Friday, January 31, 2014

What on Earth I Actually Do

Well I got a few emails from people asking me what it is that I actually do, beyond "engineer".  The short answer is, eh don't worry about it (this is the one I typically go with).  The long answer is a bit more complicated.

When you're running a plant, you don't want the operators to have to do everything because that leaves a lot of room for human error, so you automate everything.  You get some PLCs (programmable logic controllers) and toss them in there and have someone develop the logic to control your process.  I am that someone!  I develop the logic using the software seen above, and this is a picture I took of a hilariously complicated module so many of them are much simpler and have way less lines.  You can really program most anything here - get a valve to open for X amount of seconds once the pressure reaches a certain point, discharge a certain amount of ingredient into a big reactor once the temperature is high enough, even just keep the temperature within the right range based on the product you're trying to make.

What my boss is interested in working on is something that will revolutionize the pharmaceutical industry and how they manufacture.  Right now, pharmaceutical plants will make batches of product and choose three random samples per batch to test for quality - if all three pass, then the batch is considered good and goes out to the consumer.  The problem here is that if one sample fails, the entire batch must be thrown out and so they basically just wasted a bunch of time and ingredients.  Process Analytical Technology (PAT) allows the manufacturers to test and analyze their products online so that no bad batches are made.  Using statistics, the critical variables are determined and these are controlled to ensure that every batch comes out right.   

The hardest part of this is really developing a model to represent your process so you can determine the critical parameters and control them in a way that assures the same quality of product each time.  That's the FDA's big thing - product quality.  They don't want to let you just sell anything, they want to know it's good.  PAT allows that since no bad batches are made.  We are trying to get in on the ground floor of this and fortunately for me my boss is interested in having me work with him directly on these types of projects.  All the pharmaceutical companies know they need to start doing this, and they know what it is, but the problem is how to actually implement it so it meets FDA standards - that's what they don't know how to do (yet) and what I hope to help them figure out.

Also what I do is friggin paperwork.  The other thing about pharmaceutical manufacturers is that every single thing they do has to be documented so they can prove at a later date that they completed every single step in the manufacturing process to ensure that their products are reliably safe.  

As an example of the ridiculousness of this, something I spent a few weeks doing was installing Windows onto servers for a new process control system (tough work).  I had to take note of every single thing I did, every selection I made including changing the time zone, and then blow it all away.  I printed out my test spec I wrote based on everything I did and then I had to redo everything, this time signing off on everything and initial-and-dating every little thing.  I may have gotten carpal tunnel then, but I'm not sure.

Next time you pay a ton of money for a prescription, remember that the pharma company is using that to hire me to do all this tedious work like installing windows and signing off that I made the language "English".  Really makes you think.

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