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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.
In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.
In 21 CFR 211.94 it is stated that “Drug product containers and closures shall not be reactive, additive, or absorptive to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.” While the code makes this statement, and if expanded on in the related FDA Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics (May 1999), there is no prescription offered in how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of container closure systems.
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.
In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.
In 21 CFR 211.94 it is stated that “Drug product containers and closures shall not be reactive, additive, or absorptive to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.” While the code makes this statement, and if expanded on in the related FDA Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics (May 1999), there is no prescription offered in how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of container closure systems.
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