A multinational pharma company in Asia undertaking a rapid expansion needed to meet stringent USP 28 guidelines for high purity water for injectable. The existing chemically sanitisable RO-EDI system did not meet the demands of regulated markets and besides, required considerable maintenance. The customer sought a dependable system vendor for a new unit that would meet their need for high purity water, and entrusted Ion Exchange with the responsibility.
We recommended a Hot Water Sanitisable INDION High Purity Water (HPW) plant consisting of:
  • Ultra filtration
  • Softening
  • Heat Sanitisable Reverse Osmosis (RO)
  • Heat Sanitisable Ultra Filtration system
Since the customer was using surface water, UF was incorporated in pre-treatment to handle suspended solids and colloids. A heat sanitisable UF system was also offered as a polishing unit downstream of the EDI to remove endotoxins/bacteria from the product water. The factory acceptance test (FAT), witnessed by the customer, was ensured prior to dispatch of the RO-EDI plant.
Conductivity < 1.25 TOC < 500 ppb Bacteria < 10 CFU / 100 ml Endotoxins < 0.25 EU/ml
  • Chemical-free sanitisation and virtually maintenance-free system
  • Less manpower required due to high degree of automation
  • Extensive validation documentation made periodic USFDA audits effortless for the customer

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