Process Safety is always related to high-hazard industries. Can we say that in pharmaceuticals the importance of Process Safety is underestimated? What aspects of Process Safety should be prioritised by pharmaceutical companies?
To answer this question, we have to start by making the distinction between the Fine Chemicals Pharma facilities and the Finishing Pharma facilities.
In the Fine Chemicals the Active Pharmaceutical Ingredients (APIs), are made with batch-reactors and small continuous reactors. Here we have different Process Safety risks: chemical reactions, incompatibilities, high/low temperatures, high pressures, gasses, vapours and dusts. Most of these facilities are also Seveso high tier. I would say that Process Safety is very much alive in these “small molecule” facilities, from development up to full scale reactors.
In the Finishing Pharma facilities the APIs are dosed in the right amount into the final drug application (syrup, cream, pill, syringe, patch etc.). So, most of the Process Safety risks are related to “Dust”. In these facilities there is still a lot of work to do in order to understand the dust explosion hazards and acting upon. Also, do not underestimate the fact that an ethanol/water mixture, often used for decontamination and disinfection, is a flammable liquid.
There is a tendency to keep using the same methods of risk assessment. But of course, if you use the same method every time, you will end up with the same results. How can this challenge be overcome?
What we saw in the “continuous improvement” of risk analyses in the Process Industry, is that, indeed, we stayed often with the traditional methodologies: HAZID, HAZOP and SWIFT.
Because they are still suitable for the job! However, it’s clear that these methods also grew over the past decennia. What has changed is the level of detail of documentation in all the different aspects of risk analyses. Deviations, scenarios and safeguards are written in a clearer way. Consequently, risk analyses can be read by everyone with some knowledge of the installation. This is necessary with the fast changing work force we have and the overload of Process Information we cope with.
In addition, the evaluation of the risks evolved within risk matrices contributed to much more detail and distinction in “Likelihood” as well as “Severity”. For the real catastrophic scenarios we look further in detail into the safeguards we have: are they reliable, effective and independent enough? The Layers of Protection Analyses (LOPA) is an extra feature there.
Conclusion: we still call it HAZID, HAZOP and SWIFT, but it’s not what it used to be in the past. It keeps on evolving and has extra features.
What difficulties can be faced when adapting risk analyses to an extensive batch production portfolio?
The ideal risk analyses take into account the total. It means the complete installation and the specific chemicals that are applied in the process as well as the different parameters like temperature, pressure, flow rates, and so on. Consequently, when you have a batch production with about 100 reactor-systems and about 250 different chemical processes … you do the math!
What you need is a lean way to assess your process equipment for its intended use and foreseeable deviations. Besides that, you need a specific way to analyse your chemical/physical processes and analyse if the process fits into the equipment you intend to use for it. This means you need a kind of a gatekeeper to make the connection between both risk assessments.
The HAZOP offers thorough and comprehensive identification of hazard scenarios. That is what can be achieved in theory. In practice, it takes a lot of time and effort. How can the HAZOP be approached to bring the desired result in a shorter time?
If you are talking about a “known” installation or technology, there is a possibility that a thorough preparation by a few people will gain time for the whole HAZOP team. However, there are pitfalls to this approach. The whole team still needs to fully think through every scenario and evaluate if any scenario is missing.
If you are talking about a new kind of installation, a shorter exercise will probably get you into trouble as of the commissioning phase.
So, in general there is no “shorter” HAZOP possible, only a better prepared one.
The modern world turns upon technology innovations. How has the technology progress contributed to risk assessment?
Technology helped in the way that documenting risk analyses is easier. There are software tools that you can edit to the requirements for your own Company. Integration of own Risk Evaluation Matrix, automated links to LOPA-template, necessary information to startup the Mechanical Integrity, and so on and so forth. Also, the necessary Process Safety Information during the Risk Assessment is only a click away.
But I do want to emphasise that knowledge around the table at the time of the Risk Assessment stays key! No matter how good the IT-conditions are.
What would you like to achieve by attending the 2nd Edition Process Safety Excellence conference?
Most of the time, you see that companies with a Process Safety Program struggle with the same issues at the same time. Possibly we “infect” each other working on the same Process Safety topics. This means that I’m looking forward to benchmarking on Management Of Change. I’m curious about the presented approaches towards Mechanical Integrity: Asset Management and Reliability. And last but not least: are the traditional risk analyses techniques still the “best available” for Process Safety scenarios?