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A high microbial count creates an important quality question:

Is the result associated with the ingredient, supplier, manufacturing process, storage, product formulation or sampling?

Simply repeating the same test may reproduce the result without explaining the cause.

First, Confirm What Was High

Determine whether the result involved:

  • total aerobic microbial count;
  • Yeast and mould.
  • Another applicable enumeration measure.

Confirm:

  • Result.
  • Units.
  • Method.
  • Specification.
  • Sample identity.
  • Lot.

Review the Sample

Ask:

  • Was the correct lot sampled?.
  • How many units were included?.
  • Was the material homogeneous?.
  • Was the sample composite?.
  • Did the sample adequately represent the lot?.

An unexpected result may reflect genuine variability within the product.

Review Raw Materials

Consider:

  • Botanical ingredients.
  • Agricultural ingredients.
  • Supplier changes.
  • Raw-material microbiology.
  • Historical lot performance.
  • Ingredient storage.

Raw-material testing may help determine whether an ingredient could be contributing to the finished-product result.

Review Manufacturing

Potential contributors may include:

  • Equipment.
  • Sanitation.
  • Process steps.
  • Handling.
  • Filling.
  • Packaging.
  • Storage.

The laboratory result does not identify which source is responsible.

Consider Moisture & Water Activity

Where relevant, these measurements may provide useful supporting information.

They do not replace microbiological testing.

Should You Retest?

Potentially—but define what the retest is intended to determine.

Repeating the same retained sample asks whether the result is reproducible in that material.

Testing another finished-product unit asks whether the result occurs elsewhere.

Testing ingredients asks whether raw materials may contribute.

Those are different investigation questions.

What if Yeast & Mould Are High?

Review:

  • Botanical ingredients.
  • Agricultural ingredients.
  • Drying.
  • Storage.
  • Moisture.
  • Packaging.
  • Manufacturing environment where relevant.

What if Total Aerobic Count Is High?

Review:

  • Incoming microbial load.
  • Processing.
  • Sanitation.
  • Handling.
  • Storage.
  • Product history.

A high count does not identify which organisms are responsible.

What if a Later Sample Passes?

A later passing result does not automatically prove the original result was incorrect.

Different product units or samples may genuinely contain different microbial populations.

Review the sampling plan, production lot and product variability.

Common Mistakes

  • Immediately repeating the same test.
  • Ignoring raw materials.
  • Assuming the laboratory result identifies the source.
  • Treating a later passing result as proof the first result was invalid.
  • Failing to retain raw-material or finished-product samples for investigation.

Frequently Asked Questions

What does a high microbial count mean?

The submitted sample exceeded the applicable microbial-count criterion or specification.

Should I immediately retest?

Not without defining what the follow-up testing needs to determine.

Should raw materials be tested?

Potentially, if an ingredient source is a plausible contributor.

Can moisture or water activity help?

They may provide useful supporting information but do not replace microbiology.

Have an Unexpected Natural Health Product Microbiology Result?

Tell PBR the test, result, specification, product matrix and what you are trying to determine next.

Choose PBR — Because Precision Matters, Defining Excellence in Laboratory Services Since 1984.