
Optimizing Environmental Monitoring in sterile compounding: Best practices and insights
Environmental monitoring (EM) is an integral part of ensuring sterile compounding and aseptic manufacturing environments remain compliant and contamination-free. SherpaPharma’s recent webinar on December 12, 2024, brought together industry experts to discuss key topics surrounding viable environmental monitoring, including identification practices, preparing for inspections, and training strategies for EM personnel. Moderated by Alexandra Bezilla, I got the chance to chat with Gilberto Dalmaso and Vanessa Vasadi Figueroa about how different regulated industries might handle these topics. Below, I’ll recap the main takeaways for USP <797> facilities from this engaging and informative session.
You can watch the webinar in the following link
One of the most frequently asked questions we as experts get asked is when and how to perform microbial identifications as part of a viable environmental monitoring program. Under USP <797>, the requirement is to identify microbial growth to the genus level for action-level excursions. However, simply following the minimum requirements might not always be sufficient. Here are key points to consider:
- Threshold for Action: While USP <797> provides requirements for identification, sterile compounding pharmacies should evaluate risk thresholds based on their specific processes and preparation. For example, facilities should consider categories compounded, BUDs assigned, nonsterile-to-sterile compounding, facility design, and past trends when determining if more stringent identification are prudent. The FDA regards any microbial growth in an ISO Class 5 environment as an insanitary condition. Therefore, identifying this growth, even if it falls below the action level, is recommended to ensure appropriate remediation measures are taken.
- Proactive Identification: During the discussion, the experts recommended implementing routine microbial identifications, even for non-actionable events. This can help facilities build a baseline microbial profile, which is invaluable for trend analysis and early detection of potential contamination sources.
- Species-Level Identifications: While USP <797> requires genus-level identifications, species-level analysis can provide critical insights in cases of recurring contamination or unexpected findings. This practice can prevent costly investigations by pinpointing contamination sources with greater accuracy.
Another key topic of discussion was preparing for inspections, which often bring heightened scrutiny to environmental monitoring programs. Inspectors from regulatory bodies like the FDA and state boards of pharmacy are increasingly focusing on the robustness of EM practices. Here’s what the panel recommended:
- Documentation is Key: Ensure all EM activities are thoroughly documented, from sample collection logs to microbial identification reports. Inspectors expect detailed and traceable records that demonstrate compliance with USP <797> and other applicable standards.
- Standard Operating Procedures (SOPs): SOPs should clearly outline sampling frequency, locations, and methods. They should also address corrective actions for excursions. During an inspection, well-documented SOPs serve as evidence of a structured and compliant EM program.
- Historical Data and Trend Analysis: Maintain a repository of historical EM data and trend reports. These documents showcase proactive monitoring and the ability to identify and mitigate risks over time.
- Mock Inspections: Conduct internal mock inspections to assess the readiness of your EM program. These exercises help uncover gaps and ensure staff are prepared to confidently answer inspector questions. If this more than you want to take on, there are consults that can assist with this activity.
The final topic of the webinar centered around training for personnel involved in environmental monitoring. Proper training is essential to ensure consistent and accurate sampling, as well as compliance with regulatory standards. Here are the training highlights from the discussion:
- Foundational Knowledge: Training should begin with a strong foundation in microbiology principles, including the importance of aseptic technique and the role of EM in preventing contamination.
- Hands-On Practice: Practical, hands-on training is crucial for personnel responsible for sampling and counting colonies. This includes the correct handling of media, proper contact plate techniques, and the aseptic collection of air and surface samples.
- Competency Assessments: Regular competency evaluations ensure that personnel remain proficient over time. These assessments should include observation of sampling techniques and evaluation of colony enumeration, if applicable.
- Regulatory Awareness: Staff should be well-versed in regulatory requirements and industry guidance, including USP <797>, USP <1116>, and CAG-009. Understanding these documents helps personnel align their practices with inspector expectations.
- Ongoing Education: Viable environmental monitoring is a dynamic field. Incorporate ongoing training sessions to keep staff informed about changes in regulations, new technologies, and industry best practices.
The webinar provided valuable insights into viable environmental monitoring, emphasizing the importance of robust identification practices, preparation for inspections, and comprehensive training programs. As the regulatory landscape continues to evolve, USP <797> sterile compounding facilities must prioritize consistency, documentation, and staff education to maintain compliance and ensure patient safety. For those who couldn’t attend the live session, a recording is available. Stay tuned for future webinars from SherpaPharma!
Don’t miss the insights from Vanessa Figueroa and Gilberto Dalmaso shared during this webinar.
Abby Roth, founder of Pure Microbiology, has been supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries since 2004. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring.
Abby served as a USP Compounding EC member during the 2015-2020 cycle.
She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of five CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.
Abby Roth, founder of Pure Microbiology, has been supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries since 2004. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring.
Abby served as a USP Compounding EC member during the 2015-2020 cycle.
She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of five CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.
Abby Roth, founder of Pure Microbiology, has been supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries since 2004. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring.
Abby served as a USP Compounding EC member during the 2015-2020 cycle.
She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of five CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.