Cleanroom Design, Construction and HVAC: Key Requirements for the Cosmetics Industry under Current Regulations
Any cosmetic product we use every day — from soaps, make-up and perfumes to creams and toothpaste — undergoes a long and carefully controlled manufacturing process to ensure quality, safety and hygiene before it reaches the consumer. The cosmetics industry is one of the fastest-growing sectors in Spain. Every stage surrounding the manufacture of these products — from the facilities themselves to handling, packaging, storage and transport — is subject to strict controls and regulatory requirements.
These include ISO 22716, which provides guidelines for the production, control, storage and shipment of cosmetic products, and GMP (Good Manufacturing Practices). Both operate within the regulatory framework established by European Regulation (EC) No 1223/2009, which was incorporated into Spanish legislation through Royal Decree 85/2018.
The cosmetics industry must meet stringent safety and quality standards throughout the entire manufacturing process, including within cleanroom and controlled environments. Valtria, a Spanish company specialising in the design and installation of cleanrooms, containment areas and biosafety environments for the cosmetics and pharmaceutical industries, applies these good practices across its projects, rigorously following GMP requirements in relation to planning, architecture and the implementation of control measures to ensure that facilities maintain optimal conditions at all times.
What Do GMP Requirements Say About Cleanrooms in the Cosmetics Industry?
Cosmetics legislation in Spain is overseen by the Spanish Agency for Medicines and Medical Devices (AEMPS). Its purpose is to ensure appropriate levels of product safety and quality, given that cosmetic products can have a direct impact on human health.
This involves a range of requirements applicable to cleanrooms and other areas where cosmetic products are manufactured, covering aspects such as facility design, architecture, air filtration and HVAC, as well as stringent hygiene requirements for both personnel and materials.
Drawing on more than 20 years of experience in cleanroom environments, Valtria’s specialists identify the key considerations for designing and installing these areas in accordance with GMP requirements:
Design
Each cleanroom must protect the product, allow effective cleaning and disinfection, minimise the risk of mix-ups involving products, raw materials and packaging, and enable effective maintenance.
To achieve the required hygiene conditions, the different processes involved in cosmetic manufacturing should be carried out in appropriately separated areas. Production, storage, quality control and other supporting activities must therefore be organised to minimise the risk of cross-contamination.
Architecture
Spanish requirements in this area are clear. Floors, ceilings, windows and walls must be constructed from durable materials that can be cleaned effectively. The design should therefore minimise corners, recesses and other areas that could make cleaning and sanitisation more difficult.
Pipes, beams and ductwork should be installed so that they can be thoroughly cleaned if exposed. Wherever possible, however, these elements should not be exposed within the working area.
HVAC System
HVAC and ventilation systems are fundamental to the correct operation of cleanroom environments. They must provide appropriate conditions to protect cosmetic products and minimise, as far as possible, the risk of external contaminants coming into contact with the product.
Air treatment must also maintain temperature and humidity conditions appropriate to the specific manufacturing process being carried out.
As we have seen, GMP requirements establish specific criteria for cleanroom facilities. Ensuring that these requirements are properly addressed calls for specialist expertise. With extensive experience and technical know-how in the sector, Valtria provides comprehensive solutions designed to meet the demanding requirements of the cosmetics industry.
Main Production Areas
ISO 22716 establishes that different operations should be carried out in appropriately separated areas, including storage, production, quality control, changing and washing areas. Each area has its own specific requirements and should be connected to the others in a way that supports a logical sequence of operations.
Storage Areas
Storage areas must protect raw materials and packaging materials according to their specific characteristics. Where raw materials require particular temperature and/or humidity conditions, these parameters must be controlled and monitored.
Storage areas should also allow materials to be properly organised and prevent mix-ups between their different statuses, such as quarantine, approved, rejected, returned or in-process materials.
Sampling and Weighing
Sampling and weighing raw materials are critical activities because the product is exposed to the surrounding environment and may therefore become contaminated. In addition, different products may be sampled or weighed within the same area, increasing the risk of cross-contamination.
Although specific environmental conditions for sampling and weighing starting materials are not prescribed, these activities must be carried out in a way that protects the product and prevents cross-contamination. Therefore:
The air quality within the sampling area should be comparable to that of manufacturing areas where the product is exposed.
Appropriate barriers — such as airlocks, dust extraction systems and controlled pressure or airflow direction — should be implemented to prevent traces of sampled or weighed products from migrating into other areas.
Sampling and weighing areas should also be designed for effective cleaning to minimise cross-contamination between different products.
Manufacturing
Manufacturing areas where the product is exposed — for example, during raw material charging, discharge or open transfer of intermediate products — should have controlled air quality and be separated from areas such as storage, weighing and packaging.
Treated air should flow from cleaner, more critical areas towards less critical or less clean areas. Depending on the criticality of the process, airlocks may also be required to reinforce segregation between different zones.
Primary Packaging
Within the primary packaging area, the product remains exposed until its immediate container is closed. Air quality and cleanliness requirements should therefore be comparable to those applied within the manufacturing area.
There should be physical separation between manufacturing and primary packaging, together with clearly defined, unidirectional production flows covering product, packaging materials, waste and packaged product.
Primary and secondary packaging areas should also be physically and functionally separated.
Secondary Packaging
In the secondary packaging area, the product is already enclosed within its primary container, meaning air quality is less critical and the risk of product contamination is significantly lower. However, there remains a risk of mix-ups during cartoning or labelling, which could result in a product being packaged or identified incorrectly.
Order and logical material flows therefore remain essential, covering packaged products, cartons, leaflets, labels, finished products, rejected products and waste.
This area requires efficient communication with both the primary packaging and storage areas. It also typically contains significant quantities of paper, cardboard and other packaging materials that could compromise cleanliness within the primary packaging area.
It is therefore essential to clearly define the separation between primary and secondary packaging areas, including physical segregation, personnel and material flows, and the relative pressure regime between the two areas.
Washing Area
The washing area should also follow a logical material flow: soiled equipment → washing → clean equipment.
According to ISO 22716, once accessories have been cleaned, they should be stored under appropriate conditions if they are not going to be used immediately, protecting them from moisture, splashes and dirt.
For this reason, it is advisable to provide a dedicated clean equipment room adjacent to, but physically separated from, the washing area.
Changing Rooms and Sanitary Facilities
Dedicated changing areas should be provided so that personnel can remove outdoor clothing and change into workwear appropriate to their activities. Changing rooms should be separated from production areas while remaining logically connected to them, avoiding unnecessary movement through other areas.
Personnel hygiene is an important aspect of ISO 22716. Adequate sanitary facilities should therefore be provided, with a sufficient number of showers, washbasins and toilets. These facilities should be separated from production areas while remaining easily accessible.
Quality Control
Quality Control laboratories should be separate and independent from production and storage areas, while providing convenient access to changing rooms and sanitary facilities or having dedicated facilities of their own.
The layout and characteristics of the laboratory will depend on the type of testing and control procedures being performed. In general, the same fundamental principles apply as in other areas: sufficient and appropriate space, a logical sequence of operations and environmental controls suited to the activities being carried out.
