Test Validation
ASTM D4169 Transit Simulation
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems The ASTM D4169 test method is a common standard for distribution simulation testing. In it, a test plan is created to simulate a sequence of anticipated hazards likely experienced during transit. Common components of the test plan would include shock testing, drop testing, and vibration testing. Our facilities allow us to customize test plans, and we can accommodate nearly any transportation simulation testing scenario.
Industry Application
This test simulates an extreme shipping environment to appropriately challenge many types of packaging systems. Because the small parcel environment most often represents the “worst case” scenario, it is one we commonly test. Often Distribution Cycle 13 at Assurance Level 1 or 2 would fit this case. It is important, however, to compare the specifications to see if this cycle fits your intended shipping or distribution environment. This simulation includes transit drop testing, compression testing, high altitude simulation, sine vibration, random vibration, and concentrated impact. ASTM D4169 is a recognized FDA consensus standard for medical packaging validation.
Frequently Asked Questions
What is ASTM D4169 Transit Simulation?
ASTM D4169 testing is a common standard for distribution simulation testing that includes vibration/shock, drop testing. ASTM D4169 simulates an extreme shipping environment to appropriately challenge many types of packaging systems.
Why is Transit Simulation required for medical device packaging validation?
If a medical device manufacturer is bringing a new device to market, one of the three data points they must provide for their 510k submission is transit testing. Transit simulation provides data that proves a sterile barrier system can withstand the extreme rigors of distribution.
