Bioburden / Microbial Enumeration Test

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The microbial enumeration test, also called the bioburden test or the microbial load test, is performed to monitor the microbial content in raw materials, in-process samples, and finished product in the pharmaceutical, biological, cosmetics, nutritional products, and medical device industry. The FDA expects companies to monitor the bioburden load in products used for humans and animals. The bioburden test can be performed by several methods based on the nature of the material tested.

The following is a list of the extraction methods offered. The extraction method is the procedure for removing the microorganisms from the product being tested.

  • Immersion
  • Flush / Rinse
  • Surface Sampling
  • Dilution

The following is a list of the enumeration methods offered. The enumeration method is the procedure used to determine the number of viable microorganisms that are extracted from the product being tested.

  • Membrane Filtration
  • Direct Plating
  • Most Probable Number (MPN)

The microbial load test should be validated to ensure that the method is effective, accurate, and reproducible in determining the material’s microbial load in a test article. The most suitable methodology should be determined as part of method development. Validation will be performed with the method that shows the best recovery of organisms with no inhibition. Validation is performed per USP/EP for Pharmaceutical or Biotechnology products, and AAMI for medical devices. Cosmetics are tested per FDA BAM manual.

MQA can also develop custom bioburden procedures for samples that are difficult to test.

ASSAY DESCRIPTION SERVICE CODE SAMPLE REQUIREMENTS
Aerobic Bioburden by Membrane Filtration – TSA medium only ML01 > 10 mL or grams
Anaerobic Bioburden by Membrane Filtration ML02 > 10 mL or grams
Yeast and Mold Bioburden – Membrane Filtration ML03 > 10 mL or grams
Total Aerobic Bioburden by Membrane Filtration (TSA & SDA media) (bacteria & fungi) ML04 > 20 mL or grams
USP <61> Microbial Enumeration Test Bacterial & Fungal count ML05 > 20 mL or grams
Aerobic Bioburden by Pour Plate method (TSA only) ML06 > 10 mL or grams
Anaerobic Bioburden by Pour Plate method (TSA only) ML07 > 10 mL or grams
Yeasts and Molds Bioburden by Pour Plate method (SDA medium) ML08 > 10 mL or grams
Total Aerobic Bioburden by Pour Plate method (bacteria & fungi) (TSA & SDA media) ML09 > 10 mL or grams
Microbial load inhibition test per USP ML10 > 30 mL or grams
Microbial load inhibition test per USP – membrane filtration plate count – TSA and SAB media + 6 USP org ML11 >30 mL or grams
Microbial load inhibition test – pour plate count – TSA and SAB + 6 org ML12 >30 mL or grams
Custom bioburden studies ML13 Project specific
MPN test ML14 > 10 mL or grams
Cosmetics aerobic plate count (APC) ML15 > 10 mL or grams
Cosmetics anaerobic plate count ML16 > 10 mL or grams
Cosmetics fungal count ML17 > 10 mL or grams
Cosmetic preservative efficacy test ML18 > 10 mL or grams
Cosmetics APC on non-used and used product ML19 > 10 mL or grams

Please note: The microbial load test is performed on an undiluted sample. Additional dilutions will be an additional charge. Microbial load liquid samples must be shipped cold. Liquid samples will be tested within 24 hours of receipt at the lab. Samples should be collected in sterile containers.

Continue at: https://www.microqa.com/laboratories/microbiology-testing-services/bioburden-microbial-enumeration-test/

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