Ahead of the annual Extractables & Leachables Europe conference in Dublin this November, we spoke to Alicja Sobantka, Expert for Material Qualification at Octapharma, to get her view on why E&L testing is so important.
You’re looking at the different extractables and leachables studies of peroxide-cured silicon tubing and six different types of Pt-cured tubing, your presentation will go into more detail but can you share some initial findings?
In our processes we want to use optimal tubing. This translates into requirements such as cost-effectiveness, mechanical stability, chemical resistance and low interaction with our products, i.e. we want to expect the lowest possible amount of leachables in our drug products since different leachables can affect the activity and the efficacy of the active pharmaceutical ingredient (API). We find that under similar conditions Pt-cured silicone tubing leach lower amounts of chemical compounds compared to peroxide-cured ones. Pt-cured silicone tubing should therefore be used in pharmaceutical production instead of peroxide-cured silicone tubing, especially in process steps that contain living cells and in high risk process steps, where a further reduction of leachables cannot be expected.
Why is it critical to consider the material quality in respect to the patients’ health?
Different chemical compounds can leach from plastic materials and end up in the drug product that will then be administered to the patients. It therefore must be guaranteed that the patients would not be exposed to chemical compounds that might have an impact on their health.
Why do you think research in this area is so important?
Please note that as a pharmaceutical manufacturer we do not conduct any research on extractables / leachables. Due to missing data from the suppliers we feel compelled to conduct our own E&L studies to guarantee the chemical safety of the materials used. However, we see that despite a lot of progress in the domain of E&L testing, there are still some uncertainties left: for example i) what model solvents to chose to simulate the extraction force of the respective drug product? ii) which and how many analytical methods to apply for screening of extractables? iii) How to deal with unknowns?
Why do you think E&L testing in this area is so important?
In my opinion, E&L testing - under representative process conditions - is essential to get an idea of the types and the amounts of chemical compounds that might leach from plastic materials when in contact with solutions whose extraction force mimics that of the contemplable process media. Only then are we able to perform a sound chemical safety assessment of the respective plastic materials with regard to administration of our drug products.
Where do you think your research will take you next in terms of next steps for this project?
Again, please note that as a pharmaceutical manufacturer we do not conduct any research on extractables / leachables. We always aim at identifying optimal (including safe) plastic materials for our production.
What are you most looking forward to by attending and speaking at E&L Europe 2016 in Dublin in November?
We are really quite excited to hear and to meet the different experts in the field of E&L. We are also looking forward to sharing our own findings and experiences.
Alicja Sobantka is responsible for material qualification at corporate level, she performs extractables and leachables assessments including the planning and supervision of extractables and leachables studies. She will be presenting on 'Peroxide- vs. platinum-cured silicone tubing in pharmaceutical production' as part of the 'Single-Use/Bioprocessing and BPOG' session on Conference Day Two, Thursday 10 November.
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