Join us for an online event!
Audit-Ready Gas Testing: Navigating USP, EP, and FDA Requirements
Process Gas Compliance: Meeting Pharmacopeial and Regulatory Standards
Wednesday, September 24th, 2025
11:00am - 11:45am (EST)
What will you learn
By attending this webinar, you will be able to:
- Understand why process gases are critical in pharmaceutical manufacturing and compliance.
- Navigate key standards and frameworks (USP, EP, ISO, FDA, ISO 17025) that govern gas quality.
- Apply best practices for sampling hardware, purge protocols, and contamination prevention.
- Understand key technologies and methodologies
- Identify and troubleshoot common issues
- Learn from a real-world case study of hydrocarbon contamination and remediation.
Presenter
Charles Felter
Managing Partner | Gas Testing Analytical
Presentation Abstract
- The webinar is a practical introduction to pharmaceutical process gas compliance from a sampling and testing perspective. Process gases like nitrogen, oxygen, carbon dioxide, and compressed air are often overlooked, yet they directly impact product quality, sterility, and patient safety. Regulators increasingly view gases as critical raw materials, requiring the same rigor as water systems or excipients.
- In this 45-minute session, we’ll translate pharmacopeial requirements (USP, EP) and ISO/FDA expectations into a straightforward, risk-based gas testing program. The presentation will cover nitrogen, compressed air, oxygen, and carbon dioxide testing fundamentals, sampling hardware and purge methods, analytical techniques, and common pitfalls. A real-world case study of hydrocarbon contamination will illustrate how testing data drives remediation and strengthens compliance.
- This webinar is ideal for QA/Validation, QC, Engineering, and MSAT professionals responsible for utility quality in pharmaceutical or biotech manufacturing