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A result outside the applicable microbiological specification means the submitted sample did not meet the established criterion for that test.

It does not automatically identify the contamination source.

First: Verify the Quality Question

Review:

  • test performed;
  • applicable specification;
  • sample and lot identity;
  • method;
  • acceptance criterion.

Then Investigate Potential Sources

Possible areas may include:

  • raw materials;
  • supplier lots;
  • water;
  • sanitation;
  • manufacturing conditions;
  • equipment;
  • handling;
  • storage;
  • packaging.

Should You Immediately Retest?

Not automatically.

Repeating the analysis without investigating why the original result was unexpected may produce another number without answering the underlying question.

PBR's decision framework specifically emphasizes selecting follow-up testing around the investigation rather than treating retesting as the default response.

What Testing Could Help Next?

Depending on the result:

  • repeat or investigative microbiology;
  • raw-material microbiology;
  • environmental swabbing where relevant;
  • retained-unit testing;
  • moisture or water activity;
  • related finished-product testing.

Speak with PBR about the result, product matrix and investigation before selecting follow-up testing.

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