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Manufacture Bioprocessing - Single Use Systems

Four Thoughts: Single-Use Technologies

The trends

Single-use technologies are now an integral part of the bioprocessing manufacturing landscape – and we continue to see rapid growth in this area with the development of new components and processes. Single-use fluid pathways offer significant manufacturing flexibility and process efficiency for multiple biopharma modalities, but this doesn’t mean that everything is perfect. End users should continue to evaluate their processes for areas of improvement.

The biggest trend today continues to be identifying and removing vulnerabilities in the global single-use supply chain. The COVID-19 pandemic highlighted many challenges, and companies are now working to establish primary, secondary and, in some cases, tertiary suppliers for single-use components. The need for supply assurance isn’t limited to re-evaluating existing finished products, and any new designs that are created are undergoing scrutiny to understand at the component level where dual supply or equivalency can be gained to increase confidence in the supply chain.

The switch

Single-use isn’t right for every company or every manufacturing situation. Stainless steel may be preferred because of material compatibility or process conditions such as temperature, pressure or process volumes that exceed the limitations of polymeric single use systems.

If you want to make the switch to single-use, you must closely review the type of technology available, including connectors, tubing, filters, and so on. Also, spend time evaluating about your vendor selection. Do you want to use one vendor or multiple vendors? To be successful with single-use technology, you must ensure proper management of your single-use supply chain and be able to harmonize this with demand.

You must also consider quality and regulatory requirements, of course. Ensuring your supplier’s regulatory compliance program includes sterility and that their packaging claims are in alignment with your expectations will help avoid unnecessary disruption to implementation. Particulate control is of utmost importance and understanding the environmental monitoring system being used during single-use manufacturing is a critical quality attribute. It’s equally important to understand the corrective action process and align your expectations with that of your supplier.

The mistakes

Mistakes do happen when changing to single-use. Many mistakes often begin at the design phase of the product life cycle. The raw material or component selection is critical to the overall health of the product life cycle, so as your process continues to scale in volume and size, ensuring your single-use technology and associated equipment can scale with your process is critical.

Too often, unsuitable technology results in an inability to scale due to supply constraints, which causes unnecessary revalidation or stock out situations at commercialization. Creating single-use fluid pathways based on a specification and creating redundancy will build in flexibility if a change is required. Further, accounting for assurance at the design phase of your process can assure greater success with scale.

The future

I see more companies adopting single use in the future, and new technologies will add even more benefits. For example, AI technology is already being implemented to better manage the single-use supply chain. Monitoring inventory levels, automated buying and restocking of shelves will help alleviate the strain and avoid costly stock out situations. Quality monitoring systems for automated quality control and vision systems will also improve product quality.

Finally, sustainability is also of great importance; material advances will continue to progress and the increased use of sustainable and/or recyclable materials will become more common practice. 

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About the Author
Timothy Korwan

Director of Technical Applications at Avantor

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