Facility Information
Facility Information
46,000 ft2 cGMP compliant facility in Norristown, PA
8 class 100,000 (ISO 8) cGMP manufacturing suites
7 formulation development suites dedicated to R&D activities
DEA manufacturers license for Schedule II – V controlled substances & List I chemicals
DEA analytical license for Schedule I – V controlled substances
Temperature and humidity control
HEPA filtration with single pass air
Environmental monitoring system (microbial & non-viable particulates)
Organic solvent processing capabilities
Light sensitive product handling capabilities
Cold storage
Segregated storage for OEB 4 materials
Segregated specialty excipient manufacturing area
Backup generator – natural gas
Dedicated formulation suites for development activities enables us to provide the speed and flexibility our clients require for drug product development.
Processing Equipment
Processing Equipment
Equipment | Model | Manufacturer | |
---|---|---|---|
Blending | 1 pt, 2, 4, 8, 16 qt V‑blender | Blend Master | Patterson Kelly |
1 cu. ft V‑blender | Cross Flow | Patterson Kelly | |
3 cu. ft V‑blender | Cross Flow | Patterson Kelly | |
5 cu. ft V‑blender | Liquid-Solids Blender | Patterson Kelly | |
Granulation / Multi-Particulate Coating | Fluid Bed Processor | FLM-1 | Vector Corporation |
Fluid Bed Processor | FLM-3 | Vector Corporation | |
Fluid Bed Processor | VFC-LAB 3 | Vector Corporation | |
High Shear Granulator | GMX.01 | Vector Corporation | |
High Shear Granulator | GMX-Lab Micro | Vector Corporation | |
High Shear Granulator | GRAL 25 | GEA | |
Roller Compactor | TFC-LAB Micro | Vector Corporation | |
Roller Compactor | Mini-Polygran Plus | Gerteis | |
Sizing | Comil | 197S | Quadro Engineering |
Fitzmill | D6 | Fitzpatrick | |
24” Vibratory Sieve | Sweco | ||
Extrusion / Spheronization | Wet Mass Extruder | DG-L1 | LCI Corporation |
Spheronizer | QJ-230 | LCI Corporation | |
Encapsulation | Manual Capsule Filling Machines (powders) | ProFiller 3700 | Torpac |
Capsule Banding Machine | LAB-TOP | Schaefer Technologies | |
Micro-Dosing | Xcelodose 120S | Capsugel | |
Automatic Capsule Filling Machine (powders) | CF72 | CapPlus Technologies | |
Automatic Capsule Filling Machine (powders, pellets, micro-dosing) | GKF 702 | Bosch | |
Tableting | Manual Tablet Press (B/D tooling) | MTCM-1 | GlobePharma |
Instrumental Tablet Press (B tooling) | Piccola | SMI | |
Instrumented Tablet Press (B/D tooling) | Piccola PLC | SMI | |
Instrumented High Speed Tablet Press (B tooling) | XL-100 PRO | Korsch | |
Instrumented Bi-Layer Tablet Press (B/D tooling) | Eliza-Press 200L | Elizabeth-Hata International | |
Tablet Coating | Perforated Coating Pans | Compu-Lab 15/19/24” | Thomas Engineering |
Perforated Coating Pan | Compu-Lab 24/36” XR | Thomas Engineering | |
Packaging | Induction Sealers | AM-75 | Modular Packaging Systems |
Capsule/Tablet Counter | MC-2 | Modular Packaging Systems | |
Capsule/Tablet Counter | RX-4 | Rx Count | |
Capsule/Tablet Counter | KL15e | Kirby Lester | |
Liquid Filling Machine | DAB-8 | Filamatic | |
Semi-solid Filling Machine | VOF-10S | Vanguard Pharmaceutical Machinery | |
Semi-solid Filling Machine | VOF-125S | Vanguard Pharmaceutical Machinery | |
Tube Sealer (plastic & laminate) | NZT-100 | Neweco | |
Powder Filler | Nano-Filler | Per-Fil | |
Impulse Sealer | TISF-305 | TEW | |
Blister Packaging Machine | Sepha EZ Blister | Thomas Packaging | |
Liquid & Semi-Solid Processing | Homogenizer | L4RT | Silverson Machines, Inc. |
Vacuum Homogenizer Mixer | LM6 | Ekato | |
6 Gallon Jacketed Kettle | FT-6CE | Market Forge | |
200 L Jacketed Tank with Lightnin Mixer | Precision Stainless | ||
Spray Drying | Spray Dryer | Mobile Minor Closed Cycle | GEA |
Spray Dryer | B-290/295/296 | Buchi | |
Other | Convection Ovens | Isotemp Oven | Fisher Scientific |
Vacuum Ovens | TVO-5 | Cascade TEK | |
Tablet/Capsule Weight Sorters | SADE SP-140 | CI Precision | |
Capsule Polisher/Sorters | CPT 200 with SortFast | CapPlus Technologies | |
Tablet Capsule Metal Detectors | THS/PH21E & THS/PH21N | CEIA | |
Tablet Dedusters | TD101-WD | Key International |
Analytical Equipment
Analytical Equipment
Equipment | Model | Manufacturer | |
---|---|---|---|
Chromatography | HPLC (x4) with DAD (x4), RID (x1) | 1200 | Agilent Technologies |
HPLC (x6) with PDA (x2), TUV (x4), ELSD (x1) | 2695 Alliance | Waters | |
UPLC with PDA, TUV | Acquity H-Class | Waters | |
GC with FID, Headspace | 6890N | Agilent Technologies | |
Dissolution / Disintegration | 6 Vessel Dissolution, Bathless (x4) | Evolution 6100 | Distek |
Dual Pump Autosampler (x2) | Evolution 4300 | Distek | |
6 Vessel Disintegration, Bathless (x2) | 3106 | Distek | |
Spectrometry | UV/Vis w/8 Cell Transport | 8453 | Agilent Technologies |
Color Spectrophotometer | 650 | Data Color | |
Solid State Characterization | Scanning Electron Microscope | NeoScope SEM JCM-6000 | JEOL |
Microscope with Polarizer | DM750 | Leica | |
Differential Scanning Calorimeter | Q2000 | TA Instruments | |
Particle Size Analyzer | Mastersizer 3000 | Malvern | |
X-Ray Diffractometer | MiniFlex 600 | Rigaku | |
Other | TOC/Conductivity Analyzer | M9 | GE Analytical Instruments |
TOC Analyzer | 900 | GE Analytical Instruments | |
Volumetric Karl Fischer | 701 KF Titrino | Methrohm | |
Volumetric Karl Fischer | MT V30 | Mettler Toledo | |
Coulometric Karl Fischer | MT C30SX | Mettler Toledo | |
FTIR | Nicolet 380 | Thermo Fisher Scientific | |
Viscometer | LVDV-1+ | Brookfield | |
Texture Analyzer | Plus | TA Instruments | |
pH Meters | SevenMulti | Mettler Toledo | |
Balance | XS105S DR | Mettler Toledo | |
Balance | PB3002-S/FACT | Mettler Toledo | |
Balance | PB8001-S/FACT | Mettler Toledo | |
Moisture Balance | PB3002-S/FACT | Mettler Toledo | |
Moisture Balance | PB8001-S/FACT | Mettler Toledo | |
Centrifuge | Labofuge 400/400R | Thermo Fisher Scientific | |
Water Bath | Isotemp 228 | Fisher Scientific | |
Sonicator | 8510 | Branson | |
Oven | 30 - 250ᵒC | Precision | |
Wrist Action Shaker | 75 | Burrell | |
Furnace | Vulcan 3-550 | Ney |