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Bioburden assay and microbial testing services

Bio-Synthesis provides bioburden assay and microbial enumeration testing support for oligonucleotides, peptides, biological preparations, buffers, and related laboratory materials. These assays are commonly used to evaluate microbial contamination levels prior to downstream use or further processing.

What is bioburden testing?

Bioburden testing is a microbiological assay used to determine the number of viable microorganisms present in a sample before sterilization or further processing. Bioburden analysis is commonly performed on pharmaceutical materials, biological samples, laboratory reagents, and manufacturing-related materials to evaluate microbial contamination levels.

Bioburden testing typically measures Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC). Microbial enumeration may be performed using membrane filtration, pour plate, or spread plate methodologies depending on sample type and formulation characteristics.

Microbial enumeration methods

Membrane Filtration

Used for aqueous or filterable samples requiring sensitive microbial recovery and enumeration.

Pour Plate Method

Commonly used for microbial enumeration in liquid or semi-solid materials.

Spread Plate Method

Suitable for low-volume samples and surface microbial evaluation workflows.

Test Description
Total Aerobic Microbial Count (TAMC) Determines the total aerobic microbial population present in the sample.
Total Yeast & Mold Count (TYMC) Determines the level of yeast and mold contamination present in the sample.

Example bioburden assay result

Representative microbial enumeration assay result showing Total Aerobic Microbial Count (TAMC) and Total Yeast & Mold Count (TYMC) analysis.

Representative Bioburden Assay Result

Sample types supported

  • Peptides
  • Oligonucleotides
  • Buffers and solutions
  • Water samples
  • Biological preparations
  • Laboratory reagents
  • Raw materials
  • Research-use materials

Preparing samples for microbial testing

Submission Recommendations

  • Submit samples in sterile containers whenever possible
  • Clearly identify sample type and storage conditions
  • Include buffer or formulation information
  • Provide sufficient sample volume for analysis

Handling Notes

  • Ship temperature-sensitive materials appropriately
  • Avoid contaminated external packaging
  • Clearly label all submitted materials
  • Contact us for unusual sample types

Common questions

FAQ

What does bioburden testing measure?
 Bioburden testing measures the number of viable microorganisms present in a sample.
What microorganisms are evaluated?
 Testing commonly evaluates total aerobic microbial count and total yeast and mold count.
What methods are used?
 Membrane filtration, pour plate, and spread plate methodologies may be used depending on sample type.
What sample types can be tested?
 Peptides, oligonucleotides, buffers, water samples, biological materials, and related research samples may be evaluated.

Need microbial testing support?

Please contact Bio-Synthesis to discuss sample compatibility and project requirements.

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Why Choose Bio-Synthesis

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