S D AQUA FINE design, manufacture and supply the complete
customized automated (Sterile/Non-Sterile) Ointment/Cream Plant
as per the latest CGMP norms with the required Qualification
Documents as per the requirements.
Oil Phase Jacketed & Agitated Vessels, Water Phase Jacketed &
Agitated Vessels, Manufacturing Vessels with special high
viscosity, intimate mixing agitator and in-built or external
Micro-Homogenizer having Auto Lifting top lid device & Heating
cooling facility, Mixing under vacuum condition and Storage
Vessels with or without Agitators.
Ointment Plant
Important features of S D AQUA FINE Ointment Plants:
-
Transfer of products from storage vessel to filling line
-
Load Cells for Manufacturing Vessel for weight automations
-
Vacuum Transfer Systems for Oil & Water Phase
-
PLC based Automation system suitable for SCADA connectivity
-
Dedicated Skid, CIP & Sanitization System
-
Inter-connecting aseptic piping and valves system
-
SS Operating Platform
-
SS Control Panel
-
Flame-proof System on request
-
“CE” marked Equipments are offered with Third Party
Inspection & All Electrical Control with ERTL Approval &
Test
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 Ointment 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 Ointment 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.
Specifications:
-
High sanitary standard Design & Manufacturing
-
Internal surface Mirror polished to less than 0.5 Micron RA
-
Double Speed contra-mixing slow agitator with step less
speed control
-
Inbuilt/Inline High speed Homogenizer
-
Hydro Lift top covers
-
SS 316L contact parts & SS 304 Non-contact parts
-
High standard Automation System
-
Qualification Documentation like DQ, FAT & Protocols of IQ &
OQ
-
Smooth processing with low shear force
-
Teflon scrapping mechanism with Agitator
-
Internal/External re-circulation system
|