Once a sampling plan has been developed and in place (see blog post “Microbial Environmental Sampling: Developing an Air and Surface Sampling Plan, link at bottom) it’s time to understand how to sample, incubate, record, and EVALUATE results. Remember, once a sampling plan has been established, it won’t be changed up much unless the workflow changes significantly. The only “true” way to track and trend data is to have the same data points upon each sampling.
Before we continue, just a tip on physically conducting sampling and incubation: USP <797> gives word-for-word direction for these processes in box 5 (viable air sampling) and box 6 (surface sampling). This is also a great resource for developing a thorough SOP on conducting sampling.
Synopsis
EVALUATION of data consists of:
Assessment of each microbial sample to determine if any one or more sample(s) has exceeded the “allowable” limits of growth (aka Action Levels, shown in chart below)
When microbial grown exceeds “allowable” limits, identification of the growth to the genus level must be attempted
Note: USP no longer required identification of ALL growth but only growth that exceeds allowable limits. Our identified growth will drive our investigation. However, each facility can assess if they would like to hold to a stricter standard (ex., it may be of interest to identify all growth in a PEC to the genus level). Again, the minimum standard does not require identification of growth until allowable limits are exceeded but the facility or your state can follow a stricter standard.
Once this has been done, samples will be established as pass or ”limits exceeded” and will give direction to next steps:
Pass = Document the number of each colony forming unit (CFU) from each sample location in a spreadsheet (or reputable tracking system) so that tracking and trending data is readily available for future evaluation
Limits Exceeded = Identify growth to the genus level. The identification of organism will then drive the investigation. Remediation and elimination of the source will follow. This is where many get stumped and will be discussed in a future blog post: Microbial Environmental Sampling: Investigation, Remediation and Elimination of Failed Air/Surface Samples, link at bottom.
Note: USP refers to identification of growth from a sample that exceeds limits. However, if any one or more samples exceed limits, it may be advantageous to identify all growth from all samples, even those that did not exceed limits. Sometimes the extra identification can tell more of the story for what may be going on in ISO classified areas.
Evaluation of Data
Evaluation of results is as straight forward as following the action level chart in USP <797>. A simplified version of this chart for air and surface samples appears below. If one or more samples exceed the limits indicated, it is time to investigate, remediate and eliminate the source that caused the failure.
That’s it for EVALUATION of results! Now results are ready to be placed in a spreadsheet to track and trend results against other samplings and for future evaluation.
INVESTIGATION of samples that exceed limits will be addressed in a new blog post (Microbial Environmental Sampling: Investigation, Remediation and Elimination of Failed Air/Surface Samples, link at bottom). This topic can be difficult for some since we are dealing with microorganisms that are not visible with the naked eye. However, there are key principles that can help lead the investigation to identification of the source. This will be addressed in our next post!
Remember: It is not a question of IF limits will be exceeded but rather WHEN they will be exceeded. The key is to know how to manage the investigation and documentation processes and what to do in between action and resolve to keep patients safe.
Microbial Environmental Sampling: Developing an Air and Surface Sampling Plan” by clicking this link: https://smilstead5.wixsite.com/website-5/post/developing-a-microbial-environmental-sampling-plan-air-and-surface-sampling-sites
Microbial Environmental Sampling: Investigation, Remediation and Elimination of Failed Air/Surface Samples
Pharmacist (BCSCP) and the founder of Soigner Solutions (Soigner Universal, LLC). Collectively, Steve has over 20 years experience in sterile compounding of non-hazardous and hazardous preparations (including non-sterile to sterile using API). He is also experienced in non-sterile compounding and has fully developed and implemented all-inclusive compounding programs including USP <800> hazardous drug programs since the release of <800> in 2016. Steve received his Doctor of Pharmacy degree from McWhorter School of Pharmacy and holds two other degrees from Samford University and Université Sorbonne.
Thank you for visiting my site. For more information please visit www.SoignerSolutions.com or email me directly at smilstead@SoignerUniversal.com
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