Newsletter | September 23, 2025

09.23.25 -- Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

FEATURED EDITORIAL

Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

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.

INDUSTRY INSIGHTS

Regulatory Compliance For Prefilled Syringes And Auto-Injectors

Developing prefilled syringes and auto-injectors requires rigorous mechanical and compliance testing to ensure device safety, effectiveness, and regulatory approval for patient use.

The Science And Engineering Of Advanced MRI Machines

MRI uses nuclear magnetic resonance principles and advanced RF systems to generate detailed images, balancing trade-offs in field strength, coil design, and amplifier performance for diagnostics.

Material Selection With An Eye On Micro-Molding

Explore resin selection in micro-molding, and why data sheets can be misleading by offering a clear analysis of suitable materials.

"Is It On Yet?" - Silent Operation With Disc Pump

Silent disc pumps enable compact, vibration-free, discreet devices for medical, environmental, and wearable applications, improving user comfort, and product design flexibility.

RESOURCES

Medical Balloons

ARTICLES YOU MAY HAVE MISSED

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Remote Patient Monitoring: A Booming Industry Across The Globe

Staying Ahead of Enforcement: Executive Strategies To Prevent FDA Warning Letters

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