What is a single-use system in bioprocessing?

Single-use systems (SUS) in bioprocessing refer to polymer-based components that are disposable and pre-sterilised.

They’re a popular alternative to stainless steel systems, which don’t often come pre-sterilised and may be simpler and faster to use in operation, ensuring optimal hygiene, efficiency, and functionality.

The core components of a single-use system

The core components of single-use systems can vary greatly. Common examples can include:

• Bags and containers
• Tubing assemblies
• Filters
• Connectors
• Manifolds
• Bioreactors

Single-use systems, such as bags, differ from secondary containment, like reusable bioprocess containers or stainless steel hardware. Single-use systems are vessels that handle fluid media directly during manufacture, while secondary equipment often protects the product afterwards.

How do single-use systems work?

Single-use systems are suitable for use across a wealth of bioprocessing stages, including upstream and downstream processing.

Upstream Processing

Single-use systems are used in upstream processing to help the production of living cells. 

Here, SUS can be used in media buffer preparation, seed train expansion, and production bioreactors.

They provide an excellent contribution to these processes, offering lower contamination risk and fast turnaround times.

Downstream Processing

If you’re purifying a product in a downstream process, single-use systems can be a hugely beneficial implementation.

In downstream processing, single-use systems can be used in chromatography, viral inactivation, and viral filtration.

They can reduce cleaning without compromising hygiene to keep workflows efficient and products contamination-free.

The benefits of single-use systems in pharma

A benefit of single-use systems is that, thanks to their disposable and pre-sterilised properties, they can also speed up the time needed between batch production, which previously may have been spent cleaning up. This can also significantly lower energy and water consumption and costs.

What’s more, they massively reduce contamination risk, meaning you can rest assured that your systems are hygienic, consistent, and validated for controlled cleanroom use. 

A huge advantage of single-use systems is that they’re extremely flexible, making them suitable for a variety of processes and applications for both clinical and commercial manufacturing. 

Single-use system applications can include:

• mRNA vaccines
• Monoclonal antibodies
• Cell and gene therapy
• Buffer and media preparation

A good bioprocess container can also comply with and support these applications during storage, handling, and transportation.

How to choose a single-use system

When choosing a single-use system, there are a few key things you should look for:

Bag format and cleanroom compatibility

Ensuring that systems fit with your existing specs, which isn’t always possible with off-the-shelf options. For this reason, customisable options can be hugely advantageous.

For cleanroom compliance, keeping an eye out for ISO classification and mobility is often beneficial.

Supplier reliability and lead times

Opting for a reliable supplier is vital to support internal operations and logistics.

And, compromising on transparency of supply and lead times can massively hinder your business and the effectiveness of your team’s work. Dependable supply and durable products are paramount to efficient and streamlined systems.

Regulatory compliance

Regulatory compliance is non-negotiable if you’re working within bioprocessing. Single-use systems should be hygienic, consistent, and suitable for your work.

Single-use systems should also have undergone Pre-Use Post-Sterilisation Integrity Testing (PUPSIT) before purchase to ensure that product quality is qualified and the risk of flaws is minimal.

How ALLpaQ help single-use systems

Here at ALLpaQ, we provide customisable workflow solutions, including single-use support products, to ensure a perfect fit with your requirements where off-the-shelf products don’t cut it.

When you enquire with us, you’ll also receive a direct line of communication with our business development managers to ensure no surprises regarding pricing and lead times.

Learn more about our single-use support products or discover our bioprocess containers today.

Author

Phill Allen

Managing Director

Phill is an innovative thinker particularly in fluid management. His expertise lies in ensuring the seamless flow of pharmaceutical liquid logistics, whether it's optimising current processes or pioneering new approaches.

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