Climate change has a huge effect on healthcare and the role that pharmaceutical manufacturers must play. But there are also plenty of opportunities for the medical devices industry to reduce its reliance on fossil fuels in energy demand and supply, writes Nigel Lenegan, director of Energy & Carbon Reduction Solutions.
Healthcare provisions on a global scale will be severely tested by climate change, with its impact on public health and an increasing demand on healthcare resources adding to the challenges of population growth, natural resource availability, cost and supply security. Mitigation of climate change can only be achieved by reducing greenhouse gases (GHG), of which healthcare providers and associated supply chain partners, such as pharmaceutical and medical device companies, are large energy consumers and major emitters.
As such, healthcare providers will be drawn towards less carbon-intensive pharmaceutical products in a bid to limit their own carbon footprint. The ‘NHS England Carbon Emissions Carbon Footprinting Report – 2008’ suggests that 37% of the UK National Health Service’s own carbon emissions are directly attributed to the procurement of pharmaceutical and medical device products. Adaptation strategies must also be considered, because even if emissions were capped now, some level of climate change will still occur, fossil fuel costs will continue to rise and their supply will become less secure. The challenge for healthcare providers and industry partners everywhere will be to ensure that appropriate levels of care and treatment are available at the point of delivery, using a mix of mitigation and adaptation solutions to combat the effects of climate change.
Emissions from facilities, transport and products in use
Pharmaceutical and medical device manufacturers’ GHG emissions are predominantly due to facilities, transport and products in use. Two of these – transport and products in use – are a double-edged sword. Transport-derived emissions can be reduced by using biofuels such as rapeseed oil; however, action groups are concerned that energy plants are taking land that could be used to grow food. Reduction in transport could be achieved by localised manufacturing, but that would lead to increased facility emissions. Also, products in use have a large GHG footprint; for example, propellants in asthma nebulisers to ensure dose delivery effectiveness. But whatever the mix of adaptation or mitigation strategies and solutions adopted, the need for a significant reduction in energy use derived from fossil fuels will be unavoidable.
Energy use in R&D and manufacturing
Historically, and in some cases still, pharmaceutical companies did not consider the energy use of carbon emissions from their manufacturing and R&D facilities, probably because it was a small cost compared with their high profit margins. As such, it was deemed more important to deliver facilities on time as product speed to market drove facility-design decisions rather than lifecycle cost. These design solutions were of a one-size-fits-all type and were never measured or challenged. This led to facilities that were over-designed and over-performed, and with the benefit of hindsight, they produced a significant amount of energy waste.
This over-design includes cleanrooms, which were developed in the 1950s and driven by the race to conquer space. It is thought that one of the first cleanrooms was used to improve the yield of gyroscope production by removing dust particles from the manufacturing environment, which changed from 99% failure to 99% success.
The gyroscope cleanroom was a Class 100000 (FED209) type and employed terminology corresponding with ISO8 certification. This facility used 20 air changers an hour of high-efficiency particulate air (HEPA) filtered airflow distributed by ceiling-mounted supply diffusers to provide the standards of cleanliness necessary to control particulate emissions from the product/process and people, thus enabling excellent production efficiencies. Early pharmaceutical cleanrooms adopted this technology.
Improvements in gowning, cleaning and training
Since the 1950s, significant development and improvements have taken place within the pharmaceutical sector in terms of gowning, cleaning and personnel training, as well as HEPA filter technology. All of these have reduced emissions and control of both non-viable and viable particulates, and have enabled the primary contamination source within cleanrooms, where people have their emissions contained at source. Cleanroom gowning and operator action are now the primary control measure for emissions, thereby reducing the need for heating, ventilation and air-conditioning (HVAC). Yet no significant developments in HVAC have occurred to match the improvements made in other areas.
HVAC typically represents the greatest demand in almost all facility types and can be 50-75% of total energy use. Within this, ventilation systems are the major users at over 60%, which equates to 45-50% of the facility’s total energy demand. Now that HVAC is in focus, there is a realisation that it has three primary functions in cleanrooms, namely:
- displacement or dilution (determined by classification) and removal of non-viable and viable particulate emissions, predominantly the control of emissions from operatives, production materials and process equipment
- pressurisation of facilities to ensure the clean environment is protected from contamination from unclassified surroundings
- environmental control (temperature/humidity) to check temperature and humidity, and offset internal sensible heat and moisture gain and loss.
It is only recently that this situation has been realised, yet the traditional rates of airflow still prevail in current design solutions. There may be other reasons for the status quo regarding air-change rates, perhaps due to the fact that the pharmaceutical manufacturer is heavily regulated and controlled, resulting in ‘the cleaner the better’ mindset.
A scientific approach to cleanroom design
There is also an unwillingness to challenge this situation, even when facilities are overperforming by many orders of magnitude. The same can be said in R&D regarding the extent of fresh air provided to laboratories such that actual dilution airflow requirements are set aside in favour of traditional, excessive airflow rates.
However, this traditional attitude is changing, driven by energy costs, carbon-reduction legislation and corporate social responsibility considerations. Companies have begun to realise the primary energy users within their facilities, and the extent of their over-capacity and performance.
In tandem, there has been a softening of approach and regulators have advocated a ‘risk-based scientific approach’ to cleanroom design, but given the prevailing attitude, traditional norms remain, partially due to a stance taken by internal and external stakeholders, and the fear of non-compliance independent of risk. As a result, actual airflows are likely to be even greater-than-usual design requirements, which themselves can be much more important than regulatory guidance.
Excess air changes are a primary cause of wasted energy and are the reason why ventilation is the main energy user in HVAC systems. Other energy usage considerations include: the extent of fresh air that is treated; excessive filtration; poorly designed and controlled heating and cooling, especially when humidity is controlled as part of this solution; and the associated heating and cooling of the hydraulic systems and plant. These all usually operate at a 100% rate, independent of facility operating times.
Reducing energy use in R&D and manufacturing
There are also opportunities for reducing energy use in R&D manufacturing facilities. It is important to remember that given the complexities, regulatory pressures and traditional attitudes, energy reduction in cleanrooms is a journey rather than destination, and must build credibility and support along the way.
Before any energy-reduction opportunities are considered and agreed for implementation, a detailed business risk and impact assessment is required to ensure that a science-based approach has been followed. This will be a key consideration for both internal and external auditors whose approval is essential for implementation to proceed and be successful.
This risk/impact assessment should consider all the critical elements required for the successful and reliable operation of the cleanroom, and focus on the product/process and people-based demands that the facility must satisfy. Findings and control measures identified must be factored into any cost vs benefit assessment.
Good availability of design and operational information including system drawings, commissioning figures, current flow and pressure values, operational and at-rest particle count information, classification and monitoring data, and energy usage are essential to enable the comparison with critical product/process and people requirements. A good understanding of gowning, cleaning and personnel GMP training is useful to ensure that primary control measures are being addressed.
In all cases of airflow reduction, the impact on ventilation effectiveness must be considered, along with heat gains, heat losses, fresh air demand and controls hardware range, which all should come from the risk/impact assessment. Ideally, the change control process should be agreed, and include settled validation procedures to ensure that the outcome is validated and verified.
Pre-work checks on particulate, room pressure and environmental control must be undertaken, together with key plant conditions and flows to ensure that a baseline is created prior to changes being undertaken. This enables a recovery plan to be put in place in case of problems. Consider energy labelling the facility to enable improvements to be measured and recognised.
A common goal
It is possible and relatively straightforward in technical terms for the pharmaceutical and medical devices sector to quickly and effectively reduce its energy use and carbon emissions to support the global pharmaceutical industry and broader healthcare sectors in their quest to mitigate and adapt to climate change.
However, this can only be achieved in practice by collaboration between engineering, facilities, quality and regulatory stakeholders working to common goals and shared understanding.