Pharmaceutical Manufacturing & Packaging In-Depth Focus 2013
In this Pharmaceutical Manufacturing & Packaging In-Depth Focus: The chemical safety assessment process for extractables and leachables associated with packaged pharmaceutical products; INTERPHEX 2013: Show preview…
- The chemical safety assessment process for extractables and leachables associated with packaged pharmaceutical products
Dennis Jenke, Baxter Distinguished Scientist, Baxter Healthcare Corporation
Packaged pharmaceutical drug products can interact with their packaging, resulting in the migration of substances from the packaging and into the drug product. This is of concern due to the potential toxicity and/or reactivity of the migrating substances. In order to properly assess the safety risk and manage the safety hazard posed by migratory substances, it is first necessary to establish, via the application of a rigorous and extensive chemical analysis process, the identities of the migratory substances and the levels to which they will accumulate in the finished drug product. This analytical data is then evaluated by toxicologically establishing the safety hazard posed by the migratory substances, a process by which the actual user exposure to the migrating substances is balanced against a tolerable dose calculated for each migrating substance.
- INTERPHEX 2013: Show preview
From 23-25 April, INTERPHEX, the largest annual industry exhibit for pharmaceutical manufacturing & biopharma manufacturers, organised by Reed Exhibitions, will open its 2013 event at New York’s Javits Center with a with a new and improved experience for 2013. This event has evolved to meet the industry’s needs, including a re-engineered conference programme, expanded product categories on the show floor and additional networking opportunities.
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