Critical Environments Columns

1. It's Copy/Paste In Fleet Management Manufacturing 12/11/2025

   Copy and paste may be frowned upon in most work tasks, but not in the case of “fleet management.”  In the past few years, Roche and Novo Nordisk collaborated to introduce this concept of applying the copy/paste action to standardized, decentralized facilities.

2. The Module Type Package Wants All Your Equipment To Start Talking 12/11/2025

   A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.

3. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

   The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

4. 3 Ways To Deliver A Pharma 4.0 Facility 11/17/2025

   O’Callaghan supplied three ways in which Sanofi brought its sites to the modern era, which were supported throughout the event’s presentations

5. Innovation, Growth (and Happiness) Projected for Pharma 11/10/2025

   Not only is investment increasing in pharma, but innovation is propelling growth in multiple drug segments, and the people supporting this growth and innovation remain happy.

6. ISPE Awards 8 Innovative Pharma Facilities 10/31/2025

   The Facility of the Year Awards (FOYA) celebrates 20 years of innovation and excellence in 2025, and I had the pleasure of joining the celebration at the 2025 ISPE FOYA Banquet and Awards Celebration on Oct. 26, 2025.

7. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

   The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

8. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

   This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

9. Operating And Maintaining Pharmaceutical Gas Distribution Systems 9/12/2025

   Drug manufacturers face stringent requirements when using gas that comes into direct contact with the product. This guide discusses operation, maintenance, and monitoring of gas systems.

10. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

    In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.