Water is commodiously used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, and analytical reagents.
Types of Water:
- Raw Water
- Potable Water or Drinking Water
- Purified Water
- Highly purified Water
- Water for Injection
- Sterile Water for injection
- Pure Steam
Raw Water:
Raw water is a natural water available in the environment, such as rainwater, ground water, and water from bodies like lakes and rivers. Water in this form is considered as raw, as opposed to water which has been treated before consumption, such as drinking water, or water which has been input to an industrial process.
Potable Water or Drinking Water:
Drinking water should be supplied under continuous positive pressure in a plumbing system free of any defects that could lead to contamination of any product. Drinking water is un-modified except for limited treatment of the water derived from a natural or stored source.
Examples of natural sources include springs, wells, rivers, lakes and the sea.
The condition of the source water will dictate the treatment required to render it safe for human consumption (drinking). Typical treatment includes softening, removal of specific ions, particle reduction and antimicrobial treatment.
It is common for drinking-water to be derived from a public water supply that may be a combination of more than one of the natural sources listed above. It is also common for public water supply organizations to conduct tests and guarantee that the drinking water delivered is of potable quality.
Purified Water:
Purified Water is used as an excipient / ingredient in the production of non-parenteral preparations and in other pharmaceutical applications, such as cleaning of certain equipment and non-parenteral product-contact components.
Unless otherwise specified, Purified Water is also to be used for all tests and Assays for which water is indicated.
Purified water should be prepared from a potable water source as a minimum quality feed-water, should meet the pharmacopeial specifications for chemical and microbiological purity, and should be protected from recontamination and microbial proliferation.
Highly purified water:
Highly purified water (HPW) should be prepared from potable water as a minimum quality feed-water. HPW is a unique specification for water found only in the European Pharmacopoeia.
This grade of water must meet the same quality standard as water for injections (WFI) including the limit for endotoxins, but the water-treatment methods are not considered to be as reliable as distillation.
HPW may be prepared by combinations of methods such as reverse osmosis, ultra filtration and deionization
Water for Injection:
Water for injection is used as an excipient / ingredient in the production of parenteral and other preparations where product endotoxin content must be controlled, and in other pharmaceutical applications, such as cleaning of certain equipment and parenteral product-contact components.
The minimum quality of source or feed water for the generation of Water for Injection is Drinking Water as defined by the U.S. Environmental Protection Agency (EPA), EU, Japan, or WHO
Sterile Water for Injection:
Sterile Water for Injection is Water for Injection packaged and rendered sterile. It is used for extemporaneous prescription compounding and as a sterile diluent for parenteral products. It may also be used for other applications where bulk Water for Injection or Purified Water is indicated but where access to a validated
water system is either not practical or where only a relatively small quantity is needed. Sterile Water for Injection is packaged in single-dose containers not larger than 1 L in size
Pure Steam:
Steam is the technical term for water vapor, the gaseous phase of water, which is formed when water boils. Water vapor cannot be seen, though in common language it is often used to refer to the visible mist of water droplets formed as this water vapor condenses in the presence of cooler air.
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