Sampling and Testing of:
- Raw Materials
- Bulk Solution Batches & Finished Product Lots
- Manufacturing & Filling Equipment Cleaning Validations
- Customer Supplied Bulk Products
- Water System Samples
Note: Sampling of raw materials & bulk solution containers is performed in a Sampling booth equipped with a certified HEPA filter.
Instrumentation:
- Perkin Elmer Series 200 UV/VIS Detector HPLC Instruments
- Fisher Scientific Isotemp Muffle Furnace
- Mattson Genesis II FTIR
- Hewlett Packard Series II 5890 Gas Chromatograph
- Brookfield Digital LVT Viscometer
- Abbe Refractometer
- Orion pH meter
- Baxter Vacuum Drying Oven
- Environmental Chamber ( 2 @ shelf, 1 @ accelerated - conditions)
- Sartorius Analytical Balance
- YSI Model 35 Conductance Meter
- Anatel A-1000 TOC Analyzer
- American Scientific Products Model DX-38 Drying Oven
Wet Chemistry (USP/NF & FCC):
- Residue on Ignition
- Heavy Metals
- Specific Gravity (hydrometer, pycnometer or gravity cup)
- Titrations
- Loss on Drying
- % Solids
- Identification Tests
Services Available:
- Stability Testing – Accelerated & Room Temperature Chambers
- Compatibility Testing – (container vs. contents)
- Validation (Mixing Process, Packaging Process, Equipment Cleaning, Test Method)
- Method Transfer Validations
- Calibration Program – NIST Traceable
- PM (Preventive Maintenance Program)
- Annual Drug Product Reviews