Clean Rooms

Clean Rooms

MARZI MEDICAL has made an important investment in Technology and Systems to create 2 CLEAN ROOMS, dedicated exclusively to the production of SURGICAL MASKS.

The functioning of our CLEAN ROOMS has been verified through an “Operation Qualification” Process drawn up by the SYSTHEMA Company, which has evaluated them ISO 8 of the EN 14664-1: 2016 STANDARD, suitable for the production of DM Surgical Masks.

THE CLEAN ROOM allows the production of DM in a context of "controlled" BACTERIAL CHARGE, that is, thanks to the continuous air changes, which in the case of ISO 8, correspond to 20 Volumetric Parts per hour (a normal air conditioning system performs 2 air changes in 1 hour), if the operators carry out all the operations correctly, we are sure to obtain a SURGICAL MASK with the correct BACTERIAL CHARGE.

The systems that make up a clean room are:

UTA - Air Treatment Unit
Heat pump
Dehumidifier
Channeling of the air delivery and return
Controlled and interlocked accesses to the production areas, through filter areas for both operators and raw materials and finished products.
Environments dedicated to the ozonation and sanitization of materials before accessing the production areas.