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.
𝐈𝐝𝐞𝐧𝐭𝐢𝐟𝐲 𝐭𝐡𝐞 𝐌𝐢𝐜𝐫𝐨𝐨𝐫𝐠𝐚𝐧𝐢𝐬𝐦𝐬
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%)
𝐀𝐬𝐬𝐞𝐬𝐬 𝐭𝐡𝐞 𝐈𝐦𝐩𝐚𝐜𝐭
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.
𝐑𝐨𝐨𝐭 𝐂𝐚𝐮𝐬𝐞 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬
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.
𝐂𝐨𝐫𝐫𝐞𝐜𝐭𝐢𝐯𝐞 𝐚𝐧𝐝 𝐏𝐫𝐞𝐯𝐞𝐧𝐭𝐢𝐯𝐞 𝐀𝐜𝐭𝐢𝐨𝐧𝐬 (𝐂𝐀𝐏𝐀)
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.
𝐑𝐞- 𝐒𝐚𝐦𝐩𝐥𝐢𝐧𝐠 𝐚𝐧𝐝 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧
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.
𝐑𝐞𝐯𝐢𝐞𝐰 𝐚𝐧𝐝 𝐑𝐞𝐩𝐨𝐫𝐭
Document all findings, actions taken, and results. Report the incident and actions to the
quality assurance team and, if required, to regulatory authorities.