Without a doubt, the pharmaceutical industry is among the sectors that require greater calculation, evaluation and precise control when designing air conditioning systems. Certainly, the choice of units, extraction equipment, filters, ducts and diffusers, among other elements, for the air conditioning of pharmaceutical laboratories requires professional criteria. The latter must be based on the conditions established by the regulations in force in the country where the factory is located. In this way, it is feasible to guarantee optimal processes, products of proven quality and the permanent safety of the workforce.
Indeed, the pharmaceutical industry must comply with very demanding standards related to the working conditions of the operators in each dependency. As well as it must ensure the correct performance of the air conditioning and ventilation equipment. The foregoing is given by the precise thermal parameters that pharmaceutical companies must comply with in all their processes. That is, in the preparation, packaging or packaging, distribution and storage of medicines.
It is pertinent to remember that many raw materials of pharmaceutical compounds, for example, microorganisms or biomolecules, are very sensitive to variations in temperature and humidity in the environment. A fluctuation in temperature or humidity level, no matter how slight, can damage an entire drug production. Consequently, control of both environmental elements is critical to guarantee success in the processing of active principles, compounds and substances.
Maintaining the cold chain, an essential aspect in the air conditioning of pharmaceutical laboratories
Certainly, in the pharmaceutical industry, the strict maintenance of the cold chain conditions, to a great extent, the quality and integrity of the drugs produced. Thus, it is feasible to ensure that, from production to delivery to sales or application sites, the company complies with rigorous temperature standards.
In general, most medicines and pharmaceutical products need temperature and humidity conditions between 20 and 23ºC. Although this range can reach, but not exceed 30ºC. However, certain drugs, particularly biological drugs, require a reduced temperature range between 2ºC and 8ºC for their conservation. Otherwise, they run the risk of degrading and losing their effectiveness.
In this sense, the most demanded resources for the air conditioning of pharmaceutical laboratories are the cooling plants and the air treatment units (UTAS).
First of all, the chiller plants air-condition the environment and control the temperature of the production processes. These systems cool water or glycol to a lower temperature (between 7 and 12ºC) when necessary to feed a refrigerated fluid circuit. Likewise, this type of equipment also provides a solution that cools the process liquid in the event of breakdowns in the facilities.
Air handling units
For their part, the air treatment units send the already cold air to the room that requires it. They simply capture the air from outside and bring it inside. And they also extract the air from the room and recirculate it. In short, the UTAS are a good alternative to fluid thermal energy distribution technology. Likewise, they are essential components in the air conditioning infrastructure of a building.
To conclude, these units are made up of heat pumps or exchangers (with water or glycol as coolant), fans and filters that make it possible to control all air conditions (temperature, quality, ventilation and humidity).
The “clean rooms” and their importance in the air conditioning in pharmaceutical laboratories
Obviously, most environments in pharmaceutical factories require hygiene at the highest level. These refrigerated rooms are commonly known as “clean rooms”. In its interior, the processes of scientific research, preparation and quality control of medicines are carried out. In general, they have controlled spaces within a building in which the presence of air particles and other polluting elements must be kept to a minimum.
In the same way, with the incorporation of UTAS, it is possible to increase the operability in these rooms through the adjusted treatment of the air for the purification of the area. Specifically, for the air conditioning in laboratories, production areas and offices, the UTAS facilitate the control of the temperature of the coolant that circulates through the exchangers of each space and that allows the circulation of ambient air to cool it. In addition to the above, it is also feasible to add terminal ventilation systems, such as fancoils. The latter captures this cold liquid and uses it to cool the interior air, as an alternative to the building’s splits.
Maintenance of humidity levels, critical in the air conditioning of pharmaceutical laboratories
Just as the temperature is considered, health regulations require that humidity levels be adapted to processes and products in the pharmaceutical sector. This factor also affects the comfort of the operators by limiting shedding and perspiration. Along these same lines, if the humidity does not affect processes or products, relative humidity (RH) is usually set within a range. Normally at maximum levels of less than 60%, with a lower limit determined by local habits and practices. To tell the truth, the control of the lower level of humidity does not usually have as much weight to address the problems linked to microorganisms. Although it can be important to solve other aspects such as static electricity, operator comfort and detachment.
In this regard, the HR acceptance range can be as wide as between 30% and 60%, which is very common and even proposed by various regulatory entities. Even so, there are companies that successfully widen this acceptance band from 20% to 70%. Of course, they do it according to their location and local weather conditions.
Another option to achieve the ideal range of acceptance is to keep the setpoints around 25% to 55% RH. Then, it is advisable to allow the system itself to express whether the RH degrees are exceeding these limits. They can then be seasonally adjusted to determine how workers’ perception of comfort changes with changes in season.
Filtration systems to prevent contamination
Another relevant aspect of the air conditioning systems in pharmaceutical laboratories is the filtration, both of the air that enters the premises, and of the extractions and dust collection. For example, in components of the air conditioning and ventilation system, such as air handlers, it is necessary to install air filters in stages. Thus, an air handler arranged for a non-sterile drug production area (tablets, capsules, syrups, suspensions, creams) will have 35% efficiency filters in the first stage. This prevents the accumulation of dust inside the unit and will serve as a protector in the next stage.
Next, in the second filtering stage, it will have filters with 65 to 70% efficiency, as pre-filters. In turn, these will serve as protection in the third stage. In the latter, filters with an efficiency of 95% will be incorporated, as established by the regulations.
Regardless of these parameters, some pharmaceutical laboratories request the installation of HEPA filters with 95% efficiency in the second stage and 99.97% in the last. This in order to ensure a particle count below the minimum required, which is allowed.
Intersam develops air conditioning systems for pharmaceutical laboratories
At Intersam we have more than 27 years of experience in the design and development of customized air conditioning and refrigeration systems for industry and commerce.
Our air-water, water-air and air-refrigerant systems have low energy consumption and the most advanced technology. But the best thing is that we can attend air conditioning projects for pharmaceutical laboratories and other sectors in Spain and anywhere in the world. Always adapting to local health and technical regulations. Contact Us!