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
Start-up and alarm recognition.
Options include: paper or electronic chart recorder for pure steam
conductivity, temperature, extra feed water conductivity meter, online TOC
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
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.