Single-use technology has become a cornerstone of modern biopharmaceutical manufacturing. By replacing traditional stainless-steel equipment with disposable processing systems, the industry has gained flexibility, reduced risks, and accelerated innovation.
Here, we explore what single-use systems are, how they’ve transformed bioprocessing, their advantages, and the material considerations that matter when comparing them to reusable devices.
What is single-use technology for biopharmaceutical manufacturing?
Single-use technology refers to disposable processing systems for biopharma that replace traditional, reusable stainless-steel equipment. Instead of sterilizing and reusing large vessels, pipelines, and components, manufacturers use pre-sterilized polymer-based equipment designed for one-time use.
This approach covers a wide range of equipment, including bioreactors, mixers, storage bags, filters, tubing, and connectors. Single-use systems in biotechnology are now critical for drug development, vaccine production, and personalized medicine, offering greater flexibility and reducing cross-contamination risks.
How single-use technology has changed biopharma
The shift towards single-use systems
The adoption of single-use systems in bioprocessing has been a game-changer. Traditionally, cleaning and sterilizing stainless-steel equipment required significant resources and downtime. With single-use systems, pre-sterilized components can be quickly assembled and disposed of after use, enabling faster turnaround times and simplified operations. All of this turns particularly useful in the production of complex drugs based on biomolecules, where normally small, high-value batches need to be produced. In this context, single-use systems provide the perfect tool to boost the flexibility of manufacturing operations.
This shift has allowed biopharma companies to respond more rapidly to market needs, accelerate development cycles, and increase operational efficiency.
Where single-use technology is used
Single-use systems are widely used across upstream and downstream bioprocessing. They are essential in cell culture, media, and buffer preparation, mixing, filtration, and final filling stages. These solutions have proven especially valuable in clinical and commercial manufacturing of biologics, vaccines, and advanced therapies, where flexibility and contamination control are critical.
Biomanufacturing has been rapidly shifting towards single-use technologies, especially for the most innovative and high-value pharmaceutical products. Our Specialty Polymers are the best solution to support the newest generation of single-use biomanufacturing equipment thanks to their sterilisation resistance, low leachables & extractables and mechanical properties.
4 advantages of single-use systems
Simplified sterilization
Sterilization is one of the most resource-intensive aspects of traditional bioprocessing. With single-use systems, sterilization is already handled before the equipment arrives. This not only eliminates the need for cleaning validation but also reduces water, steam, and energy consumption.
Agile biopharma production lines
Single-use technology makes production more agile and flexible. Facilities can quickly switch between batches, products, or even entirely new therapies without the downtime associated with cleaning stainless-steel systems. This agility supports innovation and faster responses to evolving healthcare needs.
Cost-effective biopharmaceutical manufacturing
By reducing infrastructure investment, utilities, and cleaning costs, single-use systems contribute to more cost-effective manufacturing. They also allow smaller facilities to enter the market and scale production more efficiently. The result is lower operating costs and the ability to bring medicines to patients more quickly.
Increased productivity and reduced consumption of resources
Standard reusable manufacturing methods based on stainless steel components require perpetual labour expenses due to the need of repeated sterilisation, which also increases the use of energy and raw materials such as chemicals and water. The implementation of single-use systems eliminates the need for clean-in-place technology (CIP), which in turn increases manufacturing productivity and reduces costs by reducing cleaning and validation phases from days to hours.
Single-use vs reusable: material considerations
When comparing single-use surgical instruments and reusable devices, the choice of materials is critical. Single-use systems demand polymers that deliver high performance, biocompatibility, and compliance with strict healthcare regulations. These materials must be capable of withstanding sterilization processes while ensuring safety and functionality.
Reusable medical devices, on the other hand, need materials that can endure repeated sterilization cycles, resist chemicals, and maintain performance over time. For example, high-performance polymers can offer lighter, more sustainable alternatives to stainless steel while meeting stringent durability requirements.
What to consider when switching to single-use systems
Manufacturers evaluating a switch to single-use should carefully assess:
Sterilization methods: Compatibility with gamma irradiation, autoclaving, or alternative sterilization processes.
Regulatory compliance: Materials must meet global healthcare standards and approvals, such as USP Class VI and ISO 10993
Performance balance: Mechanical strength, chemical resistance, low leaching & extractables and long-term stability are essential for reliable processing.
Sustainability: Considering end-of-life disposal and the carbon footprint of materials.
Syensqo’s advanced specialty polymers are engineered to meet these challenges, enabling manufacturers to achieve the right balance of performance, safety, and sustainability.
Materials for pharma manufacturing equipment
Syensqo offers a range of high-performance specialty polymers designed for reliability, sterilization compatibility, and regulatory compliance in single-use biopharma systems.
Building the future of biopharma manufacturing
Single-use technology has transformed biopharmaceutical manufacturing, making it faster, more efficient, and more flexible. From simplified sterilization to agile production lines, the advantages are reshaping how drugs and therapies are brought to market. At the same time, material selection remains central to ensuring both single-use and reusable devices deliver the performance and safety the healthcare industry demands.
