Vaccine manufacturing places exceptional demands on fill-finish operations, where product sterility depends on the controlled preparation and transfer of every component entering the aseptic filling area.
Sterile vials, stoppers and product-contact machine parts must be available in step with the filling line and introduced without contamination or particle exposure. Multiple preparation systems, intermediate containers and manual transfers increase process complexity, footprint and critical interfaces. Dependence on ready-to-use components can also limit sourcing and campaign flexibility.
Manufacturers must therefore protect product efficacy and container integrity while ensuring sterile-component availability, traceability and production continuity.
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Fedegari protects the aseptic process by coordinating the preparation and transfer of every critical component.
Vials are washed and depyrogenated, while stoppers and filling-line parts undergo dedicated washing, sterilization or combined washing-and-sterilization processes. Bulk stoppers can be washed, sterilized, dried and cooled in one system, then discharged into a sterile tank connected to the system during sterilization and maintained under controlled overpressure. Automated closed handling transfers the tank to the filling isolator, where an RTP connection preserves sterility up to the point of use.
The same system can process machine parts between campaigns, increasing utilization and flexibility.
Reduced exposure, controlled connection to the barrier and readiness for closed or robotic reassembly.
Maintains treated bulk stoppers within a closed sterile environment during transfer from the washing and sterilization system to the automated manipulator.
Controlled loading, unloading, movement, connection and delivery to reduce exposure and avoidable manual intervention.
Steam sterilization for compatible reusable parts packaged in bags or canisters before protected or closed transfer.
Integrated washing and sterilization of bulk closures, followed by closed transfer in a sterile tank.
Reusable heat-sensitive parts whose material, geometry, packaging and microbial-reduction requirements support a validated low-temperature route.
Sealed RTU or pre-sterilized materials whose internal sterile state must be preserved while the outer packaging is treated before entry.
Compact layouts, fewer equipment interfaces, reduced classified-space demand or a single integrated route for compatible reusable loads.
Validated washing establishes the required cleanliness state for reusable product-contact, machine and format parts before downstream treatment.
Compatible reusable parts are packaged in bags or loaded into closed canisters before steam sterilization. The process is developed around the complete load configuration to govern air removal, steam penetration, condensate management and drying. Once treated, the selected packaging or transfer system preserves the sterile state during unloading, movement and introduction into the aseptic processing environment.
For reusable parts that cannot withstand steam, low-temperature H₂O₂ sterilization provides an alternative route when supported by material, geometry and packaging compatibility. The complete configuration is evaluated to establish sterilant access, microbial reduction, aeration and residual removal. The treated load then follows a protected transfer route designed to preserve its required state up to the aseptic interface.
Bulk stoppers are washed and steam sterilized in one integrated process developed to control cleanliness, sterility and residual moisture. Following treatment, the closures are discharged directly into a sterile transfer tank. This eliminates intermediate bagging and creates the starting point for a closed route from stopper preparation to automated delivery at the isolator.
Washing and steam sterilization are integrated within one system to establish cleanliness and sterility through a coordinated process. This architecture reduces equipment interfaces, material movements and classified-space requirements while strengthening control between the two treatments. It is selected for compatible reusable loads when layout efficiency, operator protection or a more contained process route drives the transfer strategy.
RTU components and other pre-sterilized materials already contain a protected sterile product within sealed packaging. The low-temperature H₂O₂ process treats the external surfaces before introduction into the aseptic environment without reopening the package or altering its internal sterile state. Cycle development addresses packaging geometry, surface accessibility, load arrangement and aeration as part of the complete transfer configuration.
The automated manipulator connects treatment and point of use through controlled loading, unloading, movement and delivery operations. Depending on the selected route, it handles canisters, sterile tanks or treated materials and manages their interface with the isolator or filling line. Automation removes avoidable manual interventions precisely where exposure, repeated handling and open connections create the greatest vulnerability.
Validated washing removes process residues and establishes the required cleanliness state for reusable product-contact, machine and format parts. Cycle parameters, load configuration and mechanical action are developed around the materials and geometries involved, preparing every surface for the selected downstream treatment and preventing cleaning from becoming an uncontrolled variable within the aseptic-transfer route.
A pre-filled syringe is a hermetically sealed container with a movable plunger. During thermal sterilization, the liquid expands, part of it vaporizes, dissolved gases are released and the gas already present in the headspace increases in pressure.
An aqueous solution expands by approximately 6% when heated from ambient temperature to 121°C, while the volume of a glass syringe increases by only about 1%.
The rapid growth of biologics, nanoparticle-based medicines and Advanced Therapy Medicinal Products (ATMPs) is redefining the relationship between pharmaceutical formulations and primary packaging.
Interactions between proteins such as insulin, nanoparticles and container surfaces are well-recognised phenomena that can influence product stability, efficacy and patient safety. As these therapies become increasingly sensitive, material compatibility can no longer be considered an intrinsic property of the container alone.
When manufacturers seek to move away from EtO towards a method that reduces toxic-residue concerns and the potential burden on patients, workers and the environment, selecting an alternative sterilant is only the beginning.
This is particularly true for the low-temperature sterilization of RTU glass vials in their complete packaging configuration. The sterilant must pass through the outer transport box, multiple porous barriers and enclosed packaging interfaces before reaching the internal vial surfaces. The same structure must then release residual sterilant within an acceptable aeration time.
Bulk-stopper treatment increases sourcing and campaign flexibility while eliminating bag opening, bag-waste management and repeated manual stopper feeding inside critical areas. In a documented vaccine project, this approach also reduced dependence on RTS-stopper availability during exceptional market demand.
Fedegari protects the aseptic process surrounding the product. Vials are depyrogenated, while stoppers and product-contact machine parts are washed, sterilized and transferred under controlled conditions. Closed stopper discharge, automated tank handling and RTP connection preserve protection up to the filling isolator.
Yes. Between stopper campaigns, the system can operate as a moist-heat sterilizer for filling-line machine parts. This dual-purpose configuration increases equipment utilization, provides operational backup and reduces the number of separate machines required within the component-preparation area.
The transfer tank is sterilized while connected to the treatment system. Stoppers are discharged into it without operator contact, and controlled overpressure protects the closed environment. Automated handling then positions the tank for direct RTP connection to the filling isolator.
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