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Formulation Development

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



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
Misonix Sonicator 3000 UltraSonic Mixer
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
Schaefer/Dott Bonapace IN-CAP Automatic Capsule Filler (Dosing Disc)
Feton Manual Fill Encapsulators Sizes AA and 0-4
PAM Model MF-30 Encapsulator (Manual Fill)
Schaefer Laboratory Model Capsule Bander


Tableting and Coating
Stokes Rotary Tablet Press, 16 Station, Type B-2 Tooling with Bb dies
Vector LDCS Tablet Coater with 9.25" (1.3L) and 14.5" (3.75L) pan sizes
Carver Single Station Press
Piccola B10 Minipress, 10-station table top rotary tablet 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 Testers
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
Diosna P1/6 High Shear Granulator (Multiple Processing Bowl Sizes)


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(R) 600 Precision Powder Micro-Dosing System/Automated Encapsulator
Capsugel Xcelodose(R) 600S Precision Micro-Filling System/Automated Encapsulator
Capsugel CFS 1200(TM) 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)
Vector LDCS Tablet Coating System (Multiple Pan Sizes)


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
Silverson FX60 High Shear Batch Mixer


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 CS Plus Junior H2C Conveyor Cap Induction Sealing System and Lepel Lepak Junior Induction Sealer
Loma Metal Detector
SADE P2 Tablet/Capsule Check Weigher (2)
Tablet/Capsule Inspection Belt
Micron Pharma Works TF-1 Blister Packaging Machine


Analytical and Preformulation


Liquid Chromatography
Waters Aquity UPLC
Agilent 1100s and 1200s with UV/Vis, PDA, Fluorescence, ELS and Electrochemical Detectors
Waters Alliance 2695


Gas Chromatography
HP 6890 GC with 7694 Headspace Sampler and 7683 Injector
Water Empower 2 Chromatography Data System


Data Management
Waters Empower 2 Chromatography Data System


Dissolution, USP Apparatus I & II
Distek 2100 Series Water Bath Based Dissolution Systems
Distek Premier 5100 Bathless Dissolution Systems
Distek Evolution 6100 Bathless Dissolution Systems
Distek Evolution 6300 Water-Bath Based Dissolution System
Distek Evolution 4300 Autosamples
Distek EZ-Fill 4500 Media Preparation Station
VanKel VK7000 Water-Bath Based Dissolution Systems
VanKel VK8000 Autosamplers
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
Advanced Instruments Model 3320 Osmometer
Agilent 8453 UV/Vis Spectrophotometer
AquaStar AQC34 Coulometric Karl Fischer Titrator with DO307 Oven
AquaStar C3000 Volumetric Fischer Titrator
Beckman GS-15R and Beckton Dickinson Dynac Centrifuges
BrookField RV-DVIII+ Rheometer (with Small Sample Adapter)
Metrohm Titrando Titrator Model 836, Poentiometer and Karl Fischer Titrator
Mettler Analytical Balances, Models MT5, AT201, and AT400
Muffle Furnace for ROI
Parker Balston Nitrogen Generator
Pierce Reacti-Vap III and Reacti-Therm III
PolyScience SR6 Polarimeter
Vacuum Pumps
VWR Drying Ovens, with and without vacuum
Various water baths with shaking, sonication, and heating abilities
Wrist action and other shakers
Accumet Model 15 pH Meters
Accumet Model AB15 pH Meters
Metrohm 836 Titrando Potentiometric
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 Chamber
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™) with dedicated server




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