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Interpretation of microbiological test results
Explanation of test results:
Microbiological test results are difficult to interpret for the following reasons:
Microorganisms are ubiquitous in nature and exist in the usual environmental pollution, many types of special organic matter that is dominated by humans.
Laboratory analysts may introduce microbial contamination during sample analysis and manipulation.
Microorganisms may not be evenly distributed in the sample and environment.
There is considerable variability in the results of microbial analysis.
Therefore, the small differences obtained from the expected results are of little significance.
Because of these characteristics of microbiological analysis, experimental analysis should be very careful to avoid external contamination. From the perspective of major microbial observations, the results must be explained. It includes not only the type of contamination assumed, but also the organic components present in the pharmaceutical ingredients, excipients, or test environments. In addition, the growth characteristics of its microorganisms should also be considered.
When the results appear inconsistent with the text of the pharmacopoeia or other established quality standards, an investigation should be conducted. Microbial contamination that does not meet the standard requirements usually has two obvious causes: it may be a laboratory error or an ineffective result in the experimental environment, or it may be that the product has some pollution or other forms of contamination that exceeds the prescribed standards or limits. . In another case, laboratory operations, in most cases, should be notified immediately.
A comprehensive assessment of all situations surrounding the outcome should be made. All experimental conditions and due considerations, including data drift, are compared to established limits and standards. It is important to know the statistical significance of the observation based on the variability of the results.
If the analysis result is invalid, it must be recorded based on an identifiable error. The laboratory should have an SOP requirement to verify the test (retest) and, if necessary, resample. Regarding resampling, the regulations and the Pharmacopoeia did not give an operation to investigate the results of the analysis.
In addition, discussions with the experimenter, the actual operation in the analysis can get valuable information. To determine the reliability of the results and to decide on the measures taken. If you can determine the clear cause of the inconsistent result, you should take corrective action and document the problem. Follow up on officially approved and implemented corrective actions and conduct a careful inspection.
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Non-mechanical method of cell disruption technology