Ensure compliance and patient safety using total particle air counting in sterile compounding facilities
April 17, 2025 at 16:00 BST / 17:00 CEST / 11:00 EDT / 08:00 PDT
With the critical role that sterile compounding plays in patient care, ensuring compliance with USP <797> standards and mitigating risks from airborne particulate matter is essential for all sterile compounding operations — including 503A pharmacies, hospitals, infusion centers, and 503B outsourcing facilities. For this reason it is crucial to have adequate implementation to uphold aseptic standards, reduce risks, and protect patients.
In this educational webinar, Dr. Amy Summers, 503A & 503B Compounding Consultant at Restore Health, will give a comprehensive overview of the importance of total particle air counting. Hear real-life case studies that highlight best practices that you can implement to ensure you meet regulatory requirements and maintain a sterile environment.
Key learning objectives:
- The why: Why is total particle air counting crucial for sterile compounding facilities? Understand its role in contamination control, risk reduction, and patient safety as outlined in USP <797>.
- The how: Learn how to use total air particle counters, including best practices for accurate air sampling in ISO-classified areas (ISO 5, 7, and 8).
- Avoiding pitfalls: Learn how to avoid common errors and challenges in air counting, such as incorrect sampling, misinterpretation of data, and maintenance oversights.
- Real-world case studies: Hear examples of sterile compounding facilities implementing robust particle monitoring programs, including lessons learned and benefits achieved.
- Regulatory alignment: Understand how to align particle monitoring programs with the updated USP <797> requirements, focusing on maintaining ISO air quality classifications and proper documentation.
Who should attend
- Pharmacists and pharmacy technicians
- Compounding supervisors
- Quality and compliance professionals in 503A/503B facilities, hospitals, and infusion centers
Certificate of attendance
If you attend the live webinar, you will automatically receive a certificate of attendance, including a learning outcomes summary, for continuing education purposes.
If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.
Speakers
Dr. Amy Summers, BCSCP, earned her PharmD degree from the University of California San Francisco. She formally served as Director of Operations and Pharmacist in Charge at organizations engaged in compounding, and as Managing Director of a FDA-registered 503B outsourcing facility. She is currently an independent consultant, specializing in business, operations, quality assurance, and regulatory compliance matters for the pharmaceutical compounding industry.
Moderator
