CO2 Transmission Into Bulk Drug Substance Containers

Savillex Technical Note Flash Freezing in Fluoropolymer Bottles Summary Flash freezing is the process of rapidly lowering the temperature of a liquid so that larger ice crystals do not have the chance to form. These larger crystals can potentially damage…

Savillex Technical Note CCIT Validation Summary Cell therapies and regenerative medicines both require absolute container integrity to ensure sterility. Bottles, vials, sample jars and other rigid containers are the natural choice for these applications because of their durable construction and…

Savillex Technical Note Freeze Cycle Testing Summary Storing frozen bulk drug substances (BDS) – including bioprocess solutions, vaccines, blood components, and other delicate process fluids – is common practice in the bioprocess industry. Vessels used to store these fluids must…

Savillex Technical Note Freeze Drop Testing of Bulk Drug Substance Bottles Summary Frozen storage of bulk drug substance (BDS) at temperatures at or below -70°C is common in the bioprocess industry. Storage at temperatures below -80°C can lead to spontaneous…