Production in clean rooms
The raw materials for specific medical packaging manufactured in a clean room have standard certifications from both the F.D.A (US Food and Drug Administration) and the E.E.C. (Joint EU Health Authority). These raw materials are also manufactured in clean rooms and under particularly stringent quality control.
Clean room – In the case of medical applications and the electronics industry, the level of cleanliness is higher than usual, every production process is carried out in a clean room where strict air and humidity standards are strictly monitored. The cleanliness level in the clean room is measured in units of several particles per cubic meter achieved through special filters called particle filters. In the clean room there is higher air pressure than the pressure in the outside environment, the walls of the room and all the equipment in it are made of non-particulate materials and the clean room workers also wear special clothing made of non-particulate materials, which prevents the room’s contamination. Entrance and exit to the clean room is done through a controlled entrance and exit. The room is cleaned as part of the ongoing work and with special cleaning materials and only approved standard.
ISO-14644-1 This standard is determined by the particle size of 0.1 micron, which is allowed in the volume of cubic meters (cubic meters). This standard is defined by the exponent of 10 in the number of particles allowed. For example: ISO – 1 is the permissible standard. For 10 with 1 particle unit to be found in one cubic meter. Also ISO 13485: 2016 and ISO 9001: 2015 certifications