Misapplications, Misuse & Misunderstandings

Have you ever tried to assemble a gas grill, a toy on Christmas Eve, or anything from IKEA? If you have, you might understand how that kind of confusion, pressure and frustration can cause component failure in bioprocess lines.

Manufacturers do their best to provide users with what they consider to be the proper set of assembly instructions for their product(s).  But, whether those instructions are for a two-story doll house, a trundle bed, or a bioprocess component, at the end of the day, if the instructions are confusing, or if the end user misunderstands what they are supposed to do with the parts, failure is inevitable: the tiny doorbell won’t work, the trundle bed will fall off its track, and the process line will leak and allow bacteria in.

That’s not to say that manufacturers are the lone culprits. End users can be to blame as well. For example, last year I led a customized training course on bioprocess component use, assembly and installation at a nationally renowned pharmaceutical manufacturing facility. One of the technicians in that class brought with him a set of instructions he downloaded from the internet on how to install one manufacturer’s components. That wasn’t a bad idea in and of itself. The problem was that the footer on the PDF that he brought was ©2004. That would be like using Ford’s blueprints for 1967 Mustang to assemble a 2017 Fusion Hybrid.

To complicate matters further, industry terminology can be confusing. What is the difference between percent compression and tightening torque? Can they be used interchangeably? Should they be? The answer to the last two is no, but that’s a discussion for another day. Likewise, in bioprocessing, we are dealing with components whose material has specific limitations, through no fault of their own. Misapplying these components can lead to failure just as surely as misusing them can. Do instructions always tell us this? Hairdryer tags warn us against showering with them because some bozo did and that. Should diaphragm valves have tags warning about the possibility of PTFE fraying. Probably. But how is one to know that this is a possibility without testing first?

The best solution to prevent misunderstanding and misuse of components is to test and verify, or consult an expert to do it for you. This goes for manufacturers and end users. If we do not understand the product and the individual parts inside and out, we are setting ourselves up for failure; failure that can be inconvenient at best and expensive, in terms of dollars and lives, at worst.

How many gas grills do you think the average person assembles in their lifetime? None, if they are smart, but in reality maybe one. Does that make them an expert? Probably not. But the employee at the hardware store, whose only job is to assemble gas grills every single day all summer long, might earn the title expert if he or she does it well, because they become intimately familiar with the product and the most effective and efficient steps in the assembly process.

At The BioProcess Institute, we test, we train, and we educate every day, all day long.

First, the performance and exposure testing we do brings us in tune with all types and manufacturers of components. We assemble, expose, disassemble and analyze bioprocess components constantly. We take manufacturers’ advice into consideration, but we don’t rely on it completely. If we find a more effective way to tighten their diaphragm valves, we tell them. If we believe, through meticulous testing and analysis, that their tightening torque recommendations are off, we tell them that, too. And we tell the client who entrusted us to find out.

Secondly, we train based on our testing and consulting experiences and this is what sets us apart from everyone else. In a nutshell, when something goes wrong, they call us. Time after time we answer the call; when something breaks, when there’s a deviation, for CAPAs, etc. Once we right the ship, we use each individual experience as weapon in our arsenal to help prevent similar occurrences in the future for other clients. But we don’t just educate like a pamphlet or video tries to. We train to instill proficiency. We’ve done the work and, by passing the fruits of that experience along, you reap the benefits.

We are completely devoted to helping our industry make better, safer drugs. Our consulting experience has led us to become the industry leader and we pass that expertise along to you. So leave the grill assembly to the guy at the hardware store and save yourself some grief. And leave the testing, training and education on bioprocess components to The BioProcess institute for the same reason.