Water analysis of pharmaceutical water, as Purified Water (PW), Highly Purified Water (HPW) or Water for Injection (WFI) is of special concern in the pharma industry regarding product quality and safety in process.
Online TOC Analysis for Pharmaceutical Water
Water is used in a variety of processes within the pharma industry. It is inter alia used as cleaning agent, excipient, ingredient or raw material and much more. Depending on its usage, pharmaceutical water needs a certain purity.
Since even drinking water or potable water containing organics and other substances in very low concentrations, water needs to be treated before it is used for pharmaceutical manufacturing. The treatment of the so-called feedwater - mostly drinking water - takes place on-site.
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).
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
|Purified Water||Highly Purified Water||Water for Injection|
|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 QuickTOCpharma 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