NEELAM INDUSTRIES PSG ;- Pure Steam Generators are designed and constructed to produce clean/pure steam in full compliance with cGMP guidelines as per FDA and EMEA requirements.
Engineering and Manufacturing practices follow 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 your requirements, we work in partnership with you and a dedicated team follows customer requirement as a unique project. We develop specific Quality Document (DQ, IQ and OQ) and undertake factory acceptance testing (FAT) to give assurance, performance and quality.
Pure steam applications
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 sterilization and/ or sanitization processes in autoclaves, tanks, reactors, pipe systems, etc.
Treated feed water (PW) is circulated through the degassing membrane to the evaporator column. This column is designed to have a large heat transfer area and large water-steam reservoir to provide efficient handling at peak consumption. The separator column diameter has been calculated to prevent water droplets and impurities entering the product steam. As an option, a small condenser can be installed for on-line monitoring of steam conductivity and taking samples.
The control system is based on a PLC wire operator supervision via a user-friendly touch-screen HMI with the following menu:
- Mimics of the equipment, showing the operational state in real time
- Process parameters (temperature, pressure and conductivity)
- Setting up of parameters
- Alarm information
- Start-up and alarm recognition.
Options include: paper or electronic chart recorder for pure steam conductivity, temperature, extra feed water conductivity meter, online TOC monitoring.
Compact and modular
The generator is designed as a vertical column, with a special heat exchanger in the lower part (evaporator) and an expansion chamber above (separator column). The unit and all its components such as feed water pump, pre-heater, control panel, etc. are mounted on a stainless steel AISI 304 skid.
All parts in contact with the media are made of stainless steel AISI 316L, insulated with mineral wool (asbestos-free material) with external cladding made of stainless steel AISI 304. Inner surfaces are polished to Ra ? 0.64 µm and electro polishing is optional.
Hygienic design : Including clamp connections, orbital welding techniques for tubing and components, minimisation of dead legs, piping slopes for self-drainability, double tube sheet construction, etc.