da
de
en
sv
In just a few years, single-use technology has changed everyday life in many pharmaceutical companies. From liquid handling to filtration and sampling, more companies are now choosing single-use components over traditional steel installations. This choice affects your production time, the risk of cross-contamination and your ability to quickly switch between batches. Whereas fixed equipment requires heavy cleaning routines, single-use offers a way around the most time-consuming bottlenecks.
This time, we look at what single-use means in practice, how ISO-7 cleanrooms come into play, and what considerations you should make before implementing the technology in your own production.
What is single-use?
Single-use is simply about replacing reusable equipment with disposable solutions that are discarded after use. By replacing the contact surface with the product rather than washing and reusing it, you minimise the need for extensive cleaning, CIP/SIP and time-consuming cleaning validation between batch changes. This is an advantage you will notice in production with many product variants or smaller series. In practice, the solutions often consist of single-use hoses for media transfer and couplings such as Y, T and straight hose configurators for safe and sterile connection of equipment.
To make the transition even more efficient, we can help you with ready-made single-use assemblies. By choosing a complete assembly rather than individual parts, you move the actual assembly of hoses and couplings away from your own sterile environment and into our controlled ISO 7 cleanroom. This way, you receive a pre-assembled solution that is ready for immediate use.
What is an ISO 7 cleanroom?
ISO 7 is a cleanroom class defined in ISO 14644-1 and describes an environment where the number of airborne particles per cubic metre is kept below a specified limit. For ISO 7, the concentration of particles ≥ 0.5 micrometres must not exceed 352,000 per cubic metre. This is achieved through filtered air, controlled ventilation and controlled activity in the room.
An ISO 7 cleanroom is typically characterised by:
- Filtered air and a certain number of air changes per hour.
- Overpressure in relation to surrounding rooms, so that air moves out of and not into the cleanroom.
- Smooth, easy-to-clean surfaces and fixed procedures for cleaning, clothing and access.
ISO 7 often acts as a necessary safety barrier to the most sterile areas, such as ISO 5 zones. But even though ISO 7 is a ‘background environment’, it’s not insignificant for your safety. It ensures that your equipment is assembled and packaged in air that has been cleaned of dust and particles. This means that when you open the package in your own clean production zones, you do not bring in any external contaminants into the sensitive environment.
The benefits for your daily operations
In the pharmaceutical industry, products are sensitive and regulatory requirements are high. Therefore, it’s advantageous that a large part of the risk is already managed where the single-use components are produced.
You can consider single-use components as defined, qualified building blocks in your process, rather than something that must be completely rethought in terms of cleaning, validation and handling each time. The supplier's cleanroom and quality management thus become a quiet but important backdrop to the flexibility and security you experience in your own daily operations.
The benefits of single-use are particularly evident in production and planning. Many pharmaceutical companies experience:
- Faster switching between batches and products: Pre-configured and sterile single-use assemblies eliminate time-consuming cleaning, validation and downtime between each production run.
- Less risk of cross-contamination: Single-use components that are manufactured and packaged in a controlled environment reduce the risk of residues from previous production runs.
- Increased flexibility: Single-use components make it easier to adapt your setup to new products and smaller series. With single-use components, you can more easily adapt your setup to new products and smaller series.
| The advantages of single-use | What does this mean for you in practice? |
| Less cleaning and validation | You use the components once and then discard them. This means you spend less time on both cleaning documentation and re-qualification between batches. |
| Lower risk of cross-contamination | You replace the product contact surface for each batch, reducing the risk of residues from previous productions. |
| Faster changeovers and short downtime | With single-use assemblies, you can switch to entire ‘packages’, so changing between products and batches is faster and the plant is idle less. |
| High flexibility in production | It’s easier to adapt your setup to new products, smaller series and clinical batches without major plant changes in stainless steel. |
| Lower investment and operating costs | You will have less need for cleaning equipment, utilities and cleaning chemicals. This also significantly reduces your costs. |
| Stronger compliance and documentation | Your supplier pre-validates many steps and provides documentation that makes it easier for you to meet regulatory requirements. |
What should you be aware of as a customer?
When evaluating single-use solutions, you can ask your supplier a few simple questions:
- Are your components developed for pharmaceutical applications?
- Are they assembled and packaged in an ISO 7 clean room, and can you document this?
- Will I get the necessary traceability and documentation for my own quality and regulatory requirements?
You don't need to know all the details about ISO 7, but you need to be sure that your supplier does.
Feel free to contact us before taking the leap to single-use solutions
Are you unsure whether single-use is the optimal solution for your production? We know that the transition to single-use solutions requires careful consideration, and we are therefore always available for a non-binding dialogue. Simply send us an email at inquiry@alfotech.eu or give us a call on +45 7020 0422.
Also, keep an eye out for the next article in our ISO 7 theme, where we will be zooming in on silicone hoses and their role in sterile applications.s.