Tuesday, March 19, 2024

Factor Affecting Transportation of Pharma dosages – validation points

Transportation validation shall be carried out for Finished Goods being transported to the destination(s) of distribution from the manufacturing unit. During transportation, there is number of...

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...

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...