When The Tap Isn’t Good Enough: Classification of Water in Drug Manufacturing

Water is the base ingredient for many drug products. It is also used in cleaning the equipment
and to alter the makeup of other drugs. Like other substance, water carries pathogens, minerals
and other contaminants that can actually change the composition of the drug. Bacteria within
the water can cause illness in the person ingesting the drugs. An outbreak is also possible if the
bacteria-riddled water is used to create batches of a drug.

To prevent contamination and accidental drug alterations, the U.S. Food and Drug
Administration enforces water classification policies that are use throughout the pharmaceutical
industry. These policies based on the following eight categories of water, separated by their
usage and level of sterilization.

  • Non-potable Water: non drinkable or non-potable water used in pressure washing, floor cleaning, and similar activities
  • Potable Water: used in mixing up components of the drug that will become the material used in another stage. Not used in making drug inject able or for irrigation.
  • Purified Water: used for thinning drug solutions, diluting them for use.
  • Water for Injection: dilutes the injected drugs.
  • Sterile Water for Injection: water pre-sterilized and packaged for diluting injected drugs. Intravenous fluid bags are an example.
  • Sterile Water for Inhalation: pre-packaged, sterilized water used for nebulizers and similar medical devices.
  • Bacteriostatic Water for Injection: pre-packaged, sterilized water that is treated with solutions to stop the reproduction of bacteria in water used to dilute injected drugs.
  • Sterile Water for Irrigation: pre-packaged, sterilized water used to clean open wounds. The water is free of pathogens that can infect the wound.

These water categories are necessary in maintaining drug composition and preventing the
contamination of the products by pathogens and other chemicals. The water used in the most
vulnerable ways, injections, irrigating wounds and for inhalation, are given the most attention
through sterilization. The prepackaging is necessary to ensure that the water is protected from
pathogens between the factory and the medical establishment that will use it.

In drug manufacturing, there is more to water than tap or filtered. The filtrations methods,
packaging and treatment of the water for its specific use varies. The variation, however, is
enforced to ensure that any incidents of contamination are not found in the water used to create
the drug.

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