Glossary of pharmaceutical and GMP terms with explanations

In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).

Water purification

Purified water plays a crucial role in many aspects of pharmaceutical manufacturing as it can be used at various stages of the manufacturing process.

Water purification in pharmaceutical production refers to the treatment and purification of water for use in the manufacture of drugs and medical devices. Water plays a crucial role in many aspects of pharmaceutical manufacturing, as it can be used at various stages of the manufacturing process, such as during the production of raw materials, the cleaning of equipment, the preparation of solutions and, in some cases, as a component of the drug itself.

Water purification (German translation: Wasseraufbereitung) comprises the following steps and processes, among others:

  • Filtration: Water can be filtered to remove contaminants like particles and microorganisms.
  • Distillation: The distillation of water can be used to remove mineral salts and other impurities. The water is heated to obtain pure water vapor, which then condenses.
  • Disinfection: Water can be disinfected using chemical disinfectants or physical methods such as UV radiation.
  • Purification: Application of various purification processes such as reverse osmosis (translation into German: Umkehrosmose) to remove residual mineral and organic impurities.
  • Quality control: The entire water purification process is subject to strict quality control in order to ensure that the water meets the standards and requirements of pharmaceutical manufacturing.

Pure, high-quality water plays a crucial role in the pharmaceutical industry, as even the slightest impurities (German: Verunreinigungen) or pollutants in water can compromise the quality and safety of drugs. The water purification process is therefore carefully designed and controlled in accordance with the high standards of Good Manufacturing Practice (GMP).

The European Pharmacopeia contains the following monographs with water of different qualities: Purified water (Aqua purificata; German: gereinigtes Wasser), water for injections (Aqua ad injectabilia), water for diluting concentrated hemodialysis solutions and water for preparation of extracts. There are differences in terms of microbial quality, conductivity and the required tests.

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