S D AQUA FINE WFI SYSTEMS are used for Generation of High
Purity water for pharmaceutical especially for injection. Many
years of experience and continuous development has led to all
our plants being very user friendly and robust. The plants are
built using world class equipment’s and are engineered with
highest care to ensure peak performance throughout its life
span.
WFI System
Important features of S D AQUA FINE WFI Plants:
-
Pre-engineered packaged plants and custom built plants as
per URL
-
The plants can be either chemical or hot water Sanitisable
-
Complete design with low footprint
-
Plants manufactured as per ASME, BPE and ISPE Guidelines
Construction features:
These plants are manufactured according to cGMP std. All
equipments and plants are manufactured using sanitary AISI 316 L
Stainless steel electro polished tubes and fittings with surface
finish of Ra < 0.4 um. All piping and fittings are welded using
latest Orbital welding machines.
Automation:
S D AQUA FINE WFI plants are PLC based fully automatic and have
necessary safety interlocks, data logging facility and intuitive
software for smart control and monitoring of the system. The
pumps can be provided with variable frequency drives (VFD) on
request. Various instruments like flow, pressure transmitters,
conductivity, pH and ORP analyzers continuously monitor the
plant performance and the data is logged for easy review and
study..
Documentation:
S D AQUA FINE's WFI plant is provided with documentation backed with
necessary test and calibration certificates with full NABL
traceability. For pharmaceutical and biotechnology industry. the
documentation is done to ensure proper regulatory compliance. (DQ,
FAT, IQ, OQ, and PQ).
The documentation package is well designed and organized to
provide validated information on the Project life cycle from
design stage to site to acceptance test. Our dedicated
Validation Team provides a comprehensive Validation Support to
the customer including Validation Protocol preparation, Site
Tests activities, Instrumentation Calibration and Validation
Reports organization.
Outstanding Features:
-
The plant is completely made with SS 316L stainless steel
with active surfaces being electro polished.
-
The insulation is made of glass wool covered by AISI 304
stainless steel sheet.
-
All contact parts to WFI are electro polished with
state-of-the- art technology.
-
All pipes and tubes as per ASME BPE stamping with less than
0.4 Ra.
-
The frame (non contact parts) is made of AISI 304 stainless
steel.
-
The piping system is manufactured with electro polished
pipes being orbital welded with sanitary fittings and
pharmaceutical-grade gaskets.
-
Expansion joint design for tube-to-tube sheet joints.
-
Two specially designed top coolers as per CGMP.
-
PLC based operation with all required inter locks and
validated logic with skid mounted AISI 304 stainless steel
control panel.
-
Complete documentation to serve international audit
requirements.
|