Record the observation, including the number of colonies, their morphology, and the specific
location where the sampling was conducted.
Ensure all relevant data such as date, time, and batch number are documented.
๐๐๐๐ง๐ญ๐ข๐๐ฒ ๐ญ๐ก๐ ๐๐ข๐๐ซ๐จ๐จ๐ซ๐ ๐๐ง๐ข๐ฌ๐ฆ๐ฌ
Perform microbiological identification of the colonies to determine the type of
microorganisms present.
This could involve techniques like Gram staining, biochemical tests, or molecular methods
like PCR.
After gram staining send for vitek
The VITEK system provides a confidence level or probability for the identified
microorganism. Ensure that the identification is accurate and that the confidence level is
acceptable (usually above 90%)
๐๐ฌ๐ฌ๐๐ฌ๐ฌ ๐ญ๐ก๐ ๐๐ฆ๐ฉ๐๐๐ญ
Evaluate the potential impact of the contamination on the product and process. Consider
whether the identified microorganisms are pathogenic or spoilage organisms and assess whether the level of contamination exceeds acceptable limits.
๐๐จ๐จ๐ญ ๐๐๐ฎ๐ฌ๐ ๐๐ง๐๐ฅ๐ฒ๐ฌ๐ข๐ฌ
Conduct a thorough investigation to determine the source of the contamination. This could
involve reviewing the compressed air system, examining filters, checking for leaks, and
assessing the cleanliness of the environment where the air is used.
๐๐จ๐ซ๐ซ๐๐๐ญ๐ข๐ฏ๐ ๐๐ง๐ ๐๐ซ๐๐ฏ๐๐ง๐ญ๐ข๐ฏ๐ ๐๐๐ญ๐ข๐จ๐ง๐ฌ (๐๐๐๐)
Implement corrective actions to eliminate the contamination source. This could include
repairing or replacing filters, improving the maintenance of the compressed air system, or
enhancing environmental controls.
Develop preventive actions to avoid recurrence. This might involve revising standard
operating procedures (SOPs), increasing the frequency of air quality monitoring, or
enhancing staff training on proper maintenance and handling procedures.
๐๐- ๐๐๐ฆ๐ฉ๐ฅ๐ข๐ง๐ ๐๐ง๐ ๐๐๐ฅ๐ข๐๐๐ญ๐ข๐จ๐ง
After corrective actions are implemented, re-sample the compressed air to confirm that the
contamination has been resolved. Depending on the results, further validation of the
compressed air system may be necessary.
๐๐๐ฏ๐ข๐๐ฐ ๐๐ง๐ ๐๐๐ฉ๐จ๐ซ๐ญ
Document all findings, actions taken, and results. Report the incident and actions to the
quality assurance team and, if required, to regulatory authorities.
