Written by:
Albert Canet, Klinea Project Engineer
Jordi Gibert, head of Klinea’s Biotechnology Unit
Oriol Sauquet, Head of Klinea’s Sustainability Business Unit.
Circular economy, resources reuse, and waste reduction dominate the global discourse in many sectors, but the pharmaceutical and biotechnology sectors are betting on single-use equipment, known as Single Use Systems (SUS). An example of this use of SUS in downstream operations, which grew from 17% in 2015 to 38% in 2021, partly driven by COVID [1]. As a result, the market grew by approximately 28 billion dollars in 2023 [2].
Although bioreactors have been key to SUS since the 1980s [3,4], their use has expanded to other biopharmaceutical equipment. In 2023, Single Use bioreactors represented “only” 1.3 billion dollars of the total market [2,5].
Despite their growth, their application varies depending on the operation. The use of Single Use bioreactors in 2020 represented more than 70% of development processes, but only 36% in industrial productions [6].
This article analyzes SUS versus reusable systems (Stainless Steel) from an operational, economic and sustainability perspective. The following table describes the main differences between SUS and reusable systems.
In addition to the push from COVID, SUS are key in personalized therapies for reducing contamination and adapting to small batches. However, they have technical limitations such as lower heat transfer and agitation. It is also important to highlight the compatibility of SUS materials with biopharmaceutical products and processes, as well as the presence of leachables (compounds that are released from the materials when in contact with a fluid) and extractables (substances that can be released from the materials under more aggressive conditions).
Numerous articles compare CAPEX and OPEX between the use of SUS and Stainless Steel. SUS have lower initial investment [7] due to reduced infrastructure and material requirements but higher operating costs due to the consumption of disposables. In contrast, reusable systems require higher initial investment, but generate savings in the medium and long term due to their durability and reusability.
In terms of water and energy consumption, especially for CIP and SIP processes, SUS offer an economic savings of over 40% in these consumptions [7].
Sustainability is complex to evaluate, as it depends on multiple factors. Often, the study focuses on the impact of SUS during their production (reduction in water and energy consumption), but their manufacturing and waste management also have an impact. The following table summarizes the environmental impact of SUS compared to reusable systems throughout their lifecycle.
In pre-use, SUS are continuous water consumers and can match the consumption required for the fabrication of a Stainless Steel [8]. However, during use, they save up to 85% of water [8] and require only around 2% of the energy needed for Stainless Steel systems.
The constant generation of waste and its subsequent treatment is the Achilles heel of SUS. This impact has a complex calculation, as factors such as outsourcing of management or applicable regulations are involved.
The plastic consumption per unit of product determines its carbon footprint. One study estimated a carbon footprint of 22.7 tons ofCO2 per kilogram of biological drug [9], similar to reusable systems, as the largest contribution comes from energy for clean rooms. SUS waste treatment depends on regulations and usually includes heat sterilization followed by incineration or landfill, as recycling is unfeasible due to multilayer materials. [10].
SUS have revolutionized biopharmaceuticals, expanding from bioreactors to multiple operations. The incorporation of sensors is a recent development. Their evaluation remains complex, depending on multiple factors.
You can find the extended article on page 78 of the Farmabiotec magazine.
BIBLIOGRAPHY:
- [1] Single-use technologies are here to stay. How can we improve their supply, Cytiva
- [2] Single-use Bioprocessing Market Size, Share & Trends Analysis Report By Product (Simple & Peripheral Elements, Apparatus & Plants, Work Equipment), By Workflow (Upstream, Downstream), By End-use, By Region, And Segment Forecast, 2024-2030, Grand View Research
- [3] A Brief History of Single-Use Manufacturing (biopharminternational.com) A Brief History of Single-Use Manufacturing, Jerold M. Martin, BioPharm International, 2011.
- [4] Embrancing single-use technologies to advance biopharma manufacturing, Manoj K Ramakrishna, EP News Bureau, 2023.
- [5] Single Use Bioreactors Market, Roots Analysis
- [6] Rise of Single-Use Bioprocessing Technologies: Dominating Most R&D and Clinical Manufacture, K John Morrow, Jr. et al., American Pharmaceutical Review, 2020.
- [7] Single-Use Systems: The Future of Biopharmaceutical Processing, James Hederman, Medical Design Briefs, 2022.
- [8] Which is more sustainable: stainless steel or single-use systems?, Zach Page-Belknap, CRB
- [9] Streamlined life cycle assessment of single use technologies in biopharmaceutical manufacture, Kristi Budzinski et al., New Biotechnology, 2022.
- [10] Guide to Disposal of Single-Use Bioprocess Systems, Bioprocess International, 2008
