Water Types

Seabram

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Water Systems in a Pharmaceutical Environment

 

There are many types of water, in this post I will detail the types of water and filtration systems used in the pharmaceutical industry. Per FDA, there are 8 types of water:

  • Non-Potable water
            May be present in boiler feed water, cooling water, or fire sprinkler sections. May not have any cross connection to any potable water supply and lines must be marked as non-potable.
  • Potable water
            Potable water may be sourced from municipal water supply, rivers, wells, or ponds. Must be under continuous positive pressure in defect free system.
  • USP purified water
    [USP stands for US Pharmacopeia, the use of USP indicates the use as a component or ingredient.]
            USP purified water is usually specified as having less than 100 cfu/ml microbial contamination. 
  • USP water for injection (WFI)
    [USP WFI water may only be sourced from distillation or reverse osmosis]
           USP WFI is usually specified as having 10 cfu/100ml, with an additional limit on endotoxins.
  • USP sterile water for injection
           Rendered sterile, usually after packaging.
  • LUSP sterile water for inhalation
           pyrogen specifications
  • USP bacteriostatic water for injection
           Rendered bacteriostatic through added chemicals
  • USP sterile water for irrigation

 

Biocontamination Control (Guidance by WHO)

Shortest possible pipework
ambient and hot pipes should be isolated
No dead legs greater than 1.5 times the branch diameter
The system must be separated from gauges by membranes
Utilization of Hygienic patter diaphragm valves
Pipework laid to allow drainage
Inhibit microorganisms by:

    • ultraviolet radiation
    • Heat
    • Sanitization utilizing hot water
    • Sterilization utilizing clean steam/superheated water
    • Sanitization utilizing chemical agents

Note: Hot systems (65 – 80°C) are self sanitizing

 

Types of Systems

The most important part of designing a water system is risk assessment. Different types of products require different levels of quality in the water utilized. Oral and Topical products require less pure water, with no endotoxin requirement. This may have different levels or purity depending on level and type of preservatives in addition to other factors.

Distillation or Reverse Osmosis are the only methods listed in the USP for WFI

 

Ultra Filtration

 

Distillation System

 

Reverse Osmosis System

 

Ion Exchange

 

 

 

 

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