Manufacturing facility consisting of two blocks.
The intermediate block is designed for production and handling of drug intermediates, consists of change rooms, corridors, drying room, packing room, etc.
Pharma block (API block)
Final product processing and packing areas and final product holding rooms are provided with positive filtered air supply. Each room in final product handling areas is supplied with 0.3 filters.
Air supplied to product handling area is filtered through pre-filters and 0.3 & micro filters to filter the air- borne contaminants. These filters are periodically cleaned and if necessary, they are replaced with new filters.
All enclosed buildings are used for Raw material storage, Products requiring controlled environmental conditions are handled and stored under controlled environmental conditions like temp. 25°C, relative humidity below 60%. The environmental conditions are regularly monitored and recorded. Raw materials are stored under ambient storage conditions.
The pharma block is designed for production and handling of APIs, consists of change rooms, corridors, centrifuge room, drying room, milling & packing room, quarantine room, pharma storage rooms, etc. Equipment utilized in various operations are selected in such a way, that surfaces of equipments that contact raw materials, in- process materials or finished products are not reactive, additive or absorptive. Two types of reactors are under utilization, namely stainless steel reactors and glass lined reactors.Centrifuges for isolation , crystallization and precipitation of solids from liquid phase.Based on the nature of wet products to be dried, types of driers available are rotary cone vacuum driers (RCVD) and tray driers (TD). The RCVD, which is used to dry the product, can be also used for blending of the individual lots. For uniform particle size of the product, sifters and pulverizers are used to pulverize large size particles to have uniform particle size. All made of stainless steel (SS-316).