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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.

    • HEPA-filtered unidirectional air flow continuously supplied from the ceiling of the enclosure. Open bottom with air exit inside the surrounding environment is appropriate for classical products. For highly potent and/or toxic products, a closed bottom is recommended to maintain operator protection.

    • No door opening is allowed before batch termination and line clearance of all finished goods. Doors are locked and interlocked with records of opening by alarms 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 product to be filled.

    • Entry through aseptic connector

 

  • Entry of material:

    • Closed vials: (pre-sterelized by gamma-irradiation).

      • Entry through Rapid Transfer Ports (RTP) using beta-bags, or

      • Entry through VHP airlock using PE bag wrapped vials, the PE bag being open after sanitization, or

      • Manual loading in an area under HEPA-filtered unidirectional air flow, protected from surrounding by soft walls, followed by an e-beam sterilization of the stopper.

    • Caps (pre-sterilized, e.g., by gamma-irradiation):

      • Entry through Rapid Transfer Ports (RTP) using beta-bags,

      • Entry through VHP airlock using PE bag wrapped vials, the PE bag being open after sanitization,

    • Pre-entry of other materials in sterile bags, their external part being sanitized as all non-contact parts of the equipment.

    • Fluid path which has been sterilized in an autoclave or by gamma irradiation before and which is aseptically assembled inside the barrier before processing:

      • Entry through Rapid Transfer Ports (RTP) using beta-bags,

      • Entry through RTP using containers which are suitable for steam-sterilization,

      • Pre-entry of sterile bags (steam sterilized or gamma irradiated) with the external part being sanitized as all non-contact parts of the equipment.

  • Sanitization and environment quality in the enclosure system:

    • “High-level disinfection” of all non-product contact surfaces, including all bags entered for fluid path and environmental control, within the CVFS with an appropriate sporicidal agent before batch manufacture.

    • Unidirectional airflow: unidirectional airflow systems supplying integral HEPA-filtered air and providing a Class 100 / Grade A / ISO 5 environment to the filling – re-sealing – capping area(s).

    • High quality unidirectional airflow on vials obtained by “quality by design”.