CLOSED VIAL FILLING SYSTEM

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.”
 

The key characteristics of a CVFS have been defined using a “quality by design” process and can be summarized as:

  • Surrounding environment:

Surrounding room classification should be ISO 8 minimum in operation.

  • Enclosure system:

    • Rigid wall enclosure providing full physical separation of the aseptic processing operations from operators.

    • Dynamic over pressure ensured by HEPA-filtered unidirectional air flow continuously supplied from the ceiling of the enclosure. Open bottom with air exit to the surrounding environment is appropriate for classical products. For highly potent and/or toxic products, a closed bottom is recommended to protect operators.

    • No door opening is allowed before batch termination and line clearance of all finished goods. Doors are locked with records of opening during operation.

    • Glove ports are used to access all areas of the enclosure which have to be reachable by an operator during filling operations. 

    • Entry of material through RTP's or airlocks. 

    • Product entry using aseptic connector.

 


Since 2011 Aseptic Technologies closely collaborates with SKAN AG, a world leader in barrier isolator technology.

Contact us to evaluate the most appropriate option for your specific needs.

Access directly to Skan AG website.