Cleaning Validation
It is a document act of demonstrating that cleaning procedure for the equipment used in the fabrication/packaging will reduce to an acceptable level of all residues the (product & cleaning agent) and to demonstrating that routine cleaning & storage of equipment does not allow microbial proliferation.
Importance of Cleaning Validation
“Particular attention should be accorded to the validation of cleaning procedures” (WHO) “Cleaning validation should be performed in order to confirm the effectiveness of a cleaning procedure” (PIC/s) “The data should support a conclusion that residues to an acceptable level” (FDA)
CEHT
Hold time study shall be carried out to ensure the suitability of cleaned equipment, stored in its prescribed storage conditions, and does not increase the microbial contamination level more than the limit for freshly cleaned equipment.
DEHT
The dirty equipment hold time studies shall be carried out to ensure the microbial proliferation over a period of time and the same shall be possible to clean.
• Cleaning Validation | ...