Understanding the flora in your manufacturing environment (local isolates) serves to direct an appropriate cleaning strategy, helps determine where microbial contamination is coming from and what controls need to be added to ensure patient safety.

Risk assessments are an important part of qualifications. For this, the QC teams does not only need the number of colonies forming units (cfu’s) encountered on a certain sample location, however, also accurate identification to species level is required. The counts and identifications generated during cleanroom performance qualification establish a baseline as to what local isolates are found in the manufacturing environment and are also critical for establishing alert and action limits. From this information, changes in the manufacturing environment can be assessed.

“Local Isolates are representative microorganisms of a production site that are frequently recovered through environmental monitoring within the classified zone/areas especially Grade A zone and Grade B area, personnel monitoring or positive sterility test results.”

Monitoring trends is essential

The microorganisms should be identified to species level and monitored. The results should be considered in the overall context of the trend analysis and the contamination control strategy for the site.  Consideration may also be given to the identification of grade C and D contaminants. Trends are highlighted through the Annex 1 draft as a method to effectively identify and maintain the proper quality level at each stage of the production process.

Moreover, microbial cleanroom qualification is not a one-time event. After a thorough process of installation qualification, operational qualification and performance qualification, each cleanroom shall be regularly tested for microbial contamination at risk based identified location across the cleanroom.

Next to establishing the cfu’s, the identity of the microorganisms is of the utmost importance. Trending of counts and reviewing the status of the local isolates is key in your EM strategy and delivery of patient safe products.