iSmithers will host its third international conference on Extractables & Leachables for Pharmaceutical Products from 14 – 15 September 2010 in London, UK.

This high profile event has been developed to support the safe use of polymers in the pharmaceutical and medical device industries – something that Smithers Rapra’s pharma consultants are passionate about. In recent years there has been an increasing importance placed on the examination of leachables and extractables that may arise from components used in, for example, primary container and closure systems, self-adhesive labels or secondary packaging materials, Smithers Rapra officials stated.

“As the regulatory pressure increases and evolves there is a greater need for pharmaceutical companies to investigate the possible interaction between dosage and the components of the primary closure and transfer system,” said Keith Scott, commercial manager, pharmaceutical solutions at Smithers Rapra. “Companies must have reliable methods of product testing and quality control in place - from the initial design, material choice, product testing and the understanding of regulations. More and more, our technical consultants are being asked to formulate testing strategies for drug delivery devices such as pMDI, DPI and nasal spray devices, as well as elastomeric closures for containers (stoppers, plungers etc) for injectables, to address regulatory requirements from the EMEA and FDA.

The two-day conference will feature an expert speaker panel with case studies from world-class companies, such as Boehringer Ingelheim Inc., Pfizer Inc., GlaxoSmithKline, Novo Nordisk, Novartis Pharmaceuticals and AstraZeneca as well as regulatory updates from the MHRA, Health Canada and the FDA.

Extractables are defined are “compounds that can be extracted from elastomeric, plastic compounds or coatings of the container and closure systems when in the presence of appropriate solvents under vigorous conditions”. Leachables are defined as “compounds that leach from elastomeric, plastic compounds or coatings of the container and closure system as a result of direct contact with the formulation during the shelf-life of the product”.

As specialists in polymers and polymer products utilised in the pharmaceutical industry Smithers Rapra offers a complete analysis service on leachables and extractables that exist in various delivery systems. For example: DPI’s, pMDI’s, nebulizers, elastomeric closures, stents and topical creams.