Usually one of the last items you think of when designing a new product, the packaging actually provides a critical function. It is the barrier between the world and your medical device – meant to keep your product intact and functioning as designed. Medical device packaging must be tested for stability. This will provide assurance that the product contained within the packaging is safe, sterile and effective for at least the shelf-life that is claimed. When establishing package stability, the primary package must be able to maintain its integrity while being shipped and exposed to normal handling.
21 CFR 820 requires that “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.” Included in the packaging is packaging materials, primary package, packaging components, shipping containers, and the processes associated with packaging.
There are tests that can be performed to confirm the effectiveness of your packaging. These tests have the ability to assess how the packaging and its contents interact, as well as the effects of the levels of packaging, external forces and end-use. Distribution simulations would focus on the effectiveness of your packaging to withstand the hazards associated with shipping and/or distribution. Tests included in this category include atmospheric conditioning, drop test, vibration test, and a compression test. Stability testing can be performed with accelerated aging – exposing the final product/packaging to extreme levels of stress. Package integrity is performed using various methods, including: seal integrity by visual inspection, seal integrity by peel test, seal strength by burst test, seal integrity by dye penetration, package integrity by bubble test.
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