Water System
The quality of a plant's water system is one of the most important factors affecting the manufacturing process of superior end-products.
At all M&H plants we selected and employed the most appropriate materials for the system. All our stainless steel 316L piping is orbital welded and passivated to a standardised level, preventing occurrence of biofilm. All points of use in the system (without dead legs design) are monitored daily being checked according to standard requirements stated in the official pharmacopeia.
The Feed water for produce Purified water (PW) must be treated by a Pre-treatment system to control quantity of suspended & microbial matter before passing to Double pass RO/EDI system, The treated water is then passed to the Storage and Distribution system in which the water is circulated with standard velocity in the piping 24 hours a day. It conductivity, pH, TOC and microbial limit are daily system monitored by Quality Assurance.
Purified water is supplied to produce Water for Injection through a Multi-effect still. The Water for Injection is circulated in the distribution loop and to point-of-use under controlled temperature over 70°C 24 hours a day. Additional to the routine monitoring, Endotoxins limitation has to be qualified prior to use in the production of injectable products which complies to USP (United States Pharmacopeia) criteria.