Disinfectant Validation
The objective of this validation protocol is to demonstrate the efficacy of a disinfectant solution which are being used for the surface and area...
Introduction To Validation
Where Did Validation Come From?
From disasters:
1971–7 deaths in USA
1972–5 deaths at Devenport Hospital,UK
Began in 1970’s
Originally sterilized based
Now evolved...
Basics of Cleaning Validation
Cleaning validation is primarily applicable to the cleaning of process manufacturing equipment in the pharmaceutical industry. The focus of cleaning validation is those cleaned surfaces...
Temperature and Humidity Validation: Mapping in Storage Area
Pharmaceutical ingredients are placed or stored at various places for example raw material storage area, refrigerator, quarantine area, large cold rooms, packaging room, freezer,...
Formula for Calculating Number of Air Changes in an Area (ACPH)
Number of air changes/hour in an area is
= Total Room Airflow In CFM x 60
Total Volume of room in cubic feet
For calculating Total Room Airflow...
