"Standardisation framework for Extractable and Leachable (E&L) testing and documentation for container closure systems, devices, single use bioprocessing equipment and elemental impurities were some of the hot topics of this year's E&L Europe 2013 conference.
For container closure systems and devices Dennis Jenke, Baxter Health Care, outlined the USP draft documents <661> "Plastic Packaging System and their Materials of Construction", <1663> "Assessment of Extractables Associated with Pharmaceutical Packaging and Delivery Systems" and <1664> "Assessment of Leachables Associated with Pharmaceutical Packaging and Delivery Systems" documents.
Two interest groups, being the BioProcess Equipment (BPE) and the BioPhorum Operations Group (BPOG), both presented their process for suggesting a standardised extractable test to be used by suppliers of bioprocessing equipment in order to supply the pharmaceutical customer with a valuable selection tool and to facilitate the leachable testing and documentation.
Finally the USP <232> "Elemental Impurities - Limits" including the changes in procedure and limit for the different elements, was presented by Mike Murphy, Intertek.
Other highlights included a number of cases of leachables observed in different drug products and the elucidation of sources and toxicological evaluations of the leachables. In both the toxicology presentations given by Reinhard Stidl, Baxter Innovations and Pete Watts, Bibra, the progress of the ICH M7 process for genotoxic impurities was presented leading to an opening for using the staged approach also for marketed drug products. The staged approach implies that higher acceptance criteria could be set for leachables in drug products that are used for a short period of time compared to drug products that are used for a long period of time. Also the therapeutic benefit perspective was discussed and set into the perspectives of leachables.
With an attendance of over 120 pharmaceutical experts, Carsten Worsoe at NovoNordisk, one of the conference co-chairs, commented that E&L Europe is unique in the way it brings the industry within material suppliers, pharmaceutical companies, contract laboratories and more together to discuss materials, supply chain perspectives, analytical chemistry, toxicology and regulatory approaches with respect to extractables and leachables.
The 2013 programme also addressed the importance of understanding which kind of information is valuable adding at a given step in the E&L chain from material supplier to pharmaceutical company. This issue was the topic of a joint presentation between the material supplier Promens who had developed a COC container closure material for use in the pharmaceutical area not knowing the end user requirements, a contract lab Smithers Rapra which developed an extractable program of the COC material together with Promens and performed the extractable testing and finally a pharmaceutical company who used the extractable information for performing the needed leachable testing and documentation.
Great feedback was received and this shall be used to help develop the 2014 Extractables and Leachables programme, the E&L team hopes to see you there! Remember if you cannot wait until December 2014, then join us this May for Extractables and Leachables US being held in Silver Spring, MD.