From Source Water to USP Purified Water – Is Your System Meeting Your Needs?

September 15, 2017

Pharma Vial

Manufacturing Operations depend on processing Source Water into the appropriate USP Purified Water.  It is one of the most critical processes at each manufacturing site.  If you are responsible for purified water in your operations, you need systems that are reliable in their output every day.

Some of the most frequently asked questions, like “Why are there no microbial requirements included in the monographs for Purified Water and Water for Injection?”, and the answers can be found here.

There are many United States Pharmacopeia (USP) Water Types of Purified Water:

  • Water for Injection (WFI)
  • Pure Steam
  • Sterile Purified Water
  • Sterile Water for Injection
  • Clean Steam
  • Sterile Water for Irrigation
  • Sterile Water for Inhalation
  • Bacteriostatic Water for Injection

Just as there are many purification technologies:

  • Prefiltration
  • Softening
  • Deionization
  • Distillation
  • Ion Exchange
  • RO (Reverse Osmosis)
  • Filtration
  • Shock Electrodialysis
  • UV Light
  • Ultrafiltration

You might be looking to upgrade your current purified water capacity, or replace aging systems, or add overall manufacturing capacity (greenfield or brownfield). You may even need new Purified Water systems installed. To accomplish this, you need a partner that is experienced in delivering turnkey systems to Life Sciences manufacturers, with specific expertise in USP Purified Water Systems.

Grantek has over 30 years in delivering turnkey pharmaceutical systems, including purified water systems, and can provide you with:

  • Connect with trusted partners to process knowledge in selecting the type and capacity for your H2O purification needs.
  • Project Teams that will work with you to select, automate and integrate H2O skids.
  • Integration of the H2O skid with the H2O distribution system.
  • All design, installation, startup, commissioning, documentation and 21 CFR Part 11 Validation services for a complete life sciences water system.

This expertise lets us select the best application for each site, weighing skid build vs. stick build systems. Boiler feed, semiconductor, clean steam and water for injection water systems have all been developed by Grantek, based on client needs.

Please contact Grantek for any information you may need for your purified water system, or any pharmaceutical system.  We would enjoy the opportunity to share our expertise and learn about your needs.


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