Life Science

Product quality and process reliability is essential in regards of pharmaceutical water. LAR analyzers determine contamination reliably in lowest levels meeting international reporting requirements.

Life Science

Water analysis of pharmaceutical water, as Purified Water (PW), Highly Purified Water (HPW) or Water for Injection (WFI) is of special concern in the life science industry regarding product quality and safety in process.

Depending on the respective application, requirements regarding UPW purity are defined in norms as well as pharma regulations (pharmacopoeia).

Types of Water

Process water
Pure water (PW)
Highly purified water (HPW)
Water for injections (WFI)
Ultra-pure water (UPW)

Process Control and Product Safety

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
TOC	500 ppb	≤ 0,5 mg/l	N/A	≤ 0,5 mg/l	500 ppb	≤ 0,5 mg/l

TOC Analyzer for Pharma Applications
LAR's tailor-made total organic carbon analyzer QuickTOC_pharma fulfills the special requirements of the pharma industry.

Features & benefits:

Highest thermal oxidation power at 1,200°C that easily oxidizes the bad-to-oxidize standard p-benzoquinone (part of the SST test)

Software conforming to FDA (CFR 21 Chapter 11)

Instant validation at any time

Measurement within < 3 min

According to USP Chapter <643> and EP 2.2.44
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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
Read more
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).
Read more