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Customised single-use assemblies for processes in (bio)pharmaceuticals, biotech and life sciences

Increase the safety, efficiency and scalability of your process

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single-use assemblies

What is a single-use assembly and how are they made?

A single-use assembly is a ready-to-use, customised total solution consisting of various separate plastic components that are assembled into a single unit based on a customer-specific design.

In some processes in, for example, the (bio)pharmaceutical, biotech and life sciences industries, it is not only desirable but also practically necessary to use single-use assemblies. This is particularly true in processes where sterility, hygiene and product safety are essential.

In which industries and processes are single-use assemblies used?
Single-use assemblies are already widely used in many processes in the (bio)pharmaceutical, life sciences and (food) biotech industries. In upstream processing (USP), seed train assemblies, sampling sets, pump sets and transfer assemblies are used during seed train, fermentation/cultivation and harvesting. In downstream processing (DSP), microfiltration sets, sampling manifolds, pump sets and transfer assemblies are used during separation, purification and formulation. In fill & finish (F&F), retention bag assemblies, PUPSIT assemblies, filling assemblies, pump sets and transfer assemblies are used during final filtration and final fill. Assemblies designed for this purpose are also used during sampling, buffer preparation and media preparation.

Hospital pharmacies often prepare (patient-specific) medicines, such as injections or infusions. Filling assemblies are mainly used for this purpose. In specific cases, it may be necessary to use a transfer, mixing or filtration assembly.

What are the advantages of single-use assemblies?

Product safety and sterility are essential in processes in the (bio)pharmaceutical, life sciences and (food) biotech industries. Delays and lost batches are extremely costly. Ready-to-use single-use assemblies are the solution for avoiding risks with assemblies and guaranteeing production reliability.

Ready-to-use single-use assemblies offer six advantages:

Reduced working time and therefore cost savings: Because single-use assemblies are delivered ready-to-use and sterile, you save a lot of time on preparation, assembly and validation.
Reduced risk of cross-contamination and leakage: Assemblies are precisely assembled and tested in advance, eliminating manual operations and error-prone connections.
Less production downtime: Single-use systems are flexible, allowing you to switch quickly between batches or products and limit downtime.
Savings on water and energy costs: Single-use assemblies are more sustainable than stainless steel systems because they do not require cleaning-in-place (CIP) and sterilisation-in-place (SIP).
Improved production process through quality assurance and document control: Each assembly comes with batch traceability and test certificates, ensuring consistent quality and easy documentation.
Securing the entire supply chain: Standardised and validated configurations and brand-independent assemblies prevent delivery uncertainty and (re)validation issues.

Assemble it yourself or use ready-made single-use assemblies?

Some companies choose to assemble their single-use systems themselves. This requires precision. If the connection between the components is not made correctly, this can lead to (cross-)contamination or leaks, for example. This jeopardises the safety and quality of the end product and may delay the production process, while delays and lost batches are extremely costly.

You can minimise safety and quality risks by having single-use assemblies assembled by experienced experts in a cleanroom. A specialised assembly partner also takes care of documentation, quality control and testing for leak tightness or integrity, for example, so that you can confidently use the system in critical processes on a plug-and-play basis.

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What is the process for a single-use assembly: from request to delivery?

How do we create the perfect customised single-use assembly for you?

What about quality, validation and documentation for single-use assemblies?

How can standardisation assist you with scaling up and stock management?

Getting started with single-use assemblies

Are you curious about the most suitable single-use assembly for your process? View our range of standard assemblies or contact us using the form below to find the perfect customised assembly.

Would you like to learn more about single-use assemblies for your specific process?

We are happy to help you. Please submit your question using the form below. We will contact you as soon as possible. Would you prefer direct contact? Please call us on 0297-514714.