Hi, September here already and time for another blog post. This one is a little bit special as last week I celebrated the one-year anniversary of the creation of Maven E&L Ltd. (cue the cake and candle!)
And what a year it’s been since my first blog post and setting up shop for the 1st time with Maven E&L. I’d like to thank all my clients for making it possible to reach this first milestone year.
When I sat down in 2019 and thought about what I wanted to achieve with Maven E&L I of course did not have a global pandemic in my business plan.
So this year I have spent a lot more time in front of my computer screen than planned and a less time travelling than I’d imagined. That said, I still found myself chatting and presenting on my favourite topic of extractables and leachables (E&L) and speaking with lots of interesting people
As we move from Summer into Autumn, there is still plenty to discuss. Please join me at the E&L Forum and bring your questions and comments. The list of topics to discuss continues to grow, what been on my mind this month is Knowledge Management. Over the summer I have started re-reading Isaac Asimov Foundation series, the stories revolve around a mathematician who creates a statistical approach to predict the future of large populations and started a encyclopedia to ensure knowledge wouldn't be lost when the empire fell.
It’s link to real world science is the concept of uncertainty and I’d like to link it here with risk. I have presented on several occasions on the topic of risk assessment and I truly believe risk management is key to this topic area.
The study of extractable and leachables is very much linked to the uncertainty we have in predicting whether leachables will be present in our drug products and will they affect safety or quality, but in many ways this is a problem with a solution. The certainty we have is more or less related to the lack of knowledge we have about the system under study. There will be elements perhaps that remain uncertain but there are many things which can and should be known.
For example, when a company creates a new drug product or changes an existing one there are choices to be made on the selection of packaging and manufacturing materials. If those choices are knowingly made with leachables in mind then certainty is removed (Quality by Design) and less likely that you get a nasty surprise if you test.
Also whilst we are talking about testing, identification of unknowns (extractables or leachables) can be one of the biggest concerns. How do we avoid this?
Start collecting and storing your knowledge thoughtfully and very soon you will find connections and understanding which would have been impossible without that curated database you were uncertain was worth the time and money to setup. There really are so many reasons to create and curate your knowledge management system for E&L. Here a few to leave you with but there are many more
Tracking source of extractables to materials
Spectral matching (moving beyond the NIST library)
Creation of risk assessment failure modes for common manufacturing materials
Recording Material test results for re-use in other projects
Well I hope you have been enjoying these Blog entries on E&L and I hope to be around for at least my 2nd Anniversary with Maven E&L unless the universe has another plan for 2021. Speak to you soon.