What Are Custom Single-Use Assemblies? Benefits, Applications and Configurations

In the current fast-moving biopharma and life sciences world, speed, adaptability, and safety can make or break an entire production process. More and more companys today are  moving away from traditional stainless-steel systems and choose customized single-use assemblies to help them meet their growing production needs.

But what exactly are custom single-use assemblies, and why are they so prevalent in the fluid management ? How are they designed to fit different workflows, whether you're mixing media or working with sensitive fluids?

Here, we're going to deconstruct everything you need to know about single-use assemblies — what they are, how they help, where they're used, and how you can use them for your particular process.

Let's start with the beginning.

What is Custom Single-Use Assembly in Biopharma and Fluid Management?

Single-use assemblies are pre-assembled plastic parts made up of tubings, filters, connectors, and bags. Pre-assembled for single use in fluid-handling systems for the transfer, mixing, filtration, or storage of liquids in a clean and sterile condition. Used and then discarded — no cleaning or re-sterilization necessary.

Unlike off-the-shelf kits, these assemblies are custom-made for your specific process. That means you can specify the size or type of the tubing, the filter type, the connectors, and even the number of ports you need — all before manufacturing, Usually they’re gamma-sterilized and ready to use.

And why are businesses so willing to switch to these disposable systems?

Because traditional stainless-steel systems do have their downsides: they are expensive, difficult to sanitize and require strict validation to ensure they are safe for sensitive biopharma use. Single-use assemblies offer a faster, safer, and more flexible way of working with fluids

Now that we’ve covered what these systems are, we now move on to their most important advantages.

Benefits of Single-Use Custom Assemblies

It's not just a matter of being neat when you're using custom single-use assemblies — it's a matter of being competitive, especially where time and precision are important.

So why are they then such a good investment?

Let us examine the best benefits and how they allow teams to work smarter, not harder.

Save Time with Pre-Assembled Systems

Time is money in any bioprocess. Between runs, cleaning and validating stainless-steel systems can take hours — even days. With custom-made single-use assemblies, everything comes pre-sterilized and ready to go.

This saves setup time, reduces downtime between batches, and enhances overall production. For teams with several workflows running at the same time, that kind of time savings can be a major benefit.

Minimize the Risk of Contamination

With each recycling of a system, there is always a possibility of residual residue or microbial contamination. Even the most stringent cleaning protocols can't completely remove the risk.

Single-use assemblies dispel that concern. They're sterile, sealed, and opened just once. That translates to a new beginning with each batch — no residue, no carryover particles, and no cross-contamination of products.

Agility to Meet Fast-Changing Manufacturing Requirements

What do you do when your process is changing or must scale up rapidly?

Stainless steel systems typically can't keep up. They're built to endure — but not to change.

On the other hand, there is flexibility in custom single-use assemblies. You can reconfigure them to accommodate new process steps, change flow paths, or insert new sensors and filters as required. This makes them a perfect fit for multiproduct plants and high-science development environments.

So where are these systems being used, anyway, and who are they helping most? Let's take a closer look.

Where Are Custom Single-Use Assemblies Used?

The truth is that single-use assemblies are engineered to be fitted into almost any fluid process — especially where sterility, safety, and speed really matter.

These systems are usually in the following:

● Biopharmaceutical production

● Cell and gene therapy labs

● Vaccine manufacturing

● Diagnostic test development

● Research and clinical laboratories

● CDMOs and CROs (contract research and manufacturing organizations)

And in those industries, they're used for all forms of work:

● Sterile buffer solutions or media transfer

● Downstream processing of filter fluids

● Sample collection and storage

●  Mixing ingredients for drug production

●  Filling final products into containers

● Cryopreservation of fragile cell cultures

That is, if you need to move or manipulate fluids in a sterile, unsoiled fashion reliable way — there is probably a custom single-use assembly for that.

Now, of course, not all systems are built the same. Let's talk about what actually goes into one of these assemblies and how they can be customized.

What’s Inside a Custom Single-Use Assembly? Configurations & Components

One of the best things about custom single-use assemblies is that they can be customized to your process. You don't have to change your workflow to fit the system in — the system fits your workflow.

And of what are these systems composed of, and how do they work?

Common Elements You'll Find

These assemblies are mostly built from the very same set of parts, including:

● Tubing – Generally constructed of Pt-cured silicone or thermoplastic elastomer (TPE)

● Connectors – Like Luer locks, quick connectors, sanitary flange fittings, genderless aseptic connectors

● Filters – Sterile capsule filters, depth filters, virus filters etc.

● Bags or Bottles – Used to safely hold and transport liquids

● Sampling and Sensor ports – Allow you to sample or monitor without exposing the system

● Manifolds and clamps – For governing and organizing the flow

● Single-use Sensors – Optional for pressure, pH, or flow rate measurement

Designed for Your Process, Not the Other Way Around

Every process is different. That's why customization is necessary.

No matter what application you have — whether it is screening 5 liters of buffer solution, filling    300 containers per hour, or transferring a small batch of vaccine, your system needs to suit your specific requirements not roughly.

Personalized designs allow you to:

● Choose a flow path layout

● Select specific materials for chemical compatibility.

● Add ports, connectors and filters as needed.

● Get documentation to substantiate regulatory compliance.

● Have everything gamma-sterilized and sealed.

How Are Custom Single-Use Assemblies Designed and Validated?

You might be wondering: how exactly do companies create custom single-use assemblies? Is it simply a case of picking out parts and putting them together?

Not exactly. There is a whole process there — one that entails intelligent design, precise material requirements, and strict quality inspection.

The Design Process Starts with Your Needs

The first step is to understand your process. What are you looking to transfer, mixing, or filtering? What is the volume you are working with? Do you need high flow rates or gentle handling for sensitive solutions?

Once that's clear, engineers help you select the right:

● Tubing materials (base on chemical compatibility)

● Filters (sterility or particle removal requirements)

● Connectors (for fast and secure connections)

● Bottles or bags (for liquid storage)

● Sensors or monitoring devices (if necessary)

Then, we’ll create an engineering draft drawing so you can see and approve the flow path before moving forward.

Produced in Cleanrooms, Qualified for Safety

Once the design has been approved, the assembly is constructed under an ISO-certified cleanroom (typically ISO Class 7 or 8 for bags and assemblies, ISO Class 4.8 for Final Filling products). That there are no dust, microbes, or other particles that could influence affecting your product.    This helps maintain low levels of particulate and microbial contamination.

Assemblies are usually:

● Gamma sterilized

● Stamped with both part and batch numbers

● Shipped with full documentation (COQ, COA, etc.)

● Some of the vendors, like Cobetter, have no minimum order requirement so you can order just one set to test your setup in small batches before scaling up.

Why Validation Matters

Particularly in biopharma, validation is paramount. Any materials used must adhere to rigorous industry standards like:

● USP Class VI for biocompatibility

● TSE/BSE-free material (animal-origin-free)

● Compatibility with gamma radiation

Cobetter works together with you to make sure all validation requirements are met giving you peace of mind with regulatory audits and inspections.

Now that we've had a look at how these assemblies get constructed, let's take a step back. What does the future look like for custom single-use assemblies?

Future of Biopharma Custom Single-Use Assemblies

Biopharmaceutical production is changing at a breakneck pace. And if the last decade has taught us anything, it's that flexibility, speed, and safety aren't nice to have they're essential. That's why custom single-use assemblies aren't a passing fancy. They're a critical part of the future.

So, what's coming next?

Smart Systems with Built-in Monitoring

With the arrival of digital technologies, most single-use systems are now being coupled with smart sensors. Smart sensors can sense and record temperature, flow rate, or pressure in real-time, and this makes it possible to detect issues early on as well as stay in full control.

Even assemblies themselves can be made wireless enabled, thereby enabling data to be tracked and stored automatically. This improves decision-making, reduces the likelihood of human error, and enables regulatory compliance.

Flexible and Modular Manufacturing

Traditional biomanufacturing plants are large, expensive, and difficult to retrofit. But with more  biopharmaceuticals being made in small, customized batches like gene and cell therapies companies need systems that are flexible and easy to adapt.

Modular, plug-and-play facilities based on single-use technology are the new standard. Custom assembly is the ideal fit for this paradigm. They can be rotated out from batch to batch or product to product without the need to take down whole lines or rebuild equipment.

Global Supply Chain Readiness

COVID-19 has shown us just how vulnerable global supply chains are — particularly for critical pharma components. Contract manufacturers able to design and produce in-house, on-demand customization, and scalable production like Cobetter will play a key role in helping organizations stay agile and resilient.

Now, let's talk about how Cobetter implements these concepts for customers.

Why Choose Cobetter for Custom Single-Use Assemblies?

There are plenty of companies that produce disposable systems. But not all of them give the same value, speed, or support. That is where Cobetter stands out.

With Cobetter, you don't just receive components — you are getting a design partner to help you build fluid systems that work exactly the way you need.

This is why Cobetter is unique:

● Professional design support – You don't have to do it yourself. Cobetter works with you to design assemblies that meet your process.

● High-grade materials – All the materials used meet industry standards, like USP Class VI, and are animal-derived components free.

● Cleanroom production – Assemblies are built in ISO-certified cleanrooms and sterilized and available for immediate use.

● Flexible ordering – From one prototype to a thousand units, Cobetter can adapt to you.

● Fast delivery – Due to in-house manufacturing and prudent supply chain management.

Just getting started? You can look at pre-configured systems and components straight on our Single-use Assemblies collection page.

Conclusion

If you've made it this far,  you probably already know the advantages of switching to single-use assemblies.

They're cleaner. They're faster. They provide you with the freedom to expand, customize, and enhance your process — without burdening it.

Whether it is scaling up vaccine manufacturing or handling sensitive cell therapy lots, these systems help make the complicated fluid-handling universe tractable.

Still have questions? Want to talk through your needs? Let's get your process streamlined, cleaner, and smarter — all together. Contact our team at Cobetter, and we will begin designing a solution that fits your workflow .

Frequently Asked Questions (FAQs)

1. What is a single-use custom assembly?

It’s a pre-assembled set of components like tubings, filters, connectors, and bags designed for single use in sterile fluid management during bioprocessing.

2. Why are single-use assemblies important in biopharma?

They help minimizing contamination risks by saving setup time and allowing easy changeover of the product without cleaning.

3. What are the components of a custom single-use assembly?

Most assemblies include tubings, connectors, filters, bags, clamps, and sampling ports — all customized for your needs.

4. Are they sterile and ready to use?

Yes.They are sealed and then sterilized by gamma radiation.

5. Are the assemblies being used for small-batch applications?

Yes.Whether you're running small or large batches, assemblies can be customized to suit your process.

6. How long does it take Cobetter to produce a custom single-use assembly?

Lead times may vary. For small-quantity orders, manufacturing typically takes less than 4 weeks after design approval and there’s no minimum order quantity.

7. Are single-use systems more expensive than stainless steel installations?

Not necessarily. While you pay per use, but you save on labor, cleaning, and validation, so they end up costing less in the long run.

8. Where are custom single-use assemblies applied most frequently?

They are applied in biopharma manufacturing, gene and cell therapy, diagnostics, vaccine manufacturing, and others.

9. Can I have sensors in my assembly?

Yes. You can add pressure, flow, or pH sensors to your system if you need to.

10. How do I begin with Cobetter's customized single-use assemblies?

Just send us an email at [email protected], and our team will help you design a solution that fits your process.