Complete sterility assurance programs consist of custom protocols backed with complete documentation which fulfills all necessary regulatory requirements. Testing capabilities include all areas of microbiological quality assurance.

Sterilization Validation:

• Bioburden
• Dose Verification Experiments
• Sterility Tests
• Pharmacopoeia Sterility Tests
• EO Cycle Development and Validation
• EO Residual Testing

Environmental Monitoring:

• Air Sampling
• Microbial Identification
• Surface Sampling
• Water Testing
• Personnel Monitoring
• Data Handling and Analysis

Packaging Validation & Shelf Life Testing:

• Accelerated Aging (ASTM F1980)
• Barrier Properties (ASTM F1608)
• Burst Testing (ASTM F1140)
• Dye Penetration (ASTM F1929)
• Gurley Porosity
• Restrained Burst (ASTM F2054)
• Seal Tensile Strength (ASTM F88)
• Shipping Simulation (ASTM D4169)
• Vacuum Leak (ASTM E515, D3078)
• Visual Inspection (ASTM F1886)