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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?

Ahead of the 2nd Edition Process Safety Excellence conference, we spoke with Kris Ghoos, Principal Expert Prevention, at Johnson & Johnson, Belgium about process safety and the risk assessment strategies in relation to the pharmaceutical industry.

Practical Insights From:
  • Gert Van Bortel
    Vice President Emergency Response
    BASF, Germany
  • Jan-Petter Fossum
    SVP & Head of HSEQ
    Yara International, Norway
  • Sonia Pires
    Corporate Director HSE
    AkzoNobel, Netherlands
  • Ole Brinck
    Head of Electrical, Automation, Technical Safety and Compliance
    Maersk Drilling, Denmark
  • Pol Hoorelbeke
    Vice President Safety Management
    Total, France
  • Ewa Söderberg
    Global Safety Program Manager
    Sandvik, Sweden

About the conference:

By attending this marcus evans event, you will be able to discuss how to redesign your overall process safety strategy with the right management and technical initiatives. You will listen to practical case studies on how to ensure the compliance of the whole plant with legislation requirements and how to manage the aging infrastructure to achieve safety of your plant. You will participate in interactive discussions on how to focus on actionable KPIs and what risk assessment methods are worth implementing. The practical insights from the world leading companies will help you establish a thought-out approach and move towards Process Safety excellence.

2nd Edition Process Safety Excellence conference will take place from the 25th to 26th of January 2018 in Amsterdam, Netherlands.

Copyright © 2017 Marcus Evans. All rights reserved.

About the speakers:

Kris Ghoos graduated as a Chemical Engineer in 1995. After a short position in the R&D department of Procter and Gamble, Kris moved to Janssen Pharmaceutica, part of Johnson & Johnson. The first 3 years he was a Chemical Operator in the production department. This is a batch production facility with over 300 chemical processes (bromine-installation, Hydrogenation unit, Friedl-Craft and Grignard reactions, etc.). The next 2 years he was a Process Engineer, introducing new products in the plant and optimizing the older chemical processes. For the last 17 years, Kris is working on Process Safety for the largest Chemical Plant of Johnson & Johnson. He is part of the fire-fighting team on site and he is a certified Safety Advisor in Belgium. Kris is also part of the Worldwide Core Team for Process Safety Management for Johnson & Johnson and is a certified PSM-Lead auditor within J&J and for External Manufacturers.

Process Safety: Risk Assessment Strategies


An interview with Kris Ghoos from Johnson & Johnson

Key Practical Case Studies
  • BASF disclose the complete prevention chain
  • Saudi Aramco develop a new probabilistic model to assess pipeline failure modes and rates
  • Johnson&Jonhson reveal a “personalized” approach to HAZOP
  • Vattenfall implement process safety in the daily work
  • Total analyse what can be learnt from audits in the field
Kris Ghoos
Principal Expert Prevention
Johnson & Johnson
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