Machines with sanitary capability
29 July 2020
FISA develops many machine systems for customers in the medical industry. These machines clean all types of components that can be implanted into the human body. As expected, the cleanliness requirements for this type of components are very high.
Are there lines of machines specially designed for the medical industry? How do they differ from others?
Our machines have been designed to be appropriate to different business areas. Our approaches and ways of designing machines mean that their construction will differ depending on the stage we have reached in the medical project. If we are at the beginning of manufacturing – such as making a part – there will be mainly mechanical marks (related to polishing pastes, oils, etc.). So, we’ll offer machines designed to meet these needs. In general, the closer we get to final cleaning – i.e. the last cleaning step before packaging in the cleanroom – the more specific our machines will be.
In particular, we have machines with a very special tank design for final cleaning; we use it in other sectors such as optics, watchmaking or high-tech mechanics. These machines are also used in the pharmaceutical sector.
How are your machines designed for the medical sector? Do these machines have technical differences or special features?
We use a three-grade approach to determine the characteristics of the machine based on the cleaning phase and the customer’s profile. Each grade has its own special design with specific technical characteristics. You have the first grade that covers optical, watchmaking, medical or micro-technical companies. The second grade only involves implant manufacturers, while the third grade covers aerospace but also the pharmaceutical sector.
Machines with sanitary capability
The third grade has particularly demanding requirements, so we have to design machines with sanitary capability. In the event of microbial contamination, it must be possible to decontaminate and remove all dirt without the need for disassembly.
This naturally requires special design.
- As an example, if we take the shape of tanks, we’re going to make them curve so that liquid retention is impossible.
- Turning to fittings for hydraulic connections, we move away from union fittings to use what are known as “clamp” technology fittings.
- When welding, we will use what we call orbital welds with roughness checks and we can also choose to use specific materials.
Do medical users always know what they want when it comes to cleaning? Do you advise them on the cleaning methods to use?
It depends on the customers. We have to distinguish between major users, in the market for a long time, and smaller companies that are just starting up.
In general, large groups know exactly what they want and submit very precise specifications that we have to follow to the letter. In this case, we are content to meet these specifications, which does not prevent us from suggesting different solutions to meet their requirements.
For newcomers or medium-sized companies, we advise and guide them in the choice of machines to be used. We have extensive experience in the subject and we’re delighted to share it with them. Of course, we draw particular inspiration from previous work done with the major users mentioned above.
Other than sales revenues, what have your customers in the medical sector brought you?
In particular, the medical market has enabled us to improve our procedures. Procedures in the medical sector are well thought out and it can be used in other sectors.
Moreover, other users are increasingly inspired by these methods. When I talk about procedures, I think particularly of qualification processes, such as for an installation following the IQ/OQ/PQ protocol.
Would you like to know more?
Marco Höfler, managing director of FISA Ultraschall GmbH, will be happy to advise you at any time.