Critical Environments Columns

1. Clearing The Fog On New First Air Visualization Expectations 3/18/2026

   Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.

2. Where Contamination Control Really Breaks Down In Practice 3/13/2026

   Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

3. Raising The Bar In Radiopharmaceutical Manufacturing 3/12/2026

   Ratio Therapeutics chief commercial and manufacturing officer, Scott Holbrook, joined me to discuss how his team at Ratio Therapeutics is tackling the challenges of radiopharmaceutical manufacturing.

4. SUS Interchangeability Assessment And Qualification Best Practices 3/12/2026

   Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.

5. Process Engineering's Key Role In Sterile Injectable Facility Design 2/24/2026

   Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.

6. The Rise Of The Autonomous Pharma Plant 2/18/2026

   What does a production facility of the future look like? That’s exactly what Bayer management asked its team before planning began for the world’s most modern pharmaceutical facility, Solida 1.

7. A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset 2/18/2026

   Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.

8. At Base Camp: Lilly's Manufacturing Capacity Journey 2/13/2026

   In 2025 alone, Lilly announced plans to build new facilities in Texas, Alabama, Virginia and Pennsylvania in addition to facility expansions in Indiana, Wisconsin and Puerto Rico.

9. Solving The Top 3 Pharma Packaging/Manufacturing Issues 2/5/2026

   Regulatory changes, space/footprint constraints and expanding automation garnered more votes than the other challenges. Let’s explore these challenges, and see how the industry is tackling them as we move into 2026.

10. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

    Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.