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 | |
| High Shear Granulator | GMX.01 | Vector Corporation | |
| High Shear Granulator | GRAL 25 | GEA | |
| High Shear Granulator | FM-VG-200 | Glatt | |
| Roller Compactor | TFC-LAB Micro | Vector Corporation | |
| Sizing | Comil | 197S | Quadro Engineering |
| Fitzmill | D6 | Fitzpatrick | |
| 20” Vibratory Sieve | Vorti-Siv RBF-15 | MM Industries, Inc. | |
| 24” Vibratory Sieve | Sweco | ||
| Extrusion / Spheronization | Wet Mass Extruder | DG-L1 | LCI Corporation |
| Spheronizer | QJ-230 | LCI Corporation | |
| Encapsulation | Manual Capsule Filling Machines | ProFill 100 & 3700 | Torpac |
| Capsule Banding Machine | LAB-TOP | Schaefer Technologies | |
| Micro-Dosing | Xcelodose 120S | Capsugel | |
| Automatic Capsule Filling Machine | In Cap | Dott. Bonapace & C | |
| Automatic Capsule Filling Machine | CF72 | CapPlus Technologies | |
| 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 | |
| Liquid Filling Machine | DAB-8 | Filamatic | |
| Semi-solid Filling Machine | VOF-125S | Vanguard Pharmaceutical Machinery | |
| Tube Sealer | TB3 | Gandus | |
| 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 | |
| 50 Gallon Jacketed Kettle | Hamilton | ||
| 200 L Jacketed Tank with Lightnin Mixer | Precision Stainless | ||
| Other | Spray Dryer | Mobile Minor Closed Cycle | GEA |
| Spray Dryer | B-290/295/296 | Buchi | |
| Convection Ovens | Lindberg/Blue M | Thermo | |
| Convection Ovens | Isotemp Oven | Fisher Scientific | |
| Vacuum Oven | Isotemp Vacuum Oven | Fisher Scientific | |
| Tablet/Capsule Weight Sorter | AB Plus | Mocon | |
| Capsule Polisher/Sorter | CPT 200 with SortFast | CapPlus Technologies | |
| Tablet Capsule Metal Detector | THS/PH21N | CapPlus Technologies/CEIA |
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 |