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PHARMASTILL MULTI EFFECT STILLS - NEW
SERIES MS-HPS |
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The
PHARMASTILL MULTIPLE EFFECT STILLS
produce distilled
water for injectable use
which meets the requirements of the
International Pharmacopeias including
USP, EP, JP.
The Pharmastill modular
construction offers a wide choice of
configurations allowing optimum payback
times.
Standard models range is
from 60 to 12,000 lt/h output.
Models with production
capacity untill 22,000 lt/h are
available on request. |
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CONSTRUCTION
CHARACTERISTICS
The plants is completely made in
AISI 316 L stainless steel with active
surfaces picked and passivated.
The piping system is
manufactured in mirror polished tubing
0.6 um RA, orbitally welded with
sanitary flanges and Pharmaceutical
grade Teflon gaskets.
The insulation is made of
mineral wool covered by AISI 304
stainless steel sheet, satin finished.
The frame is made of painted carbon
steel. |
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MAIN
COMPONENTS: |
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COLUMNS
Of
simple and original design, columns consist
of a tube condenser on top and a
decontamination chamber below, joined by a
flanged connection which also has the
function of support.
The column is therefore free
to expand without any restraint.
The short tube condenser,
positioned at the top of the column, does
not require any expansion joint, which must
be avoided in Pharmaceutical production
units.
The decontamination chamber is
completely empty without baffles or welded
spirals which can limit inspectability and
make the structure more sensitive to the
phenomenon of stress corrosion.
PREHEATERS AND FINAL EXCHANGERS
All
Pharmastills (excluding the series 50) are
provided with one pre-heater for each column
and two final exchangers, one for feed
water, one for the cooling water.
Preheaters and exchangers are
manufactured with seamless pipe and double
tube sheet. |
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Tube sheet |
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DECONTAMINATION SYSTEM
The
high quality of the distillate is obtained
during the passage from liquid to vapour state.
The steam produced, separates into pure vapour
ascending the height of the decontamination
column, at low speed, allowing the impure water
droplets to fall to the bottom of the column
under simple gravitational force. The
contaminants thus remain in the feed water. |
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CONTROLS AND INSTRUMENTATION |
The
control panel is provided with a PLC and
operator interface terminal. The distillate
water initially produced is diverted to
waste for a prefixed time in order to
guarantee a perfect sterilization of the
whole system.
The completely automatic
running allows: |
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- To
operate according to a weekly timer and
start-stop by storage tank level control |
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- To
operate continuously according to the
storage tank level control |
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Continuous monitoring of the conductivity
and automatic discharge of distilled water
by sanitary diverting system in case of high
conductivity . |
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DISTILLED WATER PRESSURIZING SYSTEM
The
multi effect stills produce distilled water at
atmospheric pressure and to feed large vertical
storage tanks they need a pressurizing system
with tank and pump. The exceptional flexibility
of STILMAS Pharmastill allows the height of the
distilled water outlet to be elevated without
affecting the excellent capability of non
condensable gas elimination. |
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ENDOTOXIN REDUCTION
Challenging the system with increased endotoxin
levels in the feed water has proven the
capability of the STILMAS Pharmastill to reduce
endotoxin levels by log 4 ( 10,000 times) |
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DOCUMENTATION
The Documentation Package supplied by
STILMAS for its Plants is conceived and
organized to be in compliance with the
following requirements: |
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- To
provided documented evidence of the Project
Life-cycle, from the design phase up to the
final Site Acceptance Test runs |
- To
collect all the necessary information as
needed to consistently feed and support the
Validation Activity and related Support
Systems (i.e. Design, Installation Operational & Performance
Qualification, Computer System Validation,
Instruments Calibration,
etc.) |
- To
provide to the plant user all necessary
information as needed to implement a written
and consistent set of internal
documentation such as Operating & Maintenance S.O.P.s. Preventive
Mantinence Program, Periodical Instruments
Calibration
Program, etc. |
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VALIDATION
With
regard to the Validation Activity, STILMAS is
able to provide a fully comprehensive Validation
Service Package, including Validation Protocol
Preparation, Site Tests execution and Validation
Reports organization |
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UTILITIES |
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Industrial saturated dry steam from 3 to 8
bar |
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Feed water,
demineralized or osmosed, free of silica,
chlorine, amines and volatile substances. |
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Feed water
pressure 2 bar higher than industrial steam
pressure |
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Cooling water must have a total hardness
less than 5d°F and pressure of 2-3 bar |
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Electrical energy. According to customer
requirement |
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Dry compressed air oil free, minimum
pressure 6 bar |
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