Current extractable and leachable requirements for infusion systems discussed

15 November 2011

In light of the recent introduction of the draft 510K guideline for infusion pumps by the FDA, the direction for extractable and leachable activities for infusion systems will be discussed at Pira's Extractables and Leachables (E&L) 2011 conference

During the opening of last year's E&L conference, the co-chairs, Dr Carsten Worsoe, Research Scientist at Novo Nordisk, and Thomas Egert, Chemical Characterisation, Drug Delivery Department at Boehringer Ingelheim Pharma, revealed their thoughts on the progression of extractable and leachable related areas in the future. Two areas predicted as being of high E&L interest were PODPs (Parenteral and Ophthalmic Drug Products) and administrations systems.

With the "Safety Assessment Triad" for PODPs introduced by the PQRI (Product Quality Research Institute) group, the term simulated study was initiated in order to close the gap between extractables and leachables. Presentations featuring simulated studies for both parenterals and ophthalmic will be one of the main topics at this year's E&L conference. Following the introduction of the draft 510K guideline for infusion pumps by the FDA, describing E&L activities both for pump suppliers and pharmaceutical companies applying drugs for pump use, a direction for E&L activities for infusion systems has also been given.

In addition to discussing this key topic, the conference will also deal with several other E&L related areas such as SUS (Single Use Systems), supply chain challenges, innovation of materials based on E&L knowledge, the role of CRO laboratories and actual E&L strategies for pharmaceutical companies including several case studies as well as health authority expectations.

Pira International's 5th annual Extractables and Leachables conference is due to take place on 7-8 December 2011 in Rome, Italy and will be chaired by industry experts Dr Carsten Worsoe of Novo Nordisk and Thomas Egert of Boehringer Ingelheim Pharma.

Dr Carsten Worsoe expressed the following in anticipation of the event: "I feel that depth in the coverage of E&L areas is one of the strengths of this conference and that the conference applies directly to people that are both new to the E&L area as well as to people with high experience."

Dr Carsten Worsoe will be co-chairing E&L 2011, as well as presenting on E&L's from administration systems from parenterals.

Find out more on his presentation and other topics being discussed at E&L 2011 from the full agenda.

View further details on all speakers at E&L 2011 here.