Empowering a sustainable future across industries.

Pharma

Case Study

The Challenge:

A multinational pharma company in Asia undertaking a rapid expansion needed to meet stringent USP 28 guidelines for high purity water for injectibles. 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.

The Solution:

We recommended a Hot Water Sanitisable INDION High Purity Water (HPW) plant consisting of:

• Ultra filtration
• Softening
• Heat Sanitisable Reverse Osmosis (RO)
• Heat Sanitisable Electro Deionisation (EDI)
• Heat Sanitisable Ultra Filtration system

Since 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 the product water. The factory acceptance test (FAT), witnessed by the customer, was ensured prior to dispatch of the RO-EDI plant.

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 required due to high degree of automation
• Extensive validation documentation made periodic USFDA audits effortless for the customer