Packaged surgical sutures combine variables that respond differently to sterilization: absorbable or non-absorbable polymers, braided or monofilament structures, functional coatings and multilayer barrier systems. The combinations to be treated may span Polyglactin 910, Polydioxanone, Polyester, Polyamide, Polypropylene and Polyethylene, together with aluminium pouches, paper–plastic laminates, Tyvek® sterile-barrier systems and more complex polymeric assemblies.
Sterilization must therefore do more than achieve microbial inactivation. It must preserve the characteristics that determine how the finished device performs: mechanical strength, degradation behaviour, filament structure, coating functionality, package seals and barrier integrity. Each combination presents a distinct material-compatibility and process-development challenge.
We develop sterilization around the complete packaged device.
At our Technology Centers, the interaction between suture polymer, filament architecture, coating, packaging materials and sterilant is assessed experimentally. Compatibility studies identify material response and critical product attributes, while microbiological testing, biological-indicator positioning and residual evaluation establish process effectiveness.
Vacuum, H₂O₂ injection, exposure and aeration parameters are then profiled around the most challenging locations and transferred to a defined industrial load configuration. Different sutures. Different materials. One capability to develop the right sterilization process.
Automated unloading and downstream transfer preserve load traceability, increase sterilizer utilization and support continuous production flow.
Automatic handling prepares repeatable load configurations and transfers packaged devices to the sterilizer, reducing manual intervention and product damage.
The vH₂O₂ process governs deep-vacuum phases, exposure and aeration to reach long, narrow lumens while controlling microbial reduction and residuals.
Processing heat-sensitive suture–packaging systems.
Controlled vacuum, H₂O₂ injection, exposure and aeration enable sterilization conditions to be adapted to different polymers, filament structures, coatings and packaging architectures. The process is configured around sterilant accessibility, material response and residual-removal requirements, supporting microbial inactivation without assuming that every packaged suture can tolerate the same cycle.
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.
Tyvek® bags provide a sterile barrier while allowing steam penetration, but processing machine parts inside porous packaging — particularly in double-bag configurations — introduces challenges that cannot be managed by temperature alone.
Irregular geometries, different thermal masses, folds, overlapping surfaces and contact with the trays influence air removal, steam circulation and condensate evacuation. At the same time, rapid pressure changes can mechanically stress the bags, while poorly controlled depressurization can cool the load and make drying more difficult.
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filament architectures: Braided and monofilament structures, with different materials, surface characteristics and functional requirements
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absorption profiles: absorbable and non-absorbable sutures
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specific combinations of sutures, coatings and packaging systems mapped for preliminary compatibility assessment
A risk-based assessment considers the bag, fill, headspace, seals, product sensitivity, required lethality, load, output, water impact and downstream operations. Representative bags can then be tested at Fedegari Tech Centers before the industrial process is finalized.
Superheated water provides rapid, homogeneous heating and cooling for high-capacity loads. Comparable exposure across load positions supports consistent lethality, while shorter transitions can limit unnecessary thermal stress on the product. The load exits wet, an acceptable trade-off when output and cost per bag are the main priorities.
Steam-air becomes attractive when lower water use, reduced wastewater and utility demand or dry unloading create greater value across the line. Continuous ventilation limits stratification and stagnant areas, while dry bags can move more directly to inspection, leak detection, labelling and packaging.
As the liquid heats and cools, pressure inside the bag changes. Controlled chamber counterpressure balances these variations throughout heating, exposure and cooling, helping protect bag geometry, seals and ports from excessive swelling, deformation, leakage or rupture.
High batch capacity becomes line throughput only when loads are prepared, transferred and discharged consistently. Automated handling protects the bags and validated arrangement, while identification and tracking preserve the association between each batch, its load configuration, selected sterilization route and downstream handover.
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