NAMSA offers a complete sterility assurance program and a wide array of related services including sterilization validation, reusable device studies, packaging validations, shelf life testing, and environmental monitoring. Sterilization validation services are available for processes including radiation, EO, steam, and hydrogen peroxide gas plasma. Our well-equipped facilities contain laboratories for bacteriology and sterility testing, clean rooms, aging chambers, and media preparation areas. Testing capabilities at NAMSA encompass all areas of microbiological quality assurance.
Sterilization Validation
- Bioburden
- Biological Indicator Sterility Tests
- Pharmacopeial Sterility Tests
- Bacteriostasis/Fungistasis Tests
- Growth Promotion Studies
- Dose Verification Experiments
- Fractional and Half-Cycle Studies
- Cycle Development
- EO Residual Testing
Reusable Device Studies
- Disinfection Validation
- Cleaning Studies
- Repeat Sterilization Cycles
Packaging Validation & Shelf Life Testing
- Barrier Properties
- Seal Tensile Strength
- Burst Testing
- Visual Inspection
- Sampling Plans
- Gurley Porosity
- Accelerated Aging
- Shipping Simulation
- Dye Penetration
- Vacuum Leak
Environmental Monitoring
- Viable Air Sampling
- Airborne Particle Counts
- Water Testing
- Bioburden
- Microbial Identification
- Surface Sampling
- Personnel Monitoring
- Data Handling & Analysis
