Formulation Development

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Featured Publication
Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply. By: Balaji V. Kadri - Featured in the August 2008 Issue of Pharmaceutical Technology







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Equipment List


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Formulation Development

Processing

Mixing
4 qt. and 16 qt. Patterson-Kelly (P-K) V-Blender
Turbula T10B Mixer
KitchenAid Planetary Mixer
Omni Mixer Line Homogenizer Model 17105
Fisher and Lightnin Mixers
UltraSonic Mixer (Tip Probe)
Microfluidics Model 110 Microfluidizer


Granulation/Drying
Diosna Minilab Fluid Bed Granulator/Dryer with Top Spray Insert and Wurster Column
1 L and 6 L Diosna P1/6 Vertical High Shear Granulator with Jacketed Vessels


Particle Sizing
Quadro Comil Model 197
Fitzpatrick Model J Mill
US Stoneware Ball Mill


Encapsulation
In-Cap Automatic Capsule Filler (Dosing Disk)
Feton Manual Fill Encapsulators Sizes AA and 0-4
MF-30 Encapsulator (Manual Fill)
Schaefer Capsule Bander


Tableting and Coating
Stokes Rotary Tablet Press, 16 Station, Type Bb Tooling (2)
Vector LDCS Tablet Coater with 11.5” and 15” Perforated Pan Inserts
Carver Single Station Press


In Process/Physical Testing
ATM Sonic Sifter
Brookfield Digital Rheometer
Flodex Flow Meter Flowability Index Tester
Mettler Toledo Moisture Analyzer
Mitutoyo Thickness Gauges
Advanced Instruments Osmometer Model 3320
Ro-Tap Sieve Shaker
Optimal Hardness Tester
Vanderkamp Hardness Tester
VanKel Disintegration Tester
VanKel Friabilitator
VanKel Tap Density Tester


Transfer/Packaging
Baxa Repeater Pumps
Fuji Impulse FA-300 Auto Sealer
Lepel Lepak Jr. Induction Sealer
MasterFlex Peristaltic Pumps
Spring Torque Tester


Miscellaneous
Consolidated Automatic Steam Sterilizer
Nuaire Laminar Flow Hood


cGMP Manufacturing


Solids Processing


Mixing
4 qt., 8 qt. and 16 qt. Patterson-Kelly V-Blenders
1 cu.ft., 3 cu.ft. and 5 cu.ft. Patterson-Kelly Cross-Flow V-Blenders


Granulation/Drying
Fluid Bed Processor, Glatt GPCG-3 (with top spray and rotor granulator inserts)
Hobart Models H-600DT & A-200DT
KitchenAid Planetary Mixer
Littleford MGT-125 High Shear Granulator
Powrex VG-5OM High Shear Granulator
Vector TFC-Lab Micro Roller Compactor


Particle Size Reduction
Micron-Master Jet Pulverizer Air Jet Mill
Fitzmill Model D6A
Quadro Comil Model 194 (2)


Encapsulation
Capsugel Ultra 8 II (2)
PAM Model MF-30/AL-90
Capsugel Xcelodose 600 Precision Micro-Filling System/Automated Encapsulator
Capsugel Xcelodose 600S Precision Micro-Filling System/Automated Encapsulator
Capsugel CFS1200 Liquid Encapsulator
IN-CAP Automatic Capsule Filler (Dosing Disc)


Tableting and Coating
Fette P1200 I Tablet Press, Type B Tooling with Tablet Deduster
Manesty Beta Press, 16 Station, Type B Tooling with Tablet Deduster
Schleuniger Hardness Tester
Vector Model HCT-60 Tablet Coating System (24” Pan)


Liquid/Semi-Solids Processing


Mixing
Agimixer (Countersweep, Jacketed Kettle with Homogenizer
Gifford Wood Colloid Mill
Stainless Steel Jacketed Tank (60 gallon)
Kinetics Refrigerated Chiller Unit
Lightin NS 1 Mixer
Lightnin EV 1 Mixer
Omni Macro Homogenizer


Transfer
Single Piston Bottle Filler
MasterFlex Peristalic Pumps
Baxa Repeater Pumps


Lyophilization
Virtis Lyophilizer Genesis 25 EL


Finishing/Packaging
Cap Torque Testers (2)
Capsule Polishers (2)
Kalish Bicaptight Bottle Capper
King Tablet/Capsule Counter
Lepel Induction Sealer (2)
Loma Metal Detector
SADE P2 Tablet/Capsule Check Weigher (2)
Tablet/Capsule Inspection Belt (2)


Analytical and Preformulation


Liquid Chromatography
Agilent 1100s and 1200s with UV/Vis, PDA, Fluorescence, ELS and Electrochemical Detectors
Waters Alliances


Gas Chromatography
HP 6890 GC with 7694 Headspace Sampler and 7683 Injector


Data Management
Water Empower 2 Chromatography Data System


Dissolution (USP Apparatus I and Apparatus II)
Distek Evolution 4300 Autosampler
Distek EZ-Fill 4500
Distek Premier 5100 Dissolution Baths
Distek Evolution 6300Dissolution Bath
Distek 2100 Series Dissolution System
Distek Evolution 6100 Dissolution Bath
VanKel VK7000 Dissolution Baths
VanKel VK8000 Autosampler
VanKel VK650A and VK750D Heaters/Circulators


Particle Size Analysis
Beckman Coulter LS 13 320 Laser Diffraction Particle Size Analyzer with Powder and Liquid Molecules
ATM Sonic Sifter


Additional Analytical Tools
Agilint 8453 UV/Vis Spectrophotometer
AquaStar AQC34 Coulometric Karl Fischer Titrator with DO307 Oven
AquaStar C3000 Volumetric Fischer Titrator
Advanced Instruments Model 3320 Osmometer
BrookField RV-DVIII+ Rheometer (with Small Sample Adapter)
Muffle Furnace for ROI
Metrohm Titrando Titrator Model 836, Poentiometer and Karl Fischer Titrator


Preformulation
Rigaku MiniFlex II Desktop and Portable X-ray Diffraction System
Heraeus SunTest CPS+ and SunCool Temperature Controller
Mettler Toledo FP82HT Hot Stage and FP90 Central Processor
Olympus BX51 Polarizing Microscope (Several Varying strength objectives) with Digital Camera
Perkin Elmer Spectrum One FTIR
Sirius GLpKa
TA Instruments Q100 Modulated DSC
TA Instruments Q500 TGA with Hi-Res and Modulated Modes
VTI SGA-100 Vapor Sorption Analyzer


cGMP Stability Chambers (ICH Conditions)


Walk-In Room
25°C/60% RH


Reach-In Chambers
25°C/40% RH
30°C/40% RH
30°C/65% RH (2)
40°C/15% RH
40°C/75% RH (2)
5°C


cGMP Storage Refrigerators
Puffer Hubbard 2-8°C (3)
Revco Ultima II -20°C
Warehouse Refrigerator for QA retains’ Storage 2-8°C


Data Handling
Stability Laboratory Information Management Software (SLIM™)




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