Medical devices

CAMISANA manufactures items for the medical sector in ISO Class 8 cleanrooms.
In this production space, subjected to temperature, humidity and air pressure control, with planned checks on the presence of particulate matter and bacteria, using only platinum-catalysis silicone in certified medical class (USP Class VI minimum requirement) we create using a compression press for HCR molding and an injection molding machine for LSR molding, components for medical devices and objects intended for the medical and paramedical sector such as:

• Moulded and co-moulded parts to design for healthcare equipment and equipment;
• Valves, diaphragms and seals of pumps for the management of fluids and dusts;
• Caps, mats, plates and accessories for the laboratory;
• Masks and respirators;
• Functional and aesthetic prostheses;
• Personal devices;
• Every detail according to the customer’s design.

All our productions are made in accordance with the ISO9001:2015 and ISO13485:2016 certifications Company with more than 40 years of experience, equipped with qualified personnel. We are able to examine, develop and manufacture the components of your medical devices, suggesting the most suitable raw material, following and defining the production processes in compliance with current regulations. We have a wide range of medical grade silicones that allow us to manufacture your components according to the required technical specificities:

• Hardness from 10 Sh A+-5 to 90 Sh A+-5
• Temperature resistance from -70°C (up to -110°C) to 200°C (up to 300°C)
• They are available in all colours
• USP CLSSE VI, FDA or EU Pharmacopoeia quality.

For further information regarding the production of medical and biomedical devices in the Clean Room, one of our technicians is at your disposal at +39 035882371 or by writing to info@camisana.it • Read our in-depth study on Silicone Molding