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 standardized level, preventing occurrence of biofilm. All points of use in the system (with minimized dead legs design) are monitored daily being checked according to standard requirements stated in the official pharmacopeia.

                 M&H Manufacturing                       M&H Manufacturing

The tap water treated by RO/Mixed bed or Double pass RO/EDI, yields qualified de-ionized water or purified water which complies with USP (United State Pharmacopeia) standards. The treated water is then passed to the Storage and Distribution system in which the water is circulated with standard velocity in the piping through 24 hours a day. Its’ conductivity, pH, TOC and microbial limit are daily monitored by Quality Assurance.

                  M&H Manufacturing                      M&H Manufacturing 

Purified water is supplied to produce Water for Injection through Multi-effect still. The Water for Injection is circulated in the distribution loop and to point-of-use under controlled temperature 24 hours a day.  Additional to the routine monitoring, Endotoxins limitation has to be qualified prior to use in the production of injectable products.