By Smithers Rapra
After the good fortune of the inaugural occasion in Baltimore, E&L united states is coming to windfall, RI on might 7-9 2013! Set to collect much more E&L pros with assistance from knowledgeable application committee, E&L united states will function the same breadth of shows to the 2012 convention, together with operating team updates from IPAC-RS, ELSIE and USP, plus case reports of most sensible practices in E&L trying out from EMD Millipore, Johnson&Johnson, BD clinical and extra.
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Extra info for Extractables and Leachables USA 2013
Parts were placed into a 500 mL glass bottle. 200 mL of extraction solvent is added to the bottle and capped. Identical blank control bottles were prepared in which the extraction solvent is added, but without any Test Article pieces. The Test Article and the Blank Control bottles were autoclaved at 121ºC for one hour, then placed in an oven and incubated at 50°C for 3 days and 17 hours. Extractable Analysis Several screening tests were performed on the Test Article extracts and control blanks to establish the general chemical properties of the extracted compounds.
Risk management is especially important for managing material changes. A rationalized and robust risk management approach established for materials selection, as well as for assessing compatibility, will provide a strong platform for managing intentional as well as unintentional changes to materials during the drug product lifecycle. Inhalation drug products are typically comprised of a drug formulation combined with a delivery system. The risk profile for a given material is inextricably linked to the risk profile of the delivery system components in which it is used.
Gyorgy has worked for Johnson & Johnson for 6 years and is an expert in trace level analytical method development and method validation. He was also the recipient of Johnson & Johnson Outstanding Analytical Scientist Award. ABSTRACT Toxicological equivalency of a medical device is well defined by ISO 10993-18 and the toxicological risk assessment requires extensive chemical testing. Any significant changes in the product manufacturing process must to be evaluated and data must be presented for toxicological equivalency to a clinically established product.