Building cleanrooms for the Future

Common issues identified during design reviews – new build and expansion.

Introduction

Sustainability is a key topic for all global businesses, but especially for those in the pharmaceutical or biopharmaceutical sectors, which are dedicated to health and improving lives. This ethos needs to be applied throughout entire business operations if a step change reduction in emissions is to be achieved to address the urgent realities and impacts of climate change.

The cleanroom facility – why is it so energy intensive?

Pharmaceutical, life-science and high-tech companies, and the buildings in which they manufacture their products, are major consumers of large amounts of energy. The heating, ventilation and air conditioning (HVAC) systems – which are vital to the production process – account for between 50 – 80% of site energy used in these companies. HVAC systems are therefore large contributors to the carbon emissions that a site produces and form a significant part of the product manufacturing costs.

It can be the case that when a process (such as a cleanroom operation) is not well enough understood by the manufacturer, the manufacturer errs on the side of caution and hence is overly conservative on the internal specifications he employs. This is understandable for new build facilities, where data on actual operations is unknown. But for existing facilities, where historical data on performance is available, this can and should be used to better understand the sensitivity of critical attributes to changes and process variability. It is also the case that a facility that houses, for example, a secondary packing area, may be using HVAC design parameters created for a much higher risk process, e.g. Active Pharmaceutical Ingredient (API) manufacturing and could safely operate with the main parameters at a less demanding level, dramatically reducing energy consumption and running costs, without any impact on the product.

In addition, the pharmaceutical or biopharmaceutical sectors are highly regulated by various agencies and bodies, with legal powers of enforcement. A key aspect of pharmaceutical manufacturing is the adherence to rules of Good Manufacturing Practice (GMP). GMP regulations primarily define the standards to which manufacturers are expected to adhere, but not how these standards are to be achieved. It is the responsibility of individual manufacturers to determine what steps, processes, procedures etc. they employ to meet the quality standards expected, and to verify and prove that these internal processes are effective at delivering the required results, consistently and robustly.

It is, then, not surprising that HVAC and other utilities are frequently over-designed. Facilities thus designed will generally well exceed the levels required for compliance with international standards and operate at an ever-increasing cost for the organisation as energy prices rise, with unnecessarily high carbon emissions.

How does the design & construction process contribute to excessive energy use in operation?

Experts in the field often see first-hand how even relatively new facilities operate well below optimal levels. This highlights many of the recurring issues with the standard construction process:

• Compartmentalised design teams, leading to missed opportunities for integrated design
• Lack of clear efficiency and sustainability targets maintained throughout the design and construction process
• Failure to involve operators and facilities managers who can give continuous input and engage with design teams to ensure solutions are practicable and understood
• The frequent application of a worst-case scenario approach to utility and central plant sizing without enough consideration of actual required operating loads and performance
• Insufficient time for the construction programme and handover – commissioning and tuning of building – to ensure operating requirements are met in an optimal way

The building industry is generally conservative in its technology and approach, which mainly relies on traditional design/tender or design/build approaches for major construction projects. New design and construction methods are advancing, particularly Building Integrated Modelling (BIM), which involves a common data repository for all disciplines involved, with resulting streamlining benefits: less time on site, better fault / clash detection, pre-fabrication for cost saving. However adoption of BIM is not widespread at present.

This is particularly true in the pharmaceutical cleanroom construction industry, which is typically more conservative than average due to the regulated nature of the sector. In addition, compared to typical commercial or public buildings, cleanroom facilities have a much larger energy use that can be significantly affected by initial design decisions, providing a potentially rewarding opportunity for looking at lifecycle costs from the beginning

Sustainability reviews often take place when designs are already nearly finalised, leaving little scope for influence. Changes can still be made, but not to the architectural design and layout of the facility. New builds are often therefore adjusted copies of past projects, with no account taken of past mistakes and lessons learned. They often incorporate only incremental changes, for example slightly more efficient fans and don’t explore bigger issues like over-design.

Surely a newly built facility is state-of-the-art and very efficient?

It is often the case that new buildings/facilities are much less efficient than older facilities. This is counterintuitive as modern technology and knowledge of sustainability is much better than 10, 20 or 30 years ago. But the reality is that those older, better facilities have had the advantage of time for commissioning/recommissioning and tuning to optimise. They are generally simpler, easier to understand and maintain, and have been continuously improved by the users. And of course, they have the advantage of having had real data on actual performance used to optimise the critical parameters needed for the process.

By contrast, new facilities are all too often rushed into operation with little time for commissioning, tuning and optimising energy performance. The pressures from a business and operational point of view or perhaps a building deadline, mean that issues considered less immediate can get hurried through or even forgotten about including flexibility for future changes in technology or economics. There are always competing priorities of cost, time and quality, whilst sustainability and lifecycle costs are not given enough consideration, either at the beginning of a project or during the working life of the facility. The compromises made because of this result in a sub-optimal facility.

To move forward and improve efficiency from the start, it will take a strong client, a clear brief and an integrated project team to make sure that aspirations regarding energy efficiency and sustainability become reality.

What needs to change?

It is clear to all in the industry, that the ‘business as usual’ model for design and operation of large manufacturing sites will not deliver the efficient and resilient facilities that are fundamental for providing the healthcare products for the 21stcentury. Other sectors face very similar challenges, with some already recognising that the change from traditional design, procurement, build and operation routes represents both an environmental and business opportunity.

The facilities of the (near) future need to be:

• Flexible (to changing product environments and market demand)
• Resilient (Reliable, simpler to run, robust to changes in external factors e.g. weather, water, power, security)
• Efficient (Space efficient, right sized equipment, operating to meet needs)

There are examples of good practice within the industry, for example the ISPE Sustainable facility of the year awards ISPE FOYA Sustainability link .

There are so many decisions to be made on a new project, that in the midst of considering the practicalities of the design, efficiency in operation is often overlooked until the final stages of the design process. It is sometimes assumed that good practice can be achieved simply by engineers specifying efficient motors or lighting or adding solar PV panels. These initiatives are certainly needed, but a lot more consideration is required across all disciplines from the very beginning of a project.

Keep it simple

At project conception, clear targets and a clear project lifetime should be set to allow major and minor project decisions to be evaluated and made, not only on first cost, but on lifetime cost.

• Define a project lifecycle period for decision making
  • this could be 15, 20, 30 years to reflect a realistic pharmaceutical facility lifespan, which often runs for over 50 years.
• Set unambiguous project-wide targets, these could be:
  • Net zero (carbon or energy)
  • A water and carbon budget (per year, lifetime)
  • No net increase (e.g. when site expansion projects are considered)

Defining these at project commencement and including them as part of key project decision making criteria, sends a clear message to all stakeholders including potential collaborators, investors and supply chain partners.

Ensure designers do their job

It is often the case that companies learn the hard way and end up with new cleanroom facilities that don’t serve their needs well and require significant investment to optimise and run efficiently. The response is often to review and revise company standards and specifications, trying to dictate efficiency and performance requirements to designers for the next big project. While standards are important, they can inhibit the creativity of the design process, or become seen as a target, when actually they are a minimum requirement.

At user requirement / client brief design stage, the global concept targets can be translated into clear design requirements. The URS is so important in communicating the client’s ambition to the design team, specifically with respect to an efficient design, that consideration should be given to providing specific target metrics or KPIs for the design team, who should be allowed to come up with the best solution to meet them. As HVAC is such a large energy user, such metrics could include;

• Ratio of conditioned volume of air to useful volume
• Total system specific fan and pump power.
• Include not just the fans and motors, but how well the whole distribution system is sized and designed.
• Peak load vs operational load efficiency criteria
• Demonstrate optimum efficiency at the most common load conditions, not peak conditions
• Total facility heat balance
• Identify waste heat flows and maximum % acceptable losses

Such KPIs can be kept at a suitably high level and, if challenging enough, will require the designers to step out of the ‘copy and paste’ approach to manufacturing design. It will necessitate designers to use analysis models to simulate different scenarios, enabling a greater level of questioning and understanding of client needs earlier in the design process, where decision making is far more valuable to the eventual result.

And finally, How to measure success

There are, of course, numerous ‘green building’ certifications and awards which have their merits, but none are specifically suited to cleanroom manufacturing facilities. In our opinion, it makes much more sense to be judged on how well a facility performs in real life.So, cherry pick the most suitable benchmarks that can be applied and demonstrated throughout the project lifecycle. The right KPIs will be understood by the designer, contractor, commissioning engineer and facility operator and will be demonstrable at each key project stage, from concept to construction to operation.

In summary

he efficient and resilient facilities of the future don’t need to be science fiction. With huge budgets to match, we have the technology and design tools to deliver them today at no significant cost premium. To make the construction industry change, projects need strong client leadership from the outset with a long-term vision, along with the support of truly collaborative teams, working to clear, measurable targets.

Written by Keith Beattie & Matt Harris

Keith & Matt work for Energy Efficiency Consultancy Limited (also known as EECO2), a specialist in providing sustainable solutions for the pharmaceutical, life science and other high-tech industries, through consultancy, engineering, quality and research & development services.