A new water management strategy for the pharmaceutical industry.

Our relationships with water are set to change significantly under the effects of environmental, regulatory and economic constraints. In this context, the new water efficiency strategy, with its main focus on actions targeting causes rather than simply dealing with consequences, will improve our industrial and environmental performance in terms of water use, the aim being to consume less, produce better and waste less. This article presents the main concepts and a few case histories demonstrating the application of this strategy.

1. Context and challenges
1.1 An inevitable water transition
Water usages were developed in a context in which water was perceived to be inexhaustible, unchangeable and practically free, something which is obviously not the case. Quite the contrary, in fact. Water use is set to become increasingly restricted and expensive, due to climate change and climate-related events, population growth and increased urbanization and widespread pollution. On a global level, this will lead to a water transition, in the same way as we are witnessing an energy transition.

According to the MacKinsey report(1) , by 2030, in the absence of any change in our water use, the available supply will only cover 60% of requirements. Overcoming this challenge will require a substantial effort, particularly since this a global figure: the gap to be closed on a local level (geographic and/or seasonal) will be even greater. Moreover; if the expected shortfall reaches 40% in 2030, this means that it has actually already begun. This inevitable transition will not only affect zones already prone to drought; it will have an impact throughout the world. For example, the French Senate’s report entitled “Eau, urgence declaree” (“Water, emergency declared”), published in May 2016(2) clearly reveals the challenges facing France.
Hence our relationship with water will need to change to take into account this new reality.

 

1.2 The real cost of water in industry: direct and indirect costs (figure 2)
Where industry is concerned, another factor will contribute to the change in this relationship: its cost. Today, water is wrongly considered to be inexpensive because its cost is generally only perceived via the direct “visible” costs, i.e. its costs as a commodity (e.g. €/m3 consumed; taxes and fees associated with waste volumes and quality).

This vision is very partial.
As a thermal fluid and utility (to transport, wash, rinse, dissolve, etc.), or as a solvent or ingredient, water is involved in almost every industrial operation. When calculating its overall cost it is therefore necessary to take into account all the investments (installations, networks, sensors, pumps, etc.) and operating costs (energy, reagents, tests, payroll, etc.) required for water usages, to supply standardized water for production processes in a plant and to manage the waste water it produces.
Usually, the data exist but are not linked to water (e.g. the electricity consumption of a water treatment station is accounted for under energy expenditure, whereas it is actually a water-related cost). But they should be: using processes that are economical in terms of their water use and/or “clean” not only brings down water bills, but also direct costs. The lever really is water.
To these direct costs need to be added the indirect costs, i.e. not the costs of the water itself, but costs due to water. These may include, for instance, productivity losses (e.g. reduced production or stoppage related to water), non-quality costs (e.g. finished product nonconformities due to poor quality control of water used as an ingredient or washing water), reduced performance levels (e.g. 1 mm of limescale can cause an 82% reduction in the efficiency of heat transmission(3) or reduced installation lifetime (e.g. a new process leads to more acidic waste, which will corrode networks not initially designed to handle it).

Assessments performed on concrete cases show that the direct “visible” cost (a few €/m3)may be multiplied by a factor of 5 or 10. This multiple will obviously depend on the industrial sector, the plant size, its water usages, etc.

 

1.3 Specific characteristics of the pharmaceutical industry
The pharmaceutical industry, like all sectors producing biological active substances, presents one significant specificity: the quality of its waste, due to the potential residual presence of active ingredients (from production or R&D activities), as well as their degradation byproducts.
These substances have effects on living organisms at very low concentrations: that is their purpose. Consequently, the criteria conventionally used to assess industrial waste quality are not at all representative of the potential biological effects. The pollutant load measured using these indicators (e.g. COD) may be quantitatively nil but nonetheless have a very high biological activity, or vice versa.
Furthermore it is very difficult to assess their potential toxic effects on species and ecosystems because these are as diverse and varied as the medicinal products themselves. In addition, their impacts may develop in the short, medium or even long term (e.g. endocrine disruptor effects, genotoxicity, etc.), further complicating the assessment. To make things even more difficult, even if the biological effects of certain isolated substances are known, those of the final mixture remain difficult to predict and require specific assessment.

Over and above toxic effects, other unwanted effects may be induced, such as, for example, the development of antibiotic resistance, generated by constant antibiotic pressure(4) .

The quality of pharmaceutical waste therefore represents a complex challenge, which is nonetheless of crucial importance since it involves substantial risks(5).

 

 

2. A new water management strategy
2.1 Current situation
The current water management system is primarily based on water treatment: firstly, the production of standardized water (osmosed, demineralized, iced, etc.) from raw water upstream of the process and, secondly, the collection and treatment of wastewater downstream.
In a situation whereby water becomes scarcer and more expensive, this strategy may prove to be inappropriate since it is hinged around meeting needs without worrying about the relevance and efficiency of water usages. In other words, it acts on the consequences, paying very little heed to the causes. In the case of wastewater, this leads, in particular, to the addition of more and more processes, aimed at addressing each new regulatory requirement or new risk identified via a new treatment.
Furthermore, wastewater management currently consists in collecting, mixing then treating all a site’s liquid waste. The initial intention is sound: to prevent any pollutants leaving the site without being treated.
However, this can be counter-productive because by doing this, sometimes very different effluents are mixed together: clear water with aqueous phases loaded with solvent, detergents or active substances, etc. By way of comparison, nobody would now dream of mixing up different forms of solid waste, since this would make it practically impossible to treat or recycle it in selective waste collection systems. Yet that is what we do with water, leading to the over-sizing of treatment facilities and making dedicated strategies impossible.

 

2.2 A new water efficiency strategy
The objective of water efficiency is to improve all facets of water management, i.e. to reduce water consumption, use it more efficiently and reduce waste (in terms of volume, pollutant load and toxicity).
It is an economic intelligence approach, aimed, firstly, at reducing costs (direct and indirect), impacts and risks related to water and, secondly, improving the productivity of an industrial site.
This strategy consists in targeting root causes, i.e. water usages, in order to reduce consumption requirements and wastewater (in terms of quantity and/or quality) and hence avoid the need to produce or treat water needlessly. This strategy is structured around information rather than water treatment.

The first technical objective is to know and accurately monitor consumption and waste for each water usage. This can be done during targeted campaigns or continuously, via the installation of quantitative and qualitative measurement points (flowmetry, physicochemistry: pH, conductivity, temperature, etc.) and by taking samples to analyze parameters for which no sensors exist, either in the laboratory or using quick testing kits. The data collected will then be compared with events (industrial operations and incidents) having occurred during the observation period in order to allocate to each of them their specific signature in terms of consumption and waste.

The second technical objective is to use dynamic mapping of water flows and uses to identify and quantify points for improvement and risks, and then recommend organizational and/or technical solutions. Numerous actions at source can be envisaged and will depend on the context: modification of operating conditions, substitution, reuse, recycling, selective sorting, etc.
In addition to straightforward improvement plans, this fresh approach to the monitoring of water flows and usages paves the way for new, radically different water management strategies.

 

3. Application examples
The cases presented below are based on real cases, rendered anonymous and simplified. In addition to the technical objective presented, these studies were an opportunity to demonstrate other potential improvements or risks, which are not presented.

3.1 Reduction of pollutants at source by modification of operating conditions
Context: fine chemistry industry
Problem: systematic nonconformity for phenol, despite the fact that the plant does not use this substance and is not meant to produce it.
Study: 1/ Analysis of existing data (flow rate, physicochemistry, etc.), interview with personnel (production, maintenance, environment, etc.), technical inspections.
2/ Mapping of water flows and usages at 7 points over a 3-week period (continuous measurement: flowmetry and physicochemistry + “sample library” for testing in the lab: phenol, COD, etc.)
Conclusion: 80% of the phenol comes from the degradation of a reaction intermediate, produced at the start of the week and used over a 5-day period.
Corrective action at source: reduction of kinetics and degradation via modification of the storage duration and temperature of this intermediate substance.
Results: 40% reduction in phenol flow and return to complete conformity without any investment or treatment.
Other additional correctives actions implemented:56% reduction in nitrogen flow via the substitution of cleaning chemicals and return to conformity for the “color” parameter by selective waste sorting.

 

3.2 Reduction of toxicity at source via selective sorting
Context: pharmaceutical industry
Problem:high toxic potential of effluents, but absence of knowledge with respect to its precise origin.
Study: 1/ Analysis of existing data (flow rate, physicochemistry, etc.), interview with personnel (production, maintenance, environment, etc.), technical inspections.
2/ Mapping of water flows and usages at 5 points over a 1-week period (continuous measurement: flowmetry and physicochemistry + “sample library” for testing in the lab: toxicity)
Conclusion: most of the toxicity comes from the washing operations.
Additional study: study of cleaning operations and precise monitoring of toxic load elimination at each step (pre-wash, wash 1, wash 2, rinsing)
Conclusion: in contrast with what was assumed on the basis of conductivity measurements (profession standard), the most toxic phases are actually observed at the start of the wash 1 phase, not in the pre-wash effluents.
Corrective action: selective sorting of phases concerned and storage before removal by decanting.
Results: significant reduction in effluent toxicity without investing in treatment (and reduction in risks generally).

 

 

3.3 Optimization of the water treatment process
Context: agri-food industry
Problem: operational limit of water treatment facilities leading to a risk of reduced production.
Study: complete operational monitoring of facilities (12 parameters, acquisition frequency of every minute for 2 weeks) and correlation of filter regeneration process with the data measured.
Conclusion: programming of automated system control does not adequately take into account system inertias during the regeneration and cleaning phases.
Corrective actions: reprogramming of the automated system on the basis of the data measured.
Result : 60% reduction in the amount of water used by filter washing and reduction in regeneration time from 7 to 2 days: new production capacity without any investment.

 

4. Outlook
4.1 A widespread selective sorting strategy
Given the specific characteristics of the pharmaceutical industry and, in particular, the difficulty of correctly assessing the quality of its waste and the associated potential risks, it would appear to be more efficient – from an environmental, technical and economic point of view – to implement an advanced selective sorting strategy for wastewater, as early in the process as possible (ideally at the exit of the industrial operations concerned), in order to send the most problematic phases to dedicated waste streams (e.g. removal as liquid waste, with or without prior concentration at the site).
This will help to drastically reduce the risks associated with waste, but also the nature, dimensioning and hence costs (investment, operation and taxes) of plant water treatment.

 

4.2 Connected plant and real-time calculations
The implementation of an advanced mass, real-time data flow collection and analysis system will make it possible to produce a dynamic map in order to identify points for improvement and risks. The long-term maintenance of this system (connected plant) enables real-time operational monitoring and analysis of performance in the context of continuous improvement. But it also makes it possible to accumulate data over time in order to compile long-term histories, which will then be available for consultation at any time in order to address each new issue or identify early signals of drifts/deviations or malfunction, thereby resulting in predictive maintenance, for instance: “data stored today is the raw material for tomorrow’s performance”.

Furthermore, it is now possible to conduct real-time analysis of process or system models in order to generate prediction or prescription functions. These models may be descriptive (based on physical laws, chemical or biological) and/or statistical (based on the analysis of long histories).

Complete solutions of this type, covering advanced, real-time mass data flow collection, formatting, transmission, centralization and analysis requirements are now easily accessible, adaptable to the needs of each site and utilizable by non specialists(6).

 

Conclusion

Physical and environmental constraints, the cost of water, risks related to waste quality; etc.: there is a significant industrial need to understand, reconsider and improve water usage, both in order to solve today’s problems and to effectively prepare for the future.

xperience on the ground reveals that a new strategy based on the continuous diagnosis of water flows and usages, enabling actions at source (prevent rather than cure) can be particularly effective, both economically and environmentally speaking.

n the case of the pharmaceutical industry, the necessarily strict regulatory framework for activities may limit the options for actions at source. Facilitating changes to marketing authorizations or process validation dossiers in the event of improvements in water usage performance would be an avenue to explore (as long as these changes have no impact on the manufacturing process, obviously, but for example, just cleaning operations).

But what is really slowing down the roll-out of this type of strategy is quite simply the necessary transformation in our vision of an industrial site’s water cycle and a change of practices.

And, whatever the field or sector concerned, we know that change is one of the things that people find the most difficult to implement.

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Jean-Emmanuel GILBERT & Stéphane GILBERT – AQUASSAY

jem.gilbert@aquassay.com

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Sources

[1] http://www.mckinsey.com/business-functions/sustainability-and-resource-productivity/our-insights/charting-our-water-future
[2] https://wsenat.fr/notice-rapport/2015/r15-616-notice.html
[3] https://wbatirama.com/article/14813-vendre-une-chaudiere-ne-suffit-pas.html
[4] cf CDAGOT
[5] example : “Adverse effects in wild fish living downstream from pharmaceutical manufacture discharges” Environment International,Volume 37, Issue 8, November 2011, Pages 1342-1348
[6] edatamotic.com et http://aquassay.com/ewe-cest-quoi/