Pharmaceutical
STANDARD SCHEMES FOR PURIFIED WATER
Ultra Filtration – Pretreatment
Reverse Osmosis in Stainless
Steel Construction
Hot Sanitizable RO – EDI – UV SKID
S t a n d a r d ’ s
C o m p l i a n c e
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USP, JP and PH Eur Standards
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GAMP and CFR 21 Part 11
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ISPE Base Guideline
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IPPC environmental requirement
A p p l i c a t i o n s
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PW Generation and Distribution
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WFI Generation and Distribution
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Clean Steam Generators, MEDs and Vapour Compressions Unit
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Distribution Ring Mains and Loop including user point
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Lates manufacturing practices with orbital welds, boroscopy and BPE specifications
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Utility and Wate Water Recycle
OUR QUALITY COMMITMENT
Purified Water
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PH : 6 . 2 . 7 . 2
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Conductivity @ 250 C < 0.5 Mils/cm
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Bacteria : 100 cfu/mL
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Endotoxin
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TOC < 500 ppb
Water For Injection
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PH : –
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Conductivity @ 250 C < 1 Mils/cm
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Bacteria 10 cfu/100mL
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Endotoxin : 0.25 EU.mL
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TOC < 100 PPB
DOCUMENTATION
Document |
Basis |
| DQ – Design Qualification | Raw Water until Material Selection |
| IQ – Installation Qualification | SOP until Complete Installation |
| OQ – Operation Qualification | Process until Logic Accountplacement |
| PQ – Performance Qualification | Mechanical until Quality Guarantees |
TECHNOLOGY PERSPECTIVE
Systems
Hot Sanitizable Reverse Osmosis
Hot Sanitizable EDI
Features
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Stainless steel electro-polished RO housing
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Hot Water Sanitizable membrane
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Fully Automatic PLC Based
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Skid mounted EDI and UV
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CIP mounted on skid
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Hot water sanitary (> 80 C) fully automatic RO + CEDI skid
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Robust leak free sealing with Double O-ring seal.
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Orbitally welded sanitary piping and valves with boroscopy
Benefits
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Better quality and aesthetic look
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Guaranteed and consistent treated water quality
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Ease of operations
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Compact and better
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Lesser piping and accessories and
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Guaranteed conductivity and microbial count result a chivied with user friendly integrated system
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Longer cell live and consistent quality especially silica. Proven performance after 150 cleaning cycles
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CGMP & GAMP5 compliant
OPERATION AND MAINTENANCE SERVICES
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Sparepart and Consumable Supply
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Breakdown Maintenance
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Annualy Maintenance Contract
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Consultancy, Training, and Documentation
PIPING DISTRIBUTION AND AUXILIARY PRODUCTS & SERVICES
Piping System
Storage Tank
C I P
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Made of 316L stainless steel tubes
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Surface quality from Ra <0.8µm to Ra <0.4µm
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The tubes are orbital welded together
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NPT, ISO/BSP, SAE/MS, AN, weld ends, port connectors, sanitary flanges, tube adapters
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Straights, elbows, tees, crosses, caps, plugs, nuts, ferrules
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Velocity as is standard
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316L SS storage tank for PW and HPW
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Internally electropolised
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Externally mirror / matt finish
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Jacketed hydrophobic 0.2 micron Vent Filter
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Facility for Level transmitters
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Compound Pressure gauge Included
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Pressure release valve
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Spray ball
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Steam trap assembly
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Inlet steam control valve
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Systems are fully integrated incorporating tanks, pumps, valves, spray cleaning devices, heat exchangers, piping & controls without the need to disassemble all or part of the system
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The controls incorporated into CIP systems are critically important and provide a variety of cycle times, temperatures, composition of cleaning solutions. Fully automated PLC based CIP systems are offered to suit customer specifications.