Microbio Laboratory

                        ......Complete Microbiology

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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

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