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YOPHILIZER

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PERATOR

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ANUAL

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YSTEMS

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YO

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ESEARCH

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EVELOPMENT

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ILOT

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Содержание LYOSTAR 3

Страница 1: ...LYOPHILIZER OPERATOR S MANUAL FTS SYSTEMS LYOSTAR 3 RESEARCH DEVELOPMENT PILOT SCALE FREEZE DRYER...

Страница 2: ......

Страница 3: ...oduction 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...

Страница 4: ...ized 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 vent...

Страница 5: ...y 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...

Страница 6: ...iv Rev 006 01 14 SP Scientific 2014...

Страница 7: ...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 S...

Страница 8: ...ning 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 Code...

Страница 9: ...ndenser 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...

Страница 10: ...Contents FTS Systems LyoStar 3 viii Rev 006 01 14 SP Scientific 2014...

Страница 11: ...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 A...

Страница 12: ...01 14 SP Scientific 2014 Equipment Options Stainless steel product and or condenser chamber doors Water cooling for enhanced performance Stainless steel Bio seal flange for cleanroom installation Liq...

Страница 13: ...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...

Страница 14: ...figuration 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 frequ...

Страница 15: ...e The heat transfer fluid level should be approximately full when the system is at 25 C Door Gaskets Ensure that the chamber and condenser door gaskets are 9 clean and free of defects e g cuts cracks...

Страница 16: ...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 i...

Страница 17: ...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 VO...

Страница 18: ...Getting Started FTS Systems LyoStar 3 8 Rev 006 01 14 SP Scientific 2014...

Страница 19: ...ms 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 Remova...

Страница 20: ...ystems 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...

Страница 21: ...te For additional information refer to Chapter 8 Shelf Latching Stoppering The stoppering system provides bottom up shelf collapse allowing you to fully seat partially inserted stoppers into product v...

Страница 22: ...laser absorption spectroscopy equipment Note For information about converting your system for use with TDLAS equipment contact SP Scientific Isolation Valve LyoStar 3 lyophilizers include a butterfly...

Страница 23: ...split ring gasket surrounds the chamber opening allowing the chamber to be sealed under vacuum when the door is closed Defrost Defrosting of the condenser is achieved by pumping hot refrigerant gas th...

Страница 24: ...hould 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 Exha...

Страница 25: ...mends performing automatic leak rate and function tests using your control system software Refer to the lyophilizer s performance specifications when determining whether or not the results of these te...

Страница 26: ...n thermocouple wire with standard miniature two pin male connectors Probes include resin caps with O rings for use with 13 mm vials Eight 8 temperature monitoring thermocouple probes constructed of 36...

Страница 27: ...ote that product vials must be loaded evenly across shelves for stoppering to occur correctly SP Scientific recommends using the supplied removable bottom trays when processing in vials Note For addit...

Страница 28: ...hich the water vapor can re solidify during the drying phases Using the lyophilizer s control system the chamber pressure is lowered and adequate heat is supplied to the product samples allowing the w...

Страница 29: ...you are processing product in vials activate the stoppering mechanism to seal your product vials Stoppering may be executed at any desired pressure using air or an inert gas for backfill or while the...

Страница 30: ...Operating your Lyophilizer FTS Systems LyoStar 3 20 Rev 006 01 14 SP Scientific 2014...

Страница 31: ...tion The following drawing illustrates the components of the liquid nitrogen trap WARNING LIQUID NITROGEN DUE TO ITS EXTREMELY LOW TEMPERATURES CAN CAUSE SEVERE CRYOGENIC BURNS EXERCISE CAUTION WHEN H...

Страница 32: ...o not obstruct the vent line as it could result in a pressure build up Open the liquid nitrogen supply valve 4 Switch on the Liquid Level Controller and allow time for the liquid nitrogen 5 reservoir...

Страница 33: ...s should be parallel as shown below To bypass the liquid nitrogen trap open the bypass valve and close the inlet 7 and outlet valves When liquid nitrogen is no longer needed shut off the supply line a...

Страница 34: ...ng To clean your liquid nitrogen trap Make sure that the trap is offline and that the level controller has been 1 powered off Remove any liquid nitrogen left in the center well 2 Place an appropriate...

Страница 35: ...se off and clean any remaining 9 condensate Drain the condensate using the drain line and wipe the outer reservoir clean 10 Loosen the thumbscrews again and lower the lid 11 Align and secure the reser...

Страница 36: ...Liquid Nitrogen Trap FTS Systems LyoStar 3 26 Rev 006 01 14 SP Scientific 2014...

Страница 37: ...be installed on site If your unit is equipped with both a Sample Extractor Assembly and Praxair ControLyo Nucleation On Demand Technology the ASME Coded Stainless Steel Sample Extractor will be suppli...

Страница 38: ...on and that the product chamber is not 1 under vacuum Open the product chamber door Have an assistant in position to support the 2 door Remove the upper and lower quick release pins from the hinge ass...

Страница 39: ...s vacuum break valve is closed To operate the Sample Extractor Assembly Activate the auxiliary vacuum pump to pull vacuum in the antechamber 1 After the vacuum gauge stabilizes at the maximum position...

Страница 40: ...tton on the end of the selector arm to open the spring loaded jaws Place the open jaws around the top of the selected vial and release the button to close the jaws and secure the vial Place a sample i...

Страница 41: ...ering the sample you may backfill the antechamber with an inert 8 gas such as nitrogen N2 gas via the vacuum break valve Connect your inert gas source to the vacuum break valve via the filter attachme...

Страница 42: ...the antechamber Allow the antechamber to return to atmospheric pressure Loosen the thumbscrews on each side of the antechamber and push down on 11 the front plate until it can be opened Note Vacuum p...

Страница 43: ...d Stainless Steel Sample Extractor Assembly Sample Extractor Assembly Components The ASME Coded Stainless Steel Sample Extractor is comprised of a stainless steel door with the following components Vi...

Страница 44: ...uum in the antechamber When the vacuum gauge reads approximately 30 inHg close the 3 antechamber vacuum valve by turning it to the left and deactivate the auxiliary vacuum pump Turn the antechamber lo...

Страница 45: ...tract a vial push the button on the end of the selector arm to open the spring loaded jaws Place the open jaws around the top of the selected vial and release the button to close the jaws and secure t...

Страница 46: ...or locked Securely hold the base of the antechamber and remove the clasp by 13 loosening the thumbscrew Once the clasp is removed the antechamber and vacuum components will separate from the Sample Ex...

Страница 47: ...stments Latching one 1 shelf up will position the other shelves so that a 20 ml vial may be used It also increases the accessible shelf area to 240 in 2 0 15 m 2 Notes When removing 20 ml vial samples...

Страница 48: ...Sample Extractor Assemblies FTS Systems LyoStar 3 38 Rev 006 01 14 SP Scientific 2014...

Страница 49: ...VIALS OF DIFFERENT HEIGHTS ON THE SAME SHELF The stoppering mechanism applies significant force to the vials when stoppering therefore SP Scientific does not recommend stoppering partially loaded she...

Страница 50: ...closed position The compressing shelf shall stop after the vials are fully seated 2 After stoppering return the shelves to the original position The compressing 3 shelf will stop at the initial posit...

Страница 51: ...e readings on the vacuum sensors Disable and release vacuum Inert gas shall begin to bleed into the chamber 2 The amount of gas allowed into the chamber is arbitrary You may fill the chamber to atmosp...

Страница 52: ...Stoppering FTS Systems LyoStar 3 42 Rev 006 01 14 SP Scientific 2014...

Страница 53: ...it will reduce the total number of usable shelves in your product chamber while increasing shelf clearance The shelf latching kits with allow for 2 to 1 shelf latching on a 2 shelf unit 3 to 2 and 3 t...

Страница 54: ...f latching plates 4 Slide the shelf latching plates on either side of the shelf stack between the 5 shelf fluid hoses and the shelf assembly so that the lip of the plate rests on top of the shelf asse...

Страница 55: ...ering system and return the shelves to 6 their full down position only the usable shelves will travel The shelves are then available for loading See examples Three Shelf Unit Converted To Single Usabl...

Страница 56: ...Shelf Latching FTS Systems LyoStar 3 46 Rev 006 01 14 SP Scientific 2014...

Страница 57: ...WARNING 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 DEPRESSURIZA...

Страница 58: ...n process is initiated Pressurization is stopped after receiving a depressurization signal Depressurization The depressurization process for controlled nucleation involves the rapid depressurization o...

Страница 59: ...lation that could act as nucleating agents Praxair s ControLyo Nucleation On Demand Technology can make a container nucleate at the desired conditions prior to its spontaneous nucleation As such it is...

Страница 60: ...ly recommended for lyophilization processes Both argon and nitrogen are suitable gases with argon possessing superior efficacy For laboratory scale freeze dryers the gases may be supplied from a gas c...

Страница 61: ...ig to induce nucleation 7 To avoid possible back flow of material from the environment into the product chamber it is recommended that you close the valves through which the depressurization is achiev...

Страница 62: ...stimation Therefore the freezing point should be accurately determined experimentally prior to lyophilization with analytical methods such as DSC differential scanning calorimetry or FDM freeze drying...

Страница 63: ...or equal to 75 of the nominal container volume using argon gas at a temperature within 3 C of the formulation s thermodynamic freezing point Nucleate any lyophilization container greater than or equal...

Страница 64: ...Praxair s ControLyo Nucleation On Demand Technology FTS Systems LyoStar 3 54 Rev 006 01 14 SP Scientific 2014...

Страница 65: ...Pale yellow or clear vacuum pump oil indicates good condition Dark vacuum pump oil indicates acid contamination Cloudy gray vacuum pump oil indicates water contamination Changing Vacuum Pump Oil Chang...

Страница 66: ...ontrolled amount of air into the second stage pump cylinder This reduces the partial pressure increases the pump s operating temperature and releases the vapors Note Refer to the vacuum pump manual fo...

Страница 67: ...n reduced performance and shorten compressor life Clean the fins on the unit Dust buildup may cause the unit to malfunction 4 Water Cooled Condenser The optional water cooled condenser consists of a h...

Страница 68: ...ium Hydroxide 1 R Benzyl Alcohol N Hydrofluoric Acid 40 R Sodium Hydroxide 10 R Butyl Acetate N Hydrogen Peroxide 3 R Sodium Hydroxide 60 R Calcium Chloride Sat R Hydrogen Peroxide 28 N Sodium Hypochl...

Страница 69: ...our production schedules as per your company s Standard Operating Procedures SOPs Each of the following Recommended Maintenance Schedule items includes the skill level of the individual designated to...

Страница 70: ...rtment Level 1 If your unit is equipped with a water cooled refrigeration system check cooling water flow and temperature if possible Report the low flow or high temperature conditions to your mainten...

Страница 71: ...igeration system piping and components for fluid leaks Level 2 Level 3 Check the fluid level of the heat transfer system Check heat transfer system piping and components for fluid leaks A special dye...

Страница 72: ...ontact SP Scientific Service Recommended Five Year Maintenance Task Level Complete all items outlined in the Recommended Monthly Quarterly and Annual Maintenance Schedules Level 1 Level 2 Level 3 Remo...

Страница 73: ...30 0 0 0 0 0 0 0 0 0 0 min Control with CM Guaranteed Soak X Product Driven Mode X Product Temperature 20 C Shelf Load X Extra Freeze Product Temp SP 40 C Hold Time 60 min Condenser SP 45 C Initial V...

Страница 74: ...Appendix A Sample Recipe FTS Systems LyoStar 3 64 Rev 006 01 14 SP Scientific 2014...

Страница 75: ...source in the electrical box at the Solid State Relay or Contactor See electrical schematic for reference points Power to motor OK but pump will not start Vacuum pump may be seized Motor should be rem...

Страница 76: ...circulating No nitrogen pressure see above Heat transfer pump not turning Check voltage to pump motor Replace pump if necessary Possible refrigeration system leak Find leak repair evacuate and recharg...

Страница 77: ...ock off the main line upstream of the vacuum gauge sensor so that you can use the sensor to monitor vacuum levels 7 On some models you may be able to look inside the condenser chamber and place the st...

Страница 78: ...al assistance call SP Scientific Service If the condenser is able to reach vacuum levels of at least 20 millitorr you can 6 likely rule out any leaks from the condenser area The suspected vacuum leak...

Страница 79: ...nishes Tenacious deposits Rusty Discolorations Industrial atmospheric stains Oakite No 33 Dilac Texo 12 Texo N Y Flash Klenz Caddy Cleaner Turco Scale 4368 or Permag 57 Swab and soak with clean cloth...

Страница 80: ...Appendix C Stainless Steel Cleaners FTS Systems LyoStar 3 70 Rev 006 01 14 SP Scientific 2014...

Страница 81: ......

Страница 82: ...Main Street Stone Ridge NY 12484 USA 800 251 1531 845 687 0071 935 Mearns Road Warminster PA 18974 USA 800 523 2327 215 672 7800 815 State Route 208 Gardiner NY 12525 USA 800 431 8232 845 255 5000 ww...

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