Q: What is the best approach when documenting daily environmental monitoring data?

A: There are many different ways to document daily environmental monitoring, and USP <797> does not provide specific directions on how to do that. Common approaches include automated programs or simple spreadsheets. Be sure these are accessible and ensure that your staff understands the appropriate ranges you have defined. Staff should be able to identify results that warrant concern and results that require an escalation of action.

If the daily environmental monitoring does reveal an issue, be sure your staff knows what the appropriate next step is depending on what the monitoring has revealed. I recommend having a document, either electronic or on paper, that indicates when staff should contact the Designated Person, or if appropriate in the case of a temperature or humidity issue, the facilities department.

Q: When should a facility cease compounding based on an antimicrobial action level excursion?

A: Often, an excursion will go unrecognized because of the time required for the isolates to grow. Barring a significant microbial proliferation that is visible within 24 to 48 hours, results may be received days after the excursion has occurred. The decision to cease compounding depends on a variety of factors, including whether the source of the excursion is in the hood or is in the room. If the environmental monitoring results within the hood exceed an action level, you must cease compounding in that hood, undertake the appropriate cleaning steps, and retest.

If the source of the action level excursion is within the room, that is a different issue. In this scenario, the hood is certified but the surrounding space does not meet the cleanroom requirements. While the current version of <797> does not specifically address this issue, you essentially have a segregated compounding area. In this case, you would be able to use 12-hour dating. However, in the case of an egregious situation, employ the immediate assistance of a microbiologist.

Note that growth in the cleanroom often results from one of two common issues: poor technique on behalf of the compounder, which is a personnel monitoring issue, or insufficient cleaning, where the process is insufficient, or the cleaning solutions are not appropriate. When there is an excursion or negatively trending monitoring data for the cleanroom, review staff technique as well as cleaning products and processes.

Q: If we are being surveyed against the 2008 version of USP <797>, do we need to have a remediation plan in place for BUDs if the humidity is out of range?

A: Currently, there is no humidity requirement in the 2008 version of USP <797> so whether you need to have a remediation plan in place for BUDs in such a scenario depends on your state regulations and your departmental policies. However, if humidity requirements end up in the revision of USP <797>, you would need to be able to respond to that as well. Consider the frequency of the issue: If the humidity is consistently above 60%, that is a different situation than if the humidity is out of range for a brief period of time.

Best practice is to establish a plan to address any out of range situation in advance. Although not required in <797>, I recommend having preestablished alert levels that trigger an internal response to help prevent reaching an out of range situation.

Q: If the humidity rises above 60%, but the monthly surface non-viable sampling reveals no issues, is it reasonable to continue with full <797> dating, or should the dating decrease to 12 hours?

A: In this scenario, focusing on the sampling results is key. I would recommend increasing the frequency of surface sampling beyond monthly. While this approach is not specified in either the current or proposed versions of <797>, it will provide you with meaningful data for decision-making. It is very important to correct this issue as humidity above 60% may lead to problems if left unaddressed.

This scenario is more common for warmer regions and in the summer and needs to be addressed with your facilities department. I would encourage you to put your certifier in contact with your facilities department to best address this issue.

The proposed revision to <797> uses the term should, which means that it is a recommendation—not a requirement—to make adjustments. However, your state may take a more stringent approach. Of course, a humidity monitor is necessary to record the humidity; it must be calibrated to ensure accurate readings.

Evaluating the need to decrease BUDs can be a complex process. If this is a one-time excursion just slightly above 60%, you may feel comfortable continuing with your normal BUDs. However, if excursions are a constant issue, it is important to be aware of the increased risk of microbial contamination and consider decreasing the BUDs. The new BUD might be as short as 12 hours, given that a preparation area that is not in a desired state of control could be considered a segregated compounding area rather than a cleanroom suite.

This is one of the parameters that should be included in a report to your Infection Control Committee. It may be helpful to involve both the infection control practitioners and the risk managers in your organization in the solutions process.

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, is director of accreditation and medication safety for Cardinal Health and is a member of the USP Compounding Expert Committee. She is the author of The Chapter <800> Answer Book and many resources for pharmacy. Her comments herein are her own and not official information from USP.