Does Understanding Your Supply Chain Matter?
Whether you are packaging a surgical suture kit or a hip implant to be delivered to the OR, getting to know your supply chain is critical to every aspect of your medical device or pharmaceutical product.
Have you ever considered how a package gets to you? Think about it! Close your eyes and pretend you’re a package being delivered to your house. Think about the vibrations you feel when sitting in the back of a semi-truck or a van navigating winding roads. How does each pot hole or braking and acceleration affect you? Do you feel the pressure when going up and down hills? Are other packages piled on top of you? Are you traveling in only one vehicle or are you transitioning between a combination of cars, trucks, planes, ships and trains?
These are only some of the considerations packaging engineers consider when designing product-package systems. A key consideration for packaging engineers is what the products distribution channel is. What mode(s) of transportation will the package be subjected to? For how long? Is the environment constantly changing in pressure and temperature? Furthermore, how is the product interacting with its package and how is the product-package system interacting with its surroundings in the distribution channel?
How to Get to Know Your Supply Chain
The best way to learn your supply chain is to start from the beginning and to develop a process map. Outline your understanding of the product and package experience with a step-by-step approach. Is the pack out process manual, semi-automatic, or automatic process? Keep an eye on the type of materials used in the pack out process, this could be affected throughout distribution. The next step might be sterilization of the sterile-barrier-system (SBS). Where does sterilization take place? Is it in-house or at a third-party sterilizer? Regardless, how is the packaged product transported to sterilization? In a bulk package that is heavily insulated and contains dry ice or simply into a plastic tub or corrugated box. Consider what type of vehicles are transporting the package and the orientation of the packages in each transportation method and so on, until you get to the end consumer and disposition of your product-package system.
From a process standpoint, think of ways to establish ‘phases’ of the supply chain. Within each phase, document each and every touch point that the product-package system is handled. Diving further into the supply chain, it may benefit the package development process to think critically about what factors affect each touch point. This will increase your ability to spot inefficiencies or gaps in the supply chain.
Translating Your Supply Chain to the Lab
For the medical device and pharmaceutical industries, the bottom line is this: did the package do it’s job and protect the product’s integrity?
Luckily, guidance is provided to packaging engineers by ISO 11607 parts I and II for requirements on packaging design. However, to understand if the package system concept is robust enough, we need to put the product-package system to the test.
Packaging engineers can gain confidence that their package can withstand the supply chain experience through laboratory testing. Test standards like ASTM D4332 can simulate the different temperatures and humidity packages will be subjected to during transit across different regions, ASTM D4169 can subject packages to vibration profiles, shocks, and pressure changes that they may experience during distribution, and tests like ASTM F2096, ASTM F1886, and ASTM F1929 can confirm if there is a breach of sterile barrier in your product-packaging system.
Understanding Your Supply Chain Matters
Understanding your supply chain is key to getting your product to market with speed and confidence. Knowing your supply chain can save a lot of up-front work. By understanding how to mitigate risks at each phase and touchpoint of the supply chain, you are protecting the future of your product launch. If you have questions or want to double check your level of confidence, the Packaging Compliance Labs engineering team is standing by to help.