A clean room is, by definition, a room in which the concentration of particles is constantly controlled: it is managed in such a way as to minimize the introduction, generation and retention of particles. It is a closed environment, in overpressure conditions (thanks to which there is a filter with absolute HEPA type filters).
The rooms of the clean room are made with criteria such that floors, walls, ceiling, doors and windows offer maximum ease of cleaning, washing and disinfection, also the personnel who access these rooms must have PPEs that limit the introduction as much as possible of contaminants.
Market research shows that we are one of the very few implant companies in the world to produce the plastic components of its packaging within its factories. This allows us to monitor with particular attention the production, control and cleaning process of the packaging, to guarantee the customer a product of the highest possible quality.
Inside the new production building two of the three clean rooms are communicating, and both are ISO 7 classified: one is dedicated to the molding of the plastic components of the packaging while the other is functional to the assembly of the systems in their packaging.
To check the suitability of these safe environments, relevant parameters undergo regular monitoring:
- overpressure of the rooms (checked daily);
- air particles contamination;
- surfaces microbiological contamination;
- microclimatic conditions (temperature and relative humidity in %)
- bioburden (quantity of bacteria existing on an unsterilized surface) collected on each class of product.
Microbiological control levels called “alerts” and a subsequent “intervention” level have been set to warn the operator in case of any level change. In this way, it is possible to act in a preventive way and, in extreme cases, to restore optimal conditions in a very short time with corrective actions.
In our case, periodic monitoring confirms the suitability of the premises and shows that our average values are well below the alert limits, effectively eradicating the risks of contamination during both the creation of the containers and the packaging of the product.
To exchange material from and to the clean room to another external space and vice versa it exists the Pass Box: it is a small passage with specific decontamination systems, delimited by two doors not to be opened simultaneously.
In the plastic-moulding clean room we produce all those components that are necessary to pack our implants: the internal transparent mini-ampoule, the external cylindrical container, the implant holder, the screw lodge, the internal coloured cap and the external coloured cap.
We own two plastic moulding machines, of different sizes and capacities depending on the pieces to be made.
The plastic materials we use comply with the quality standards dictated by international regulations and are of different types depending on the processing required.
The moulding process begins in the dryers positioned outside the room which give the neutral plastic granules the right humidity conditions to be processed. After this fundamental step, the granules are conveyed directly into the clean room inside the printing machine, through a special controlled conduit: by doing this, the raw material does not come in contact with the external atmosphere and maintains its characteristics. Dye granules in variable quantities can be added to the neutral granules, to create the coloured components corresponding to the colour code of the implant diameters.
The specialized operator doses the quantity of granular plastic required and he also establishes the necessary temperature for the melting. By melting, a plastic fluid is created which is injected into the appropriate mould via a filling channel. After few seconds the filled mould opens again, the extruded and already formed figure detaches and descends into the collection container.
We have also decided to produce our transparent ampoule in the clean room which acts as the container for the implant: it is entirely made by us, in controlled hygienic conditions, through a process that avoids the production of plastic production waste. In fact, only the ampoule will come out of the mould, ready to receive the implant. Environment friendly!
The transparent package thus created can leave the controlled environment of the clean room to find its final location in the B&B Dental cardboard packaging. The implant is ready to be sterilized with gamma rays and then it will be ready to reach you all over the world!