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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

  • USP, JP and PH Eur Standards
  • GAMP and CFR 21 Part 11
  • ISPE Base Guideline
  • IPPC environmental requirement

A p p l i c a t i o n s

  • PW Generation and Distribution
  • WFI Generation and Distribution
  • Clean Steam Generators, MEDs and Vapour Compressions Unit
  • Distribution Ring Mains and Loop including user point
  • Lates manufacturing practices with orbital welds, boroscopy and BPE specifications
  • Utility and Wate Water Recycle

OUR QUALITY COMMITMENT

Purified Water

  • PH : 6 . 2 . 7 . 2
  • Conductivity @ 250 C  < 0.5 Mils/cm
  • Bacteria : 100 cfu/mL
  • Endotoxin
  • TOC  < 500 ppb

Water For Injection

  • PH : –
  • Conductivity @ 250 C < 1 Mils/cm
  • Bacteria 10 cfu/100mL
  • Endotoxin : 0.25 EU.mL
  • 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

  • Stainless steel electro-polished RO housing
  • Hot Water Sanitizable membrane
  • Fully Automatic PLC Based
  • Skid mounted EDI and UV
  • CIP mounted on skid
  • Hot water sanitary (> 80 C) fully automatic RO + CEDI skid
  • Robust leak free sealing with Double O-ring seal.
  • Orbitally welded sanitary piping and valves with boroscopy

Benefits

  • Better quality and aesthetic look
  • Guaranteed and consistent treated water quality
  • Ease of operations
  • Compact and better
  • Lesser piping and accessories and
  • Guaranteed conductivity and microbial count result a chivied with user friendly integrated system
  • Longer cell live and consistent quality especially silica. Proven performance after 150 cleaning cycles
  • CGMP & GAMP5 compliant

OPERATION AND MAINTENANCE SERVICES

 

  • Sparepart and Consumable Supply

  • Breakdown Maintenance

  • Annualy Maintenance Contract

  • Consultancy, Training, and Documentation

PIPING DISTRIBUTION AND AUXILIARY PRODUCTS & SERVICES

Piping System

Storage Tank

C I P

  • Made of 316L stainless steel tubes
  • Surface quality from Ra <0.8µm to Ra <0.4µm
  • The tubes are orbital welded together
  • NPT, ISO/BSP, SAE/MS, AN, weld ends, port connectors, sanitary flanges, tube adapters
  • Straights, elbows, tees, crosses, caps, plugs, nuts, ferrules
  • Velocity as is standard
  • 316L SS storage tank for PW and HPW
  • Internally electropolised
  • Externally mirror / matt finish
  • Jacketed hydrophobic 0.2 micron Vent Filter
  • Facility for Level transmitters
  • Compound Pressure gauge Included
  • Pressure release valve
  • Spray ball
  • Steam trap assembly
  • Inlet steam control valve
  • 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
  • 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.