EU Ecodesign Directive: is it time for a change in pharmaceutical facility regulations

Compliance with the EU Ecodesign Directive is driving pharmaceutical manufacturing facilities’ energy consumption up, not down as intended. With a review of the regulations currently underway, Jim Heemer and Hugh Reynolds of Jacobs explain the background to this anomaly, its impact on energy optimisation – and what can be done about it.

About the regulations

The EU Ecodesign Directive was introduced in 2009 with the objective of reducing carbon emissions by 20% by 2020, compared to 2005 levels. Although not prescriptive, the Directive is the basis for a raft of EU regulations which affect equipment accounting for more than 40% of energy use across the EU. The regulations seek to optimise energy consumption in everything from lightbulbs to pumps and boilers, including heating, ventilation and air conditioning (HVAC) systems.

In the pharmaceutical context, HVAC systems are critical to maintaining the required temperature and humidity in manufacturing areas. With HVAC systems representing one of the major energy consumers in a pharmaceutical plant, understanding barriers and enablers to maximize the operational efficiency of these systems is a key route to reducing both operating costs and environmental impacts.

Against this backdrop, ensuring that the regulations governing HVAC systems within pharmaceutical plants are fit for purpose is in everyone’s best interest and will represent a positive step forward for the sector.

Unintended consequences

Regulation 1253/2014 for ventilation units was introduced in 2014 and became effective in 2016. This regulation applies to the majority of air-handling units (AHUs) used in industry and includes the requirement that AHUs include a heat recovery system. For a pharmaceutical facility, however, there are certain applications where a heat recovery system is not appropriate – for example, in clean rooms. The regulation as drafted therefore poses a design challenge for facilities and can in some cases, increase the energy consumption of the installation, increasing associated costs and emissions.

Unique considerations in pharmaceutical facility design

Every heat recovery system unit is equipped with a heat exchanger which transfers heat contained in contaminated exhaust air to a fresh air supply. However, many pharmaceutical facilities use an airside economiser to cool a pharmaceutical utility and sometimes also a clean space. This device is not considered a heat recovery system, but generates free cooling in colder weather, by mixing fresh air with return air.

In many cases (though not all), this makes an economiser more efficient and cost-effective than a heat exchanger. However, the current regulations demand that even when an economiser is in place, a heat recovery system must also be provided.

If heating is required, this can make sense, but since heat recovery is not needed for pharmaceutical clean rooms, the regulations effectively add an unwanted, unneeded drain on energy within pharmaceutical manufacturing - without achieving any substantive benefit.

So assuming outdoor airflows are in the normal range (below 30%), the average Ecodesign-compliant facility will generate a higher carbon footprint than a facility using airside economisers.

Fit for purpose?

The evidence shows that as currently drafted, the regulation is not fit for purpose within pharmaceutical facilities.

Jacobs assessed pharmaceutical manufacturing sites in Ireland, Greece, Finland and Switzerland for systems based on Ecodesign versus a standard (airside economiser). The findings were that the lower the heating demand the less effective the eco-design system was.  For example, in Greece systems with outside air makeup less than 46% standard design is more effective, this reduces to 27% in Ireland, 24% in Switzerland and 12% in Finland. Given that systems in pharmaceutical facilities will typically operate with outside air in the range 10% to 15% then standard design is a better option for a lot of applications.

Adopting the current regulations has led to additional bulk and expenditure. The cross-section of an AHU has increased by some 66% (necessitating larger plantrooms), while costs are up by approximately 28%, due to the need for increased engineering, additional equipment and more complex systems, controls and tests regimes. These systems also require additional care in design, installation, commissioning and maintenance costs, filter replacement and instrumentation calibration – while their complexity increases the risk of potential system failure.

Far from enabling its fundamental purpose - a lower carbon footprint – the regulation is in fact driving up emissions and costs in some applications.

An opportunity for change

A review study on the Ecodesign and Energy Regulations on Ventilation Units is now underway, giving the pharmaceutical industry the opportunity to address this anomaly within the current Directive. The review began in February 2019 and is expected to conclude in 2020. A number of stakeholders, including Jacobs, have raised the issue of the requirement for Heat Recovery when it is not warranted and it is under consideration as part of the study.

With more than 70 years’ experience delivering leading-edge biopharma facilities, Jacobs partners with leaders in life sciences to deliver sustainable operations. We are constantly striving to push the boundaries of innovation to drive sustainability and promote a complementary regulatory environment that drives down emissions and minimises carbon footprints.

The Ecodesign review creates a chance to provide evidence which will support a better way forward for HVAC, delivering more sustainable facilities in a way which works in practice, not just theory.

We call upon stakeholders across the pharmaceutical industry to engage with the consultation and take part in the formal review. Information can be found at https://www.ecoventilation-review.eu/

By amending the Ecodesign Directive to take account of the unique design aspects of pharmaceutical plants, the EU can ensure that these facilities continue to play their part in driving a more sustainable future.