Cleanrooms, also known as controlled-environment rooms, are spaces that house production operations or processes requiring environments that are completely free of particles in order to guarantee the quality of such activities. Cleanrooms in the pharmaceutical industry must meet strict sterility standards to ensure that the work carried out in this sector is performed flawlessly.
The design of cleanrooms in the pharmaceutical sector must be geared towards minimising the risk of contamination and preventing the presence of pathogens, thereby ensuring safe and controlled environments.
The walls are typically made up of self-supporting sandwich panels, assembled using tongue-and-groove systems. Surfaces must be completely smooth and continuous, using materials such as steel (stainless, galvanised or plastic-coated), melamine or thermosetting resins.
As for the core, insulating materials such as extruded polystyrene, polyurethane or rock wool are used, depending on the thermal and strength requirements of the project.
Both walls and ceilings must be inert and resistant to chemical agents. The joints between surfaces (floor, walls and ceiling) must incorporate sanitary solutions, such as half-round profiles, to prevent the accumulation of particles and facilitate cleaning.
Doors are also usually of the sandwich type, whilst windows must have double glazing to ensure insulation and airtightness.
With regard to flooring, the use of materials such as PVC is recommended in high-traffic areas, due to its wear resistance and ease of maintenance. Furthermore, floors must be antistatic, particularly in pharmaceutical cleanrooms housing sensitive equipment. In environments with aggressive chemicals, epoxy resins offer high resistance and impermeability.
One key factor to consider is the lighting fixtures, which must be very easy to use, maintain and clean, and must be designed, above all, to prevent the build-up of particles. Specifically, LED lighting fixtures emit less heat and have a longer service life
These factors are vitally important for the effectiveness of cleanrooms in pharmacies.
On the one hand, filtration is essential to retain particles and guarantee airtightness and sterility. The use of HEPA (High Efficiency Particulate Air) filters is particularly noteworthy.
These are highly efficient units (>99.999%), capable of retaining particles as small as 0.3 μm (the most penetrating particle size).
Similarly, the climate control system must meet strict standards to ensure the humidity, pressure, temperature, and comfort levels required for the well-being of the staff and the success of the activities performed.
Likewise, it is crucial to control cross-contamination through strict monitoring of the clothing worn by staff entering and exiting the cleanrooms. To this end, air showers and activated carbon gas extraction systems, among other methods, are incorporated.
In short, cleanrooms are essential for bacteriological and particulate containment in pharmaceutical production and research processes.
The specific standard governing cleanrooms is ISO 14644. Specifically, for cleanrooms in the pharmaceutical industry, Good Manufacturing Practices (GMP) dictate the essential guidelines for achieving the necessary quality standards.
Furthermore, and crucially for this type of cleanroom, is ISO 14644-1, which establishes the maximum permissible particle concentrations (per cubic meter of air) based on specific particle size (in micrometers).
Among the applications of biotechnology in the pharmaceutical industry are new production techniques designed to create innovative new products. This, in turn, also improves existing processes and helps to identify therapeutic approaches.
Some of the filters validated for the pharmaceutical industry are as follows: · Aquafil™ polyethersulfone membrane cartridge filter · Biofil™ Plus polyethersulfone membrane cartridge filters · Biofil™ II polyethersulfone membrane cartridge filters. · Fluorofil™ ePTFE (expanded polytetrafluoroethylene) Membrane Cartridge Filters
Validation in the pharmaceutical industry can be defined as documented evidence that a system or process is capable of consistently producing a series of consistent results, thereby ensuring the quality of the medicinal product in question
Cleanrooms are spaces used for operations or production processes that require an environment completely free of particles in order to ensure the quality of these activities.
