Insulin production increasingly relies on high-throughput syringes and cartridge filling lines, with cartridges serving reusable and disposable delivery pens. At these output levels, filling capacity alone does not determine production performance.
Closures and reusable filling-line parts must be washed, sterilized, handled and delivered to the filling area at the required pace and under controlled aseptic conditions. If these upstream activities are managed as separate, disconnected operations, they can become a bottleneck while increasing equipment, transfers, manual handling and operating costs.
The challenge is therefore to keep both material streams continuously ready for filling without adding unnecessary process complexity or contamination interfaces.
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We coordinate the sterile preparation of the two material streams required by insulin vial and cartridge filling: closures and elastomeric components, and reusable filling-line parts. Closures are washed, sterilized, dried and transferred through an integrated treatment system, while machine parts can be processed through dedicated GMP washing and steam sterilization or a combined washer-sterilizer.
By configuring these technologies as one sterile supply strategy, Fedegari addresses the two priorities that matter most to insulin manufacturers: reducing operating and production costs and maintaining aseptic conditions throughout component handling. The resulting process architecture is configured around the actual filling line, reducing separate equipment, transfers and manual interfaces while providing the basis for a project-specific operating-cost assessment.
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.
A combined system is attractive when reduced footprint, labour, handling and intermediate transfers create more value than the production flexibility of separate equipment. The choice should be based on load diversity, required capacity, cycle turnaround, utilities, maintenance strategy and production scheduling.
It can combine washing, rinsing, sterilization, drying, cooling and controlled discharge while reducing intermediate machines, storage and handling. The value should be quantified against the actual closure volume, facility layout, transfer method, turnaround requirement and existing operating model.
Depending on the final format, the flow can include vial stoppers, compatible cartridge elastomeric components and reusable filling-line or product-contact parts. Each family requires a validated cleaning, sterilization and transfer strategy developed around its material, geometry, load configuration and acceptance criteria.
Pass-through equipment creates a controlled boundary between preparation and classified areas, supports validated sterilization and reduces open transfers after treatment. It contributes to the site's Contamination Control Strategy, but compliance depends on the complete facility, operating procedures, qualification and process controls.
No universal payback should be promised. A result below one year may be possible depending on production volume, the existing process configuration and selected equipment scope. The expected return must be confirmed through a project-specific assessment of capacity, labour, utilities, consumables and current operating costs.
Conventional terminal heat sterilization can compromise insulin structure, potency and stability. Sterility therefore depends on sterile filtration, the controlled filling environment and the validated preparation and transfer of every closure and reusable product-contact component entering the aseptic process.
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