Growing Supply: Cobalt-60 Production in the United States
Cobalt-60 is a vital radioisotope used in a variety of applications, notably the sterilization of over 16...
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Endotoxin Retention Testing for Filters
Bacterial endotoxins can negatively impact the quality and effectiveness of pharmaceutical products, medical devices, and other materials,...
Always Inspection Ready: Mastering FDA Inspection Preparation and Response
With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This...
Understanding PDA/ANSI Standard 06-2025: A Roadmap for Culture Change
A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Watch...
Expanding Your Pharmaceutical QMS for Combination Product Success
As combination products, such as prefilled syringes, auto-injectors, and drug-device kits, become more prevalent, pharmaceutical and biologic...
Ensuring Drug–Device Compatibility: Foundations for Safe and Effective Combination Products
As combination products continue to advance healthcare, ensuring compatibility between drug formulations and device components is essential...
Reprocessing Rethought: Mastering the Worst-Case Soil Challenge
To perform cleaning validations according to ANSI/AAMI ST98:2022, the intended use and clinical conditions of medical devices...
2-part webinar: Navigating the 2025 ISO 10993-1 Revision + Challenges Encountered During ISO 10993-18 Testing & Possible Ways Out
Part 1 Navigating the 2025 ISO 10993-1 Revision ISO 10993‑1 is the standard that outlines the framework for the...
Data Integrity in the Age of AI: Securing Connected Devices
As artificial intelligence becomes increasingly embedded in medical devices and healthcare systems, the concept of data integrity...
Reprocessing Implants: Challenges for Validation
Implant caddies or similar implant storage units for single use implants are commonly opened and exposed during...