Work Word Definitions

I know I use work words all the time like changeover and shutdown and I have never really told you what these words mean. So today feels like a good day to explain them (possibly because I have nothing more interesting to write about). To begin with you have to understand where I work and what we do here. I am a process engineer at a biotech manufacturing site. Generally we make process improvements (through new equipment, procedures, parts etc) to the way we make our drugs. Now my company has several drugs that we make at this plant (there are others that are made at other sites), 3 to be specific, all of which are produced using mammalian cell culture (we use CHO cells here). This process for all biotech involves a series of increasing sized bioreactors, followed by a purification train (including operations such as chromatography). Okay so what is a changeover? Since we make 3 different drugs, one at a time (for a set number of batches determined by the corporate supply chain) there comes a time when we must change over from one drug to another drug. Tricky huh? So the way that works here (and it will be different for different sites and different companies) is we need a 4 day window in each piece of equipment from the last operation from product 1 until the first operation of product 2. Us engineers like to use those 4 days to squeeze in mechanical changes to the equipment. That is what we are doing right now. Now a shutdown is pretty similar, it generally occurs between products, it again involves downtime in equipment. The main difference being the length of the shutdown is more driven by the work that needs to get done during it (both project work by groups like mine, maintenance work, revalidation work etc), and often run up to 30 days. Now keep in mind that both of these are rolling operations, so it can take months for them to roll from the smallest bioreactors to the final purification operations.

Did I do a good job explaining that?