The pharmaceutical arm of Rubber Consultants, RC Pharma exhibited at the Extractables & Leachables Conference 2014 at the Novotel Barcelona City hotel from 10th-12th November 2014.
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 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.
Other services offered by Rubber Consultants are:
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