The HVAC system plays an important role in product, personnel, environment, instrument and machine protection. This can be presented as clean environment, removal of hazard contaminant and provide a suitable temperature and humidity control within acceptable noise level by providing clean environment.
HVAC utility is designed to control the level of viable and non-viable particulate exposure that a drug or medicinal device might receive in addition to regulating temperature and relative humidity conditions. HVAC utility is qualified to demonstrate operating conditions of the area.
The areas serviced by the HVAC utility are classified based on viable and non-viable particulate levels during static operating conditions and dynamic operating conditions.
The purpose of validation plan is to schedule the tasks to demonstrate the plan on HVAC system in Sterile Area. This plan will define who will be responsible to initiate, execute, review and approve each task assigned, how the data/document will be generated and what the entire validation package will be compiled and collected. This validation plan is being written in compliance with validation master plan (VMP).