NEWS
October 9, 2026
Modular white room vs. Conventional construction: when to choose each
The design stage of a clean room is not easy at all. In fact, many and very diverse criteria must be taken into account to ensure, before the cleanroom project goes ahead, that we are considering the most suitable design for the cleanroom. Let’s see what criteria are taken into account to define a clean room project taking the pharmaceutical sector as an example
The criteria to be assessed in the definition of a cleanroom project for the pharmaceutical sector are diverse and should be carefully considered To ensure the efficiency and effectiveness of the space. When we are defining a project of these characteristics, it is vitally important to analyze the needs of the team and the limitations that derive from the location of the room, among other criteria that we will define below. All this, with the aim of ensuring that the design of the clean room is the most suitable for, when it begins to be used, it is truly useful.
The definition of a cleanroom project in pharmacy is a complex process that involves the consideration of a series of key criteria and factors. Not only should the needs of the work team be defined and a list of requirements that respond to these needs, but also to know the limitations that originate from the infrastructure and develop a design that covers all areas of work. All this in order to determine the level of the clean room to share all the elements necessary for its construction. In this way, since the design stages of the clean room, aspects such as the degree of clothing, the distribution of clothing and the flow of materials and people, as well as waste and finished products are being taken into account.
Determining needs is essential when establishing the criteria to be assessed in the definition of a project of clean room for him pharmaceutical sector. This allows you to ensure that the cleanroom design meets all the necessary requirements to guarantee a controlled and safe environment for the handling of pharmaceutical products. Let us remember that the pharmaceutical industry is a bit special since the production of medicines is highly controlled to ensure that everything that is manufactured is safe for users. For this reason, it is not unusual for the cleanroom project to take into account criteria such as pharmacotechnics, sterile medicines (both dangerous and non-hazardous), storage of equipment or cell therapies, among others.
To continue with the process of defining a clean room project, after analyzing the existing needs according to the design of the clean room, A user requirements document must be prepared in which the security measures, the distribution plans, the required supplies, the quantities to be elaborated and the flowcharts are fixed. This will help to avoid errors or delays in the construction and start-up of the room, which can affect the efficiency and productivity of the equipment in the short or medium term.
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Secondly, in addition to designing the clean room, by defining a project of these characteristics, It is important to take into account the size and location of the same. The room project must be large enough to house the equipment and processes necessary for the job, but it should not be so large that it is expensive and difficult to maintain in adequate conditions. In addition, the location of the room should allow easy access for staff and equipment, as well as adequate air circulation and natural light input.
To draw the plans of the clean room project, a classification of the different zones that compose it must be made to know its disposal and the flows of the human team, materials, waste and finished product.
To determine the levels of the cleanrooms, it is necessary to follow an evaluation and measurement process based on the different ISO standards. This includes carrying out an analysis of the environment in which the room will be built, as well as a review of the applicable regulations and regulations. In addition, the conditions of use and handling of the products to be stored or processed in the room must be taken into account.
Once these variables have been identified, The criteria established by ISO 14644 can be used to determine the level of the clean room, where the different degrees that define it must be used (Grade A, Grade B, Grade C and Grade D), with their consequent application (ISO-4.8, ISO-5, ISO-7 and ISO-8). It is important to note that to obtain the degrees, the number of air renewals must be directly proportional to the volume of the room and the equipment and people present, so this should also be taken into account when designing the clean room. To this must be added the recommendations of minimum degrees depending on the aseptic preparation.
For example, for the preparation and treatment of dangerous medicines, a minimum degree of work area A is required, with a negative pressure and a B or C grade in the work zone environment. For this reason, defining the project and the design of the clean room without having this factor would not make any sense.
After evaluating the project level, The following criteria to be taken into account in the design of the clean room is the adaptation of the room to the human team. On the one hand, the type of clothing will be fixed according to the degree, in addition to the change when going from one grade to another (for example, from grade D to grade C). The sharing of a defined design of changing rooms and exchange rooms is another factor that determines the suitability of the room, with pre-vesting accesses and toilets that facilitate the flow of people between Aseptic or sterile areas. Just as important is to define the design of the material lock, with a distribution according to the size of the equipment and the flows of waste and air.
The White room design It requires taking into account a series of aspects that go beyond air quality and the level of pollution, in addition to the aforementioned criteria. These include the maintainability, availability, and operating costs of the room, as well as reduction of requirements when the room is not in use.
It is also essential to consider the temperature of the room, as well as the compatibility with other facilities of the hospital and the Utilities available in it. In addition, cleanup measures should be established between processes and a maximum level of noise accepted in the rooms, not to mention the factors that depend on the property engineering (Technical supervision of the facilities, quality control, monitoring reports, review and validation of the plant maintenance plan, etc.). All these aspects are crucial to ensure a safe, controlled environment In the clean rooms and, therefore, they must always be taken into account to define a room project of these characteristics.
Yes, depending on the sector to which the clean room is directed and the processes that are going to be carried out inside, the regulations can establish other mandatory requirements that must be taken into account.
All, taking into account that the regulations establish very specific requirements for this type of installation, it is mandatory to take all these criteria into account since, otherwise, security could not be guaranteed.
No, all the criteria are important because, although there are some that may seem more obvious, if not all of them are taken into account, the cleanroom project may end up being useless due to a lack of care when it comes to proposing the design of the project.
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