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SMART Freeze Drying

FTS Systems
SMART Freeze Drying

SMART Freeze-Dryer Technology is a patented system that puts the experience of the world’s top lyophilization scientists into an easy-to-use cycle development tool. Developed exclusively with leading academics at The University of Connecticut and Purdue University, this technology is available on the LyoStar freeze-dryer (including a retrofit option for existing LyoStar II systems).

SMART Freeze-Dryer technology eliminates the trial-and-error approach normally involved in developing new lyophilization cycles. It enables experts and novices alike to develop new cycles quickly, while also ensuring that those cycles are elegant and efficient.

The SMART tools provide instant feedback on important product data — such as product resistance, heat flow, and mass transfer — that was previously unavailable.

Click here to see case studies of how facilities like yours have saved time and money utilizing the LyoStarII with SMART Freeze-DryingTM Technology

Click here for an overview of the new LyoS software.

KEY FEATURES

  • SMART Freeze Dryer Technology (PLC) helps automate and shorten the development of the freeze drying cycle
  • Get product information that has previously been unavailable – such as product resistance, heat flow and mass transfer
  • Designed to minimize issues with transfer of freeze drying cycles to your production freeze dryer
  • Easy to use operator interface
  • Condenser coil type configuration to maximize condenser efficiency
  • Available with optional 21 CFR Part 11
  • Clean room configurations available

KEY BENEFITS

  • Substantially decrease cycle development time with SMART
  • Understand more about your product and its obstacles and opportunities in lyophilization cycle development
  • Easily transfer cycles to larger systems
  • Increase ROI with greater throughput and optimized cycles
  • Spend more time looking at formulation strategies to maximize product effectiveness
  • Developed by lyophilization scientists for lyophilization scientists

HOW TO SELECT

To configure a LyoStar II with SMART Freeze Dryer Technology to fit your requirements, select options from each of the groups below.  For assistance in determining which option is right for you or to receive a quote, please contact a product specialist.  We will be glad to discuss with you the options and their importance and use.
LyoStar-II-with-SMART-options.JPG

SPECIFICATIONS

Specification  
Shelf Temperature Control Range (°C)
-70 to +60C
Lowest Condenser Temperature
-85C
Maximum Condenser Capacity (L)
30 L
Condenser Surface Area (in2 / cm2)
828 / 5481
Maximum Ice Condensing Capacity in 24 hours (L)
This specification is based on freeze drying water as aggessively as possible. 
The ability to collect ice is application dependent and your actual rate will most likely be lower
20
Condenser Pull-Down from 20 °C to -75 °C (minutes)
< 10
Shelf Pull-Down from 20 °C to -40 °C
(minutes)
< 25
Vacuum Time to 100 Millitorr (minutes)
< 20
Lowest System Vacuum (mT)
< 10
Temperature Uniformity (°C)\\
+/- 1.0C


Shelf Configuration
Number of Shelves
Shelf Area
Shelf Clearance
Shelf Clearance with Optional Shelf Latching
 
Bulk and Stoppering** (ft2 / cm2)
Bulk and Stoppering** (in / mm)
1 Shelf Latched (in / mm)
2 Shelves Latched (in / mm)
1 Shelf
1.5 / 1394
9.5 / 241
-
-
2 Shelves
3.1 / 2880
4.5 / 114
9.25 / 235
-
3 Shelves
4.6 / 4274
2.8 / 71
4.25 / 108
8.5 / 216
4 Shelves
6.1 / 5667
2.0 / 51
2.6 / 66
4.0 / 102
5 Shelves
7.6 / 7061
1.5 / 38
-
-


Dimensional Data
Width (in / cm)
33 / 84
Depth (in / cm)
43 / 109
Height (in / cm)
75 / 190
Approximate Weight (lb / kg)
1300 / 590
Minimum Clearance on All Sides (ft / cm)
2 / 61

APPLICATION EXAMPLES

  • Laboratory research and development and/or small production freeze drying
  • Process development with intent to move process to clinical size freeze dryer
  • Serum bottles and vials

OPTIONAL COMPONENTS

LyoStar-II-with-SMART-options.JPG

ACCESSORIES

VirTis 96 Well Freeze Drying Systems (pdf)
Freeze-Drying Product Sensors (pdf)

yoStar II Accessories
                                   
Model Number                                 Description
                                   
VP200                                 200 liters per minute vacuum pump
                                   
Options   l                              
                                   
Voltage   C                             208V/60Hz
                                   
    D                             220V/50Hz
                                   
                                   
OME-06                                 Oil mist eliminator for VP100
                                   
FDPS13                                 Special product sensor, 13mm
                                   
FDPS20                                 Special SS encased product sensor, 20mm
                                   
TS-1120                                 Bulk tray 11" x 20"
                                   
TRB-1120                                 Removable bottom tray 11" x 20"
                                   
LYO-LGT                                 WL Gore LyoGuard Trays
                                   
LYO-RDT                                 WL Gore LyoGuard R&D Trays
                                   
LYO-SE                                 Sample extractor
Options   l                              
                                   
    A                             120V/60Hz
                                   
    Q                             195-230V/ 50 or 60Hz
                                   
                                   
LNT-LYOII                                 Auto refilling Liquid Nitrogen Trap
                                   
LYO-MA                                 Moisture sensor on chamber
                                   
LYO-DTA                                 Desktop computer (Includes mobile cart and 115V UPS)
                                   
LYO-DTD                                 Desktop computer (Includes mobile cart and 230V UPS)
                                   
LSLP-2.1                                 Shelf latching kit for LYO2, 1 shelf up
                                   
LSLP-3.1                                 Shelf latching kit for LYO3, 1 shelf up
                                   
LSLP-3.2                                 Shelf latching kit for LYO3, 2 shelves up
                                   
LSLP-4.1                                 Shelf latching kit for LYO4, 1 shelf up
                                   
LSLP-4.2                                 Shelf latching kit for LYO4, 2 shelves up
                                   
LSLP-4.3                                 Shelf latching kit for LYO4, 3 shelves up
                                   
IQ/OQ-LYO                                 Installation Qualification/Operation Qualification documentation. Includes MSDS, component serial numbers and calibration certificates, refrigeration and wiring diagrams, QC test data, acceptance criteria and suggested OQ protocols
                                   
SMART Freeze Dryer Technology Option                    
                                   
SMART Freeze Dryer Technology Upgrade                 Does not include field retrofit charge
                                   
                                   
Transformers
                                   
Model Number                                 Description
                                   
TX-50                                 Transformer, step down, 50A
                                   
TX-50-SU                                 Transformer, step up, 50A

LITERATURE & ADDITIONAL SPECIFICATIONS

Literature
LyoStar 3 Specifications
LyoS_Overview ppt
LyoStar II - Brochure (pdf)
LyoStar II - Specifications (pdf)


Articles of Interest on SMART Freeze DryingTM Technology

Freeze Drying Heat & Mass Transfer: Factors in Dry Cake Resistance by Manometric Temperature Measurement (MTM) - Tank, Nail, Pikal - AAPS Biotech 2005
(pdf)

Collapse Measurement by FD Microscopy... Influence of Solute Concentration on Collapse Behavior & Effect on Cycle Design - Meister, Ellnain, Gieseler(pdf)

Design of Freeze-Drying Process for Pharmaceuticals: Practical Advice - Tang, Pikal(pdf)

Effect of Concentration, Vial Size & Fill Depth on the Product Resistance of Sucrose...- Schneid, Gieseler - PittCon 2007(pdf)

PAT-for-Freeze-Drying-Cycle-optimization-in-the-laboratory---Gieseler (pdf)

SMART Freeze-Drying Technology: Impact of Water Readsorption of PVP in MTM - Gieseler, Mather, Pikal(pdf)

SMART Freeze- Drying - Sesholtz, Mather(pdf)

Entwichlung von Lyophilisationszyklen ohne aufwendige Vorversuche - Mather(pdf)

Suppression de la methode par essais et ereurs dans le developpement des cycles de lyophilisation.(pdf)

Eliminando las aproximaciones sucesivas de los chiclos de liofilizacion en desarrollo (pdf)

 

 

 

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Presenter: Mark Shon

Importance of Controlling Nucleation Temperature During the Freeze Step


23 Feb 2012
9 AM & 2 PM ET

Register Now




Instructor: Dr. Jeff Schwegman

Lyophilization Cycle Development & Optimization:
A Hands On Laboratory Course


Two 2012
Sessions Added!

June 5-8, 2012
Oct 23-26, 2012


Learn More