Your questions, answered: Experts address top questions from our latest webinar

At SherpaPharma, we recently hosted a live Q&A webinar on environmental monitoring (EM), bringing together industry experts to tackle the most pressing questions from professionals in the field. This session hosted by Alex Bezilla, featured Vanessa Figueroa, Abby Roth, and Gilberto Damaso, who shared their expertise on questions directly from the audience in a live, discussion-based format.

If you missed the webinar or just want to review the top questions from the event, here’s a summary.

Regulatory bodies frequently identify issues in environmental monitoring programs, particularly in areas such as data trending and analysis, where many companies struggle to properly interpret trends and apply corrective actions.

Another common issue is the lack of scientific justification in monitoring plans. Inspectors expect companies to provide a clear rationale for their sampling locations and methods, ensuring that they are based on risk assessments rather than arbitrary selection. Investigations of contamination events are another critical area of scrutiny. Regulatory agencies expect thorough root cause analyses and well-documented corrective and preventive actions. Additionally, data integrity has become an increasing concern, with regulators focusing on the reliability of manual plate counting and the security of recorded data.

There is considerable debate over the use of settle plates versus active air samplers. Active air sampling is widely regarded as the more reliable method, particularly in Grade A areas, where it provides more meaningful data on contamination levels. Settle plates, while mentioned in regulatory guidelines, are not a compendial method and should only be used if validated and scientifically justified.

Some experts argue that settle plates can be useful in certain situations where active sampling is not feasible due to equipment or environmental constraints, but they should not replace active monitoring as the primary air sampling method.

Mold contamination is a major concern in controlled environments, and while regulatory bodies do not specify exact limits, the expectation is that mold should not be present in Grade A and B areas. Its presence indicates weaknesses in contamination control and requires immediate investigation.

In Grade C and D areas, mold levels should be minimized, with proactive measures in place to prevent its introduction, such as robust material transfer protocols and the use of effective sporicidal agents.

While regulations do not explicitly mandate double plate readings, many companies implement them as a best practice to ensure data accuracy, particularly in critical areas like Grade A and B.

A second reading can help identify potential errors in colony counting and improve data integrity. Some industry professionals advocate for the use of automated colony counters to minimize human error and enhance the reliability of results. However you decide to read plates, the method must have robust reasoning and justification.

The selection of sampling locations should be based on a risk assessment rather than a fixed formula. ISO 14644-1 provides guidance on the number of sampling points for non-viable particulate monitoring, but viable sampling locations require additional considerations. Factors such as personnel movement, material flow, proximity to open product, and aseptic interventions should guide the selection of monitoring points. Companies should also regularly review and adjust their EM programs to reflect changes in processes and facility layouts.

Real-time environmental monitoring offers significant advantages by allowing for immediate response to contamination events. Unlike traditional methods, which may take days to provide results, real-time monitoring enables companies to identify deviations as they occur, allowing for batch segregation or corrective actions before product quality is impacted.

However, while real-time data enhances situational awareness, it does not necessarily predict future contamination trends. Its primary value lies in improving response time and enhancing overall process control.

One of the most common mistakes is failing to understand the sensitivity and limitations of their monitoring methods.

Misinterpreting data or overreacting to non-critical findings can lead to unnecessary corrective actions, while underreacting to significant trends may result in compliance risks.

Another issue is failing to close out investigations properly or timely, leaving potential contamination sources unaddressed. Companies should ensure that their responses to EM data are proportionate to the level of risk and based on a sound scientific understanding of their processes.

The Q&A session highlighted some of the biggest challenges and misconceptions in environmental monitoring. While regulations provide a framework, scientific rationale and risk-based decision-making are crucial and expected for effective EM programs.

At SherpaPharma, we’re committed to providing insights and tools to help the industry stay ahead of regulatory expectations. If you’re looking to optimize your EM strategy, feel free to reach out to us!

Stay tuned for more webinars and industry discussions throughout the year!