Title E & L USA : Extractables & Leachables : [conference proceedings] : delivering pharmaceuticals safely : 7-9 May 2013, Providence, RI, USA / organised by Smithers Rapra.

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Providence, RI : Smithers Information Ltd., 2013.

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Online eBook. Access restricted to current Rider University students, faculty, and staff.
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Description	1 online resource (138 pages) : illustrations, portraits
Physical Medium	polychrome
Description	text file
Bibliography	Includes bibliographical references.
Contents	9781909030664_Front Cover; Contents; THE REGULATORY STANDPOINT; Paper 1 Introduction to extractables and leachables; Paper 2 Regulatory perspective; UPDATES FROM INDUSTRY WORKING GROUPS; Paper 3 PQRI-PODP working group update; Paper 4 The United States Pharmacopeia and the issue of leachables and extractables: past, present and future; Paper 5 Risk management concepts and strategies applied to materials quality; E & L APPLICATIONS & CONSIDERATIONS; Paper 6 Risk Based Assessment of Extractable and Leachable Substances from Single-Use Systems Including case studies.
	Paper 7 Product equivalency for medical devices case studies for biodegradable and permanent implantable devices; Paper 8 Extractable and leachable studies of twist-off ports (T.O.P.) used for blood pack containers; E & L CASE STUDIES ON PARENTERALS; Paper 9 E & L's from elastomeric components for parenteral packaging: Understanding the impact of process parameters and sterilization methods; Paper 10 Extractable and leachable study of container closure/delivery systems for parenteral medications; TOXICOLOGICAL PERSPECTIVES ON E & LS.
	Paper 11 Determining acceptable levels of leachables into pharmaceutical products -- a toxicological perspectivePaper 12 Case studies of toxicology risk assessment of extractables and leachables; Paper 13 Current status of the ELSIE; demonstration of the practical use of the ELSIE safety database for the rapid assessment of risk from a controlled extraction study; MATERIALS COMPOSITION AND QUALITY; Paper 14 Correlating material composition to extractables and then to leachables.
	Paper 15 Characterization of E & L associated with pharmaceutically relevant materials: some analytical challenges and case studiesCHALLENGES IN E & L STUDIES; Paper 16 (Halo)butyl rubber oligomers in pharmaceutical rubbers; Paper 17 Case studies relating to implantable medical device and biologic products; Paper 18 Analytical challenges associated with high toxicological risk compounds (Nitrosamines): Raising the Safety Concern Threshold; 9781909030664_BackCover.
Summary	These proceedings cover all the presentations from this second E & L USA conference. Organized by Smithers Rapra the conference once again brought together the pharmaceutical supply chain and discussed the latest research in minimizing the risks associated with extractables and leachables. The conference provided a unique opportunity to learn about the latest developments from industry practitioners and working groups to meet regulatory requirements and ensure compatibility in drug-package combinations.
Local Note	eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America
Subject	Drugs -- Congresses.
	Drugs.
	Pharmaceutical industry -- Congresses.
	Pharmaceutical industry.
Genre/Form	Electronic books.
	Conference papers and proceedings.
Subject	Medication.
Genre/Form	Conference papers and proceedings.
Added Author	Smithers Rapra (Firm)
Added Title	E and L USA : Extractables and Leachables
Other Form:	Print version: Rapra, Smithers. Extractables and Leachables USA 2013. Shrewsbury : iSmithers Rapra Publishing, ©2013 9781909030664
ISBN	9781909030510 (electronic book)
	1909030511 (electronic book)
	9781910242087
	191024208X
	9781909030664

Title E & L USA : Extractables & Leachables : [conference proceedings] : delivering pharmaceuticals safely : 7-9 May 2013, Providence, RI, USA / organised by Smithers Rapra.

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