Benchmark - 71 Pages

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Benchmark

Catalog excerpts

^TSP SCIENTIFIC Custom Designed Clinical & Production Freeze Dryers designed to help you build your business

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Custom Designed to Meet Your Requirements ■API Manufacturing

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SP Scientific Benchmark Lyophilizers - Shelf Area & Clearance

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Convenient "service side" layout of clean room installation. Design eel for easy accessibility to major components and maintenance points.

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Benchmark Design Flexibility System Installed in Isolator

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Isolator Interface

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Internal Condenser When space saving is

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in Factory Acceptance Testing documentation helps shorten commission system performance

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common measuring points under steady state AISI type 316L stainless mirror finish is available

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Shelf stack temperature uniformity - heat transfer fluid circuit designed in parallel (rather than in sequence) Stainless braided Teflon hoses transport ■ A compensating radiant shelf is included ensuring all product Is under the same Full shelf compression is achieved in all Benchmark stoppering models. m If room height is a problem we can reduce height of cylinder, and the shelves will have "daylight1' between them at full stroke

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Bulk feed Shelf Stack (watch the load height)

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ControLyo™ Nucleation On-Demand » Load vials onto shelf of Lyophilzer at 4°C and equilibrate » Pressurize system with inert gas (Nitrogen or Argon) J Ramp temperature down to -4°C and begin equilibration for 45' 'Depressurize to induce nucleation All Steps are Programmed Into the Software ^Continue to ramp down to -45°G to complete freezing step

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Lyos Software with ControLyo™ Nucleation Gn-Demand Technology Cycle SI;ITLIS Recipe Name DC Funk Pi esUH [billon Active Frcezincj'I henrnil Troatnie.nl: Ramp Time fclu HO Hold nirta uHto iMift Product Dirven Mode ^r£ Mu-cle alion Control Pressurize After Slep D-ejne-ssiJiizE Aft*-r SI-J|■ itoui iirue DiiUal v~-iuu.jiii SP 100 mToii Hold Time ]_l^kj MM '^SfaJ mttt I MM Lailr^ MM MM MM raifta MM MM . JTITTi I Mid «^*J MM ">"' Pi assure Rise SP rMM MM HMJ 'MM 53 S3 S3 IMM kMfl dM» ^ MMj «gi 53 WMJ IMM R&Tctil lima Cdil Recipe

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Tn = Temperature of Onset of Nucleation

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Nucleation Temperatures for 3% Sucrose Solutions Product Temperatures Uncontrolled Nucleation

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Controlled Nucleation THERMOCOUPLE PROBE AVERAGE rJc-.". Chart Modify Chart Current Time Print Screen

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Improved Uniformity

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"DRIED" PRODUCT SUBLIMATION FRONT FROZEN PRODUCT

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Reduction in Primary Drying Times d olle ontr Un c

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Experimental Demonstration of Benefits of Controlled Nucleation * Increase In pore size and reduction In dry layer resistance * Faster primary drying •Reduced freezing stress on biological 'Reduced reconstitution times •Drying time optimization s Improved cake appearance

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Poly bottom captured Detail showing poly between 'bands' Fully assembled tray

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Optional Auto Locking Doors Eliminates potential problems caused by manual time with door closure

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Auto locking door details Automatic locking Separation between clean and mechanical spaces SIP ASME code compatible Compatible with cylindrical or rectangular chambers

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Available as a cost saving for SIP units Simplest technology

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&®m ML Isolator Iwntarface Detail

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Isolation Waive BL J^cifcwator Valve Sized to Avoid Vapor Restriction

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External Condenser Barometric control is possible (iso valve) Faster turn around Less chance of oil back-streaming Temperatures more uniform Higher ice capacities

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Condenser Load Testing at Factory with Customer Verification

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EMterriial Wairticafl Condenser

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Refrigeration Options 8L- Single compressor direct expansion EL - Cascade system direct expansion LL - Dual compressors In parallel direct expansion RSL -Redundant system fluid condenser Upgrades to Screw compressors

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Typfica!! SI Synoptic [l&demal) Circ. Pump Alarm Summary Splash Screen Leah Test Screen Function Test Screen Semi-Auto Functions Historical Trend Product Probe Screen Cycle Continue Cancel Curieiit Cycle Historical Expoit Cycle Status Cycle Function Test Total Time Phase Time Step Time Shelf Temp.

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Redundant Compressors and Pumps (Internal & SIP) Mnnii.il Opeiations Locked Out! Component Mode Enahled! 4.8 PSIG Cond. Outlet Vacuum CM Cond. Inlet Shelf Outlet Shelf Inlet Drain Drain Cham Drain ^PSP SCfENTlFlO

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>Fiscally responsible

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Vacuum Pumps with Roots Blowers

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Steam in Place (SIP) Injectibles SIP Longer Lead Time ASME Pressure vessel Orbital Welding

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Heated MKS Capacitance Manometer Pressure and Vacuum sensors mounted on Triclover connections Heated Head Capacitance Manometer Ceramic Thermocouple Jacks 0.2 Micron Hydrophobic N2 Filter Clean Diaphragm Valves

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Cleaning in place includes spray nozzles in the chamber and condenser Used to remove cyto-toxic products or insoluble residues

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Recirculated Wash Valve Selection Step 1 Valve Selection Step 2 Valve Selection Step 3 Valve Selection Step 4 Valve Selection Step S Valve Selection Step 6 Valve Selection Step 7 Valve Selection Step 8 Vacuum Pulse Setpoint Drain Phase Time Drying Phase Time Cycle Start Alarm Summary | ^ SUPER Previous Picture Splash Screen Leak Test Screen Function Test Screen Semi-Auto Functions Historical Trend Product Probe Screen Maintenance Screen Cycle Continue Cancel Current Cycle Historical Export Print Screen Cycle Status Total Time Phase Time Step Time Shelf Temp. Cond. Temp.

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ienchmairk Control Platforms Allen Bradley Mlcrologix controller. Many of the features available on the more expensive Maestro but limited options to keep the cost down. BE, EC-1, CM, PRCM security historical data export all SLG 5/03 AB controls offers world wide support for parts and service. The Maestro has additional options such as 21cfrll compliant security and System Integration Testing, unlimited product probes, customized programming. Best choice for high tech R& D facilities or GMP production. ^PSP SCfENTlFlO

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Circ. Pump Splash Screen Leah Test Screen Function Test Screen Semt-Jbito Functions Historical Trend Product Probe Screen Cycle Continue Cancel Cuneiit Cycle Historical Expoit Cycle Status Cycle Function Test Total Time Phase Time Step Time Shelf Temp.

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All SP SCIENTIFIC catalogs and technical brochures

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