Pharma Case Study
 
The Challenge:
A multinational located in Asia was undertaking a rapid expansion and needed to upgrade/scrap the existing RO-EDI (Reverse Osmosis – Electro Deionisation) system to meet their need for high purity water. The existing system required considerable maintenance and was a chemically sanitisable RO-EDI, which did not meet the demands of regulated markets. Finally the customer decided to purchase an entirely new unit and wanted a dependable system vendor. They entrusted Ion Exchange with this project. The challenge was to meet stringent USP 28 guidelines for high purity water for injection.
 
The Solution:
  • We recommended a Hot Water Sanitisable INDION High Purity Water (HPW) consisting of:Ultra filtration
  • Softening
  • Heat Sanitisable Reverse Osmosis (RO)
  • Heat Sanitisable Electro Deionisation (EDI)
  • Heat Sanitisable Ultra Filtration system
 
As the customer was using surface water, UF was incorporated in pretreatment 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 product water. FAT was ensured prior to dispatch of the RO-EDI system, witnessed by the customer.
 
Result:

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 due to high degree of automation
  • Our extensive validation documentation made periodic USFDA audits very easy for customer