Following recurring episodes of drought that have intensified in recent years (79 departments reached a level of drought crisis severity in 2022), France is implementing a WATER action plan in March 2023 comprising 53 priority measures for resilient and coordinated water management.

This March 2023 WATER plan aims to structure and organize water use for all stakeholders in the region (agricultural, industrial, and domestic) with a target of reducing water withdrawal by 10% by 2030.

Measure No. 15 is undoubtedly one of the most important and ambitious, as it opens up the possibility of reusing non-potable water: “Regulatory barriers to the use of non-conventional water (water that is not potable) will be lifted in both the agri-food industry and other industrial sectors, while respecting the protection of human health and ecosystems .“

This was followed on June 30, 2023, by the publication of a ”drought” decree relating to restriction measures during periods of drought applicable to ICPEs (Installations Classées pour la Protection de l’Environnement, or Classified Installations for Environmental Protection), such as pharmaceutical sites – ICPE category 3450.

1. Drought decree

The drought decree (ministerial decree of June 30, 2023, amended by the Decree of July 3, 2024) defines restrictions on water withdrawal and consumption at industrial sites where water withdrawal exceeds 10,000 m³/year.

These withdrawal restrictions depend on the severity of the drought, as well as the terms and conditions for exemptions for certain facilities.

1.1 Drought severity levels

The volumes withdrawn must be reduced according to the severity of the drought affecting water resources:

This reduction in water withdrawal must be implemented within three days of the date on which the drought severity level is triggered (Article 2-III of the decree).

1.2 Concept of the reference volume VRef

The reference volume Vref to which the reduction in withdrawal must be applied corresponds to the average daily water withdrawal of an establishment (or its daily consumption). The method of calculation is described in Article 2-II of this decree.

1.3 Exemptions

The following are not subject to this decree:

1) Facilities necessary for the “production of medicines of major therapeutic interest and their active ingredients, or medicines contributing to a public health policy defined by the Minister of Health.”

2) Operators of establishments that have reduced their water withdrawal by at least 20% since January 1, 2018.

3) Operators of establishments that use at least 20% reused water in relation to their water withdrawal, subject to compliance with the health and environmental requirements in force.

The triggering of one of the drought alert levels, by reducing the amount of water available to an industrial site, can have a major impact on the production of medicines.

It is essential for a site to anticipate the possible occurrence of such situations by putting in place a drought plan to adapt and reorganize its consumption, adjust its schedules, and even temporarily reduce its activity.

This constraint raises questions about the real cost of water for manufacturers: beyond the listed price, the value of water increases significantly when a water shortage threatens the ability to complete production. This dynamic, which can be represented in a simplified way in an educational model, leads to the notion of the missing cubic meter of water, an essential concept for understanding the economic and operational challenges associated with drought restrictions.

1.4 The notion of the “cost of the missing cubic meter of water”: a critical indicator with disproportionate economic value.

In the context of drought restrictions, the missing cubic meter of water refers to the volume of water essential for continuing industrial activity. This is not an “optional” or “comfort” cubic meter, but one whose absence directly jeopardizes the continuity of production at a pharmaceutical site.

The economic value of this cubic meter then becomes very high (see Figure 1). A drought restriction, sometimes triggered quickly and unpredictably, can deprive the site of a few essential cubic meters and lead to a partial or total shutdown of activity, with major financial consequences: production losses, critical delays, and impacts on the supply of medicines. It is this disproportion between the real price of water and the industrial impact of not having access to it that defines the (astronomical) cost of each cubic meter of water that is missing.

This reality requires manufacturers to be highly proactive: they must have reliable measurement systems, understand precisely all uses of water, and sustainably reduce non-essential consumption in order to remain above these critical thresholds.

Faced with a regulatory constraint that could be triggered at any time, water efficiency or even water sobriety are not just an environmental option but are becoming a sine qua non condition for preserving business continuity and limiting exposure to the extremely high cost of each missing cubic meter of water.

2. Mapping water usage

To effectively implement a water conservation program, it is essential to have a precise understanding of all water flows on the site, in terms of both volume and quality. This first fundamental step involves creating a comprehensive map of all water usage within the site.

The water used in the pharmaceutical industry (whether drinking water, technical process water, or water for pharmaceutical use) serves a wide variety of purposes, from supporting utilities to manufacturing drugs and cleaning in place. This diversity means that each flow must be characterized: understanding what volumes are consumed, where they are used, what treatments they require, and what qualities they have.

The following categories can be distinguished:

– Domestic and sanitary uses

(cold water and hot water)

Supplies toilets, showers, changing rooms, kitchens, and drinking water networks dedicated to staff needs.

– Fire safety uses

Drinking water is also used to supply fire reserves and sprinkler systems. These volumes are generally only consumed in the event of an incident or periodic testing.

– Outdoor uses

Some facilities use drinking water to water plants or green spaces when no alternative (river water, rainwater) is available.

However, most consumption comes from process water, which is divided into two categories:

– Technical process water

Essential to the site’s technical infrastructure, this water is used as a heat or cooling vector. It enables industrial utilities to function (cooling towers, chilled water production, steam boiler supply, air conditioning, cooling circuits, softened water for pre-washing equipment).

– Water for pharmaceutical use

This is regulated water produced from drinking water. It includes purified water (PE.0008) and water for injectable preparations (PE.0169) used in the manufacture of active ingredients or as an excipient in formulations, and in cleaning and sterilization cycles in place (CIP/SIP). See Figure 2.

To visualize water consumption flows, the use of the “Sankey diagram” tool (see Figure 3) makes it possible to highlight the main flows in a complex system and thus prioritize actions to optimize these flows.

Detailed knowledge of these different categories of water, from their origin to their end use, makes it possible to identify flows that can be reduced at source, optimized, treated for recycling for the same use, or reallocated to a less demanding use.

Detailed knowledge of these different categories of water, from their origin to their end use, makes it possible to identify flows that can be reduced at source, optimized, treated for recycling for the same use, or reallocated to a less demanding use.

By combining this detailed understanding of uses with an approach to controlling volumes and qualities, sites can build an ambitious water conservation strategy while ensuring continuity of pharmaceutical production.

3. Water efficiency

Once all water flows on the site have been characterized and the major uses identified, the question arises as to what levers can be used to reduce consumption while maintaining continuity of production. Detailed knowledge of water volumes and qualities paves the way for a structured approach, ranging from reducing losses to transforming the process.

Several levels of action can be considered, from the most immediate to the most challenging.

– Improve water efficiency: eliminate leaks and avoidable losses.

This step, which should be carried out as a priority, consists of eliminating all consumption that should not exist: leaks, excessive purging, and suboptimal operating practices.

At a pharmaceutical site, these losses can represent tens of percent of total consumption when the networks are old or poorly instrumented. Implementing leak detection campaigns, checking drains, performing preventive maintenance on networks, and installing measurement points can immediately reduce consumption without impacting production. This “water efficiency” approach is often the simplest to implement and the most cost-effective, as it eliminates volumes consumed without adding value.

– Optimizing consumption: acting on existing processes

Once losses have been reduced, the challenge is to optimize legitimate uses. This involves adjusting operating parameters, reducing the volumes used per cycle, limiting historical oversizing, and better managing utilities. In the pharmaceutical industry, this particularly concerns cleaning cycles (CIP/SIP), pharmaceutical water generation equipment, cooling towers, chillers, and steam systems. Reviewing washing frequencies, adjusting rinsing times, improving reverse osmosis yields, and reducing tower purges can generate significant savings. This optimization phase requires a good understanding of the process and close dialogue between the production, quality, and maintenance/technical teams.

– Internal recycling: reusing water for the same or a similar purpose

Once consumption has been optimized, the next step is to recover the water already used in the process. Many flows can be recovered, filtered, or treated for reinjection into a similar use: rinse water reused in a washing cycle, steam condensate reused in boiler feed, or partial recycling of cooling tower water or chilled water. These actions reduce drinking water demand and improve the overall efficiency of the site. Internal recycling is often easier to implement than external reuse because it remains within the site perimeter and for controlled uses.

– Reuse after treatment (REUT)

REUT (REUSE in English) is the reuse of treated wastewater from industrial or urban effluents for compatible non-critical uses: cooling tower feed, watering, outdoor cleaning, depending on the quality of the water obtained.

When internal water savings are insufficient or have been fully exploited, the use of REUT becomes a relevant objective in order to avoid being subject to drought restrictions: Pharmaceutical sites that use at least 20% reused water in relation to their water withdrawal (reference volume VRef) are eligible for exemption from drought regulations.

The recycling of this non-conventional water is regulated by legislation. Since the 2023 Water Plan, numerous decrees have been published to specify the conditions for using this water. (See Bibliography).

– Rethinking the process: a final but crucial step.

When all of the above levers have been exploited and the site remains exposed to the risk of a shortage of cubic meters of water, it becomes necessary to consider more profound changes to the process. This may include modifying certain production stages, adopting less water-intensive technologies, redesigning cleaning cycles, centralizing certain equipment, or integrating innovative treatment units. This step, which requires greater human and financial resources, aims to structurally reduce the site’s water consumption. It often represents the tipping point between short-term adaptation and true water resilience.

4. Opportunities & feedback from industrial experience

The implementation of a water efficiency strategy is based on concrete, tested, and documented actions.

The available feedback shows that structured approaches can significantly reduce water consumption, sometimes gradually, sometimes through more ambitious transformations. These results demonstrate that, even within a demanding regulatory framework, there is room for maneuver.

To illustrate this approach, the following two cases provide concrete examples of actions taken over a decade to reduce water consumption (Examples 1 and 2).

These examples show the savings potential that an industrial site can achieve by taking a structured approach. Actions such as eliminating leaks through better instrumentation, optimizing cleaning cycles (CIP/SIP) by adjusting rinsing steps, improving reverse osmosis yields, and reducing cooling tower blowdowns all have in common that they directly affect consumption volumes while preserving the integrity of the process.

These approaches can be structured using recognized standards, such as ISO 46001 – Water Efficiency Management Systems. This methodological framework offers a step-by-step approach to analyzing flows, setting targets, implementing actions, and monitoring water performance. Although not specific to the pharmaceutical industry, this standard provides a solid basis for organizing a consistent, reproducible water strategy that is aligned with continuous improvement practices.

Example 1.

Reduction in annual raw water consumption over 10 years at a French site. In the case presented, the main measures taken to achieve this reduction are:

• Repair of leaks
• Liquid ring vacuum pump + chilled water exchanger to reuse water for savings (equipment with water lost to closed circuit)
• Open cooling tower to adiabatic tower (TAR)

N.B.: shutdown of a building in 2015 explaining the 2015/2016 differential

Example 2.

Reduction in annual raw water consumption over 10 years at a French site. In the case presented, the main measures taken to achieve this reduction are:

• Repair of leaks
• Replacement of the water-waste vacuum pump
• Reduction in pipette washing water consumption
• Removal of water-waste air conditioning systems
• 50% reduction in dryer discharge
• Optimization of the water production unit (EPU, EPPI)
• Internal communication on good “water conservation” habits

Conclusion

Although the measures presented—reducing losses, optimizing consumption, recycling, and reuse—may currently be perceived as proactive actions, they are likely only the first steps in a much more profound transformation.

Climate projections confirm that droughts will become more frequent, longer, and more severe in the coming decades.

In this context, it is essential to embark on a structured approach to water conservation now.

Not only to meet current legislative constraints related to the restrictions set out in the drought decree, but also to prepare for a future in which water resources could become one of the main factors limiting pharmaceutical production.

It is not unrealistic to imagine that, within ten years, some sites will face restrictions that could permanently disrupt manufacturing capacity. Water management is strategic for the long-term sustainability of the pharmaceutical industry in France.

Anticipating, acting, and structuring our approach today is therefore no longer an option: it is a necessary condition for ensuring the long-term resilience of pharmaceutical sites in the face of a rapidly changing water environment.

This article is part of the work carried out by the A3P “Energy Performance” GIC, and more specifically within the WATER sub-group. The objective of the GIC is to establish a practical guide of recommendations on reducing the environmental footprint of drug production sites.

This first article by the WATER subgroup on the impact and opportunities of the drought decree will be followed by a presentation of the working group’s recommendations for improved water performance.

Bibliography

• Decree of September 8, 2025, on the conditions for the production and use of treated wastewater for urban cleaning and amending the decree of December 14, 2023, on the conditions for the production and use of treated wastewater for watering green spaces and the decree of December 18, 2023, on the conditions for the production and use of treated wastewater for crop irrigation.
• Decree of March 14, 2025, on the use of water unfit for human consumption for domestic purposes within facilities classified for environmental protection.
• Decree No. 2025-239 of March 14, 2025, relating to the use of water unfit for human consumption for domestic purposes within facilities classified for environmental protection and basic nuclear facilities, and amending the provisions relating to the use of treated wastewater and rainwater for non-domestic purposes
• Decree No. 2024-796 of July 12, 2024, on the use of water unfit for human consumption
• Order of July 8, 2024, on water reused for the preparation, processing, and preservation in food sector businesses of all foodstuffs and goods intended for human consumption
• Order of July 3, 2024 amending the order of June 30, 2023 relating to restrictive measures, during periods of drought, concerning water abstraction and water consumption by facilities classified for environmental protection
• Decree of December 14, 2023 on the conditions for the production and use of treated wastewater for watering green spaces
• Decree No. 2023-835 of August 29, 2023, on the uses and conditions of use of rainwater and treated wastewater
• Decree of June 30, 2023, on restrictive measures during periods of drought concerning water abstraction and consumption by facilities classified for environmental protection.