The LyoTip™ device is designed so that the drug can be filled and closed with standard fill/finish equipment. For example, the diameter, weight and other physical characteristics of LyoTip™ drug container are similar to those of 3 cc vials.
The formulated drug is filled into the bottom drug container utilizing standard vial filling equipment.
The upper closure component is placed into the drug container using the standard stoppering mechanism or machinery. The assembled components will have openings that have been designed to allow the sublimed water vapor to escape during lyophilization.
The assembled components are placed onto the lyophilizer shelf and the product is lyophilized using Integrity Biosolution's optimized, patent pending, cycle.
Upon completion of the lyophilization process, the upper closure component is further pressed down upon the bottom drug container to create a seal. Also, during this time, the lyophilized product is compressed to a small volume to minimize exposure to any possible degredation elements as well as minimizing any wasted or "hold up" volume during the injection process.
The LyoTip™ device is removed from the lyophilizer and the seal integrity is further ensured by an ultrasonic welding step that serves as a capping and crimping process.
Lyotip Convenient Manufacturing 4 
