It's been a while since I have been able to post so I thought I'd answer a question here concerning how to avoid chaos when surface sampling goes wrong.
Work Smarter, Not Harder by Being Proactive: This is my best advice to alleviate some of the anxiety over sample excursions. If possible, schedule air/surface sampling three days prior to monthly cleaning (monthly surface sampling will be mandated in the upcoming revision of USP <797> for Category 1 & 2 compounding). Doing this removes the stress from organizing an unscheduled cleaning and provides more opportunity to investigate and assess the excursion. Theoretically, if adequate and effective processes are in place, since the sample that exceeded actionable levels took place prior to the cleaning then any objectionable growth should no longer exist (whether the excursion was isolated or throughout the entire suite). However, it is of utmost importance that assumptions be put aside and remember that there is still the requirement to identify the source, to put action into place and to prove that the action was credible.
Additionally, sampling in this way allows the facility the ability to resample the area in question “blindly” and immediately and gives more insight to the investigation. If a sample is returned and is not exceeding the actionable levels, this “might” indicate that the excursion is not due to an ongoing issue but rather to something that occurred once at an isolated moment in time and just happened to be picked up. Conversely speaking, a repeat excursion “might” indicate an ongoing issue.
Note: Even if a sample comes back not exceeding actionable levels, the soured must still be identified, action applied, and proven that the action was effective.
To read full post on air and surface sampling, click below:
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