Transportation and Distribution testing is required for all shipping containers used to transport medical devices. This is important as the shipping and distribution environment presents hazards (i.e. shock, vibration, compression, altitude, temperature, and humidity) that can be detrimental to the product and the sterile barrier. This blog post provides guidance on selecting the correct test schedules and methods to ensure the challenges presented are representative of the environment to which the product is subjected.
There are a number of testing options in the standards, and the choices may not always be clear. ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) provides 18 Distribution Cycles (DCs) based on modes of transportation, not on package or product type. The first step in determining the appropriate testing method is to decide how the package will be transported. Will it travel by air, rail, truck, or a combination of these? The most common mode of transport for most medical devices and pharmaceutical products is small parcel through UPS, FedEx, or other carriers. This transport option experiences both air and truck as a routine part of transportation and directly correlates to DC 13 [Air (intercity) and motor freight (local, single package up to 150 lb. (61.8 kg)]. If a package system is over 150 lb., or unitized (i.e. pallet or skid) and shipped via air and truck, then DC 12 would be selected, which subjects the package system to the hazards described above. If the predesigned options don’t fit one’s particular transportation route, there is a user defined cycle (DC 2) that allows for any custom combination of distribution hazards.
After selecting the correct DC, the next step is to select the Assurance Level (AL). The AL is selected based on probability of occurrence pertaining to drop heights, compressive loads, and vibration intensity. Product cost and patient risk (e.g. a permanent implantable device) are considered when selecting the AL. Assurance Level I (AL I) is the most severe and conservative, AL II is the most common and suggested by the standard, and AL III is the least severe/conservative. A more severe AL level may be chosen to challenge the shipping container to determine if the protective packaging is sufficient, over engineered, or under engineered. A risk assessment and justification should be written for all choices made.
If you would like to learn more about building distribution test plans or transportation testing please see our webinar Transportation and Distribution Testing for Medical Devices.