Deciding on the correct packaging method for medical devices is important for package integrity.
In the medical industry choosing the right packaging method for high-valued medical devices is essential to the end user and must comply with safety regulations. When engineering a price-to-performance equipoise that meets the validation requirement (ISO 11607, EN868, AS TM D1585, AS TM F3475, etc.), it is important to consider these variables for each new packaged product. Factors such as environment, materials, material cossts, printing requirements, user requirements, and sterilization method all are considerations when choosing the appropriate packaging for the device. Another variable might include the products shape or consistency. Factors to consider include proper form and fitting, cost, plus integrity during sterilization and throughout the supply chain.
There are two common types of packaging commonly used for high profile 3 dimensional medical devices, flow wrapping and thermoforming, each exhibiting their own strengths and weaknesses. However, it’s important to note that flat products like a pair of surgeon’s gloves or a gauze sponge can use what is called 4 side seal flat pack, where just two pieces of paper or film are brought together and sealed around the product. Low volume, high profile medical devices can also use preformed trays and die cut lids.
- Flow Wrapping – Flow wrapping is one of the early packaging techniques for medical devices where a permeable substrate is wrapped and hermetically sealed around the device. Flow-wrapping is widely viewed as one of the most cost-effective methods for packaging high-profile products. In medical device applications flow wrap is more frequently applied where the product sterility of the outside of the product is not crucial such as infusion bags, IV sets and kits where one or more devices are contained in an inner package that provides an adequate sterile barrier. Much attention has been given to sealants and materials which have improved flow wrapping to ensure package strength and ease of use.
- Thermoforming – The thermoforming method of packaging has taken over as the most popular option for packaging medical devices. Thermoforming uses horizontal form, fill and seal technology (HFFS) that combines two materials together. A cavity is formed in the bottom web; the product is inserted into the cavity and the lid is sealed to the bottom web. This creates a sterile barrier system that uses a sealed, rigid, semi-rigid or flexible package, where the product is protected from contamination prior to use. Sometimes the thermoformed tray can serve not only as a protective barrier for the contents but also as a dispenser, surgical tray or measuring device. Thermoforming is often preferred over flow-wrapping since it generally provides better aseptic presentation of the product and better product protection. Like flow wrapping, the package must ensure superior integrity and ease of use.
Flow Wrapping Vs. Thermoforming
Which method to use, flow wrapping or thermoforming, depends of the nature of the product, sterility requirements, and desired point of use characteristics.
Which method is best? The choice of flow wrapping, or thermoforming depends on the specific medical device or product and whether the package is intended to serve as a Sterile Barrier System or a Product Protection System, in the context of ISO 11607: 2019. Think of product characteristics, protection requirements, sterilization processes and how the product will be used.
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