In 1999, Sterne built its first clean room, making medical device manufacture its core business.
In more than 600m² of clean rooms, an ultra-protected work environment where medical devices are mainly manufactured according to ISO 9001-2015 and ISO 13485-2016 standards; the Sterne company transforms exclusively medical-grade platinum silicone, that is implantable in the human body for the short or long term.
These ultra-protected production areas have regulated access and receive regular particulate and bacteriological controls. These areas represent the ideal work environment for products destined to the health industry, such as :
silicone gastric rings, silicone rubber catheters, silicone probes, silicone medical devices & components, short/long term implantable silicone devices,...
Sterne owns 4 clean rooms :
two ISO 6 classified clean rooms, one ISO 7 classified clean room, and one ISO 8 classified clean room.
These specific environments are used for various applications. Two ISO 6 clean rooms are dedicated to molding and calendaring production but also to the manufacture of custom fabricated silicone. One ISO 7 clean room is used for injection production, which is mainly automated, and one ISO 8 clean room is dedicated to extrusion for production by linear meter.
According to ISO 14 644-1, a clean room is defined by the degree of hygiene of a room, in accordance with its number of parts in the air.
Thus, clean rooms are classified according to the environment hygiene degree. Indeed, an ISO 6 clean room will be "cleaner" than an ISO 8 clean room where the number of particles in the air per cubic meter will be higher.
At Sterne, criteria such as:
• temperature and moisture control
• control of over pressure between rooms
• air speed measurement with an anemometer
• particulate count
• microbiological air and contact measurements
constitute the main work instructions, used with references according to standards:
- ISO 144644-1 : classification of particulate cleanliness of the air
- ISO 14644-2 : monitoring the maintenance of clean room performance
- ISO 14644-3 : clean rooms and mastered environments
As part of the design and use of the different ISO rooms.