Comparing pharmaceutical sustainability data from facility to facility, and company to company, can be a bit like comparing apples and oranges. The variation in measurement and reporting can make it nigh on impossible. On a hopeful note, however, the end of 2025 saw the launch of the first global standard offering a harmonised, practical framework to measure and assess the environmental impact of pharmaceutical products throughout their lifecycle.
This new standard, BSI PAS 2090, revolves around the concept of a Life Cycle Assessment (LCA). This method is used to evaluate the environmental impact of a drug across its entire life cycle, with the findings often used to identify where the greatest environmental impact is occurring.
Two of the most influential participants in the creation of the standard were Courtney Soulsby and Daniel Witte. Soulsby is the Sector Development Director at BSI, whilst Witte is a Director in the Corporate Sustainability Advisory team at SLR Consulting, which provides the Project Management Office (PMO) to the Pharmaceutical LCA Consortium, a group of eleven pharmaceutical companies that co-sponsored the standard. Both experts were critical in leading and coordinating the development, and spoke to Cleanroom Technology about the pivotal standard.
Speaking to Soulsby and Witte, one of the first big steps critical to the success of 2090 was getting consensus from pharma giants. In this, the standard succeeded by drawing major attention from contributors such as AstraZeneca, GSK, Sanofi, and Novo Nordisk, as well as over 475 stakeholders in 35 countries.
Outside of the pharmaceutical sector, the standard was also supported by NHS England, and the Office for Life Sciences (OLS). Pharmaceutical companies are seemingly crying out for harmonisation, but as end users of medicines, healthcare facilities also have a huge vested interest in knowing the carbon footprint of medicine. Once the standard was released, this demand for a consistent method for LCA was evident, with Witte saying that it “smashed records” in first week downloads.
Companies are required to disclose “how much primary and secondary data… [they] used,” ensuring fair comparison
Need for consistency
So what have companies been working with prior to now? Frameworks, such as the ISO (International Standards Organization), currently provide an idea of how to do a generalised LCA. However, the lack of sector and product specificity is an issue when it comes to extracting definable meaning from results. If all pharmaceutical companies are interpreting the generalised guidance slightly differently and using varying methodologies, it will be impossible to compare findings in any meaningful way without disclaimers.
It also creates the potential for companies to selectively choose data in order to reflect a desired outcome, resulting in what is often called “greenwashing”, unintentionally or intentionally.
PAS 2090 should put all companies on a more level playing field, enabling more direct comparison and findings, and allowing actionable sustainability insights across the entire spectrum of products.
Cleanroom-specific challenges in reporting
A large part of the standard’s data collection advice surrounds energy usage. For the cleanroom manufacturing portion of a drug’s journey, one of the main concerns of the standard was making the LCA individual product-specific. Witte and Soulsby say that this can be a particular problem in facilities that have multiple products in one space, such as a large facility or CDMO. Witte explains: “Attributing the product’s percentage of energy use within a cleanroom is one of the things that will need to be done.”
To determine this percentage, most sites lack the granular data down to a process level. With says based on what he has seen, it is “quite rare” to have energy and material use data broken down to a process level.
Whilst the duo recommend cleanroom designers think of this in the design phase in the future, for now, many facilities have to work with what they have. The consortium also developed technical guidance to accompany PAS 2090, which includes supplementary information to make allocation by mass, floor area or number of products. In the future, integration with a building management system (BMS) might be an efficient route.
For now, consideration of PPE in cleanroom production was not taken into account; PPE in the final use was.
It is “quite rare” to have energy and material use data broken down to a process level
Hot spots in the product cycle
A central concept within PAS 2090 is the identification of environmental “hot spots” across the pharmaceutical product life cycle. Soulsby says that the standard enables the industry to “really confidently understand where the key hot spots are,” shifting the focus beyond data collection toward meaningful action.
For cleanroom environments, this is particularly relevant. Energy-intensive systems such as HVAC are implicitly flagged as potential hot spots due to their high consumption. By standardising how life cycle assessments are conducted, PAS 2090 enables consistent identification of these high-impact areas, creating a clearer pathway for the industry to prioritise sustainability interventions where they will have the greatest benefit.
An even playing field for big pharma and SMEs
Something that both Witte and Soulsby were keen to talk about was how the standard was designed to be used by both Big Pharma firms, as well as more modest SMEs. The standard gives an allowance for both primary and secondary data. Secondary data, which, unlike primary data collected first hand, is created by “some level of assumptions or estimations”. By allowing a combination of both, Soulsby emphasises that the framework ensures that “most organisations should be able to pick it up and do some form of life cycle assessment”. Transparency is also built into this flexibility. Companies are required to disclose “how much primary and secondary data… [they] used,” ensuring fair comparison even where estimates are necessary.
In addition, the development team is working on further tools to reduce barriers, including “a digital tool… aimed at people who are not LCA practitioners.” Together, these measures position PAS 2090 as a standard intended not just for large, resource-rich organisations, but for widespread adoption across the pharmaceutical landscape.
The future of PAS 2090
There are clear signs that PAS 2090 could influence procurement decisions within healthcare systems. As Courtney Soulsby explains, “there is definitely a lot of interest from stakeholders asking for data,” particularly around how environmental impact can inform purchasing. This is also something that healthcare systems could incorporate into their decision-making processes for systems like procurement.
However, this is very much an evolving conversation. Courtney Soulsby says that rather than requesting full datasets for all products, there is a shift toward “a really targeted way, with the goal of determining hot spots and… where the challenges are,” indicating a more strategic use of LCA data in procurement.
Looking ahead into 2026 and beyond, PAS 2090 is likely to influence not just how environmental impact is measured, but how cleanrooms themselves are designed. As life cycle assessments move to a product-level focus, facilities will need to support far greater data granularity.
This means embedding capabilities such as granular energy metering, improved product traceability, and more precise attribution of HVAC usage from the outset. Cleanrooms have long been recognised as energy-intensive environments, but this standard brings new pressure to quantify and justify that use based on the product. Ultimately, designing cleanrooms for LCA compliance will be key to enabling accurate reporting and unlocking meaningful, data-driven sustainability improvements across pharmaceutical manufacturing.