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Use-Life vs. Shelf-Life of Sterile Packaging​

Updated: Mar 10, 2022

4/20/20

There have been many discussions regarding sterile storage since the FDA mandated that manufacturers add an expiration date to their products. That being said, in the context of this thought, I am not addressing event-related storage. Use-life and shelf-life are very different, and several surveyors seem not to understand this. Simply put, use-life is the time frame you have to use the product. Shelf-life is the amount of time the product can remain in storage after use. However, some manufacturers use the terms interchangeably. Some manufacturers will state storage after sterilization in terms of sterility maintenance and provide a time frame for it. For one single packaging device, the storage time frames can even change with the sterilization modality. Read your IFU's carefully and contact the manufacturer of the products you use if you are unsure of its lifespan.



At Evolved Sterile Processing, our consultants have a greater focus on sterile processing. With our decades of experience, we will help you develop better processes and educational resources for your staff.

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