Critical Environments Columns

1. 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.

2. Is Your Pharma Facility Ready For The Next Public Health Crisis? 7/17/2025

   Preventive measures wane as a sense of security resumes. Follow these tips to protect business continuity in the next global health crisis.

3. Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification 7/1/2025

   A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

4. Peeling Back The Layers Of Radiolabeled Peptide Production 6/12/2025

   From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.

5. Navigating Data Management Requirements For Sterile Manufacturing 6/11/2025

   Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.

6. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

7. Lilly's Calculated Approach To Upgrade Trade-Offs 5/22/2025

   If the disruption of implementing and adapting to new technology costs more than its benefits, teams should proceed cautiously.

8. How Modular Facility Design Can Accelerate GMP Facility Construction 5/20/2025

   Autolus Therapeutics' COO talks about the accelerated construction of the company's cell therapy manufacturing facility, The Nucleus.

9. How Modeling Predicts Bottlenecks In Takeda's Multimodal Facilities 5/20/2025

   A functional simulation requires many manual inputs, including data smoothing, vendor collaboration, and even direct communication with tenured employees who know the job best.

10. Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis 5/6/2025

    Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.