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Intertek to Provide Expert Training on Extractables / Leachables Assessment for Inhaler Medicines



  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 information on 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.kettle@intertek.com
or
Dr Armin Hauk
Head of Trace Analysis Laboratory Basel
Intertek Basel, Switzerland
TEL.: +41 61 686 48 56
Armin.hauk@intertek.com
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