Phase 2 packages single use instruments and disposables in both flexible and rigid packaging configurations.
Utilizing our relationships with industry leaders in sterilization, we manage ETO and Gamma Sterilization process from validation to product release.
We use band, bar and tray sealers within our ISO Class 8 (100,000) cleanrooms to create sterile barrier for products we manufacture.
Phase 2 also provides in house, on-demand Instruction For Use (IFU) printing including both static and variable information labels.
We have experience with the following packaging validation requirements to ensure packaging integrity, seal strength, accelerated aging and shelf life studies, distribution and transportation:
- ASTM F1929, Dye Migration or Penetration
- ASTM F2096, Bubble Leak
- ASTM F1886, Visual Inspection
- ASTM F88, Tensile Testing for rigid packaging systems
- ASTM F2054, Burst Testing for flexible packaging systems
- ASTM F1980, Accelerated Aging and Shelf Life Studies
- ASTM D4169 & ISTA 1,2,3 series, Distribution and Transit Testing