Manufacturing plants have typically deployed bioreactors, tubing and other processing equipment made from stainless steel. In recent years, however, the industry has seen a shift towards single-use equipment made from plastics. This was particularly accelerated by the Covid-19 pandemic, which required large-scale production facilities to be set up at record speed.
According to the American Pharmaceutical Review, single-use systems are now widely adopted in pharmaceutical manufacturing, with nearly 85 percent of bioprocessing making significant use of disposables, particularly in upstream processes like cell culture, cell separation and harvest.
“Disposable” is often synonymous with waste, however advocates for single-use systems argue that they are in fact better for the environment because they don’t require energy-intensive sterilization processes, among other factors. Here we take a look at how both types of system fare on sustainability.
Energy and water usage
Clean in Place (CIP) and Sterilization in Place (SIP) are procedures that manufacturers must perform on fixed equipment to prevent contamination between the production of different drug batches. These sterilization methods need large quantities of heat and purified water as well as hazardous chemicals like caustics. Additionally, equipment needs to be tested regularly and might need partial or complete CIP revalidation.
According to the Bioprocess Systems Alliance, single-use items create less of a carbon footprint because sterilization is not needed. Dr Heinz-Christian Rost, Life Science Market Manager at Parker Hannifin, Engineered Materials Group Europe, says: “With single-use systems the process is simplified. You are basically plugging a fully validated sterile product into your production environment.”
Read the full report: Single-use systems - how to overcome challenges and mitigate risk in bioprocessing
Single-use systems take up less space and weigh less than fixed equipment. A traditional manufacturing plant may have 1,000-litre stainless steel bioreactors on site, but facilities set up to deploy single-use equipment are generally aimed at smaller batch production, using smaller containers, taking up less space overall and therefore having a lower total energy consumption.
On the other hand, the constant need for disposables means continuous production requires more energy and water. A years’ worth of single-use items surpasses the amount of water needed for stainless steel equipment fabrication, which has a lifetime of 15 to 20 years.
Materials and the supply chain
The rise in popularity in recent years of single-use equipment combined with increased demand during the pandemic has led to shortages in the polymers used to produce many items. “We are seeing a higher demand for single-use equipment right now and suppliers cannot keep up with this demand,” says Ken Wong, Sanofi’s Head of Procurement for Asia.
“For the last two years sub-suppliers are also struggling to keep up with demand, so there has been a knock-on effect on parts all the way up to assembly lines,” Wong adds. “For example, there is a shortage of plastic and cardboard packaging that, even though it is not obvious to most people, is hindering the supply chain.”
The longer lifetime of reusable equipment means it is less vulnerable to supply chain shortages.
Recycling and waste
Stainless steel bioreactors have a lifetime of roughly 600 production batches, after which they can be sold and repurposed or melted down and recycled. However, it is worth taking into account that the latter is an energy-intensive procedure. Additionally other parts of the assembly such as air filters still need to be replaced regularly.
Single-use equipment cannot be recycled because it is biomedical waste. “Discarding it is not an easy process until we find a different way to solve it,” says Wong, adding that “modelling has shown that water and energy savings from using disposables offset the waste issue. But it also depends on who you talk to. Some people care more about the fact that waste can become an eyesore.”
Quick links
- How to deploy single-use technology to control frozen bulk storage
- How to shift to single-use assemblies to protect complex drug products
- Adopting single-use systems in biomanufacturing
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