Sterile Package Testing – 2016

Quest Engineering Solutions is pleased to announce that its testing capabilities now include the inspection of sterile barrier systems as a follow-on to shipping simulation, aging simulation or as a stand-alone activity.

Many of our customers request testing to ASTM D4169 shipping simulation tests and request any combination of the following tests for sterile barrier systems:

Medical Device Package Validation Testing

  • ASTM F88: Seal Strength (Peel Test)
  • ASTM F1140: Burst Test (Unrestrained)
  • ASTM F1886: Determining Integrity of Seals by Visual Inspection
  • ASTM F1929: Dye Penetration
  • ASTM F2054: Burst Test (Restrained)
  • ASTM F2096: Gross Leak Detection (Bubble Test)

Quest Engineering Solutions is in the process of validating the test methods for film/Tyvek pouches and PETG/Tyvek trays, but also have the capability to validate new test methods and different materials in accordance with ISO 11607.

Quest’s services focus on the physical and virtual testing of your product. We offer the following testing services:

  • Vibration
  • Airflow, impedance and performance measurements
  • Altitude
  • Audio, noise measurement and evaluation
  • Burn-in
  • ESS, HALT, Stress screening
  • EMI/EMC
  • Product Safety Testing
  • Finite Element Analysis, including thermal, mechanical, airflow and others
  • Humidity
  • ISTA and ASTM package testing
  • Materials Testing, including tensile testing
  • Mechanical Shock, Fragility
  • Salt Spray Testing
  • Temperature, component, module and system cooling
  • Thermal Imaging
  • Temperature Cycling, Thermal Shock
  • Transportation simulation (packaging testing)
  • MIL Spec Testing
  • Custom Projects and Turnkey test setups.