Device for pharmaceutical labs is designed to seal a vial and its standard stopper in one step inside a lyophilizer in a sterile environment to help eliminate the risk of microbiological contamination
Biocorp has developed the Lyoseal cap, an innovative solution for sealing vials for lyophilised drugs.
This patented device for use in pharmaceutical laboratories has been designed to seal a vial and its standard stopper in one step inside a lyophiliser in a sterile environment to help eliminate the risk of microbiological contamination.
The European Medicines Agency (EMEA) and the FDA recommend that "partially stoppered freeze dried vials should be maintained in a sterile environment until the cap has been crimped".
Lyoseal goes further by making it possible to seal all medicine vials in the lyophilizer itself, in a (class A) aseptic area.
This eliminates the crimping operation required with a conventional aluminum seal (capping), and the re-handling that increase the risk of microbiological contamination of the medicines.
The top of the stopper remains sterile when the end-user removes the flip-off cap.
It is guaranteed tamper-proof because the cap cannot be put back on once it has been removed, enabling the proprietary drug to be clearly distinguished from a possible counterfeited copy.
In addition, this device avoids the need to have an extra aseptic area outside the lyophilizer, thus making savings on production.
The cap is made of plastic that can be sterilized by autoclaving with a maintained temperature of 121C, yet is resistant to a temperature of -70C required for freeze-drying.
Two models will be available: 0.8inch (20mm) and 0.5 inch (13mm).
Biocorp won the New Innovative Technologies Award this year at the PDA Annual Meeting for its Lyoseal aseptic cap.
It will be exhibiting next year at the Pharmapack trade show in Paris from Jan 24 to 25 and at the PDA Annual Meeting in Las Vegas from March 19 to 23.
