
Production Facilities - Engineering Section
High Purity Water Treatment System:
Due to the nature of water purification, standard products cannot always completely meet the needs of a specific application. Taking this into account one of our main focuses has become custom designed and manufactured systems. Custom pretreatment, reverse osmosis, electro deionization and storage systems are only a small sample of our capabilities.
Reverse Osmosis and Electro-Deionization (EDI) Systems
RO System is a full line of equipment to meet all of our USP28 purified water. We are current with all the USP regulations. Our RO Plant has complete multi-filtration process on one skid. RO Series unit contains complete pretreatment, reverse osmosis, re-pressurization pump, motor, status lights, and UV disinfection.In Electro deionization or EDI systems, the continuous regeneration of the ion is produced by decomposition of water. It is a continuous and chemical-free process of removing ionized and ionizable species from the feed water using DC power. Water circulates through circulation loop system and UV disinfection at 3 steps (i) after EDI (ii) Supply point to circulation loop (iii) Return process.
Water system include a programmable logic controller (PLC), electronic sensors can monitor all vital functions of the system including flow, pressure, tank levels, water quality, filter condition, membrane condition, conductivity and electrical supply. The control system automatically responds to changes in these variables, initiating the proper response to virtually any operating condition. The PLC displays all operating conditions and tells us what the unit is doing at any time.
CLEAN ROOM FACILITY
The formulation of the drugs requires high clean room standards. HiGlance has considered the highest hygienic demands, cleanliness levels and germfree environments to run our entire processes. Full air-conditioning, specified quality –temperature, humidity and sensitive filtering of enormous and controlled air volumes are done by HVAC to meet these demands and to follow international regulations like ISO 14644:2005 FDA and cGMP -guidelines at each stage in production, up to and including packaging and storage. We have maintained Class 100,000 (Federal Standard STD-209E form) in clean room for manufacturing, assembly and packing. Staff enters and leaves through airlocks and wears protective clothing such as caps, face masks, boots and cover-alls. In clean rooms all the clean room workers have to pass through an air blast upon entering to remove particles and ensure minimal contamination of the environment. Synthetic floor and wall systems (epoxy) antistatic are done in clean room area that are resistant to the action of (bio) chemical substances. All doors are high-speed roll door designed specifically to meet hygienic standards– a combination of US FDA and ISO standards. Its seals, maintains the pressure differentials, a prerequisite in pharmaceutical facilities.
Heat Ventilation Air Conditioning (HVAC)
In HiGlance Cleanroom is maintained by HVAC, is executed by the World Renowned Voltas Limited. that recovers heat and cooling energy, secure air filtration, eliminate particles and microbial contamination and treat and supply air by highest hygienic demands. The design of the HVAC System is of latest International standards. Total 47 AHUs independent for each rooms and 400TR chilling plant are provided to meet design requirements for inside Temperature & Relative Humidity with air pressure in adjoining rooms to ensure human & product safety.
All clean areas are provided with ceiling mounted HEPA Filters of 99.97% efficiency down to 0.3 microns and 25 air changes/hr for supply air. The Return air is sucked near floor level through air risers provided with cleanable filters of 90% efficiency down to 10 microns – thus providing semi laminar airflow within each room to remove internally generated contaminants. The fresh air before entering the AHU's passes through five layer filtration process. Inter room design pressure differential is maintained automatically by BUILDING MANAGEMENT SYSTEM (BMS) . Performance of HVAC-systems and design points are being simulated and calculated with BMS software.
BULDING MANAGEMENT SYSTEM (BMS)
HiGlance has a fully-integrated control system in which building services are monitored and controlled by a computer-based management system known as BMS (Building Management Systems). BMS is executed by the World Renowned Siemens Limited. BMS is Micro Processor Based software and is designed as user Friendly. It provided central operation and control, monitoring status, raise alarms when critical parameters exceed design limits, maintenance of historical record, serve as tool for diagnosing faults, generate graphic and other reports as required, and maintain confidentiality.This software give alarm signals to show threshold design limits being exceeded for Temp/RH, pressure drop across MICRO Filters & Pre filters, Faults Indication of Water/Brine Chilling Machines.
BMS has provision for start-stop and monitoring of each item of equipment. It controls inside temperature, RH and supply air quantity with sensors located at approved locations. With the help of this software we can monitor pressure drop in pre filters & MICRO Filters, inside & outside Temp/RH, air quantity of selected areas, control valves position, Damper Actuator Position, Inlet/Outlet Water Temp. of COND/CHB of each chilling machine, as also at Header etc Indication of set points of controls & facility for re-adjustment by selected person on using secret code.
Portable Operating Terminal (POT) facility is there for monitoring parameters at any of the stand-alone control panels. Dynamic Psychometric Chart is built in the system to display DB, WB, RH and absolute humidity at any selected point. Indication of all variables is available both in FPS & CGS systems. Central Work Station (CWS) with printer displays and provides data in tables and mimic diagrams, Visual alarms to indicate threshold limits being exceeded, historical data, and generation of periodic reports on prescribed formats. The software can be used on each individual system, allowing service personnel, system mangers, commissioning staff, and the like, to have access, from any suitable PC, to the system.
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