Page 22 - Microbiology in workplace

GMP Training – Microbiology in the Workplace by www.gmpsop.com

Water for injection (WFI)

This water is intended for the formulation of parenteral, dialysis, or inhalant
products. It should be prepared by distillation or reverse osmosis.

WFI is usually held under high temperature (> 80°C) to ensure that there is no
chance of microbial growth. WFI is monitored by QC, usually daily, to ensure
that the system remains bio burden- and endotoxin-free.

Typical limits for WFI are:
Target: no organisms / 100 mL
Action: < 10 organisms / 100 mL and <0.25 endotoxin units/mL *

** The presence of any endotoxin in WFI is usually a major concern.

GOOD TO KNOW - ISSUES AND PROBLEMS WITH WATER SYSTEMS

These concerns are based on the product types being manufactured:

For topicals and inhalants, there must be no presence of pseudomonads in
the water testing profile.

Systems must be able to be regularly sanitized. Each unit within a water
system may have different sanitation conditions.

Manufacturers need active change control and maintenance programs.

The QC test program should carefully document:
- Sample points and timing "worst-case"
- Sufficient frequency of testing in order to generate meaningful results

Pay attention to the limits and responses to out-of-limits.

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