Sustainable freezing in biopharma: Emerging trends & the role of natural gas
There will continue to be an ongoing need for cryopreservation and cold chain management of drug substances. However, these processes will no longer depend on F-Gases.
The utilization of F-gases, also known as fluorinated greenhouse gases, is steadily declining in the biopharmaceutical sector and is expected to be banned in the near future. Regulatory frameworks, such as EU Regulation 573/2024, are setting the standards as they support the overarching goal of curbing emissions linked to F-gases used for freezing drug substances in single-use containers.
To enable more environmentally friendly freezing of drug substances, the industry must develop and implement more sustainable technologies. One notable trend is the growing adoption of natural gases for refrigeration. This transition is already evident at Single Use Support, where all freezing platforms and ultra-low temperature storage platforms are now available with natural gas technology.
- But is sustainable freezing truly possible?
- What challenges accompany the shift to natural gas-powered refrigeration platforms in pharmaceutical manufacturing?
- And which emerging trends further advance the principles of green engineering (even more) to go toward Global Warming Potential of zero?
Alexander Fuchs, Director Product Innovation at Single Use Support, sheds light on these aspects.
What natural gases are used and what role do they play in Biopharma freezers?
Alexander Fuchs: We equip our plate-based freezers, blast freezers and ULT storage freezers with natural gas refrigeration technology. R170 ethane, R1150 ethylene, R290 propane and R1270 propylene are natural gases that are not exclusively used by Single Use Support but increasingly adopted by other solution providers as well. The EU regulation 573/2024 mandates a gradual 70% reduction in F-gas emissions by 2030 to mitigate global warming potential (GWP). This directive has prompted manufacturers and solution providers to transition to sustainable alternatives. Non-compliance with the F-gas Regulation beyond 2030 entails penalties, underscoring the urgency of meeting sustainability targets. Even though solutions with F-gas cannot be placed on the market after 2030, they can still be used with the requirement of shortened maintenance intervals the greater the amount of F-gas used.
While freezing equipment performing below -50° C is exempt from these regulations until 2030, Single Use Support and its customers already now embrace the trend toward eco-friendly solutions. Even as we offer solutions like the RoSS.pFTU plate freezer for controlled freezing of single-use bags, the RoSS.BLST blast freezer for controlled freezing of bulk packaging including bottles to -80° C, and the RoSS.ULTF for ultra-cold storage down to -80° C, all powered by natural gases.
What are the big advantages of using natural gases?
Alexander Fuchs: First and foremost, natural gases are not scarce and more readily available than fossil fuels. The incorporation of natural gases into a manufacturing suite does not require a complete overhaul, as these processes can be smoothly assimilated into the biopharmaceutical cold chain storage. Moreover, natural gases are more efficient than F-gases. This energy efficiency translates into a significantly reduced charge requirement, about 1/6th of what was previously needed with F-gases for our RoSS.ULTF, while achieving equivalent performance outcomes.
So why hasn't natural gas always been the obvious choice?
Alexander Fuchs: Natural gas is more flammable. The combustibility of natural gas poses a safety concern in biomanufacturing environments. Exceeding a threshold of 500 g per platform triggers a cascade of measures, including infrastructure upgrades.
As long as the natural gas charge remains below 500 g per platform, safety protocols are unaffected. This is why we design our RoSS.BLST and RoSS.ULTF to stay below this threshold and as technically permanently sealed systems in accordance with EN378 and ISO 60335-2-89.
Importantly, the freezing performance remains uncompromised. So, switching to R170 (ethane) or R290 (propane), for example, does not impact cooling efficiency or reliability. Once safety requirements are met, users experience no noticeable difference.
How do natural gases pave the way to Green Engineering and sustainable biopharma practices?
Alexander Fuchs: Driven by the F-gases regulation, manufacturers and solution providers are compelled to pursue sustainability. Having such initiatives and guidelines in place is essential to collaboratively reduce emissions and lower GWP. The growing emphasis on natural gas usage supports Green Engineering by integrating life cycle thinking into all engineering processes. This entails minimizing resource depletion, reducing waste generation, and optimizing energy inputs and outputs for maximum safety and eco-friendliness.
"The use of natural gases is, after all, a step towards a more sustainable biomanufacturing environment."
Alexander Fuchs | Single Use Support
However, it's imperative to view this as just one step toward a fully sustainable biomanufacturing landscape. It lays the foundation for future engineering innovations and solutions aimed at refining current technologies and achieving holistic sustainability. For example, CO2 could be a very promising refrigerant for the future - even though it cannot be used for ultra-cold conditions to -80° C. As an environmentally compatible temperature control solution carbon dioxide does not have ozone depletion potential and offers a very low GWP.
Are natural gases the end of the line for sustainable freezing?
Switching to natural gas and natural refrigerants marks an important step toward sustainable freezing, as it significantly reduces emissions and Global Warming Potential. However, further alternatives stemming from the great commitment of life science solution providers to ongoing development will soon enter the market.
One promising approach is the use of pressurized air as a refrigerant. We are currently testing and evaluating temperature control units designed to achieve a Global Warming Potential of zero. These units will be integrated into our freezing devices, representing another major step toward making the freezing of drug substances even more sustainable.
"Starting in 2026, customers will be able to access advanced cooling technologies with a GWP of zero in Single Use Support’s freezers."
Alexander Fuchs | Single Use Support
Overall, there is still room for improvement. The entire industry must commit to a green path; one that goes beyond natural gas. Like other innovators, Single Use Support will continue collaborating with customers to develop eco-friendly solutions. After all, innovation will shape the future of sustainability.
