Tubes for the Medical Area produced in a Certified Clean Room
At Tucab, we manufacture tubes according to the client's needs and specifications for different application areas, namely, for the hospital medical sector. We are the only company in the Iberian Peninsula, in the extrusion area, that manufactures tubes in a Certified Clean Room (space with a controlled environment in which the indoor air pressure is higher than the outdoor air pressure and this is renewed more than 30,000 times an hour) .
TUCAB has the know-how to produce non-sterile extrusion tubes for non-active medical devices in the third party, and for that, it is:
- Equipped with a clean room classified as ISO 8 in accordance with ISO 14644-1:2015, through annual tests by an accredited entity.
- Company certified by UNI CEI EN ISO 13485:2016 by the certifying entity TÜV Rheinland Italia S.r.l.
In addition to the mandatory requirements mentioned above, the manufacture of products for the medical area also requires the fulfillment of strict procedures, such as:
- Acquisition of certified raw material for the production of tubes for medical devices
- Special care with the uniform and hygiene of workers
- Monitoring of operating conditions in the room (such as temperatures, humidity, pressure in the room) by a scientific environmental monitor
- Tube packaging
- Control of product specifications
The control of product specifications
, that is, internal and external diameters, thicknesses and lengths, is carried out during production
using monitoring equipment, such as the diameter gauge (which monitors the outside diameter of the tube at 100%), caliper and three-point micrometers. (You can see more information about this equipment in this ARTICLE
), in addition to the monitoring that is carried out during production, a post-production validation is also carried
out by those responsible for the Quality department, which consists of analyzing the results taken from the continuous measurements of the diameter gauge, as well as measurements of samples taken during production.