NEWS
October 9, 2026
Modular white room vs. Conventional construction: when to choose each
As we know, there are numerous standards and regulations in the so-called high-health risk areas such as laboratories and hospitals to ensure safety. In other posts we have talked about ISO regulations or GMP standards. On this occasion we tell you everything you need to know about the UNE rules and, specifically, about UNE 100713.
The UNE standards are a set of quality standards in the manufacturing processes established by the Spanish Association of Standardization. In principle, this series of standards is not mandatory, but what is established according to the UNE standards can be mandatory if established by law. Although there are guidelines and regulations of this type for all types of sectors and processes, what is related to clean rooms is specifically within the UNE 100713 standard, as we will see below.
The UNE 100713 regulations include all the necessary requirements for the correct use of conditioning facilities in high-risk areas, such as: hospitals, clinics, operating rooms, sterilization areas or intensive care units, with the aim of protect the health of patients and health personnel. These are some of the sectors in which the White Rooms are more present, so they must ensure that they meet the requirements established in the UNE Standards..
Each of these areas, due to the risks involved, has its own specific treatment and health requirements to ensure air quality and the correct use of the facilities. These requirements and specifications are included in UNE 100713, thus complementing other standards such as ISO or GMP.
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The UNE 100713 standard reviews the high-risk facilities at the internal level and divides them taking into account the hygienic and physiological requirements of each area according to the risk. Within a hospital there are different levels of risk depending on the area where it is located, that is why some special units and rooms such as the operating rooms have their own cleaning and disinfection protocols, in addition to the relevant revisions of the quality of the facilities in relation to ventilation.
It is necessary to analyze the level of hygiene for the correct use of the rooms and thus protect the safety and health of patients, especially those who are in high-risk situations. The good use and behavior of the facilities by workers in the health sector is essential to ensure quality and hygiene conditions, which is precisely what is established in the UNE regulations.
Each work area also has its own maintenance, cleaning and disinfection protocol, which requires compliance with very marked technical requirements to prevent the transmission of diseases and contamination of germs and other agents that can pose a serious risk. In these sectors, the revision of the air ducts, the closing gates and firewalls, and the smoke extraction zones are important, so sticking to the regulations is especially important.
All these characteristics necessary for the inspection are included in the annexes of the UNE 100713 standard, where the protocols to be followed are specified, as well as the factors to be reviewed so that, once the services are installed, the pertinent tests can be carried out in terms of reception, hygiene and ventilation systems in specific premises, as well as temperature and pressure control for proper operation.
The last revision of the UNE 100713 was carried out in 2015 and establishes the factors that must be reviewed frequently to comply with a demanding ventilation that covers the needs of a hygienic nature and, at the same time, maintain favorable conditions of temperature, humidity and pressure of the environment.
The priority in this health field is, to the extent possible, to avoid outside pollution and the prevention of infections, reducing the existence of polluting agents. For this reason, the UNE standards mark in detail how the design of the facilities should be with their inlets and outlets from the air, and emphasizes the ease of access to cleaning points, maintenance, disinfection and changes of filters to favor its correct circulation, so that this rule must be taken into account when designing a clean room.
Now you know what the UNE rules are and why you should always follow them. The UNE 100713 regulations are impossible to ignore when dealing with clean rooms, so don’t hesitate to Download the rule here.
The UNE standards are drafted by the National Standardization Agency (UNE), with a special technical committee in which all those interested in its preparation can be present and anyone (even if it does not belong to the UNE) can give their opinion. The process goes through a series of phases until a consensus is reached for its subsequent publication in the BOE.
For clean rooms the main standard is ISO and the correct manufacturing standards (GMP). These establish the conditions and standards that facilities of this type must comply with to ensure safety. However, it must also be taken into account that in certain industries and sectors there may be specific regulation that must be taken into account.
Initially, when the standards are drafted, they are voluntary. However, these can be made mandatory if the authority approves them as mandatory laws or regulations. Therefore, it will depend on each case.
We handle the design, installation, management, and maintenance of cleanrooms, prioritizing safety and offering customized solutions. We will also contact you to discuss your project and prepare a quote tailored to your needs.
