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Bioburden Testing (microbial limit test, USP 61)

Bioburden testing is required by regulatory authorities for investigational new drug (IND) submission and is especially critical in process development for biologicals and devices.  Bioburden testing will provide the quantity of viable microorganisms in or on a therapeutic, medical device or raw material before sterilization. 

 
Ultimately, this service can provide an accurate basis for calculating effective sterilization doses for a given therapeutic.

 
 
BioReliance tests for bioburden in several areas of drug manufacturing and production including:

  • Bulk Lot Release Testing
  • Final Product Release Testing
  • Raw Materials Testing
  • Medical Devices

 

BioReliance scientists perform bioburden testing services for clients in Biopharma and can perform any of the several extraction and enumeration methods outlined in USP 61 for determining the bioburden of a given therapeutic. 

We can provide a fast turn around time and the highest quality testing to help you rapidly assess and control microbial levels and produce therapeutics that are safe for use in humans.

 

To see our bioburden assays, use the search tool to the right or click here.

 

How is bioburden testing performed?

BioReliance CRO follows the bioburden testing procedure described in ISO 11737. Following extraction, aliquots are plated to determine the number of mesophilic aerobes, fungi and bacterial spores by genetic analysis (PCR) or array. Incubation under anaerobic conditions also is available.  

 

Bioburden testing and microbial limits

Often, it is necessary to evaluate a non-sterile pharmaceutical product for the presence of objectionable organisms, depending on the intended use of the material. BioReliance recommends a microbial limit approach for the evaluation for objectionable organisms. 

Microbial limits testing includes the quantitative phase of testing determining the bioburden of given pharmaceutical manufacturing samples, and the number of total aerobic organisms, yeasts, and molds. BioReliance is compliant with the bioburden testing procedure described in ISO 11737.

 

The qualitative phase of microbial limit testing examines samples per U.S. FDA criteria for “objectionable organisms.” For minimum coverage, these criteria require testing for the following:

  • bacteria Escherichia coli (E. coli)
  • bacteria Staphylococcus aureus (S. aureus)
  • yeast Candida albicans (C. albicans)
  • bacteria Pseudomonas aeruginosa (Ps. aeruginosa)
  • fungus Aspergillus niger (A. niger)

                 

BioReliance CRO is an expert in bioburden testing and can provide you with advice on the best assay for your drug study or lot release needs, contact us.