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Extractables & Leachables for Pharmaceutical Products 2011
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 Extractables & Leachables for Pharmaceutical Products 2011 Contents Paper 1 Origins of extractables and leachables from polymer products Tim Hulme & Dr Martin Forrest, Smithers Rapra, UK Paper 2 An update of ELSIE activities Paper 3 PQRI PODP Extractables & Leachables Working Group:Research project on container closure systems used in parenteral and ophthalmic drug products – accomplishments and next steps Paper 4 The simulation study: the replacement of controlled extraction studies for PODP E&L documentation ? Paper 5 Closing the gap between extractables and leachables Paper 6 Extractables and Leachables: Scientific and Regulatory considerations Paper 7 Extractables and leachables: UK regulatory perspective Paper 8 Extractables & Leachables from CCS: Life-Cycle Management and Patient Safety Considerations for Parenteral and Ophthalmic Drugs Paper 9 How to set acceptance criteria for leachable studies: selection and toxicological evaluation of analytical targets Paper 10 Current extractables/leachables thinking and its impact on the E&L approach of an elastomeric closure supplier Paper 11 Best practice from a seal manufacturer’s view Paper 12 Extractables/leachables from single-use systems components Paper 13 Extraction studies on the development of packaging materials for dialysis solutions:presentation of a standard procedure and some results Paper 14 Thermodesorption GC/MS as a powerful analytical tool for E&L screenings in pharma or medical grade polymers Paper 15 Producing processed plastic materials for controlled extractables testing by the ELSIE Materials Working Group Paper 16 A control strategy for leachables in a dry powder inhaler Paper 17 Characterisation of drug and drug product related contaminates: when is a leachable not a leachable? Paper 18 Extractables & leachables for medical devices: meeting the 510 (k) requirements |
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2015-08-23 20:59:51, 10.96 M
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