The raw materials intended for specific medical packaging manufactured in a clean room have standard approvals of both the FDA and the European Health Authority (EEC). These raw materials are also manufactured in clean rooms and under strict quality control.
Clean room – The packaging industry for medical applications and the electronics industry requires a higher level of cleanliness than usual. The entire manufacturing process is carried out in a clean room, where standards are strictly controlled in terms of air pressure and humidity. The cleanliness level in the clean room is measured in units of the number of particles per cubic meter obtained by 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 is made of materials that do not emit particles, and the employees in the clean room wear special clothing that is made of materials that do not emit particles, thus preventing the pollution of the room. Entry and exit into the clean room is done through a controlled entry and exit complex. Cleaning the room is done as part of the regular work and with special cleaning materials and certified standard only.
ISO-14644-1 This standard is determined according to the number of particles in the size of 0.1 microns, which is permitted in the volume of cubic meters. To 10 units of particles to be found in one cubic meter.