Probably one of the most significant developments in sterilization and aseptic practices in the pharmaceutical business is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator. This application has led to many years of success and provided assurance that aseptic handling and filling operations are microbial-free. In this article we will focus on filling isolator systems and equipment. Since the use of this technology began, we have been singularly focused on sterility by maximizing injection rates and saturation levels and assuring media fills are successful in qualification testing.
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