Capabilities
Pre-Formulation
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We do Stability Assessment, including Dissolution
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Major Analytical Instruments: |
Major Processing/Packaging Equipments: |
| Multiple Waters HPLC System (with UV, PDA, and RI Detectors) | Multiple rotary tablet presses with capacity up to 100,000 tablets per hour |
| Agilent GC System 6890 | Multiple automatic encapsulation machines with capacity up to 50,000 capsules hour (capable of filling powder, granule, pellets, and minitablets, ranging from size 00 to 04) |
| Multiple Dissolution Stations with Auto Sampler (USP Apparatus I, II, and III) | |
| Bechman and Shimadzu UV Spectrophotometers | Vertical High Shear Granulator with capacity ranging from 1/2 Kg to 50 Kg/run |
| Infrared Spectrophotometers | Tray Drying Ovens |
| DSC | Multiple Comil and Fitzmills |
| Polarimeter | V-Blenders (8 qt., 1 cubic feet, 5 cubic feet, and 10 cubic feet) |
| Karl-Fisher Titrator | Perforated Coating System (fitted with 15”, 19” and 24” pans) |
| Various pH meters, hardness testers, friabilitors, and torque testers | Kalish Automatic Packaging Line with capacity up to 60 bottles/minute |
| Various balances and scales | Various semiautomatic compression and encapsulation machines |
| Multiple stability chambers covering 25 o C/60% RH, 30 o C/65% RH, and 40 o C/75% RH |
Various granulation and compounding equipment for R & D use |
| Various automatic and semiautomatic packaging lines | |
| Various ovens, vacuum ovens, and incubators | Various planetary mixers, mixing tanks |
| Induction Cap Sealing Machine | |
| Pharmaceutical Metal Detector | |
| Tablet Top Tablet/Capsule Counter | |
| Tablet Press: Two sets of Jenn-Chiang Tablet press |
You can download .pdf product sheets on this information at our: Media Center
Pharmaceutical Services
Solid Dose Formulations Capabilities
· Granulation: We provide complete granulation services, using Fluid Bed, High Shear, and Planetary Mixers.
· Blending: We currently have High Shear and Diffusion blending capabilities.
· Compression: Our labs currently offer single punch, rotary and real time compaction event services. We also have higher speed presses available to us for scale-up.
· Encapsulation: We currently have Tamping and Dosator machines available.
· Coating: Our labs currently operate Wurster columns and Side Vented pans for coating
· Packaging: bulk, bottle, blister
Semi-Solid Dose Formulations Capabilities
· Cream, lotion
Analytical Capabilities
· Chromatography: We provide method development, validation, and routine testing.
· Spectroscopy: Our current capabilities are IR and UV.
· Physical Testing: We provide particle size analysis, surface analysis, DSC/TGA, photo microscopy, viscosity, disintegration, and numerous other physical tests.
Key equipment and instrumentation in our laboratories:
Formulation Development
· Homogenizer
· Filler: Ladish sanitary fittings, 316 stainless steel, 12 L / min (3 Gal / min) Steripump, 30 L (7 Gal) stainless steel hopper
· Vector FLM-1 and FLM-3 fluid bed processors
· Tangential Granulator - Kugelcoater (~3 kg)
· Planetary Mixer - 20 liters (~8 kg) and 4 qt. (~2 kg)
· Baker Perkins high shear granulator/blender - 7 liters
· Lodige high shear granulator/blender - 50 liters
· PK "V" blenders: 2, 4, 8, 16 quart and 1, 3 cubic foot
· Single station tablet press
· Instrumented sixteen station tablet press ("B" Tooling)
· Four station, laboratory tablet press
· Benchtop encapsulation machines (2 pc. Hard-shell)
· Side vented coating pans (15", 19", 24" & 36")
· 20" solid (sugar) coating pan
· Dome extruder
· 120 mm and 240 mm spheronizer
· Comil 197
· Vortisiv classifier
· Wurster columns - 4"
· Sixteen station tablet press ("D" Tooling)
· Single station (Model "F) tablet press
· Conventional (20") coating pan
· Vorti-siv classifier
· 1 and 3 liter Vector Fluid Bed Processors
Analytical Methods Development and Testing
· Waters HPLC System
· UV Spectrophotometer
· IR Spectrophotometer
· Texture Analyzer
· Dissolution Apparatus
· Sonic sifter
· Moisture balance
· Karl Fisher titration
· Tablet micrometers
· Disintegration baths
· Tablet hardness testers
· Tap density tester
· Powder flow testing apparatus
· Surface Analyzer
· Colorimeter
· Stereo Microscope with camera
CMC
· In-house QC Testing
· Method development & validation
· Pre-formulation studies & formulation development
· Manufacturing of clinical trial materials
· Process optimization
· Stability assessment and studies: forced degradation and room conditions
· Pharmaceutical formulation and scale-up
· Documentation for IND/NDA/ANDA submissions
Drug Delivery Systems: Sustained Release, Fast Dissolve
API Synthesis (off-shore)
· Custom synthesis of organic molecules from milligram to kilogram quantities
· Custom manufacture of chemicals in bulk quantities
· Development of new processes for the synthesis of target molecules
· Optimization of existing synthetic processes or methods
· Development of biotransformation processes for the preparation of chiral molecules
· Screening biocatalysts for the resolution or asymmetric synthesis of molecules and development of biotransformation process