When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose. Numerous international standardsi and pharmacopeial chaptersii focus on functional performance testing and they all recommend conducting tests that simulate real-world conditions based on the intended use of the device or packaging. This simulation includes matching the physical properties of the drug when using placebos, duplicating the number of punctures and the expected needle size that would be encountered in actual practice and testing samples that had been conditioned with the appropriate sterilization treatments, transportation simulations, storage conditions and thermal exposure to approximate actual expected sample environmental exposure which might affect performance.
Mike Ulman
February 18, 2025
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