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PST Certificate

DIFFERENT INFUTION SOLUTION FILLED WITH BFS MACHINE IN 500 ML. BOTTLE

The plant will be carried out according to cGMP rules technical devices indicated by the CGMP in order to avoid any phenomenon of distilled water contamination with demineralised or sub-standardwater or sub-standard water. The water still has been offered with 4 stages to reduce the consumption of steam and, consequently, the cost for the distilled water produced. The water still is self-sanitizable before its start-up, as required byh cGMP guidelines. The process is controlled by PLC assuring a distilled water production having the charactersitics indicated by the most restrictive international Pharmacopoeia.

The WFI cooling group at the preparators use point, will be designed in such a way to reduce any dead corner, and will allow the cooling of the distilled water at the prefixed temperature maintaining, in the main loop, a continous circulation of distilled water at a minimum temperature of (85* C) at the end of the sterilzation cycle. The internal finishing of the storage tank, of the loop piping of the valves and all the other accessories for WFI control will have roughness degree in accordance with cGMP guidelines. The pure steam generator is compliance with cGMP guidelines and it is suitable to produce pure steam with the characteristics mentioned in the USP XXIV.

The preparators will be designed for 2 batches of autoclave load, each one of 1600 liters, so as to have the daily number of analysis for solution control and reduce costs. Moreover, during the preparatory discharge phase, the operator will always be able to know the amount of solution remaining inside the preparatory. The raw materials, duly pre-weighted with printer are loaded into preparators by means of a triblender connected to preparators through a stainless steel pipe and valves. The autoclave is provided with regulator of the programmed sterilization time Fo calcultion.

Ibrahim A Al-Arfaj
General Manager