LN2 Cryogenic Storage Chamber Qualification in 3 Steps

LN2 Cryogenic Storage Chamber Qualification in 3 Steps

Qualifying a liquid nitrogen (LN₂) cryogenic storage chamber requires a different approach than traditional controlled temperature units due to the unique nature of LN₂ storage conditions. This whitepaper from Alcami’s Validation Team offers a step-by-step framework to help users understand, operate, and qualify their LN₂ storage chambers in accordance with validation best practices. Whether you’re storing in vapor or liquid phase, ensuring consistent temperature performance and regulatory compliance is critical.

In this whitepaper, you will learn:

• Key differences between cryogenic storage and mechanical freezers
• How to determine the correct LN₂ phase and liquid level settings for your application
• Best practices for temperature monitoring, stratification, and alarm set points
• Study design recommendations for qualification, including full cycle data capture
• Equipment and safety considerations to ensure accurate and safe performance testing