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Microbiological testing helps natural health product manufacturers, supplement companies, importers and quality teams evaluate the microbial quality of ingredients and finished products against established specifications.
Depending on the product and specification, testing may include microbial enumeration, yeast and mould, and testing for specified microorganisms.
PBR Laboratories provides natural health product microbiology testing from Edmonton for clients throughout Alberta, Western Canada and Canada, including applicable testing using United States Pharmacopeia <61>, <62>, <2021> and <2022>.
The appropriate testing program depends on the product, matrix, specification and quality decision the results need to support.
Natural health product microbiology testing evaluates the number and/or presence of microorganisms in a submitted ingredient or finished product.
Depending on the product and applicable specification, microbiological testing can help determine:
Microbial enumeration and specified-microorganism testing answer different questions. The appropriate combination should therefore be based on the product specification rather than applying the same microbiology panel to every natural health product.
Depending on the matrix, method and specification, PBR's microbiological testing capabilities include:
Total aerobic microbial count provides quantitative information about the aerobic microbial population present in the submitted sample.
The result can be compared with the applicable specification to determine whether the sample meets the established microbial-count criterion.
Yeast and mould testing measures fungal populations in the submitted product.
Elevated results may lead to investigation of ingredients, storage conditions, moisture, manufacturing practices or other potential contributing factors.
Testing for bile-tolerant Gram-negative bacteria can form part of the microbiological specification for applicable products.
Testing may be required to determine whether Escherichia coli is detected in an applicable product according to the specified method and acceptance criteria.
Salmonella testing evaluates applicable samples for the specified organism according to the selected analytical method.
Testing for Staphylococcus aureus may form part of the specified-microorganism requirements for applicable products.
Testing for Pseudomonas aeruginosa may be relevant for applicable matrices and specifications.
PBR's service documentation supports these microbiological testing areas for applicable matrices.
PBR provides microbiological testing using applicable United States Pharmacopeia methods, including:
These methods do not all answer the same analytical question.
The correct method depends on the product category, matrix, specification and microbiological requirement.
United States Pharmacopeia <61> addresses microbial enumeration testing for applicable nonsterile products.
Testing can include:
The test provides quantitative information about the microbial population measured in the submitted sample.
The result is then evaluated against the applicable microbiological specification or acceptance criterion.
For quality teams, the decision is not simply:
“Were microorganisms detected?”
The more useful question is:
“Does the measured microbial count meet the specification established for this product?”
United States Pharmacopeia <62> addresses testing for specified microorganisms in applicable nonsterile products.
Depending on the product and specification, testing may involve organisms such as:
Enumeration determines how much microbial growth is present.
Specified-microorganism testing determines whether a particular microorganism is detected according to the applicable method.
A product can therefore meet an overall microbial-count criterion while still requiring testing for specified microorganisms.
United States Pharmacopeia <2021> provides microbial enumeration methodology specifically applicable to nutritional and dietary supplement products.
Testing can include:
PBR's service catalogue documents United States Pharmacopeia <2021>/<2022> microbiological capabilities for applicable plant, oil and edible matrices.
Depending on the applicable specification, results can contribute to:
microbiological quality assessment → specification comparison → investigation → finished-product quality decision
The result should be interpreted against the criteria established for the specific product.
United States Pharmacopeia <2022> addresses specified-microorganism testing for applicable nutritional and dietary supplement products.
PBR's documented supplement microbiology capabilities include testing areas such as:
The required microorganisms should be determined from the applicable product specification rather than automatically selecting every available organism.
What is the difference between USP <61>, <62>, <2021> and <2022>?
The chapters address two primary microbiological questions across different product contexts:
| Testing Objective | USP Method |
|---|---|
| Microbial enumeration for applicable nonsterile products | USP <61> |
| Specified microorganisms for applicable nonsterile products | USP <62> |
| Microbial enumeration for applicable nutritional and dietary supplements | USP <2021> |
| Specified microorganisms for applicable nutritional and dietary supplements | USP <2022> |
The correct method depends on the product, matrix and applicable specification.
Ask PBR which microbiological method is appropriate for your product.
Natural health products may contain botanical, agricultural, protein, mineral and other ingredients with different microbiological characteristics.
Microbial quality can be influenced by:
Microbiological testing provides analytical information that can help quality teams determine whether the submitted sample meets established microbiological criteria.
Testing should complement—not replace—appropriate manufacturing and quality controls.
Raw-material and finished-product testing answer different quality questions.
Testing can support:
Testing can support:
Passing an incoming-material microbiology test does not automatically demonstrate that the finished product meets its microbiological specification.
Manufacturing, handling, processing and packaging occur between those two stages.
A microbial count above an applicable acceptance criterion means that the submitted sample did not meet that particular microbiological criterion.
It does not automatically identify the source.
An investigation may need to consider:
The appropriate next step depends on the product, specification and quality system.
Detection of a specified microorganism should be evaluated against the applicable product specification and quality procedures.
Relevant information may include:
Simply repeating the test should not replace an appropriate investigation into an unexpected result.
PBR's decision framework emphasizes connecting analytical results with the underlying quality question and appropriate follow-up.
Laboratory results apply to the submitted sample.
If the result will be used to make a decision about an entire batch or lot, sample representativeness becomes important.
Common problems include:
PBR's testing framework identifies sampling, matrix suitability, handling and retained samples as important considerations when laboratory results support quality decisions.
Ask PBR about sample requirements before submitting your product.
Botanical materials can introduce microbiological variability associated with growing, harvesting, drying, processing and storage.
Testing may include microbial enumeration and specified microorganisms depending on the product specification.
Powdered supplements may require microbial enumeration and specified-microorganism testing based on ingredients, manufacturing conditions and specifications.
Protein and sports nutrition formulations can contain multiple ingredients from different suppliers. Microbiological testing may be considered alongside nutritional, moisture and compositional analysis.
Microbiological testing requirements depend on the ingredients, finished dosage form and applicable specification.
Liquid formulations can present different microbiological considerations from dry products. Testing should be selected according to the formulation and applicable specification.
The need for microbiological testing depends on the complete formulation, ingredients and finished-product specification rather than the product category alone.
PBR Laboratories provides microbiological testing support from Edmonton for natural health product manufacturers, supplement companies, ingredient suppliers, importers and quality teams.
PBR gives Alberta companies regional access to laboratory testing and direct communication about product matrices, microbiological specifications and sample requirements.
PBR supports natural health product and supplement companies throughout Western Canada with microbiological testing selected around the product, method and quality decision.
PBR supports clients across Canada requiring applicable natural health product microbiology testing, including USP <61>, <62>, <2021> and <2022>.
The objective is not simply to provide a microbiological result. PBR helps clients understand how the result relates to the specification and the decision that follows.
Depending on the product and specification, testing may include total aerobic microbial count, yeast and mould, bile-tolerant Gram-negative bacteria and specified microorganisms such as Escherichia coli, Salmonella, Staphylococcus aureus and Pseudomonas aeruginosa.
PBR provides applicable natural health product and supplement microbiology testing using USP <61>, <62>, <2021> and <2022>. The correct method depends on the product category, matrix and applicable specification.
USP <61> addresses microbial enumeration for applicable nonsterile products, including quantitative assessment of aerobic microorganisms and yeast and mould.
USP <62> addresses tests for specified microorganisms in applicable nonsterile products.
USP <2021> addresses microbial enumeration for applicable nutritional and dietary supplement products.
USP <2022> addresses testing for specified microorganisms in applicable nutritional and dietary supplement products.
Microbial enumeration measures the quantity of microorganisms present under the applicable method. Specified-microorganism testing evaluates whether a particular microorganism is detected. A product specification may require both.
No. The laboratory result applies to the submitted sample and the specific parameters tested. How well the result represents a larger batch depends on sampling, product homogeneity and other quality-system factors.
Review the result against the applicable specification and investigate sampling, ingredients, manufacturing, sanitation, storage and other relevant factors before deciding on follow-up testing.
Yes. PBR provides laboratory support from Edmonton for clients throughout Alberta, Western Canada and Canada.
Tell PBR what product you are testing, the matrix or dosage form, the applicable microbiological specification and whether you require USP <61>, <62>, <2021> or <2022>.
PBR can discuss the appropriate available testing and sample requirements for your product.