Objective
To understand
What is Bioburden?
Sources of Bioburden
To Implement
Methods & Systems to Control Bioburden
Ultimate Goal
use.
What is bioburden?
Bioburden is the measure of living
eye
Enumeration expressed in terms of CFU
CFU-Colony Forming Unit
Sources of Bioburden
Raw Material
Processing Equipment
Environment (Air / particulate matter) &
Personnel
Packing Material
Human handling
Contact with liquids (can be particularly
dangerous endotoxins)
Material Degradation
Process Equipment
Immediately clean after use
Use bioburden reduction agents where ever
Packing Material
Use the appropriate material for suitable
sterilization process
Packing material should posses chemical
In Summary
Know your device bioburden!
Bioburden must be monitored and tracked on a regular
basis
Be aware and catch issues before require corrective
action
Monitoring, training, and controlling production areas
are key