• Neelam Industries

Pure Steam Generators

Neelam Industries offers Pure Steam Generators designed and constructed to produce clean/pure steam. These are in full compliance with cGMP guidelines as per FDA and EMEA requirements and engineering and manufacturing practices following ISO 9001 procedures, ASME BPE criteria, GAMP guidelines, etc. Design and construction meets the most stringent regulations and codes from Europe, USA and others concerning safety and pressure vessels. To ensure the equipment meets actual users’ requirements, the company works in partnership with customers and a dedicated team follows customer requirements as a unique project. The company develops specific quality documents (DQ, IQ and OQ) and undertakes factory acceptance testing (FAT) to give assurance, performance and quality. Clean steam is defined as saturated steam produced from additive-free water, relatively free from non-condensable gases and dry, but not overheated. Pure steam is the same as clean steam, but when condensed it meets the USP and the EU pH standards for WFI, which state that endotoxins level is typically below 0.25 Eu/ml. Clean steam should be used when the steam or resulting condensate comes into direct or indirect contact with any medical device or pharmaceutical product. Thus, it is the ideal heat transfer media for carrying out sterilisation and/or sanitisation processes in autoclaves, tanks, reactors, pipe systems, etc.