#ACHEMA2024: The place to be for latest bio-process technologies update.

Two weeks ago, I was attending #ACHEMA 2024 in Frankfurt (10 to 14 June), the world's biggest Forum of Process Industries, along with my teammates from Fluor Corporation Project Development Studio (PDS): Didier BAKOUR, Alexandre Mercier and Jakub Wróbel. We had the pleasure of engaging in discussions with more than 40 different suppliers and shared our views and thoughts about our mutual expectations.

#ACHEMA 2024 is a forum organized each 2 to 3 years, reuniting manufacturers and service providers from over 50 countries presenting their products for chemical, pharmaceutical and biotech research and manufacturing as well as energy and environmental services. This forum is the driving force and groundbreaker for the international process industries and their suppliers.

Fluor Corporation operates around the world in more than 100 countries for more than 100 years. We collaborate with client counterparts to design complex projects that may include engineering, procurement, fabrication, construction, maintenance and project management (EPCM). From the earliest stages of project design, we involve the construction and commissioning teams to provide capital cost and schedule efficiency.

Projects Development Studio (PDS) is our worldwide experts team designated to work on concept designs, FEED (front end engineering and design), value engineering and technology consultations for our clients around the world.

As we are engaged with our clients to deliver best-in-class facility and process designs, #ACHEMA 2024 was a great opportunity for Fluor Corporation and PDS to have a concentrated update of the latest groundbreaking technologies proposed by the finest manufacturers and service providers around the world and to reinforce our relationship with them.

Following are some of the highlights of #ACHEMA 2024 edition:

1.???? Latest version of EU GMP ANNEX 1 has been seriously considered as a priority by aseptic equipment manufacturers, and various types of innovative technologies are already on the market. Some are adapted for clinical scale manufacturing, and others are already available for commercial scale manufacturing.

2.???? Actual geopolitical context is definitely impacting supply chains and extending delays of procurement. Some suppliers proposed some standardized solutions or transferred back to Europe/US their subcontracted/outsourced activities, but still, as soon as there is some customization in projects, delays tend to dramatically increase, impacting schedules and eventually time to market.

3.???? Digitalization is here. Digital twins are already being deployed. Questions are: will they be continually maintained/updated by clients in routine operations? It depends on how important this is for each client.

4.???? Extensive representation of Asian suppliers at #ACHEMA 2024. The technological gap with European/US suppliers is being closed.

5.???? Suppliers are already responding to EU Hydrogen Strategy (COM/2020/301) and RePowerEU plan (COM/2020/299) by proposing various hydrogen energy options.

On a personal standing point, here are my thoughts and take-aways:

1.???? Continuous improvement in facility and process design:

As facility and process designers involved in major projects around the world, it is important for us to loop the loop and get the bigger picture: Did the designs and the technologies that we propose in our projects work as expected in operations? What can be challenged in each project in the selection of the various technologies available on the market (most appropriate options for each project case)? How could we better integrate each technology? How can we better design facilities and processes including those technologies?

Continuous technical discussions and alignments with process/equipment suppliers and clients are the best way to address those questions and rise to the challenge. This is why #ACHEMA 2024 has been an important rendezvous for us.

This comes in continuity of the effort engaged by 福陆 for a couple of years now, and for which we have been recently rewarded by having one of our recent designs recognized as the 2023 ISPE Facility of the Year (https://ispe.org/facility-year-awards/winners/2023/pharma-4). But this only underscores our responsibility to continue this effort and deliver a design of the highest quality for every project.

2.???? Sustainability as a driving force

Sustainability has become a driver in almost every project, impacting design and technologies. Suppliers are working on it by proposing more energy-efficient technologies. We are, too. At #ACHEMA 2024, we had the opportunity to share with our suppliers the design drivers of Fluor Corporation. One of the examples was the reduction of classified area surface and fostering isolator technologies relying on grade C or D background rather than traditional filling operations A/B. This relies on the assumption that heating, ventilation and air conditioning (HVAC) is one of the most energy-consuming sources on-site (more than 20%).

3.???? Aligning with EU GMP Annex 1

As process and facilities designers working for clients around the world, we centralize their feedback about better applying the latest EU GMP Annex 1. This annex focuses not only on equipment; it goes beyond by encouraging an integrated facility/process/equipment design based on risk assessment and contamination control strategy (CCS). We have to be aligned with our suppliers to better respond to this annex and deliver more compliant facilities and processes. This was one of the topics that we shared with aseptic equipment suppliers that we've met at #ACHEMA 2024. We clarified that we've set the following objectives for ourselves: Reduce human intervention, rely more on isolator technologies, rely more on smart automated solutions like magnetic shuttles or robotic arms to reduce particles generating actions (container movements, microbial monitoring and sampling, format changeover, loading/unloading), and reduce the interfaces between aseptic process steps (freeze dryers, fillers, crimpers, etc.). Encourage machine designs that allow dirty interventions out of classified area.

4.???? Time to market

As facility and process designers and as an EPCM, we have a significant impact on time to market. This topic has become not only a business priority but also a sanitary priority. The example of COVID-19 and the urgent need for massive quantities of vaccines back in 2020 was just one example. But guess what, there are still plenty of diseases as deadly as COVID-19, with millions of patients around the world waiting for a miracle. We need to rise up to our responsibilities and work together with our suppliers to tackle time to market and consider it a priority. We've done it before with COVID-19, and we can do it again for the rest.

In conclusion, as facility and process designers, we are the ones holding the keys to a multivariate equation whose variables are productivity, product quality, sustainability, cost, and schedule. Solving this equation relies only on a close relationship with suppliers and clients. It also relies on leveraging our experience from past and ongoing projects in the most efficient way. This is what we've been discussing at #ACHEMA 2024 with our suppliers, and we will continue our discussions after it. We need each other to help our clients solve that equation.

We would like to thank every supplier that we've had the pleasure of engaging with at this edition of #ACHEMA 2024. The self-challenging and continuous improvement spirit of most of them deserves to be saluted. We will gladly continue to be close to them, as much as we are with our clients.

Houssam Benyettou, PharmD