RC Pharma exhibited at Extractables & Leachables Conference

The pharmaceutical arm of TARRC's consultancy operation, RC Pharma, successfully exhibited at the 4th International Conference of Extractables & Leachables for Pharmaceutical Products held at the Ashling Hotel in Dublin, Ireland from 27th-28th September 2011.

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 Conference covered many areas:

  

·         Regulatory updates on extractables and leachables

·         Strategies for minimising risk

·         Medical grade polymers

·         Implantables and their packaging

·         Innovations in processing technologies

·         Managing risk with extractables and leachables

·         Controlled extraction studies and routine extractables testing

·         Leachables studies

·         Analytical techniques used to determine leachables and extractables

·         Biological evaluation by chemical characterisation

·         E&L implications on raw material suppliers

·         The convertor’s role in E&Ls

·         Drug manufacturers’ E&L considerations

·         N-1, N-2, N-3 case studies 

As well as the formal sessions, plenty of time was 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.

Running alonside the conference is a small exhibition for companies offering their services related to the pharmaceutical and healthcare industry. RC Pharma is one of the companies exhibiting.

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”.

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