As you saw from my First Post Maven E&L is up and running. You will have to excuse a few mistakes here and there as this is the first Blog Series I have written.
The aim will be to share some advice and interesting things as to why I am passionate about the topic of extractables and leachable and have spend over twenty years in this area. I hope to make this semi-regular so check the website for updates.
I'm just back from speaking the Qepler conference, held in Berlin 15-16th October. Those nice Qepler people took plenty of pictures (I don't pose well!) and I have to say it was an excellent E&L conference. There aren't too many conferences just for E&L so I wish them well and look forward to the next one.
Among the topics discussed were;
Current work on USP <665>
A number of talks of E&L Safety Assessment (more on that in a minute)
A couple of talks on extractable study design from CROs
Talks from suppliers on what extractables you might expect to see (Elastomers, Plastics and Glass)
and talks covering technical risk assessment (from me), data integrity and errors in analytical identification
As you can see a wide range of topics all very relevant to Extractables and Leachable topic area.
Although there were three separate safety assessment talks (each over 30mins in length) each had something different to say and cover a different area and illustrated how the lack of a unified guidance leads to differences in approach and experiences with regulators. The proposals for Ophthalmic thresholds were particularly interesting.
My presentation covered risk assessment which is a specialty of mine. I believe this topic area is an exercise in quality risk management. If we have complete knowledge and understanding the risk from leachables is invariably low. We shouldn't rush into expansive (and expensive) studies before we understand what the studies are going to achieve to remove or reduce the risks we have either from our container closure or manufacturing systems
Well hope you enjoy this brief blog entry. As I said at the beginning I hope to write a semi-regular one. Let me know what topics you would like to see covered. I have a few ideas. The next one is going to cover - Extractables Studies - How many many kinds are there.
If you want discuss any E&L topic further contact me Jason.Creasey@MavenEandL.com