Life Science

Water Analysis in Life Sciences

The requirements for water analysis in life science are high. Besides ensuring high product quality, process safety and reliability are among the most important objectives.

Pharmaceutical water in particular places high demands on the accuracy of online analysis, since the water quality of e.g. water for injection is decisive for the product quality. For the compliance of the water quality there are standards as well as pharmaceutical standards (pharmacopoeia), which define the requirements for such pharmaceutical water, such as water for injection (WFI) and ultra pure water (UPW).

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  • Application scheme for pharmaceutical water
  • Application scheme for purified water

Types of Pharmaceutical Water and their Limitations

Depending on its usage pharmaceutical water needs treatment with various filters and/or disinfection (see the schematic pharma water system above). Generally, there are three types of pharma water defined, :

  • Purified Water (PW) or Aqua Purificata
  • Highly Purified Water (HPW) or Aqua Valde Purificata
  • Water for Injection (WFI) or Aqua Ad Iniectabilia

International Pharmacopeias

In pharma industry the production of Purified Water (PW) and the maximum TOC (total organic carbon) level is defined by more than one authority.

The most popular pharmacopeias are:

  • Chinese Pharmacopoeia (CP),
  • European Pharmacopoeia (EP),
  • Indian Pharmacopoeia (IP),
  • Japanese Pharmacopoeia (JP), and
  • U.S. Pharmacopeial Convention (USP).

In the pharmaceutical sector water is inter alia used as

  • Cleaning agent
  • Excipient
  • Ingredient
  • Raw material and much more

Depending on its usage, pharmaceutical water needs a certain purity. 
Requirements on water quality and monitoring equipment are high.

  • Water for injections (WFI) is a demanding application of UPW in the pharmaceutical industry. In the manufacture of any type of active ingredient and medicine, the entire production process, including the cleaning process, is seamlessly monitored.
  • Highly purified water (HPW) is used as cleaning agent
  • Ultra-pure water (UPW) is often used as process water for the production of pills, capsules and other oral medication.

Purification of water

  • Even drinking water or potable water contain organics and other substances in very low concentration
  • pharmaceutically used water needs to be purified before it is used in manufacturing processes
  • The treatment of this so-called feedwater or make-up water takes place on-site and is very costly

Comparison of phamaceutical water Limits

 

Purified Water

Highly Purified Water

   Water for Injection

TOC    

USP

EP

     USP

  EP

  USP

EP

   500 ppb    

≤ 0,5 mg/l    

   N/A

    ≤ 0,5 mg/l

   500 ppb

  ≤ 0,5 mg/l

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