In Reply to Parent Post by mobylad
What is the difference between the above two?
Bioburden test is performed to determine the number and nature of microorganisms on a product prior to sterilization.
According to the standard ISO/TS 11139:2006 (Sterilization of health care products ? Vocabulary), the definitions of sterility, test for sterility & bioburden are listed below;
State of being free from viable micro-organisms. [ISO/TS 11139:2006]
Population of viable micro-organisms on a product and/or sterile barrier system. [ISO/TS 11139:2006]
Test for sterility:
Technical operation defined in an official pharmacopoeia performed on product following exposure to a sterilization process [ISO/TS 11139:2006]
Test of sterility:
Technical operation performed as part of development, validation or requalification to determine the presence or absence of viable microorganisms on product or portions thereof. [ISO/TS 11139:2006]