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Single-Use Systems for Biomanufacturing

Navigating the advantages, limitations and innovations of single-use systems for biomanufacturing.

Due to factors such as cost-effectiveness, flexibility, and reduced cleaning time, there has been an increase in utilization and popularization of single-use systems (SUS). In this article, readers will glean insights into the potential of single-use technologies and the tools necessary to properly evaluate these systems for their biomanufacturing needs.

Technological improvements to single-use systems

While SUS have their limitations, the efforts of subject matter experts across the industry have been instrumental in overcoming many. Research for new materials and innovative manufacturing practices to reduce product cost, environmental impact and scalability challenges is driven by the need to address the following:

  1. Environmental Considerations
  2. Scalability
  3. Quality Control Processes

Environmental considerations

The advancement of single-use technologies has been instrumental in augmenting the scale of established components, such as tubing, flexible containers, filters, and connectors, and the environmental impact of these technologies must be assessed before their application to ensure that they are appropriate for the intended use and environmentally compatible.

Three elements must be considered when determining environmental compatibility: the system’s production, application and maintenance, and disposal.

For stainless steel, production involves manufacturing processes such as smelting and refining—processes which consume large amounts of energy. This environmental drawback can be offset by reduced waste generation and longer lifespan during the application and disposal stages.

Similarly, the production of SUS often requires high temperatures and significant energy. Reduction of emissions and usage of solar or other renewable energy sources in the production process helps to offset these environmental impacts.

Single-use systems require very little if any maintenance, unlike stainless steel that often requires resources such as water, chemicals, and heat.

For both systems, appropriately disposing of the material, participating in buyback and recycling programs can further balance the environmental impacts of production and application.

Overall, organizations producing these systems should be able to wholistically demonstrate their sustainability through offering insight into how they sustainably produce their products and services. By complying with the various guidelines set forth by governing bodies such as EcoVadis, companies can make a meaningful impact on the environment.

The evolution of single-use system scalability

While stainless steel bioreactors have long been the choice for large scale production, the single-use technology is making strides in meeting the evolving needs of the industry.
Companies like AdvantaPure are at the forefront of this evolution. For example, the 1.5” large bore high pressure silicone tubing, compatible with connectors from both Nordson and CPC (Colder Products Company), could enhance fluid transfer capabilities, translating to increased batches produced in less time.

As the industry matures, a growing convergence between the two technologies is becoming more apparent. Manufacturers are now able to benefit from both systems and leverage the flexibility and efficiency that comes with that union.

Quality control in for single-use systems

The adoption of quality process controls can be tailored to individual manufacturer’s preferences, accommodating either a single-use system or a stainless steel (SS) system.
When selecting a SUS supplier, a thorough evaluation of all validation documentation and quality systems can provide insights into how closely the supplier adheres to industry standards. Adherence to ISO 9001:2015 and other relevant standards can be a signifier of a commitment to quality and regulatory compliance.

Conclusion

The widespread adoption of single-use systems within a maturing biomanufacturing sector has presented both opportunities and challenges. While SUS provide numerous benefits such as cost-effectiveness, flexibility, and reduced downtime, concerns regarding their environmental impact and scalability have also been raised.

Recognizing these challenges, suppliers must proactively address these concerns to enhance the implementation and sustainability of SUS. Through rigorous testing, validation protocols, and advanced materials, organizations must ensure that all SUS meet the highest standards of safety, quality, sustainability and reliability. 


Paula Martinelli is the Global Product Manager for Life Sciences at AdvantaPure. With more than 20 years of experience in the global pharmaceutical and biopharmaceutical industries, Paula is an expert in single-use technology. Her expertise includes single-use product validation, product management, new product development, global market development, and business continuity plan implementation.

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