Multiple Effect Stills
The Neelam multiple effect stills consist of a series of pressure vessels
in the form of columns, called distillation columns or effects, that are
interconnected, communicating vessels. Each column is divided into two
parts: a double tube sheet (DTS) heat exchanger that acts as an evaporator,
and an upper chamber used to separate pyrogens preventing the drops carrying
impurities from reaching the end of the column. The group is supplied as a
compact unit on a skid with all components readily accessible.
Accessories
Inlet water conductivity monitoring
Point to obtain pure steam from the first column
Condenser for higher WFI
Hot stand-by mode
Sanitization/Sterilization of the different columns and WFI
condensers Protection panels
Description
Neelam Industries Multiple Effect Water for Injection Stills are FINN AQUA
based designed and constructed to produce pyrogen-free sterile water (WFI)
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 your order as a unique project. We
develop specific Quality Plans (DQ, IQ and OQ) and undertake factory
acceptance testing (FAT) to give assurance, performance and quality.
The design of the unit offers excellent performance for production of water
for injection. Simplicity and efficiency: A group of distillation columns in
series designed to evaporate the purified water and condense pure steam.
Their design allows the steam water drops, containing impurities, particles
and pyrogens to be separated by the effect of gravity. This design has
proven to reduce the level of endotoxins by 3 to 4 log.
The unit and all its components such as feed water pump, pre-heater and
condensers 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 an available option.
Hygienic design: Including clamp connections, orbital welding techniques
for tubing and components, minimisation of dead legs and proper piping
slopes for self-drainability, double tube sheet construction in first
column, condenser and pre-heaters, diaphragm valves for distillate/reject,
etc
All welding is carried out in inert gas atmospheres (argon), with automatic
orbital welding whenever possible.
Sampling of WFI: the generated WFI can be provided with a collection
mechanism for detailed chemical analysis.
Online printing of relevant parameters of the process is provided for
process documentation.
Generated WFI meeting the below specified standards microbiological
standard
endotoxins < o.25 eu/ml
toc < 500 ppb
conductivity <1 ms at 20 deg.c
microbial limit <10 cfu per 100 ml
physio chemical standard
ammonia <0.3 ppm
calcium <0.5 ppm
carbon dioxide <4.0 ppm
heavy metals <0.5 ppm
total solids <0.001 %
chlorides <0.5 ppm
sulphates <0.5 ppm
ph =5-7
conductivity at still outlet <0.5 ms/cm at 97 oc without
compensationmagnesium <1.2 ppm
nitrate <0.2 ppm
All other parameters to comply with USP and BP standard.
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