This risk assessment is conducted for the HVAC System of the Sterile Formulations Facility and consists of the air handling units for manufacturing areas.
The HVAC system for this Sterile Formulations Facility has been designed for obtaining and maintaining the required working conditions by means of providing specified Temperature, RH & Differential pressure in the rooms and by controlling the non-viable & viable particle count inside the clean room areas catered.
The HVAC System shall be designed to achieve the desired indoor environment conditions as per defined Hygiene Zones required for various activities of pharmaceutical drugs. The system shall be designed in conformance to all International cGMP standards for HVAC systems.
The requirements of all the classes are given below.
Double HDPE wire mesh shall be provided at the fresh air inlet before the pre filters for preventing entry of insects and dust particles
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