All HVAC systems in the industry must be balanced by gates to ensure that the required amount of air passes through the diffusers or return grids. However, in the pharmaceutical industry this procedure is very important, since not only the necessary flow rates are obtained, but a good air balancing gives rise to the differential pressures and airflow senses that will avoid cross contamination as required by the norm.
Control and Automation
Although there is no mention of a type of control specific to the critical HVAC system, it is clear that the temperature and humidity conditions, as well as differential pressures and airflow senses in production areas, must be maintained and monitored. The control of such conditions can be performed simply or, if desired, it is possible to use as a central control that maintains the system balanced when the doors are left open for prolonged periods and the differential pressures do not recover during the next 20 seconds. If this occurred and the system failed to compensate for pressure losses, an audiovisual alarm would be issued to correct the problem as far as possible.
Installing frequency inverters in equipment motors facilitates the balancing of the air system and also maintains a constant flow, even when the air filters become saturated.
Validation is an essential element for compliance with good manufacturing process which allows demonstrating the functionality of HVAC system. This is a set of qualifications made by specialists in the sector. The qualification is defined as the performance of specific tests based on scientific knowledge to demonstrate that the equipment, critical systems, facilities, personnel and suppliers comply with the previously established requirements, and must be concluded before validating the processes.
It is documented evidence that the proposed design for facilities, systems and equipment is suitable for the intended purpose.
It is the documented evidence that facilities systems and equipment that have been installed in accordance with the previously established design specifications.
It is documented evidence that equipment, facilities and systems operate on a consistent basis in accordance with the established design specifications.
It is documented evidence that facilities, systems, and equipment perform by meeting previously agreed acceptance criteria.
In itself, the design, operation and maintenance of a critical HVAC system for the pharmaceutical sector is a challenge, since it must be in constant monitoring and validation, so that it can continue with the tasks performed there.