Italian
The Critical Medicines Act aims to strengthen the production of essential medicines in the European Union. Deerns Italy: “Compliance, sustainability, and cost control must be integrated from the early stages of design.”
Europe aims to bring back a greater production capacity of essential medicines to its territory, but building new facilities may not be enough. The real challenge will be to create structures that can quickly become operational, meet regulatory requirements, and maintain high levels of efficiency throughout their lifecycle.
This is one of the objectives of the Critical Medicines Act, the regulation through which the European Union aims to strengthen the domestic production of critical medicines and their active ingredients. A necessity that has emerged strongly during the crises of recent years, which have highlighted the vulnerability of pharmaceutical supply chains in the face of health emergencies, geopolitical tensions, logistical disruptions, and sudden increases in demand.
Antibiotics, insulin, analgesics, oncological drugs, and other essential products for healthcare systems cannot depend on excessively concentrated supply chains or those that are difficult to convert quickly.
On flexibility, efficiency, sustainability, and compliance of facilities, aimed at reducing time-to-market, focuses Deerns Italia, an international engineering and consulting company specialized in the design of high-tech environments, including pharmaceutical and biotechnology plants.
“It is not enough to build or expand a facility. It is essential to design from the early stages a production capacity that is compliant, flexible, and ready to evolve over time, fundamental requirements to reduce time-to-market, but also to reconcile operational continuity, sustainability, and cost control,” says Cosimo Verteramo, Division Director Life Science & Electronics at Deerns.
Pharmaceutical facilities between technical complexity and investments
Life Sciences facilities are among the most complex industrial buildings to design and construct. Cleanrooms, process plants, HVAC systems for air treatment, utility distribution networks, contamination control, and qualification and validation requirements contribute to particularly high initial investments.
This complexity is compounded by an increasingly difficult financial context. The rise in energy prices, materials, and raw materials, along with geopolitical uncertainty and growing international competition, is prompting pharmaceutical and biotechnology companies to carefully assess every capital investment.
The reduction of CAPEX, that is, the costs incurred to build, expand, or modernize a facility, cannot, however, be achieved simply by cutting components or reducing the performance of the plants. In a regulated sector directly linked to people’s health, every choice must ensure quality, product safety, and production continuity.
The goal, according to Deerns, is to ensure that every euro invested produces actual operational, regulatory, and commercial value.
The Hidden Cost of Traditional Design
For many years, the design of pharmaceutical facilities has followed strongly conservative criteria. To reduce the risk of issues during regulatory inspections and validation phases, it has often been chosen to increase safety margins through oversized plants, high redundancies, air changes exceeding actual needs, and more restrictive environmental classifications.
This approach, defined as over-design, arises from the need to contain project and regulatory risks, but it can generate costs that will accompany the structure throughout its entire life cycle.
An HVAC system that is larger than necessary, for example, not only incurs a higher initial cost but also leads to increased energy consumption, a greater number of components, higher maintenance requirements, and more complex operational management. The same applies to redundancies and technical solutions introduced in a generalized manner, without a detailed risk analysis and an understanding of actual production needs.
These costs are compounded by those arising from fragmented design. When engineering, quality, microbiology, and validation intervene at different times, potential incompatibilities can emerge when the project is already in an advanced stage or the facility is under construction. The consequences can be redesigns, late modifications, delays in commissioning and qualification, increased costs, and postponement of production start-up.
At a time when Europe needs to rapidly increase its production capacity, these delays represent a problem that goes beyond the individual business case. A completed facility that is not yet validated, or unable to adapt to changes in demand, does not contribute effectively to the availability of medicines.
“The hidden cost of traditional design does not always emerge in the initial estimate,” notes Verteramo. “It manifests during construction, in qualification, in energy consumption, and in maintenance, or in the time lost before being able to start production. In this sector, a delay is not just an extra cost for the company: it can reduce the system’s ability to respond promptly to the demand for drugs.”
Quality by Design: compliance enters the project
One of the fundamental tools for controlling costs and obtaining a facility ready for validation is the principle of Quality by Design.
In the traditional model, the project is often developed by prioritizing engineering and construction aspects, while quality, contamination control strategy, and validation requirements only take center stage in a later phase. This separation can lead to inefficiencies: a technically valid choice may indeed prove incompatible with microbiological needs, operational flows, or the qualification pathway of the facility.
Quality by Design turns this logic on its head. Quality objectives and validation requirements are incorporated into the concept from the very beginning, becoming an essential element of the design.
Engineers, microbiologists, quality specialists, and production process managers must therefore work together to define layouts, flows, environment classifications, HVAC strategies, and contamination control measures.
The benefits concern the entire project: lower risk of redesigns, fewer changes during qualification and validation, greater alignment among workgroups, and more predictability in delivery times and production start-up.
“Compliance cannot be an added control at the end of the design process,” Verteramo continues. “It must become one of the starting points. Integrating engineering, quality, microbiology, and contamination control from the early stages allows for identifying critical issues sooner and choosing solutions that are simultaneously compliant, efficient, and feasible.”
Digital technologies to predict before building
This change is also supported by digital technologies. Advanced monitoring systems, IoT sensors, Digital Twin applications, and data-driven control strategies allow for a more precise understanding of plant behavior and performance evaluation.
The digital model can be used during the design phase to compare different configurations, analyze consumption, verify the response of systems, and identify any critical issues before construction.
Once the plant is operational, the collected data allows for monitoring environmental conditions, identifying anomalies, and adapting the operation of the systems to actual production needs.
The goal is not to replace the judgment of specialists, but to provide them with more solid information to make decisions and reduce the reliance on generic safety margins. Artificial intelligence can also progressively contribute to performance analysis, identifying inefficiencies, and predictive management of plants, as long as these solutions are introduced in a controlled manner and fully compatible with the regulatory framework.
Smart Compliance and Sustainability
Another fundamental aspect concerns the relationship between compliance and sustainability. Life Sciences facilities, particularly those equipped with cleanrooms, can have very high energy consumption. Air treatment systems must control temperature, humidity, pressure, filtration, and the number of air changes, often without interruption.
For a long time, reducing consumption has been seen as potentially incompatible with security and compliance. According to Deerns, the two needs can instead reinforce each other through a vision of Smart Compliance & Sustainability.
Intelligent environmental control systems, optimized strategies for cleanrooms, dynamic management of HVAC systems, and advanced monitoring technologies allow for intervention on consumption while maintaining the necessary conditions for production.
Reducing water usage, lowering the operating temperatures of fluids, recovering energy, and minimizing waste can also generate direct economic benefits, in addition to improving the environmental performance of the facility.
“The key is to achieve these benefits through an integrated vision, without compromising regulatory compliance,” says Verteramo. “Sustainability and compliance should not be seen as two opposing goals. When solutions are designed and validated correctly, reducing consumption and waste can also enhance the reliability and economic sustainability of the facility.”
The biggest challenge is cultural
The main obstacle to the adoption of innovative solutions may not be technological, but cultural. Pharmaceutical companies operate within a very strict regulatory framework, and any perceived risk regarding compliance is understandably approached with caution.
The change must therefore proceed gradually, through solutions capable of concretely demonstrating their benefits and fully maintaining the required standards.
Today, these solutions can be virtually simulated through “digital twins” that replicate the facility, allowing for the verification of their benefits at zero risk even in existing and operational plants.
“The European challenge is not simply to build more production capacity, but to create facilities that are truly usable, resilient, and ready to evolve. Every investment must generate value not only at the time of inauguration but throughout the entire lifecycle of the facility,” concludes Cosimo Verteramo.
