Molded glass vials demonstrate robust CCI performance under deep-cold storage conditions🔄

Molded glass vials demonstrate robust CCI performance under deep-cold storage conditions🔄
 
Container closure integrity (CCI) is a critical quality attribute throughout the lifecycle of sterile pharmaceutical products, helping to ensure product integrity and patient safety. However, numerous studies have shown that deep-cold storage conditions can increase the risk of temporary CCI failures that may remain undetected using conventional testing methods such as blue dye testing. 

Although substantial low-temperature CCI data are available for tubular vials, molded vials have received comparatively less attention despite their advantages in mechanical strength, chemical durability and suitability for sensitive pharmaceutical formulations. 
 
To help address this gap, SGD Pharma partnered with LIGHTHOUSE Instruments, the industry leading CCI experts with over 20 years of trusted scientific experience. Together, we evaluated the performance of molded glass vials stored at -80°C. The study combined laser-based headspace analysis for the detection of temporary defects with residual seal force (RSF) measurements to assess seal integrity under deep-cold conditions. 

The findings demonstrated that molded glass vials, like tubing vials, provide robust CCI during ultra-low temperature storage. In addition, the study highlights the value of combining analytical seal quality testing with laser-based headspace analysis to support component selection, process validation and comprehensive CCI control strategies for cold-chain pharmaceutical applications. 

Click here to read the full report : https://lnkd.in/e8YjZAN8

PharmaceuticalPackaging ContainerClosureIntegrity CCI GlassPackaging Biopharma