Single-use without compromise: Safe media transfer with platinum-cured silicone

In pharma and biotech, single-use is about much more than simply replacing heavy steel components with plastic. It is about moving the risk and complexity away from your production and into a controlled environment where sterility is paramount. 

As we highlighted in our previous article, the foundation for safe production is laid in the ISO 7 cleanroom. But when designing a sterile process setup, you face one of your most critical decisions: the choice of material for media transfer. Silicone hoses are one of the industry's preferred choices, but behind its popular surface lie technical requirements for cleanliness and handling. And this is where the small details make a big difference to your process safety. 

Components made of silicone have become a fixture in pharmaceutical processes because the material is chemically neutral and physically robust. To maintain sterility, it's important that the surface of the hose neither affects nor reacts with the liquids flowing through it. 

In addition to chemical safety, silicone offers: 

• Natural flexibility that handles the constant mechanical stresses of a pump. 
• Thermal stability ranging from -40°C to +200°C. 
• Robustness that makes the hose suitable for everything from simple transfers to temperature-sensitive batches. 

But the material alone is not enough. The real safety lies in the precise handling and packaging that ensures the hose remains untouched until it reaches your production line. 

It's with good reason that platinum-cured silicone is described as the gold standard for sterile applications. It ensures a level of purity that is difficult to match. If we take a broad view and look across industries, peroxide-cured silicone hoses are still widely used because they are temperature resistant. 

But if we move into your world – pharma and biotech – the picture is completely different. Here, platinum-cured silicone is often the first choice today. While standard silicone hoses provide the right material properties, our Platinum Cleanroom hose adds an extra layer of safety. By using platinum-cured hose, you avoid chemical residues and get hose that is completely odourless and tasteless. 

One of the biggest sources of contamination in a sterile environment is the installation of new components in the Cleanroom. To support your sterility requirements, the Platinum Cleanroom hose is handled in a dedicated ISO 7 environment. This ensures that protection is built into every step of the journey, so you receive a hose that is 100% ready for use. 

We deliver the hose wrapped in two sterile bags, each sealed separately. In this way, we solve a specific operational challenge in your airlock procedures: 

1. The outer bag catches external particles from transport and storage.  
2. The inner bag, which is sealed under controlled ISO 7 conditions, ensures that the hose remains untouched by the outside world until it is in your own clean zone. 

The system reduces the need for manual disinfection and minimises the risk of employees accidentally bringing microparticles or dust into sensitive process zones. 

Although the Platinum Cleanroom hose is suitable for single use, you don't have to compromise on your process strategy. The hose is designed to maintain its integrity and withstand both repeated autoclaving (high-pressure steam) and gamma sterilisation (radiation). This makes the hose very versatile, whether used once or as part of a multi-use setup. It allows you to standardise your component selection and simplifies both documentation and inventory management. 

Of course, you receive your hose with full traceability via batch number, so you always have a transparent history to back you up. We know that documentation is a big part of everyday life, which is why the hose complies with all relevant standards such as FDA 21 CFR 177.2600, USP Class VI and E.P. 3.1.9. This is your guarantee that the material meets the strictest requirements, making both documentation and the next audit much easier to manage. 

We don't see the silicone hose as an insulated product, but as an important part of a complete, sterile system. Our strength lies in combining the right material with insight into the cleanroom conditions our customers work under. 

Are you in the process of evaluating your current media transfer strategy? We are happy to share our knowledge of how the Platinum Cleanroom hose can optimise your sterile flow. Please contact us by telephone on +45 7020 0422 or by e-mail at inquiry@alfotech.eu. 

Later this spring, we will conclude our series on single-use with a focus on the critical connections in your production. We will dive into the couplings that tie your entire flow together and ensure a complete single-use setup.