F57 EVO COMPACT Aseptic Processing
Machine overview
Versatility and compliance.
The F57 EVO COMPACT accomplishes a series of operations that include container feeding, filling and closing. With a focus on all-round versatility, the machine can be configured with different filling groups and pumps for ophthalmic or injectable products. It handles both glass and plastic containers and supports a wide range of closure combinations, including droppers, pumps, dip tubes, preservative-free caps and dosing cups. Easy adaptability and format change flexibility make it the ideal solution for CDMOs producing a large variety of Finished Dosage Forms. To support its vocation for aseptic processing in Grade A environments, the F57 EVO COMPACT can be integrated in Open or Closed-RABS.
Production plant
Pharmasiena
Machine highlights
-
Annex 1 design
Configured for aseptic processing and installed within a RABS, the machine’s design ensures first air protection in critical areas and correct handling of sterile componentry.
-
Filling systems
Variety of systems available according to product being processed: volumetric, massive ceramic, peristaltic or differential pumps.
-
Self-adapting accuracy
Thanks to the integrated 100% IPC check-weighing system, pumps self-adjust to ensure the correct volume enters the container.
-
Sterile handling
Closure components come in sterile bags and are handled appropriately to conserve aseptic conditions and reduce contamination risks.
-
Quality control
Non-conformities are rejected individually and repeated non-conformities, when detected, result in machine stoppage.
-
Nitrogen purging
Available when required for additional product protection.
Focus on sterility assurance
All stages are tailored to deal with aseptic processing requisites, including unscramblers with autoclavable components, special RTU debagging and extraction solutions, as well as volumetric pumps equipped with CIP-SIP systems, or peristaltic pumps supported by single-use assemblies.
