Package Testing

Situation: "Our product was just approved by the FDA. We are preparirng for commercialization and are not sure of what needs to be done from a packaging validation standpoint. "

Solution:
Life Science Outsourcing is an ISTA certified package test of laboratory. Validation services are based on ISO 11607 and EN 868. Since sterilization, shipping, handling and storage are dynamic events impacting a medical device package, LSO will provide you with a solution

LSO Services Include:

• Protocol Development
• Conditioning Studies - To increase shelf life
• Transportation Simulation ISTA 1A - According to ASTM D4169
• Package Integrity Testing
  • Dye Penetration (ASTM F1929)
  • Bubble Emission Leak Test ( ASTM D3078 & FPA SPMC 005-96)
• Package Strength Testing
  • Peel Test (ASTM F880)
  • Burst Test (ASTM F1140)
  • Visual Inspection (ASTM F1866)
• Microbial Barrier Testing
• Final Report Preparation
  

Additional Information:

• Why use LSO medical package testing?
• Regulatory Requirements of Medical Device Package
• Accelerated Aging/Shelf Life Study
• Distribution Simulation
• Primary Packaging
• Secondary Packaging