All pharmaceutical industry products must be produced in air conditioned and clean space. International standards and directives such as FDA and GMP are applied in each phase of production including the packaging and storing phase. For this reason, the air conditioning and ventilation system in the pharmaceutical industry is one of the most vital elements in the manufacturing process.
The working area is sensitive to airborne contamination which is why it is necessary to provide adequate protection from ingress of pollutants. The manufacturing process itself also generates fumes that need to be exhausted from the plant to prevent the contamination of areas in which the production takes place. Only the familiarity with all the specificities of the pharmaceutical industry guarantees successful designing and manufacturing of optimal HVAC solution. HVAC systems need to adapt to the changing science and technology in pharmaceutical industries. The three core functions of heating, ventilation, and air-conditioning are interconnected, especially with the need to provide thermal comfort and acceptable indoor air quality within reasonable installation, operation, and maintenance costs. HVAC systems can provide ventilation, reduce air infiltration, and maintain pressure relationships between spaces. The means of air delivery and removal from spaces is known as room air distribution. HVAC system executes four canonic functions; Control airborne particles, dust and micro-organisms through air filtration using high-efficiency particulate air (HEPA) filters. Maintain room pressure areas that must remain “cleaner” than surrounding areas must be kept under a “positive” pressurization, meaning that air flow must be from the “cleaner” area towards the adjoining space (through doors or other openings) to reduce the chance of airborne contamination. This is achieved by the HVAC system providing more air into the “cleaner” space than is mechanically removed from that same space. Maintain space moisture humidity is controlled by cooling air to dew point temperatures or by using desiccant dehumidifiers. Humidity can affect the efficacy and stability of drugs and is sometimes important to effectively mold the tablets. Maintain space temperature which can affect production directly or indirectly by fostering the growth of microbial contaminants on workers.
HVAC systems have a major impact on:
- Environmental control
- Hazard control
- Life safety
- Energy consumption of the building.
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