Among the sites that require the highest precision, calculation, evaluation and strict control of environmental conditions within the HVAC sector are the pharmaceutical industry. Extraction equipment, ducts, filters, diffusers, among other systems, must be chosen with care and based on the elements established by applicable regulations, so that the processes are optimal and the products, quality and staff remain safe and secure.
The pharmaceutical industry is one of the sectors that requires the strictest air controls in the interior environment of the production areas. The Ministry of Health establishes the minimum requirements that must be met in the manufacturing process of medicines marketed in the country, in addition to the specifications that some products require such as temperature, humidity and air quality to be manufactured.
HVAC systems within the pharmaceutical industry are considered critical, as they are purified water and compressed air systems, because they are in direct contact with the product. Each laboratory has defined methods to carry out the good manufacturing practices throughout the production process, which often exceeds the minimum requirements of the official regulations. In this way, HVAC systems are not exempt from rigorous monitoring and mandatory requirements when carrying out system validation.
Deciding which HVAC system is correct at the time of design and installation depends to a large extent on how the production areas will be classified, which is done based on the type of drug to be manufactured. Basically, there are two groups of drugs as sterile and non-sterile. For each group, the standard classifies the production areas according to the degree of asepsis necessary for their manufacture.
Within the group of sterile drugs, we can find, among others, all injectable drugs. In the group of non-sterile medicaments, there are, as pharmaceutical forms, tablets, capsules, syrups, suspensions, emulsions, ointments, creams, gels, among others.
The engineer responsible for the design of the HVAC system within this industry should conduct a preliminary investigation, focusing on the type of drug to be manufactured and the classification that corresponds to the area where production is desired, before beginning to develop the calculations or estimates as this helps in the selection of the equipment needed to integrate the system.
In itself, the correct design of the HVAC system is of paramount importance. Firstly, because it must comply with what is specified in the current regulations; Secondly, because when the equipment is finally installed, the system itself should not generate cross-contamination, and thirdly, because inside the air handling units and inside the ducts, there should be no growth of fungi, yeasts, bacteria or any other type of contamination that compromises the quality of the product or the safety of the personnel. Please, go to this site for more information about HVAC systems.