Circularity and life cycle assessment are foundational pillars of sustainability within the pharmaceutical industry, essential for minimizing our environmental impact. This holistic approach demands a thorough examination of every stage in the life cycle of goods and materials, from raw material extraction to disposal or recycling. By embracing circularity, we aim to optimize resource use, reduce waste, and mitigate our footprint on the planet.

To effectively implement circularity principles, we must first understand the intricate web of manufacturing processes and their environmental repercussions. This includes considering inbound and outbound materials and goods, as well as solid, liquid, and gaseous effluents. Auxiliary services and functions, such as those within the supply chain and quality controls, also play a crucial role in the circularity equation.

Given the complexity of assessing environmental impacts across the entire life cycle, leveraging software tools becomes invaluable. These tools enable us to analyze a vast array of data relevant to materials and goods, facilitating informed decision-making and optimization.

In the pharmaceutical realm, circularity manifests in various domains:

• Material Selection: Beginning from the design phase, prioritize reusable or recyclable materials and those sourced from renewable energy. Packaging materials, notorious for their environmental impact, should be predominantly recyclable.
• Facility Design Practices: Optimize facility design to maximize reuse and recycling. This includes strategies like steam condensate reuse and closed loops for heat exchange, alongside minimizing leaks and harnessing local resources like well water.
• Operational and Maintenance Practices: Implement robust waste sorting mechanisms and preventive maintenance programs to prolong the life of equipment and reduce material losses. Operator training is essential for maximizing efficiency during manufacturing processes.
• Enhanced Manufacturing Process Knowledge: Utilize technologies like Process Analytical Technology to refine manufacturing processes and optimize resource use.

A significant environmental burden within pharmaceutical facilities stems from solid, liquid, and gaseous effluents. It is imperative to treat these in accordance with local regulations and adopt practices that minimize their impact. Solid waste should be recyclable wherever feasible, with exceptions for special waste requiring specific treatment. Incineration technologies can convert solid waste into a source of thermal energy, while liquid effluents should undergo purification before disposal. Gaseous emissions must be subjected to adequate treatment before release into the atmosphere, with air recirculation encouraged where compliant with regulations.

Furthermore, a comprehensive life cycle assessment should account for the decommissioning phase, aiming to minimize contamination through careful material selection during the design phase.

Achieving circularity demands interdisciplinary collaboration and expertise, promising substantial reductions in our environmental footprint over the mid- to long-term. Embracing these principles not only safeguards our planet but also ensures the sustainability of our operations in the pharmaceutical industry.

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Energy efficiency first is a guiding principle widely used in EU policies concerning environment and sustainability as its application may contemporary guarantee lower primary energy consumption, less energy distribution losses, reduced operational costs and decarbonization.

First, it is worth underlining what energy efficiency means. According to the EN ISO 50001:2018, energy efficiency may be defined as the ratio between an output (of performance or energy, etc.) and an input of energy. Then, the efficiency can be increased by reducing the input, increasing the output, or applying a combination of the two.

Such a concept is clear when related to machines as the energy efficiency coincides (more or less) with the engine efficiency. The latter determines the difference between input and output values.

Regarding manufacturing plants, the complexity of achieving energy efficiency increases. This is because both personnel behaviors and equipment operations can impact the plant’s energy efficiency and often, the energy consumption is not accurately aligned with actual needs.

Such an aspect may be due to insufficient metering and control systems, and consequently, operations cannot instantaneously follow energy use requirements. Moreover, manually controlled activities are hardly reproducible, and the related consumption is usually not computed. Another cause may be the oversizing of plants, machinery, and user requirements.

It should be noted that in the case of energy production systems powered by fossil fuels, increased energy efficiency promotes a reduction in CO2 emissions into the atmosphere.

From theory to practice, we report the strategy adopted to improve the energy efficiency in a green-field project related to a sterile drugs facility.

Three main measures were applied: the building envelope insulation improvement, the hot water production through a heat recovery chiller and the supply air flow rate in classified areas.

In detail, the first measure regards the building envelope insulation enhancement. The local regulation reports minimum requirements for thermal transmittance in new or renovated buildings, but they are not mandatory for manufacturing plants. However, such values are used as references in the design. This choice leads to a decrease in yearly consumption of 3% for electricity and 12% for natural gas.

The second energy efficiency improvement measure regards the heat recovery from a chiller to generate hot water feeding HVAC systems instead of installing a dedicated natural gas boiler. The benefit of this design choice is a relevant decrease in natural gas consumption, i.e.: -54% yearly. On the other hand, the heat recovery from the chiller entails a 7% increase in electricity consumption. Even if the two effects are opposed, the overall benefit is clear in terms of energy saving and, in this case, even decarbonization.

Finally, supply air flow rate decrease in classified areas is shown. This measure is composed of two different ones: the reduction during the manufacturing operations (in-operation periods) and the further attenuation in the at-rest periods.

In detail, during the design, the generally adopted method of imposing predetermined values of Air Change per Hour (ACH), based on experience and empirical considerations, is replaced by accurate calculations of required supply air flow rates and ventilation effectiveness for each area. The latter are evaluated through computational fluid dynamics (CFD) analyses for the most complex spaces and configurations.

Then, the air flow rate reduction and attenuation result as a consequence of the adopted method and do not implicate any safety or GMP risk. Such a measure determines multiple benefits: it entails not only the decrease of ventilation energy but also the reduction of energy consumption for cooling and heating since the treated air volume lowers. The energy saving per year due to this design choice accounts for 8% of the overall electricity consumption.

In summary, the reported energy efficiency improvement measures lead to a remarkable reduction in natural gas consumption and an additional decrease in used electricity. As a result, the overall saving of 32% of the annual energy consumption is obtained.

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