Expert Knowledge in Water Treatment

Limit Values

Established Thresholds for Water Quality in Pharmaceutical Production

A limit value is a defined measure or specified threshold that sets the maximum permissible or acceptable level of a particular parameter or property. Exceeding a limit value can indicate potential risks or hazards and often requires corrective or control measures.

Examples of Limit Values:

PW (Purified Water) According to Ph. Eur.

  • Conductivity (at 20°C): < 4.3 µS/cm
  • Microbial Count: < 100 CFU/ml
  • Total Organic Carbon (TOC): < 0.5 mg/l
  • Endotoxin Level: Not Applicable (N/A)

WFI (Water for Injection) According to Ph. Eur.

  • Conductivity (at 20°C): 1.1 µS/cm
  • Microbial Count: < 10 CFU/ml
  • Total Organic Carbon (TOC): < 0.5 mg/l
  • Endotoxin Level: 0.25 EU/ml
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