Critical Environments Columns

  1. A Facilities Expert Answers Audience Questions On Construction And Validation 5/5/2025

    Bioprocessing facility expert Herman Bozenhardt responds to some unanswered audience questions from a Pharmaceutical Online Live event on facility design and validation.

  2. Using Virtual Reality To Enhance Aseptic Contamination Control 5/1/2025

    Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.

  3. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

    Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

  4. Experts' Advice On Facility Design And Construction 4/24/2025

    This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.

  5. Retrofitting Facilities For Modern Bioprocessing And Pharma Production 3/11/2025

    The U.K. National Health Service is developing a former warehouse into a multi-modal aseptic manufacturing hub. The project's production head talks pros, cons, and strategy.

  6. Strengthening Shop-Floor QA From The Ground Up 2/24/2025

    Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.

  7. Consumables Are Leading The Cleanroom Market — Here's Why 2/19/2025

    As the industry expands, so, too does demand for PPE. This market analysis looks at the trends in consumables and other cleanroom technology used to make medicine.

  8. Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis 2/18/2025

    Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

  9. Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings 2/14/2025

    Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.

  10. Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide 2/5/2025

    Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.