When packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and ...

Engineering decisions in fill/finish directly shape product quality and sterility assurance. This article examines how inert ...

CCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, ...

Decisions made during clinical manufacturing have lasting consequences at commercial scale. This article examines how ...

Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow ...

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s ...

These delivery systems frequently employ fittings called luer connectors to link various system components. Unfortunately, because luer connectors are ubiquitous, easy-to-use, and compatible between ...

Nordson MEDICAL introduces Divert™ ULTRA, ultra-high-pressure stopcocks engineered for reliable flow control, ergonomic operation, and precision in demanding medical applications up to 1,500 psi.

This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained. CSV Assumes The AI System Sits Still — It Doesn't. The ...

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the ...

Standard extraction protocols routinely fail tissue-derived products, hydrogels, absorbables, and silicone implants. Learn ...

Castor is a clinical trial platform for medical device, biopharma, diagnostics, and academic research teams. It unifies electronic data capture, ePRO, eConsent, and randomization in one system, and ...