By Sunny J. Modi, PhD, Director of Package Testing for Eurofins Medical Device Testing, Lancaster, PA
Have you ever wondered how items ordered through e-commerce channel end up at your front door safe and sound? Sometimes, these items arrive in imperfect shape or with even worse damage. While this may be acceptable for some consumer products, medical device packaging has to provide an even higher level of protection, where the items inside the box or carton must remain free of defects, sterile, and fully functional. Behind the scenes, there is a product or packaging engineer who is thinking of creative ways to design a packaging system that will ensure safe arrival of the medical device at its final destination. This article provides general insights into developing a test plan to perform shipping and transport studies that will assist in meeting the requirements for the European Union (EU) or the Code of Federal Regulations (CFR) for FDA.
The Medical Device Regulation (MDR) issued in 2017 provides general guidance on packaging systems for many EU countries. The wide-ranging rules in the MDR provide guidance on how to design, manufacture, and package medical devices that minimize the risk posed by contaminants, pathogens, and residues to patients. In addition, the medical device must remain sterile and not adversely affected during transport and storage conditions, and the integrity of the packaging systems must be clearly evident to the final user. Similarly, within the United States, the Food and Drug Administration under Title 21 of the CFR provides guidelines for safely manufacturing, packing, storing, and installation of medical devices. Per Title 21 CFR Part 820 on labeling and packaging control, “Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution” (21CFR820.130).1 Similar to the MDR in the EU, the FDA expects the manufacturer to prove the overall integrity and safety of the packaging system. Therefore, the packaging system is subject to rigorous validation processes that includes full validation of the packaging process, accelerated and/or real-time shelf-life testing, package strength testing via mechanical performance of the packaging materials, verification of the sterile barrier system, and finally, performance testing via distribution testing.
Distribution testing, shipping studies, transit testing, and packaging simulation are terms commonly used to describe testing of packaging materials, components, and shipping containers. Furthermore, these tests measure the effectiveness of the packaging systems and medical devices when exposed to various real-world conditions and demands. Packaging systems and medical devices are exposed to mechanical and climatic stresses while being filled, moved, stored, and transported. However, there are multiple standards available to test the system and evaluate the responses of a particular design or material when exposed to different stresses.
One standard that is commonly used to evaluate the packaging performance is ASTM D4169-16. According to the ASTM D4169-16, distribution simulation “provides a uniform basis for evaluating, in a laboratory setting, the ability of a shipping container to withstand the different distribution environments. This is accomplished by subjecting shipping containers to a series of test plans consisting of different anticipated mechanical hazards.”2 These mechanical hazard elements are determined based on the modes of transportation that will be used to deliver the medical device to its final destination.
In addition to the regulations outlined previously, the FDA recommends packaging design as an essential step during the product development phase. As the packaging system is being finalized, performing a simple packaging test helps identify and understand the fatigue points of the packaging system. The most common sequence of tests includes manual handling, vehicle stacking, loose load and vehicle vibrations, low-pressure/high-altitude testing, and concentrated impacts, which should be included in a manufacturer’s test plans. The manual handling test sequence is used to determine the shipping container’s ability to withstand the hazards occurring during loading, unloading, stacking, sorting, or palletizing. The main hazards from this operation are the impacts caused by dropping or throwing the packaging system (see Figure 1). The vehicle stacking test is intended to determine the ability of the shipping container to withstand the compressive load that occurs during vehicle transport. The primary hazard is compression of the box, which can cause instability within a pallet load.
Loose load and vehicle vibration testing are intended to determine the ability of the shipping container to withstand the repetitive shocks, which can occur during transportation of the medical devices. Based on the mode of transportation via rail, air, truck, or boat, the test levels and methods account for the magnitude, frequency range, duration, and direction of vibration, thus effectively measuring the shipping container’s vertical vibration resistance (see Figure 2).
The low-pressure/high-altitude testing provides a visual feedback on shipping containers with nonporous packaging systems as they are exposed to the anticipated reduction in pressure during specific modes of transports like feeder aircraft or ground transportation over mountain passes. Finally, a concentrated impact schedule provides a simulation of anticipated low-level concentrated impacts as received by packages during sorting operations and in transit. The concentrated impact test is only applicable to single-wall corrugated shipping containers under 44 ECT or 275 Burst reading.
The second type of stress is climatic, which plays a vital role in the durability and performance of the packaging system during warehousing and transportation. ASTM D4169 and D4332 provide multiple climatic conditions for packaging systems and medical devices to equilibrate for 72 hours or for a sufficient time based on the logistical channel. As the packaging system goes through various degrees of humidity and temperature cycles, the structural properties to the material change, leading to potential material and sterility failures. These changes can be simulated using state-of-the-art chambers that provide the ability to move the packaging system from one temperature and humidity to another to simulate the logistical channels of the medical device (see Figure 3).
Therefore, designing a successful test plan based on a manufacturer’s distribution channel can help alleviate last minute challenges. In addition, testing the performance of a packaging design before using it to ship medical devices to customers offers multiple benefits. An engineer can simulate various mechanical stresses in a lab setting and understand the responses from the packaging systems.
Based on the type of products and packaging systems, these tests can help to ensure that the packaging needs are met and can prepare for the modes of transportation that will be used to deliver devices to end consumers. The key to successful regulatory compliance is working with a qualified and experienced testing partner that provides guidance on regulatory requirements and specific testing procedures that align with the device company’s shipping and distribution environments.
- 21 C.F.R. § 820.130, Code of Federal Regulations, Quality System Regulation, Device Packaging.
- ASTM D4169-16, “ Standard Practice for Performance Testing of Shipping Containers and Systems,” Philadelphia, American Society for Testing and Materials, 2016.