To control the sources of contamination
Have you ever experienced problems with your production equipment or water networks? Or do you want to prevent these risks?
Some bacteria such as Ralstonia picketi can proliferate and impact the expected quality of your water (PW, WFI) and your finished product.
La Pharmacopée Européenne impose The European Pharmacopoeia lists the following specifications for total viable germs:
- PW: ≤ 100 CFU / ml
- WFI: ≤ 10 CFU / 100 ml
A loss of control can have serious consequences that can alter the quality of the medicine as well as its safety, which could affect public health. A production shut-down would also have dramatic consequences for any manufacturer.
It is therefore essential to control the risks of contamination, which means knowing how to detect them.