Webinar

Best Sampling Practices Webinar – Essential Insights for Pharmacy Cleanrooms

Presented by Abby Roth | Sponsored by NuAire | Hosted by Pharmacy Purchasing & Products (PP&P Magazine)

Date: February 28, 2025

Speaker: Abby Roth, Microbiology Expert, Pure Microbiology

Host: Allie McDowell, Special Projects Editor, PP&P Magazine

Why Sampling Matters in Cleanroom Environments

Proper sampling techniques are critical for maintaining USP <797> compliance and ensuring a controlled sterile compounding environment. This webinar, led by industry expert Abby Roth, covers best practices for viable air and surface sampling, media reading, and data interpretation.

Key Learning Objectives:

Discuss best practices for viable sampling in cleanrooms
Understand USP <797> surface sampling requirements
Learn how to analyze viable air, surface, and fingertip samples
Evaluate your sample collection, storage, and shipping procedures

Surface & Air Sampling: Key Takeaways

Who Conducts Sample Collection?

In-House Sampling: Requires an Environmental Monitoring (EM) program, trained staff, and a designated person (DP) oversight.
Vendor-Supported Sampling: Vendors must follow your written EM program, with documented staff training.
Hybrid Approach: Both pharmacy and vendors may perform sampling, but consistency across locations and equipment is essential.

Defining a Strong Sampling Program

A USP <797>-compliant sampling program consists of multiple SOPs and processes, not just copied regulatory language. Your program should include:

Routine surface & air sampling schedules
Proper training & competency assessments for staff
Defined protocols for incubation, investigation & data trending

Surface Sampling Requirements for USP <797> Compliance

When to Conduct Surface Sampling:

Baseline testing for new facilities or equipment
After servicing of cleanrooms or biosafety cabinets
In response to identified trends or contamination concerns
Monthly for Category 1 & 2 CSPs, weekly for Category 3 CSPs

Types of Media & Devices:

Tryptic Soy Agar (TSA) with Neutralizers (Lecithin & Polysorbate 80)
Contact Plates for flat surfaces
Swabs for irregular surfaces (processed in a contract lab)
Slides/Paddles for hard-to-reach areas

✅ Ensure all media have Certificates of Analysis (COA) verifying sterility & growth promotion.

Watch the Webinar On-Demand

Learn how to improve your cleanroom sampling program from leading expert Abby Roth. This webinar provides practical guidance on environmental monitoring, data analysis, and regulatory compliance.

📢 Stay Updated: Follow Abby Roth on LinkedIn for more cleanroom insights!

View the SlideShare Presentation

Best Sampling Practices Webinar – USP <797> Compliance & Environmental Monitoring from NuAire

Related Resources

*This webinar was hosted by Pharmacy Purchasing & Products (PP&P Magazine) on February 28, 2025, and sponsored by NuAire. Learn more at www.pppmag.com.