We all, in some way, have seen a Clean Room at the cinema, on television or in the press. They are the typical rooms, almost laboratories, where people dress in blue insulating suits before entering. But do you know what a clean room really is under an ISO-7 control system?

Clean Room Concept

The clean room is a rigorously designed facility to obtain the lowest levels of contamination.

These rooms must have the following environmental parameters strictly under control:

  • Air particles
  • Temperature
  • Humidity
  • Air flow
  • Internal air pressure
  • Illumination

In addition, the total asepsis both within the room and in all the components, tools and utensils, as well as the personnel entering it. This usually goes through rigorous security processes to avoid introducing any type of contamination in the room.

 Security and control system

A rigorous security and control system are carried out in a clean room. Possibly, it is one of the places with greater security and control in the world given the different activities and products that are developed or produced in them.

These security and control systems manage aspects such as:

  • The air entering the room has been filtered and specially treated to remove suspended particles and microorganisms. It is renewed between 20 and 30 times per hour so as not to accumulate particles.
  • The rooms are maintained on a pressure scale somewhat higher than those outside. This is so that, when the doors open, the air comes out and no outside air can enter, contaminated with particles.
  • The walls are covered with phenolic resin and the corners are rounded and protected with stainless steel plates to avoid dirt accumulation.
  • Operators must wear special suits that prevent the emission and release of particles and fibers.
  • The rooms have locks to maintain pressure differences.
  • In the clean rooms HEPA filters are used to retain particles. In addition, annual external audits and periodic internal controls are carried out to ensure total aseptic space.
  • Medical products manufactured in a clean room are, therefore, guaranteed to be free of any particles that can contaminate them. In addition, white room injection does not necessarily imply a higher final production cost.

Functions of the Clean Room ISO-7

These types of spaces are used in sectors whose processes require an air without impurities. Especially the microelectronic products and pharmaceutical industry.

They are also used in areas such as:

  • Micro mechanisms.
  • Optics.
  • Biotechnology.
  • Medicine.
  • Food.

The Clean Room ISO-7 of Triana Plastic Industries

In Industrias Plásticas Triana we have a Clean Room space with an area of ​​195m2.

The room has a production capacity and is equipped with:

  • Production capacity of 80,000 15ml cups (ref. 3233) per day
  • Equipped with 5 injection machines of 100TN
  • 1 150TN injection machine
  • 1 silkscreen printer
  • 2 assembly machines (seal caps, nozzles with cannula)
  • 1 PP film wrapper
  • Manual assembly zone
  • Air ultrafiltration decontamination system

The modularity of the room allows a degree of adaptability to customer needs by offering a specific solution. The room has a specific sanitary protocol in compliance with its ISO 7 classification according to ISO 14644 and ISO 14698.

More information

 

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