New Cap Seals Pharmaceutical Vials Without Risk

Biocorp of France has developed the Lyoseal cap for sealing vials that come with lyophilised medicines.

Biocorp of France has developed the Lyoseal cap for sealing vials that come with lyophilised medicines.

Intended for use by pharmaceutical laboratories, the Lyoseal cap is a patented device: it has been designed to seal a vial and its standard stopper inside a lyophilizer in one step, within a sterile environment, thus eliminating the risk of microbiological contamination, it is claimed.

The European Medicines Agency (EMEA), the EU's regulatory body and the Food and Drug Administration (FDA), its US counterpart, both recommend that partially stoppered freeze-dried vials be maintained in a sterile environment until the cap has been crimped.

Biocopr claimed that Lyoseal goes further by making it possible to seal all the medicine vials in the lyophilizer itself, in a Class A aseptic area, eliminating the crimping operation that is required with a conventional aluminium seal (capping), whilst also doing away with the re-handling process, which increases the risk of microbiological contamination of lyophilised medicines.

The Lyoseal cap is claimed to provide another advantage: the top of the stopper remains sterile when the user removes the flip-off cap.

Biocorp said that Lyoseal is guaranteed tamper-proof, since the cap cannot be put back on once it has been removed.

That means that Lyoseal enables the proprietary drug to be clearly distinguished from a possible counterfeited copy.

Furthermore, Bopcorp also claimed that its device avoids the need for an additional aseptic area outside the lyophilizer, thus generating savings at production level.

The Lyoseal cap is manufactured in plastics that can be sterilised by autoclaving (+121-degrees C) yet which at the same time are resistant to a temperature of -70-degress C, as required for freeze-drying.

Two different-size models will be available - 20mm and 13mm, added the company.

During this year, Biocorp was nominated by the American Parenteral Drug Association (PDA) for its Lyoseal technology.

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