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ULTRA-PURE PYROGEN-FREE STEAM GENERATORS
MODEL PSG-DTS |
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STILMAS ULTRAPURE STEAM
GENERATORS, series PSG-DTS
with parallel bodies are designed and constructed in
accordance with the International Pharmacopeias and the
CGMP-FDA.
They are capable of resolving any problem of
sterilization and sanitization of pharmaceutical
equipment and process lines (autoclaves, piping, tanks,
filters etc.)
The Pure Steam Generators can be heated by industrial
steam, or superheated water. |
CONSTRUCTION CHARACTERISTICS
The Pure Steam
Generator comprises two parallel bodies:
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Double
tube sheet sanitary shell and tube evaporator with
seamless
pipes
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Decontamination column
The unit is manufactured entirely in AISI 316 L
stainless steel with pickled and passivated surfaces
in standard version.
Pharmaceutical grade Teflon gaskets.
All components are easily demountable, accessible
and are mounted on a strong carbon steel framework.
The insulation is made of mineral wool, protected by
AISI 304 satin stainless steel sheet. |
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Detail of tube sheet |
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DISTILLED WATER PRODUCTION
When small quantities
of water for injection are needed, it is possible to
condense the pyrogen free steam by a suitable shell and tube
double tube sheet condenser. The condensing unit can be
connected to the pure steam outlet positioned on the
generator support frame or connected to one use point of the
pure steam distribution piping. In such a case the
condensing unit is provided with support frame for wall
installation.
DEGASSING
SYSTEM
When the Pure Steam is
requested with limited non condensable gases content, the
generator can be provided with our feed water GASBUSTER
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CONTROL
SYSTEM |
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The entire
regulation unit for total automatic operation includes: |
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A pneumatic regulator of pure steam pressure from 0 e 6
bar controlling the modulating industrial steam valve. |
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A water level regulator controlling the feed water
pneumatic valve |
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A control panel comprising: |
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PLC controlling various operating phases |
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Air pressure reducers (to 1.4 bar for modulating valve;
to 4 bar for utilities) |
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Thermal magnetic motor protection device for pump |
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Pneumatic electrovalves and contacts |
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DOCUMENTATION
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; |
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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,
a.s.o.) |
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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, a.s.o. |
VALIDATION
As regards 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. The Validation Activity is
performed by a dedicated Validation Team, strongly
referenced in the Pharmaceutical Validation Area, which
operates in strict coordination with the Project Team. |
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