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Bioburden Test
Bioburden testing is an enumeration of the microorganisms present on a product, and may be used for assessing of incoming materials, as an indicator to the manufacturing conditions, and to get data for sterilization and their validations. Determination of the efficiency in recovery and characterization of different organisms are both required for compliance with bioburden standards. All aspects of bioburden testing test limits , characterization and estimation of recovery efficiency – are performed according to specified ISO/ IP /USP standards
1. Aerobic Bioburden
Aerobic microbial count. Enumeration of mold and yeasts as well as bacteria.
TURNAROUND TIME: 7 days
2. Fungi, Yeast and Mold Bioburden
Estimated with selective media for yeast and mold and fungi.
TURNAROUND TIME: 7-10 days
3. Spore Bioburden
Aerobic spore count. Extracts from samples are eliminated of vegetative cells and spores recovered.
TURNAROUND TIME: 5-10 days
4. Anaerobe Bioburden
Anaerobe microflora count. Extracts are incubated under anaerobic conditions.
TURNAROUND TIME: 5-10 days
5. Aerobe Bioburden Panel (Aerobe / Spore / Fungi)
Full aerobic estimation for products that have demonstrated no anaerobes.
TURNAROUND TIME: 7-10 days
6. Bioburden Testing
Intended for items for which a complete bioburden profile is needed.
TURNAROUND TIME: 7-10 days
7. Total Bioburden Profile (Aerobe / Anaerobe / Spore / Fungi)
8. Bioburden Recovery Efficiency Test (Repetitive Recovery Method)
This method is not for items which show a very low bioburden (e.g., less than 50 CFU per device).
TURNAROUND TIME: 7-10 days
9. Bioburden Recovery Efficiency Test (Spore Inoculation Method)
Samples are inoculated with bacterial spores and exposed to the bioburden procedure. The recovered spores are enumerated and a factor calculated for application in the bioburden evaluations.
TURNAROUND TIME: 3-5 days