Bioburden Testing

Shubhda Research Institute
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Given below is general information pertaining to the bioburden Test: 

Bioburden testing is an evaluation of the numbers and types of microorganisms present in a sample or product. Typically, the Bioburden Test is used for assessment of raw materials and intermediates. The testing acts as a pointer to the conditions during manufacturing.
A determination of the recovery efficiency and characterization (grouping microorganisms into categories) are both required for compliance with bioburden standards. Depending on client requirement the bioburden testing is done based on pharmacopeial standards or other standards like ISO 11737

Aerobe Bioburden:

Aerobe micro flora count .Test conditions may also recover mold and yeasts as well as bacteria. 

 7-10 days

Anaerobe Bioburden:

Anaerobic micro flora count. Extracts are incubated under anaerobic conditions (Some facultative organisms may also grow)

 7-10 days 

Fungi Bioburden:

Mold and yeast count. Extracts are plated using media designed to select for yeast and mold organisms (fungi)

7-10 days 

Spore Bioburden:

Aerobic spore count. Extracts are heat shocked to eliminate vegetative cells but recover spores.

  5-10 days

Aerobe and Fungi Bioburden:

Separate aerobe and fungi micro flora counts

7-10 days

Aerobe Bioburden Panel:

Aerobe / Spore / Fungi. Full aerobe characterization for products that have demonstrated no anaerobe bioburden.

 7-10 days

Total Bioburden Panel:

Aerobe /Anaerobe / Spore / Fungi. Intended for items for which a full characterization of the bioburden is needed.

 7-10 days

Bioburden Recovery Efficiency – Repetitive Recovery Method:

Devices are extracted multiple times to determine overall efficiency of the first extraction. The percent efficiency and the correction factor are calculated for use in future bioburden evaluation performed on the product. 

 7-10 days

Bioburden Recovery Efficiency – Spore Inoculation Method:

Devices are inoculated with a known quantity of bacterial spores and then subjected to the established bioburden procedure. The recovered spores are then counted and a correction factor is calculated for use in future bioburden evaluations


Bioburden - Pathogenic microorganisms:
Bioburden evaluation for E coli, Salmonella, Pseudomonas, Enterobacteria, S aureus, Bile Tolerant bacteria etc.

TAT: 3 -10 days
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