Page 71 - Water purification system for hemodialysis _ New guideline อ.กลศร

Validating an On-Line Fluid Preparation System

• The Pharmacopoeia states that sterility can not be

guaranteed by testing: it has to be assured by the

application of a suitable validated production process, and

manufacturers of on-line systems have to perform such

validation to gain approval for their systems

INGRID LEDEBO. J Am Soc Nephrol 13: S78–S83, 2002