IN SHORT
How should radiopharma facilities handle conflicts between product protection, radiation protection and time pressure?
The strongest solution is to design out avoidable conflicts before an operator has to choose under pressure. Good radiopharma design anticipates abnormal interventions as well as normal operation.
What this means in practice
Use URS, Design Qualification and risk assessment to test shielding, visibility, access, remote intervention, automation and recovery scenarios while changes are still practical and affordable.
Strategic consultancy & operational designA few weeks ago, my daughter came home with a question from her studies: the classic trolley problem. A train is out of control. If you do nothing, it continues on its track and five people die. You can switch it onto another track, but then one person dies instead.
It is one of those thought experiments that sounds almost simple until you really start discussing it. We did. Dr. Wolfgang Pitsch and I started looking at how different legal and ethical approaches deal with questions such as lesser harm, active intervention, proportionality and the difference between competing interests. Somewhere during that conversation, I realised why the question felt strangely familiar.
Where radiopharma creates competing risks
Radiopharmacy has its own versions of the switch.
We protect the patient, the product and the employee. We protect against contamination and against radiation exposure. Most of the time, these objectives reinforce each other. Sometimes they do not.
Imagine an intervention inside equipment containing radioactive material. Acting quickly may protect the process or product, but increase radiation exposure to the operator. Waiting may reduce occupational exposure, but increase the risk to the batch, the equipment or ultimately the patient waiting for the dose. Suddenly there is a decision to make. Which risk matters more? What is acceptable? Who decides? And in radiopharmacy, where short-lived isotopes do not politely wait while we debate, that decision may have to be made very quickly.
The better question is why someone has to pull the lever
This is where professional judgement matters enormously. But the longer I thought about the trolley problem, the less interested I became in the question of which track we should choose. I became much more interested in another question:
Why would we design a system in which someone eventually has to stand at that switch at all?
Could better shielding change the situation? Could the operator have better visibility? Could the intervention be performed remotely? Could automation remove the exposure altogether? Could maintenance access be designed differently? Could the abnormal situation already be anticipated during the URS, DQ or risk assessment? Could the intervention strategy be defined before somebody has to invent one early in the morning while everyone around them is reminding them that the patient is waiting?
That last sentence probably feels familiar to many people who have worked in radiopharmacy.
Not because we routinely face dramatic life-or-death choices. We do not. But many of us have experienced much smaller versions of the same tension: two legitimate objectives pulling in different directions, limited time, incomplete information and a decision that suddenly feels much more significant because a patient is waiting at the end of the process.
Those moments stay with you.
They also teach you things that are difficult to learn from drawings, specifications or procedures alone. You learn where access really matters, where visibility is insufficient, where an intervention becomes awkward, where the theoretical recovery strategy does not quite match reality, and where a seemingly minor design choice can make an already pressured situation unnecessarily difficult.
Design should learn from real interventions
That is one of the reasons I believe real-life radiopharmacy experience is so important during design.
The value of experience is not that experienced people have all the answers. It is that we have already encountered some of the questions.
Hopefully the less painful versions.
We have seen situations where somebody had to make a judgement that, with hindsight, might have been made easier by a different layout, better access, more information, another technical solution or simply by thinking about the abnormal situation earlier.
And there is something positive in that. We learned from those moments. We can bring that learning into the next project so that somebody else does not have to discover the same problem under pressure.
Professional judgement should not compensate for poor design
Not every conflict can be designed away. Real emergencies exist, unexpected things happen and experienced people will always need to assess imperfect information and make difficult decisions. That is exactly why I believe so strongly in professional judgement.
But professional judgement should not become our excuse for poor design.
There is a difference between asking a competent person to respond intelligently to an exceptional situation and repeatedly asking competent people to compensate for a system that was never properly designed for reality.
Perhaps that is where the trolley problem becomes particularly useful for radiopharma. The famous question is whether you would pull the lever. The system question is why we are making someone pull it at all.
Design the decisions people will face
When we design facilities, equipment and processes, we are not only designing walls, flows, shielding, classifications and specifications. We are also designing the decisions that people will have to make later. A design choice made quietly during a project may determine whether an operator years later faces a straightforward intervention or a conflict between two legitimate objectives.
A missing window, insufficient access, a maintenance point that can only be reached from the wrong side, a process that assumes somebody can intervene manually, an alarm that gives too little information or a recovery strategy that was never properly developed because normal operation looked fine on the drawing: all of these can appear relatively small during a project. They become much less small when someone has to make the decision they created.
So perhaps one of the questions we should ask more often during design is not simply whether something complies, or even whether it will work. We should also ask what difficult choices we are designing for the people who will eventually have to operate it, and whether we can remove some of those choices while they are still relatively cheap to remove.
Because the best decision under pressure may sometimes be the decision nobody ever has to make.
What am I missing?
Where in our radiopharmaceutical systems are we still expecting people to solve in seconds what we could have prevented during design?
#WhatAmIMissing #Radiopharma #FacilityDesign #GMP #RadiationProtection #OperationalExcellence


