BIO-BURDEN

Objective
To understand
What is Bioburden?
Sources of Bioburden

To Implement
Methods & Systems to Control Bioburden

Ultimate Goal

Deliver an effective product that is safe to

use.

What is bioburden?
Bioburden is the measure of living

microbes on/or in a surface of an article

that has not yet been sterilized.
Most commonly, bioburden is important

when being tested for on medical devices

or objects used in medical care facilities.

How to measure Bio-Burden

By means of physical appearance through naked

eye
Enumeration expressed in terms of CFU
CFU-Colony Forming Unit

Why test for bioburden?

The following microbes, though not

usually much to worry about in normal

life, can be extremely dangerous and
life-threatening if unintentionally
inserted into the body during medical
procedures.
By testing for bioburden, scientists

can determine the most effective

ways to sterilize medical equipment to

Sources of Bioburden
Raw Material
Processing Equipment
Environment (Air / particulate matter) &

Personnel
Packing Material
Human handling
Contact with liquids (can be particularly
dangerous endotoxins)

Why Bio-burden Control is Critical

Product Degradation /Spoilage
Safety
Efficacy
Appearance

Material Degradation

Solution for Bioburden

Control
Use everything sterile

Process Equipment
Immediately clean after use
Use bioburden reduction agents where ever

possible NaOH, Acids, Hyprochloride

Use Autoclaved glassware for critical operations
If in doubt, clean/ sanitize again
Store either in very dry state or with biostatic
liquid- no not store wet/ moist
Periodically clean equipment thoroughly for
removing soil/ grime from hard to clean areas

Environment & Personnel

Areas of Focus:
Production areas
Storage areas
Production equipment
Keep Lab area clean
Use Laminar Flow Hood for all critical sample
Aliquot when possible to reduce risk
Following good handing procedures
Sanitize hands before critical material handling
Hold containers away from mouth/ brim
Keep your body and other things away from the product

Packing Material
Use the appropriate material for suitable

sterilization process
Packing material should posses chemical

indicator in-order to verify the sterilants

effectiveness.
Choose the packing material based on its

sealing capacity through out the validity of

the product.

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

Thank you for your attention!