Bioburden microbial enumeration test

Bioburden microbial enumeration test

Microbial Enumeration tests for nonsterile products, following test procedures outlined in USP <61>, provides an evaluation of the microbial content of a product also known as bioburden testing. USP <62> is the method described for the screening of objectionable organisms or pathogens and USP <60> is the method described for Burkholderia cepacia complex. The USP requires validation/suitability testing and provides a rugged process for the detection of objectionable organisms. Product-specific objectionable organisms can be determined based on the product type, optimizing the testing process.

This test method has defined procedures for the detection of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella species, and Candida albicans, Burkholderia cepacia complex and a quantitative for bile-tolerant gram-negative bacteria. USP <61/62> testing is recommended on all pharmaceutical raw materials, nonsterile products (such as liquids and powders), transdermal patches, and dietary supplements. USP 60 testing is recommended for inhalation use products or aqueous preparations for oral, oromucosal and nasal use.

The advantage of using Nelson Labs is our rugged validation method for the test process, combined with a professional team of experts who provide individualized consultation. We’ll help you design the appropriate test plan for determining the objectionable organisms in your product.

Applicable Standards

The full title of this standard is “EN ISO 11737-1:2018 – Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products.”

It is part of a series of standards related to the sterilization of healthcare products that includes ISO 11737-2, ISO 11737-3 and ISO 11737-4.

  • USP 60
  • USP 61
  • USP 62

The goal of bioburden testing is to quantify and identify microorganisms to ensure products meet specified quality standards and regulations. Here is a brief overview of how it’s performed:

  1. Sample Collection. Representative samples are collected aseptically from the medical device.
  2. Sample Preparation. Microorganisms are extracted from samples and diluted appropriately for counting.
  3. Microbial Enumeration. Viable microorganisms are quantified using either plate count or membrane filtration methodology. The plate count method involves spreading diluted samples on agar plates, incubating them and counting visible colonies for bioburden determination. The membrane filtration method filters samples through a membrane before counting and determination.
  4. Microorganism Identification. Microorganisms are identified as needed at this point in the process.
  5. Analysis and Reporting. Results are analyzed and a comprehensive report is compiled that includes bioburden levels and identified microorganisms.
  6. Validation and Calibration. Testing methods are validated for accuracy and precision.

Sample Specifications

  • MEP110 : The USP requires 10 grams/mL/patches/doses for the initial preparation, unless the batch is less than 1 L/kg. The Salmonella screen also requires 10 grams/mL of sample. It is recommended to supply 30-40 grams/mL for the USP <61> and <62> suitability test
  • MEP115 : The USP requires 10 grams/mL/patches/doses for the initial preparation, unless the batch is less than 1 L/kg. It is recommended to supply 30-40 grams/mL/patches/doses for the USP <61> and <62> suitability testing.
  • MEP215 : The USP requires 10 patches for the initial preparation, unless the batch is less than 1 L/kg. It is recommended to supply 20-30 patches for the testing.
  • MEP250 : The USP requires 10 grams/mL/patches/doses for the initial preparation unless the batch is less than 1 L/kg. It is recommended to supply 20-30 grams/mL/patches/doses for the testing.
  • MEP265 : 20 grams or 10 mL

Study Outline

USP <60> analysis is performed to determine the presence of Burkholderia cepacia complex. The test involves an initial enrichment of the sample and then streaking the enriched sample onto a selective agar for determination of the presence of Burkholderia species.

The USP <61/62> test system uses the compendia method, as set forth by USP, for the testing of nonsterile pharmaceutical products and other nonsterile articles for bacterial load and pathogenic organisms. USP <61> testing includes an enumeration plate count and suitability testing, which validates the plate count. USP 62 testing evaluates the presence or absence of specific organisms.

The suitability test verifies the validity of the testing method by demonstrating that any antimicrobial properties of the product do not inhibit possible recovery of growth. The suitability is performed with inoculation of the product with <100 colony-forming units (CFU) of the defined organisms.

USP <61> describes the validation of the plate count preparation and plating method by demonstrating recovery of Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, and Aspergillus brasiliensis on the appropriate media. The testing is performed to determine the total aerobic microbial counts and total yeast and mold counts. The plating of the sample can be performed by membrane filtration, pour plating, or the spread plate method. The sample is diluted, plated for the total aerobic microbial count and total yeast and mold count, and incubated.

USP <62> analysis is performed to determine the presence of specified microorganisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant gram-negative bacteria, Clostridia species, Salmonella species, and/or Candida albicans. The test involves an initial enrichment of the sample and then streaking the enriched sample onto selective agars for determination of the presence of the defined objectionable organisms.

Continue at:  https://namsa.com/tests/bioburden-total-fungi-membrane-filtration/

Microbiological Examination of Nonsterile Products

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Manostaxx
Manostaxx – Industrial Management Consulting

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