Lyophilization process validation Archives • Asita Freeze dryer

Minor vs. Major Lyophilization Defects: A Comprehensive Guide

July 15, 2025 by INDRAPATI

Two pharmaceutical vials on a stainless steel tray, labeled as minor and major lyophilization defect vials. The minor defect vial has a smooth white cake, while the major defect vial shows a cracked cake with visible black particles. A QC checklist and gloved hand are visible in the background.

Minor vs. Major Lyophilization Defects are a critical concern in the pharmaceutical industry, especially for injectable drugs, biologics, and vaccines. …

Lyophilization Validation Protocols: Best Practices

December 4, 2024 by INDRAPATI

Did you know the Lyophilization Validation Protocols and lyophilization process validation market is growing fast? This growth is due to …