RC Pharma exhibited at Extractables & Leachables Conference 2012 in Vienna

Mark Perkins on the RC Pharma stand in ViennaThe pharmaceutical arm of TARRC's consultancy, RC Pharma, successfully exhibited at the 5th International Conference of Extractables & Leachables for Pharmaceutical Products held at the NH Danube City Hotel in Vienna, Austria from 12th-13th December 2012.

Extractables – Compounds that migrate from a given component under aggressive conditions. What can come out.

Leachables – Compounds that migrate from a given component under normal operating conditions. What does come out.

The programme delivered cutting-edge analysis of testing techniques and high-level insight into the global regulatory landscape, while allowing extensive time for debate and networking. Attendees were provided with the latest information on regulatory updates, results from industry working groups and progress in analysis of new materials for pharmaceutical packaging. Additionally, the extensive networking and social agenda provided a valuable knowledge-sharing experience for delegates.

Event highlights included:
- The European regulatory perspective from Dr Dima Al-Hadithi at the MHRA
- A truly interactive and informative panel discussion featuring toxicologists from NovoNordisk, Pfizer, Safebridge and Forthtox
- A clear update on the implications of the work of the PQRI PODP working group from Chris Houston of Bausch & Lomb
- New presentations on topical products and dialysis systems, which sparked much discussion between participants
- An evening social programme of wine tasting and a visit to Vienna's biggest Christmas market provided a chance to network and share ideas with senior industry figures in a relaxed environment
- Opportunities to put questions to the experts, including E&L specialists from Smithers Rapra

Save the date for the 2013 edition 4-5 December in London, UK!

As well as the formal sessions, plenty of time was been built into the programme to enable delegates to network, to renew old acquaintances and make new ones.

The examination of extractables and leachables from materials in contact with a drug product or the patient is growing in importance due to increased regulatory scrutiny from organisations such as the Food and Drugs Administration (FDA) and the European Medicines Agency (EMEA).  Regulators are concerned with the interaction of various drug delivery devices, such as metered dose and dry powder inhalers (MDI and DPI) and now parenterals and ophthalmics are of increasing interest, as well as pharmaceutical process equipment.

RC Pharma offers Extractable and Leachable (E&L) testing services to the pharmaceutical industry and as part of Rubber Consultants has been offering reliable, high quality testing services to the polymer industry since 1984.

RC Pharma can carry out E&L testing on a wide range of products including OINDPs (orally, inhaled and nasal drug products) such as MDIs (metered dose inhalers) and DPIs (dry powder inhalers) and PODPs (parenteral and ophthalmic drug products), eg. prefilled syringes, bags, tubing, vials, filters, closures, bottles etc.

Our E&L testing is carried out to the PQRI “Safety Thresholds and Best Practices for Extractables and Leachables in OINDPs”.

For more information on the E&L Conference please visit the conference website.

For more information on RC Pharma and the services on offer please visit the official website.

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January 2013
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