The History of cleanroom

The Americans are the pioneers of cleanroom technology. However, the origins aren’t linked to the medical world but to the microchips one.

In fact, the first microelectronics industries and in particular those that manufactured semiconductors started to increasingly push the development of cleanrooms, with the aim of increasing production efficiency and product quality in terms of purity.

The particles suspended in the air (micro-dust) irreparably damaged the micro-photo-engravings that form the chips, creating a faulty electronic circuit and therefore waste.

The cleanroom in medical sector

Subsequently, the use of cleanrooms also developed in the medical field for very similar reasons.

In a cleanroom, the air is filtered to remove particles, bacteria and other contaminants. Furthermore, the materials used for the walls, floors and ceiling are designed to minimize the release of particles.

The production of these products requires a highly sterile environment to avoid contamination by bacteria, viruses, particles and other contaminants.

Cleanrooms are divided into categories based on their efficiency. The category depends on the maximum number of particles allowed per cubic meter and their size.

The cleanroom in Leghe Leggere

Inside our cleanroom there is a fully automated by robots in-line washing system, both in the loading and unloading phases, and in the intermediate phases of the cycle.

How does this system work?

It starts with a first wash in water with both powder and liquid surfactant, up to the last step in demineralised water. At the end of the process, any impurities present on the devices have been removed.

After the washing phase, the primary packaging takes place (blisters, tyvek bags or vacuum bags) which guarantees perfect sealing against external polluting agents.

The packaging work is completed with the labeling and insertion of the blisters in the special boxes which are protected from dust by a transparent shrink film.

Thanks to the cleanroom and washing system, any implantable medical device that leaves our company is free from any impurities.