The keys in the design, construction, and HVAC of cleanrooms in the Cosmetics Industry under current regulations.

Published JUNE 2023  -  CLEANROOMS

Blog > News > The keys in the design, construction, and HVAC of cleanrooms in the Cosmetics Industry under current regulations.

Any cosmetic product we use on a daily basis, such as soaps, makeup, perfumes, creams, or toothpaste, goes through a long and careful manufacturing process to ensure a result of quality, safety, and hygiene when it reaches the hands of users. The cosmetic industry is one of the sectors with the highest annual growth in our country. Everything surrounding this industrial area, from the facilities where these products are manufactured to their handling, packaging, storage, and transportation, must undergo strict control that is subject to different regulations applied in our country. This includes the ISO 22716 cosmetic regulation that governs the phases involved in the manufacturing of these products, such as quality control tests, packaging, storage, distribution, and the GMP (Good Manufacturing Practices) regulations or Good Practices for the Use of Cosmetic Products. Both are regulated by European Regulation No. 1223/2009, which was implemented in Spanish legislation through Royal Decree 85/2018.

The cosmetic sector must comply with the safety and quality standards required throughout its manufacturing process, including clean rooms or sterile environments. Valtria, the Spanish company specialized in the design and installation of clean rooms, containment areas, and biosafety for the cosmetic and pharmaceutical industries, applies these good practices in each of its projects, strictly complying with GMP regulations in terms of planning, architecture, and control measures implementation to ensure that the facilities meet optimal conditions at all times.

What does the GMP regulation say about clean rooms in the cosmetic industry? 

Cosmetic legislation is managed by the Spanish Agency of Medicines and Medical Devices (AEMPS). Its objective is to maintain and facilitate optimal safety and quality conditions for the product because it understands that its final use can directly affect people's health. This includes a list of requirements that clean rooms, the places where the manufacturing of cosmetic industry products takes place, must comply with. These requirements range from design projects, architecture, filtration, and air conditioning to impeccable cleanliness of both personnel and all materials. Valtria's experts, with more than 20 years of experience working in clean rooms, provide us with the main key points in the design and installation of these areas following the GMP regulations:

  • Design:

    Each of these rooms must guarantee product protection, allow efficient cleaning and disinfection, prevent any risk of product confusion, mix-up of raw materials and packaging, as well as achieve optimal maintenance. To achieve these hygiene parameters, all processes involved in the manufacturing of any cosmetic product must be carried out in separate rooms. In other words, separate areas must be built to avoid cross-contamination in production, storage, quality control, and other complementary activities.

  • Architecture:

    The Spanish regulation in this regard is very clear, as explained by Vatria. The floors, ceilings, windows, and walls must be made of resistant and easily cleanable materials. Therefore, to facilitate this task, spaces such as corners or recesses that hinder hygiene should be avoided. Regarding pipes, beams, or ducts in the rooms, they must be installed in such a way that they allow thorough cleaning if they are visible, but it is recommended that these elements are not exposed in the work area.

  • HVAC System: 

    The air conditioning and ventilation of clean rooms are crucial for the proper manufacturing process. The regulation states that it must be suitable to protect cosmetic products, avoiding external contaminants from coming into contact with the product as much as possible. With regard to temperature and humidity, the air treatment must be adjusted to specific conditions depending on the type of production being carried out.

As we have seen, GMP regulations establish specific requirements for the construction of cleanrooms. And the way to ensure maximum compliance with these demands is to rely on specialized companies like Valtria, which, with its extensive track record, experience, know-how, and expertise in this sector, offers complete solutions that satisfy the most demanding requirements in the cosmetics industry.

Main production areas

ISO 22716 states that there should be separate areas for different operations: storage, production, quality control, dressing rooms, washing, etc. Each of these areas has its own requirements and should be connected to others in a way that allows for a logical sequence of operations.

  • Warehouses:

    Warehouses should protect raw materials and packaging materials based on their characteristics.

    If there are raw materials that require specific temperature and/or humidity conditions, they should be controlled and monitored.

    Warehouses should allow for the organization of materials and prevent confusion among different states of the materials (quarantine, approved, rejected, returned, in process, etc.).

  • Sampling and Weighing: 

    Sampling and weighing of raw materials are two critical activities because the product is exposed to the environment and can become contaminated. Additionally, all products are sampled or weighed in the same area, increasing the risk of cross-contamination.

    ISO 22716 does not specify the conditions for sampling and weighing of starting materials. It only states that they should be performed while protecting the product and avoiding cross-contamination. Therefore:

    • The air quality in the sampling area should be similar to the air quality in the manufacturing area where the product is exposed.

    • There should be barriers (airlocks, dust collection systems, direction of pressure or airflow, etc.) to prevent cross-contamination through the migration of traces from the sampled/weighed product to other areas.

    • Sampling/weighing areas should be easily cleanable to avoid cross-contamination among different sampled/weighed products.

  • Manufacturing:

    The manufacturing areas where the product is exposed (raw material loading, unloading or transfer of intermediate products in open containers, etc.) should have controlled air quality and be separated from other areas such as warehouses, weighing areas, packaging, etc. The condition that treated air flows from the most critical and cleanest area to less critical or dirtier areas must be met. Depending on the process's criticality, it may be necessary to establish airlocks or barriers to reinforce separation.

  • Primary Packaging:

    In the Primary Packaging or filling area, the product is exposed until the container is closed, so it requires air quality and cleanliness similar to that required in the manufacturing area. There should be physical separation between Manufacturing and Primary Packaging and clear production flows without backward steps (product flow, packaging material flow, waste flow, packaged product flow, etc.). There should also be physical and functional separation from Secondary Packaging.

  • Secondary Packaging:

    In the Secondary Packaging area, the product is already closed in its package, so air quality is not as critical, and the risk of product contamination is minimal. However, there is a risk of confusion in the boxing or labeling process, which could lead to incorrect packaging or identification (mix-up). Therefore, it is still important to maintain order and a logical flow of materials (packaged product, boxes or cases, leaflets, labels, finished product, rejected product, waste, etc.).

    This area needs smooth communication with the Primary Packaging area and also with the warehouse area. Additionally, it often has a significant amount of paper, cardboard, packaging materials, etc., which can compromise the cleanliness of the Primary Packaging area.

    Therefore, it is crucial to define the separation between the Primary and Secondary Packaging areas, including physical separations, material and personnel flows, and relative pressure differentials between them.

  • Washing Area:

    The washing area should also be established with a logical flow of materials: dirty material, washing, and clean material. According to ISO 22716, cleaned accessories, if not immediately put to use, should be kept in suitable conditions, protected from moisture, splashes, and dirt. Therefore, it is advisable to have a clean equipment room adjacent to the washing area but separate from it.

  • Dressing rooms and toilets:

    There should be dressing areas where employees can leave their street clothes and change into appropriate work attire for the task at hand. The dressing rooms should be separated from the production areas but logically connected to them to prevent personnel from having to pass through certain areas to access others.

    Personal hygiene is an important point in ISO 22716. Adequate toilet facilities equipped with a sufficient number of showers, sinks, and toilets must be available. These toilet facilities should be separated from the production areas but easily accessible.

  • Quality Control:

    Quality Control laboratories should be separate and independent from the Production and Warehouse areas but have easy access to the dressing rooms and toilets or have their own dressing rooms and toilets.

    The layout and characteristics of the laboratory will depend on the type of tests and control procedures to be performed. In general, the same general principles that apply to the rest of the areas are applied: sufficient and appropriate spaces, logical sequence of operations, and appropriate environmental control for the activities to be carried out.

Miguel Ruiz
GMP Consultor 


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