Every day I’m reminded that there is no slam dunk in business. Everything is hard work and perseverance. Even apparently simple things are fraught with complications and layers of nuance.  The great appeal of gambling that some find so convincing is that complexity and vexing details have been somehow suspended and a path is clear for the slam dunk. Slam dunks do happen I suppose, but over time the slams outnumber the dunks.

In chemical manufacturing, there are no trivial operations. Every step in the manufacturing sequence requires thought and infrastructure. Even fillling drums with water and shipping it out has complications-  quality control, portion control, container quality, inventory control, purchasing, pallets and dunnage, quality control overhead.  Then there is the matter of receiving & shipping, accounts payable and receivable, auditing, taxes, sales and marketing, and all of the other overhead that goes with operating an above-the-board business operation.  Then there is the matter of managing a staff and all of the HR delights that go along with that.

Now imagine if you were manufacturing hazardous or controlled substances. Suddenly, your staff are partitioned into those who work with hazardous materials and those who do not. Those who do need a steady supply of personal protective equipment (PPE) as well as lots of documented training programs to operate in hazardous environments. They’ll need physical exams, coats, gloves, boots, eye protection, and respirators with annual training. A smart employer will have the piss wagon come by now and then looking for drug use.

Let’s say that you want to replace a process solvent. You want to replace ether with toluene. In order to do this, you’ll have to validate the process in R&D for scale up. The process change will have to go through some kind of stage gate process to validate the benefit of the change and the approval of all customers. Some process changes must be approved by the customer. Woe is he who wants to make such a change in the cGMP or military chemicals world.  Developing a perpetual motion machine may be easier.

Process changes will alter the material streams in your facility. This may trigger PSM protocols that will have to play out on its own schedule. Or it may trigger environmental permits or LVE limits under TSCA.

Process changes may also alter the quality or safety margins that you have previously been relying on, but didn’t know it. This often occurs when a company tries to intensify a process. Suddenly the process is generating more watts per kg of reaction mass than before. Or all of a sudden the reaction mass doesn’t filter well or the pot residence time during distillation is deleterious at the higher concentration or with the higher boiling composition. All changes have a down side. These are some of them.  There is no slam dunk.