A Bone of Contention

Did you hear about the guy who went in for a hip replacement and the surgeon swapped out all 206 of his bones just to be on the safe side? Me neither, because that would never happen. Right? Then why does it happen every day in the bioprocessing industry?

In our industry, a single process can contain hundreds or even thousands of components working in harmony to manufacture a pharmaceutical product. But, although they work together, these components should not be treated as a set. In order to avoid excessive maintenance, it is important to follow these three simple rules: 1) know the process; 2) think like an individual component; and 3) apply sound risk management when establishing maintenance cycles.

When you understand the process, you are better able to look for trouble in the right place and not waste time focusing on the majority of the areas where the risk is low. Each and every component’s application range must be considered individually in order to determine its appropriate maintenance cycle. Just as in the practice of medicine, replacements and adjustments should always be made based on actual data. This helps reduce risk and cost at the same time because you are not opening up a system with a worst-case-scenario mindset; unnecessarily exposing it to contamination and replacing costly gaskets and diaphragms that are still able provide many more cycles of service life.

When the proverbial squeaky wheel is telling you something important, listen to it. But when the other wheels aren’t squeaking at all you need to hear that, too. If you think like each component, you will be less likely to treat them as if they are a set that needs to be changed out all at once; thus avoiding unintentional risk caused by exposing an entire system to change-outs which are only required in a small area. For example, a WFI pump outlet is always under much higher pressure than the rest of the system and has more extreme ups and downs (see chart). Gaskets and diaphragms located there naturally experience added wear and tear and thus the adjacent piping usually has more rouge. As a result, the pump requires more frequent maintenance cycles than the rest of the system. Similarly, in a Clean-in-Place (CIP) system, a valve may turn on and off ten times more often than every other valve in the process so it understandably needs more attention. This is also true for other parts like spray balls.

Understanding the cause of a failure can save headaches and dollars. A sound risk management approach uses testing to balance the real data collected before adjusting a maintenance cycle. Sometimes a component fails because it, alone, is operating outside of its design specifications. The point is to not overreact when failures happen. I know of a major player in the industry who changed their global policy on diaphragm replacement after a single diaphragm failure. In the desire by many to get to the root case, sometimes the kneejerk reaction is to design to the worst upset condition or the worst location. This response is even more stressful when it involves a nonconformance or CAPA. Avoid reacting too hastily and broad brushing implementation beyond specific areas of the process. Certainly, there are isolated cases when drastic measures are unavoidable, but, if you understand the process, think like each component, and apply sound risk management to address issues, global replacement will become the exception instead of the rule.

Every day at The BioProcess Institute we help clients navigate the maintenance cycles of their process lines by analyzing real data so that the process can be modified to treat each component or segment individually. We also analyze used components and failures and compare them to what we have already seen over the past 30 years of failure investigations and analyses.

Like the best physicians, our experience has shown us that asking the right question can lead to the root of the problem before drastic measures are taken. A surgeon would never open up a patient in a hundred different locations to look for problems and make replacements at each incision. The doctor would first perform tests followed by thoughtful analysis of the resultant data. They call it a “surgical strike” for a reason. The same goes for maintenance of a process: perform testing, analyze the data, and only then come up with a strategy.

At The BioProcess Institute, process is literally our middle name and we will work our fingers to the bone on your process issues.

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