The Crystal^®Closed Vial Technology concept brings a new solution for the aseptic filling of injectable drugs with:

 

• A ready-to-fill, gamma irradiated, closed vial.

  Closed Vials, made of Cyclo Olefin Co-polymer (COC) and stoppers, made of a special Thermo Plastic Elastomer (TPE), are moulded and closed by robots in a ISO 5 clean room prior to gamma irradiation, generating clean and sterile ready-to-fill vials.

• A filling process consisting of piercing the stopper with a filling needle and re-sealing it with a laser.

  Thanks to the use of ready-to-fill vials, the complete filling process turns all up-stream cleaning operations obsolete.
  After loading of the vials, these are filled in ISO 5 conditions using a specially designed needle which avoids coring effect when piercing the stopper.
  After filling, the closure integrity is restored by re-sealing the stopper material, at the piercing trace, with a low energy laser beam.
  The cap has the particularity to create an effective seal with the stopper surface and to protect it until use by the practitioner, as the capping being made in aseptic environment.

   

• A new advanced containment system, the Closed Vial Filling System (CVFS)

  The CVFS being defined as:

  “An aseptic filling system providing an environment achieving uncompromised ISO 5 protection that surrounds containers which are delivered closed and sterile inside, are filled through their stoppers and then immediately re-sealed to preclude the possibility of microbial ingress.”

Initially, the Crystal^® Closed Vial Technology was only designed for aseptic liquid applications. Nevertheless, to expand the advantages of the Ready-to-Fill Closed Vials to all aseptic filling operations, Aseptic Technologies has developed freeze drying in the Closed Vial and has enlarged the concept to potent and bio-hazard processes.