Intertek to Provide Expert Training on Extractables / Leachables Assessment for Inhaler Medicines Business Wire BASEL, Switzerland -- April 23, 2013 Intertek, the leading quality solutions provider to industries worldwide, has been invited to present during the European Compliance Academy(ECA)training course: The Quality of Inhalation Drug Products. This course will provide delegates with understanding and best practices in the development and analytical quality control of Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) drug products. A key part of the event programme will be a training session on extractables / leachables (E&L) assessment which will be presented by Dr Armin Hauk, Head of Trace Analysis at Intertek’s Basel laboratory. In recent years the market for inhaled drug products has become increasingly important whilst at the same time, the number of regulatory requirements has increased. One of the most challenging issues in the development of inhalation drug products is the control of extractables and leachables (E&L). The high degree of concern with inhaled administration routes which deliver medication direct to the lungs lies with the rubber and plastic inhaler device components being in constant contact with the product formulation and that this formulation is primarily a propellant including an organic solvent which has the potential to extract substances from the device components (extractables). Potential extractables include plasticizers, antioxidants, lubricants, vulcanizers, peroxides, monomers, catalysts, residual solvents, pigments and oligomers. Dr Hauk will cover both the strategies and methodologies for E&L studies to help fulfill regulatory requirements and will present an overview of instrumentation and techniques which enable comprehensive qualitative and quantitative analysis in extracts from such studies. Dr Hauk will also provide guidance on how to manage and assess the data from extractables studies to derive a meaningful list of leachables, how to validate leachables methods and how to evaluate E&L data. “Conducting appropriate extractable and leachable studies for inhaler products, with the potential complexity of the polymer materials in mind, requires suitable, validated and sensitive analytical methods” shares Dr Hauk. The Quality of Inhalation Drug Products will take place 7-8 November 2013, Heidelberg, Germany.For more informationon the course please see the ECA website. About Intertek Intertek is the leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value to customers’ products, processes and assets. With a network of more than 1,000 laboratories and offices and over 35,000 people in more than 100 countries, Intertek supports companies’ success in a global marketplace. Intertek helps its customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. Intertek Group plc (LSE: ITRK) is listed on the London Stock Exchange and is a constituent of the FTSE 100 index. Visit: www.intertek.com. Contact: Intertek Chemicals and Pharmaceuticals Dr Lorna Kettle, Marketing Manager Europe TEL.:+44 161 721 1476 Lorna.email@example.com or Dr Armin Hauk Head of Trace Analysis Laboratory Basel Intertek Basel, Switzerland TEL.: +41 61 686 48 56 Armin.firstname.lastname@example.org
Intertek to Provide Expert Training on Extractables / Leachables Assessment for Inhaler Medicines
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