Not long ago I had the opportunity to engage in some discussions around printers in clean rooms, and encountered an individual who asserted with all the confidence of the righteous that USP <797> did not permit paper, much less printers, in clean rooms. The interesting thing is that you cannot find any place in the chapter that says that, or even infers it.
As it happened, I was sitting next to Eric Kastango at the time who, and I thought he was going to explode. (He didn't; he's better than that).
It turns out that Jim Wagner and Eric Kastango have done some work that demonstrates that the removal of a syringe from its paper container by "popping" it out as people often do creates over 8,000 particle per pop. By comparison, a review Eric did of a syringe-filling device that places a thermal printer
inside its ISO Class 5 environment produced fewer than 10 particles. So it is likely that supposedly "legal" activities in a clean room (such as removing a syringe from its packaging) will produce substantially greater numbers of particles than any modern printer (nobody uses dot-matrix printers any more, do they?).
So what really bothers me is what I have come to call the "checklist" mentality, the tendency to substitute a checklist for rational thought. As long as the checklist items are checked, everything is ok, no matter how far one had to stretch to check off the items on the list.
I currently teach in a USP <797> course and I see this all the time. In fact, when Jim Wagner teaches his portion on air flow and air quality management, he spends a lot of time demonstrating with smoke the need to carefully evaluate the work area so you always know you are working in first air, and understand where your first air areas actually are. In other words, you have to understand your work area, you can't just check off that you are in a hood, and therefore anything you do is fine.
It's a kind of intellectual shortcut that reduces understanding and knowledge to a set of checkmarks on a list. I see it as a form of intellectual laziness that somehow avoids real understanding of the issue, and any real accountability for a decision. The checklist represents the decision, and the checker needs think no further.
Please understand that I think checklists are great when they do what they are intended to do, which is to remind the checker of all the things they need to think about and make certain that all necessary tasks and obligations have been met.
But when checklists become substitutes for thought and understanding, when people oversimplify professional concerns to a set of line-items that may or may not actually achieve their goal, then they are not checklists.
The issue is not new. The gospel of Matthew (Matt 23:23-24) records:
23Woe unto you, scribes and Pharisees, hypocrites! for ye pay tithe of mint and anise and cummin, and have omitted the weightier matters of the law, judgment, mercy, and faith: these ought ye to have done, and not to leave the other undone.
24Ye blind guides, which strain at a gnat, and swallow a camel.
It has always been easier to reduce things to an incomplete set of rules than to operate from a perspective of understanding.
But we are professionals; we are the people who are supposed to study, and know, and understand, and perform based on that understanding. So before we proclaim with absolute certainty that something is true, let us first be certain of our information, and be informed of its context, and know the science behind our assertions. Let us avoid the temptation to reduce a complex scientific matter to a set of simplistic rules. Let us instead investigate matters like the scientists we are (or should be) and let the data inform our conclusions.