LyoStar™ 3 is the ultimate R&D lyophilizer.
Standard Features
Hydraulic stoppering system with shelf-latching for various vial sizes.•
Two-stage rotary vane vacuum pump with oil mist eliminator.•
Durable, long-lasting 316L stainless steel chambers and product shelves.•
High capacity external coil condenser.•
High-performance cascade refrigeration system.•
Powerful scroll compressors.•
Isolation valve for chamber isolation during barometric endpoint testing,•condenser defrost and periodic leak checking.
Sixteen (16), 24 AWG Type T product temperature-monitoring thermocouples.•Eight (8), 36 AWG Type T product temperature-monitoring thermocouples
provided with resin caps with O-rings for use with 13 mm vials. Eight (8), 36
AWG Type T product temperature-monitoring thermocouples encased in
polytetrafluoroethylene (PTFE) sheathing and provided with PTFE caps for
use with 20 mm vials.
Two (2) 100 Ohm Resistance Temperature Detectors (RTDs) (i.e., for•monitoring the shelf inlet and shelf outlet temperatures).
Two (2) Capacitance Manometers (i.e., for monitoring vacuum in both the•product and the condenser chambers)
Pirani vacuum transducer (i.e., for pressure monitoring in the product•chamber).
Two-stage rotary vane vacuum pump with oil mist eliminator.•
Advanced cycle development and optimization tools, including Barometric•Endpoint and Pirani Capacitance Differential Feedback (PRCM) testing.

Introduction
FTS Systems LyoStar™ 3
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Equipment Options
Stainless steel product and/or condenser chamber doors.•
Water-cooling for enhanced performance.•
Stainless steel Bio-seal flange for cleanroom installation.•
Liquid nitrogen trap.•
Sample Extractor Assembly.•

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© SP Scientific 2014
Chapter
2
Getting Started
Initial Inspection
Your LyoStar™ 3 lyophilizer was carefully packed and thoroughly inspected before
leaving the factory. However, in the unlikely event that shipping damage has occurred,
retain all packing material and contact your freight carrier immediately.
DO NOT ACCEPT DAMAGED SHIPMENTS FROM A CARRIER WITHOUT A SIGNED
NOTIFICATION OF DAMAGES.
Upon receiving your shipment, inspect all contents of your equipment for damage.
Check packing material for small accessory items. Remove all packing material
carefully and inspect for concealed shipping damage. Inspect the inside of the
machine for any visible damage. If concealed damage or loss is discovered, contact
the freight carrier immediately.1Keep all contents, packing material and related
paperwork intact until a written report is obtained.
Note: SP Scientific will cooperate in the matter of collecting your claim, but is not responsible
for the collection or free replacement of the material. When possible, replacement parts will be
shipped and invoiced to you, making them a part of your claim.
Setup Procedure
The LyoStar™ 3 research & development lyophilizer is designed for single level
installation in either a machine room or cleanroom. The unit should be installed in a
location that is convenient for both operation and service.
Note: SP Scientific recommends installing your LyoStar™ 3 lyophilizers in an area equipped
with an adequate fire suppression system, as the system’s pressure relief devices are not
intended to withstand substantial increases in pressure due to extreme external temperatures
(e.g., such as in the event of a facility fire).
The following procedure will guide you with the setup of your LyoStar™ 3 lyophilizer.
Uncrate and unwrap the unit.1.
Note: The LyoStar™ 3 and the control system workstation and peripherals
(e.g., printer) supplied with the control system are typically packaged separately.
1“Concealed damage or loss” refers to damage or loss that does not become apparent until the merchandise has been
unpacked and inspected. Should damage or loss be discovered, you may make a written request for inspection by the carrier's
agent within 15 days of the delivery date. You may then file a claim with the freight carrier or SP Scientific, depending on the
terms of your shipment. If your shipment was “FOB Destination” file your claim with SP Scientific and include the inspection
report and any other supporting documents. If your shipment was “FOB Shipping Point” file your claim with the freight carrier
and include the inspection report and any other supporting documents.

Getting Started
FTS Systems LyoStar™ 3
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Inspect the inside of the unit for any visible damage. Check refrigeration lines,2. heat transfer lines and vacuum lines for damage. Check for visible liquid at or
near the base of the unit.
Open the product and condenser chamber doors. Remove all packing3. material from chambers.
Note: LyoStar™ 3 lyophilizers are equipped with stoppering, therefore, it may be
necessary to power up the unit and adjust the shelves before removing all packing
material. At this point, leave the shelf packing in place. Wait until you have completed
the installation procedure before powering up the unit.
Inspect chamber parts for possible damage and leaks. Check the bottom of4. the product chamber for traces of oil. The heat transfer fluid contains a
fluorescent dye, making leaks easily visible with a black light. The condenser
and chamber should be clean and dry. The condenser drain valve should be
closed.
Services and Utilities. Review the Layout Drawing from your equipment and5. confirm that the services and utilities available at your facility meet a standard
voltage configuration requirement:
•208/230 VAC, 50/60 Hz, 1 phase, 40 A
•220 VAC, 60 Hz, 1 phase, 40 A
•240 VAC, 50 Hz, 1 phase, 40 A
•400 VAC, 50 Hz, 3 phase, 30 A
•480 VAC, 60 Hz, 3 phase, 30 A
Ensure that the voltage, phase, frequency and amperage listed on the
lyophilizer’s serial tag match your facility’s available power supply (i.e., the
power outlet you intend to use must meet the voltage and amperage
requirements listed on the serial tag).
Note: LyoStar™ 3 includes two Uninterruptible Power Supplies (UPS), which permit
the control system software to continue operating in the event of a power failure. One
UPS provides backup power to the computer workstation (HMI/SCADA and
peripherals) and one UPS provides backup power to the PLC and all critical
instruments.
DO NOT CONNECT THE SYSTEM TO POWER AT THIS TIME.
CAUTION! ONLY A QUALIFIED ELECTRICIAN SHOULD CONNECT THE UNIT TO
THE AVAILABLE ELECTRICAL SUPPLY.
Position the unit on a firm, level floor in an area that provides adequate air6. circulation. The LyoStar™ 3 is designed for installation and operation in a
room with a controlled temperature of between 19 °C and 25 °C
and a maximum relative humidity of 70%.
Note: Do not allow the intake air for the LyoStar™ 3 to exceed 30 °C. If the ambient
room temperature exceeds 30°C, do not operate the lyophilizer until adequate cooling
or ventilation is established.

FTS Systems LyoStar™ 3
Getting Started
Rev 006, 01/14 5
© SP Scientific 2014
Clearance. Twenty-four (24) inches (61 cm) of obtainable clearance is7. recommended on all sides of the unit for serviceability and efficient operation.
If multiple machines are being operated in a single area, position them so that
the hot exhaust from one does not blow into the intake of another. If machines
are placed side-by-side, increase the minimum clearance to 48 inches
(122 cm).
Cleanroom systems: Position the freeze dryer so that the wall flange is flush against
the periphery of the wall opening. Screw, caulk and secure it to the wall.
Heat Transfer System. The heat transfer system is shipped with heat8. transfer fluid. The fluid circuit is a sealed system and under normal setup or
operating conditions does not require additional fluid. The heat transfer fluid
level may be monitored through the sight glass located on the side of the heat
transfer fluid reservoir. This sight glass is visible through the upper rear grill
panel.
Note: The heat transfer fluid level should be approximately ¾ full when the system is
at 25 °C.
Door Gaskets. Ensure that the chamber and condenser door gaskets are9. clean and free of defects (e.g., cuts, cracks, tears). If the gasket shows any
signs of cracks or tears replace it immediately. Failure to do so shall result in
poor vacuum integrity. As a minimum, gaskets should be inspected quarterly
and replaced annually.
Note: The door gaskets do not require vacuum grease for pre-seal or operation.
Vacuum System10.
Vacuum Pump Oil. Check the vacuum pump oil. The vacuum pump is
shipped with oil in it. The vacuum pump oil should be clearly visible in the
sight glass on the front of the pump. The oil level should read between the
center and top of the sight glass while the pump is off and to the top of the
sight glass while the pump is in use. Add oil only if necessary. DO NOT
OVERFILL!
Note: For information on vacuum system maintenance, refer to Chapter 10: General
Maintenance, Vacuum System .
Oil Mist Eliminator. The LyoStar™ 3’s vacuum system is equipped with an
Oil Mist Eliminator. Ensure that it is properly attached to the vacuum system
before operating the lyophilizer.
Oil Mist Eliminator (OME)
Vacuum Pump Oil Sight Glass

Getting Started
FTS Systems LyoStar™ 3
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© SP Scientific 2014
Vacuum Pump Exhaust. If applicable, check your facilities vacuum pump
exhaust piping. SP Scientific recommends an adequate vacuum pump
exhaust system be installed, as pump vapors can be unpleasant in the lab
and are not typically permitted in a clean room environment. SP Scientific
suggests vacuum pump exhaust piping travel horizontally from the pump
across to a “T” equipped with a drainable trap and then 90 degrees vertically
to an outside vent. Always place the drain trap as close to the pump as
possible. Exhaust lines should have an inside diameter no smaller than the
discharge of the pump. Filters are also available. If you cannot exhaust
directly outside the facility, a hood may be used.
Doors and Ports. Ensure that all ports, including the condenser drain port,11. are closed and/or sealed. Close the product and condenser chamber doors.
Optional Water-Cooled Units. If your unit is equipped with an optional water-12. cooled refrigeration system, ensure that the flow rate and temperature of the
water meets the lyophilizer’s specified requirements. During warmer months,
water temperature may increase. If water from a controlled temperature
source is not used, take steps to ensure that the water temperature is
maintained within the unit’s specified temperature range.
Attach the cooling water supply to the cooling water inlet connector and a
water return line to the cooling water outlet connector. SP Scientific
recommends installing manual shut off valves and pipe unions on both the
cooling water inlet and cooling water outlet connectors for ease of service.
Note: SP Scientific recommends installing a 30 x 40 mesh or finer strainer on the
cooling water supply (reference: McMaster Carr 98775K45).
Pneumatic Isolation Valve. Standard LyoStar™ 3 lyophilizers are equipped13. with a pneumatic isolation valve. This valve requires a water-free compressed
air source. Ensure that your air source meets the unit’s specified
requirements. Connect the compressed air source at this time.
Inert Gas for Backfill. Nitrogen or other inert gas may be used to backfill the14. product chamber prior to stoppering. When using inert gas for backfill, ensure
that the source meets the specified requirements. Connect the source to the
sterile air inlet port.
Drain for condensed pump oil mist
Vacuum Exhaust Piping

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© SP Scientific 2014
Inert Gas for Systems with Praxair’s ControLyo™ Nucleation On-15. Demand Technology. LyoStar™3 lyophilizers equipped with ControLyo™
Nucleation On-Demand Technology require an inert gas source for system
pressurization. Argon (preferred), nitrogen or other suitable inert gas should
be supplied with the gas pressure capable of delivering 4 scfm when
regulated between 50 and 60 psig. Connect the source using a ¾-inch male
NPT fitting.
Notes: Without proper ventilation , operation of ControLyo™ may cause the oxygen
concentration of ambient air to drop below acceptable levels. To ensure that ventilation
is adequate for the depressurization process, the volume to vent percentage ratio
(VV/VR) must be less than 6.5%, where VV equals the product chamber volume
multiplied by 10, and VR equals the total volume of the room in which the lyophilizer is
located. In addition, SP Scientific recommends the use of an O2sensor to monitor
oxygen concentration while operating ControLyo™.
For additional information, refer to Chapter 9: Praxair’s ControLyo™ Nucleation
On-Demand Technology.
Vacuum Level Control and Vacuum Release. Nitrogen, room air or16. customer specified inert gas should be provided within a pressure range of
atmospheric to 5 psig maximum for vacuum level control and/or vacuum
release.
Control System Connections.17.
Note: For additional information, refer to the setup procedure included in your control
system operator’s manual.
VERIFY THAT THE RED VOLTAGE-SELECTING SWITCH LOCATED ON THE
BACK OF THE WORKSTATION TOWER IS APPROPRIATELY CONFIGURED
FOR YOUR INPUT POWER (115 VAC OR 230 VAC). CONNECTING THE
WORKSTATION TO POWER WHILE THE SWITCH IS IN THE WRONG
POSITION COULD CAUSE SEVERE DAMAGE TO THE WORKSTATION.
Connect the supplied data communications cable(s) (e.g., RS-232, Ethernet,
etc.) between the LyoStar™ 3 lyophilizer and the control system workstation.
Your LyoStar™ 3 includes an Uninterruptible Power Supply (UPS) to be used
with control system workstation. Connect the power cables of the monitor, PC
and peripherals to the open electrical sockets on the UPS. Plug the UPS into
the available power supply and enable power.
Ensure that all electrical control panel switches, as well as the main circuit18. breaker are in the off position.
Connect remaining utilities and/or attach additional equipment.19.
Connect the lyophilizer to the available power supply (check available power20. supply against the lyophilizer’s requirements as stated on the serial tag).
Note: The UPS which provides backup power to the PLC and all critical instruments is
installed within the LyoStar™ 3 frame.
CAUTION! ONLY A QUALIFIED ELECTRICIAN SHOULD CONNECT THE UNIT TO
THE AVAILABLE ELECTRICAL SUPPLY.
Turn on the main circuit breaker and all remaining control panel switches, if21. applicable.

Getting Started
FTS Systems LyoStar™ 3
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Rev 006, 01/14 9
© SP Scientific 2014
Chapter
3
The Freeze-Drying System
PRACTICAL OPERATING TIP. REFER TO YOUR CONTROL SYSTEM OPERATOR’S MANUAL
FOR SPECIFIC DETAILS REGARDING THE OPERATION OF YOUR UNIT.
Components and Subsystems
Before operating your LyoStar™ 3 for the first time, take a few moments to familiarize
yourself with the lyophilizer’s components and subsystems. The LyoStar™ 3
lyophilizer consists of the following main components:
Product drying chamber.•
Product shelves.•
Ice condenser.•
Shelf heat-transfer system.•
Stoppering system.•
Condenser cooling system.•
Removable spool piece for optional installation of TDLAS apparatus.2•
Isolation valve.•
Refrigeration system.•
Vacuum system.•
Aeration and vacuum level control.•
Electrical system and associated wiring.•
Control system software and related hardware components.•
2Tunable diode laser absorption spectroscopy (TDLAS) is a method of measuring the concentration of a gas or gas component.

The Freeze-Drying System
FTS Systems LyoStar™ 3
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© SP Scientific 2014
Product Drying Chamber
Standard Chamber
The standard product-drying chamber is a horizontally mounted square vessel
manufactured from grade 316L stainless steel. The chamber is designed for and
provided with reinforcement capable of withstanding full vacuum. It is insulated to limit
energy loss and includes all ports and connections required for connecting the
lyophilizer’s necessary sub-systems and components. An inert gas port is located on
the lyophilizer’s rear panel.
ControLyo™ Chamber
LyoStar™ 3 lyophilizers equipped with Praxair's ControLyo™ Nucleation On-Demand
Technology require a specially designed product chamber. The ControLyo™ product
chamber is similar in design to the standard chamber. However, it also meets the
design, fabrication, inspection, testing, and certification of pressure vessels operating
at either internal or external pressures exceeding 15 psig as stated by the American
Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code, Section
VIII, Division I. The Maximum Allowable Working Pressure (MAWP) of the product
chamber for systems equipped with Praxair's ControLyo™ Nucleation On-Demand
Technology is 28.5 psig.
Note: For additional information, refer to Chapter 9: Praxair’s ControLyo™ Nucleation
On-Demand Technology and/or your control system operator’s manual.
Standard Chamber Door
The standard product chamber door is a full-view acrylic door. A split-ring gasket
surrounds the chamber opening allowing the chamber to be sealed under vacuum
when the door is closed.
ControLyo™ / Stainless Steel Chamber Door
LyoStar™ 3 lyophilizers equipped with Praxair's ControLyo™ Nucleation On-Demand
Technology are equipped with a stainless steel drying chamber door that meets the
design, fabrication, inspection, testing, and certification of pressure vessels operating
at either internal or external pressures exceeding 15 psig as stated by the American
Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code, Section
VIII, Division I. The Maximum Allowable Working Pressure (MAWP) of the product
chamber door for systems equipped with Praxair's ControLyo™ Nucleation On-
Demand Technology is 28.5 psig.
Note: For additional information, refer to Chapter 9: Praxair’s ControLyo™ Nucleation
On-Demand Technology and/or your control system operator’s manual.
Stainless Steel Chamber Door
Standard LyoStar™ 3 lyophilizers may be configured with an optional stainless steel
drying chamber door.