Deciding on the correct packaging method for medical device packaging equipment 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 validation requirements (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 costs, printing requirements, user requirements, and sterilization method all are considerations when choosing the appropriate packaging for the device. Another variable might include the product’s 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 exhibits 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.
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 pack machine, or thermoformer 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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