Transportation and Distribution Simulation Studies

Transportation and Distribution Simulation studies are a laboratory simulation of the general damage-inducing transits, forces, and conditions of transport environments. These studies assess the performance of the sterile barrier packaging as medical device would arrive at the customer. They are required prior to market release to show product handling. This test includes all shipping materials used for transportation.

Standard for Transportation and Distribution Simulation

• ATSM D4169 (Standard Practice for Performance Testing of Shipping Containers and Systems)
• ASTM D7386(Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems)
• ISTA 3A standards
• ISTA 2A standards
• ISO 11607 (Packaging for Terminally Sterilized Medical Devices) outlines three possible approaches to transit simulation of single-use products, and the schedules differ in quantity and detail.

Objectives of Transportation and Distribution Simulation

Transportation and Distribution Performance studies are applicable across broad circumstances, such as various vehicle types and routes or a varying amount of handling exposures. The study can include simple shaped random vibration, different drop heights, and atmospheric conditioning. There are generally two objectives: Assessing the performance of the shipping carton and its robustness in transport and subjecting the shipping carton’s contents to the rigors of transport. Especially, the latter is more important for the medical device manufacturer. This permits performance testing of the sterile barrier packaging and assessment of the product during transportation.

Our Transportation and Distribution Simulation Service

We understand that it is very important to provide products to the end users under conditions suitable for the purpose. With the state-of-the-art facilities, STEMart provides a range of packaging tests to simulate the typical hazards a package may potentially encounter in the distribution, these transportation tests include:

• Climatic Conditioning
• Initial and Final Manual Handling Test
• Mechanical Handling Test
• Vehicle and Warehouse Stacking/Compression Test
• Vehicle Vibration Test
• Loose Load Vibration Test
• Low Pressure/High Altitude Test
• Impact and Drop Test
• Handling, Bridge Impact Test
• Loading Stability During Handling and in Vehicle
• Concentrated Impact Test
• Assessment of Shock and Fragility Performance

With extensive expertise in consulting, package validations encompassing package and sterilization configurations, material qualification, and package development, STEMart can provide a full-service experience, help manufacturers:

• Assess packaging and labels performance
• Reduce damage
• Save packaging costs
• Achieve regulatory compliance
• Speed up the product launch process

If you have any additional questions about Medical Device Transportation and Distribution Performance or would like to consult with the experts at STEMart, please feel free to contact us.