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Sterile Handling

A complete range of specific machines featuring cutting-edge technology that will guarantee the sterile handling of the product
ASK FOR MORE INFORMATION

Sterile Handling

A complete range of specific machines featuring cutting-edge technology that will guarantee the sterile handling of the product
ASK FOR MORE INFORMATION

Sterile Handling

Stevanato Group Engineering Systems offers a complete range of specific machines featuring cutting-edge technology that will guarantee the sterile handling of the product reducing errors in the operational processes and avoiding additional contamination through lubricants and particles.

Every machine is also specifically designed to guarantee the highest levels of precision, quality and efficiency.


 

Automatic Lid and Bag Sealing Machine

The Automatic Lid and Bag Sealing Machine processes Nest and Tub packaging, producing sealed Ready to Use products (either vials, cartridges, syringes and hybrid products) ready for sterilization.

The input material of the automatic machine is a nest full of products placed on top of a tub packaging.

The automatic machine first places a Tyvek® Sheet on top of the nest, then it applies a Tyvek® Lid that is sealed onto the tub all along the perimeter. The final process step is the insertion of the sealed tub into a bag that is then automatically closed, producing as final output a product that is ready for the sterilization process.

The machine is ready to repeat the bag sealing process, producing a double-bag packaging configuration.

 It is possible to process packaging of different sizes (e.g tubs 3” and 4”) and bags of different sizes and materials, that can be combined also in the same product (e.g. external bag larger than the internal one).


Benefits

  • Flexibility for different Tub and bag sizes
  • Possibility to produce double-bag packaging configurations
  • Integration of lid sealing and bag sealing automatic processes into one machine
  • Compact layout
  • Low-particle generation process


Integration with additional modules: nesting, buffer, bridge and marking

The machine can be easily integrated with additional modules to complete the process; in fact, it is possible to integrate the following modules:

  • Nesting module: it is installed at the beginning of the machine and it fills the empty nest with the primary packaging containers coming from the upstream process
  • Buffer module: it is positioned between the Lid sealing and the Bag Sealing operations and it is designed on a vertical position, in order to minimize the impact on the layout
  • Bridge module: it creates a direct connection between the area where the machine is installed (typically ISO7 environment) and the external area of lower classification
  • Marking module: it prints on each tub unique data for batch and product traceability; alternatively, a labeling unit can be installed

Bridge

Buffer


Integrated machine to seal tubs into the final RTU packaging configuration, in the most flexible way across products and packaging in a variety of sizes and materials

Process controls and vision systems

It is possible to increase the range of process controls in order get a step-by-step verification of the process.

In particular, it is possible to check:

  • the position and welding of the lid on the tub
  • the presence of the internal sheet
  • the laser marking data or label data on the tub (OCR and OCV are options available)
  • the completeness of the nest before the lid sealing

 

Flexible Manufacturing Lines for Ready-To-Use Containers

Ready-To-Use containers are a special class of primary packaging that can be directly filled without any intermediate process, since the products and the related packaging are provided sterile and suitable for integration in the filling machines.

To fulfill this requirement, it is necessary to apply a specific sequence of processes: washing, drying, silicone spray, depyrogenation, nesting, bag sealing and sterilization are just an example of processes that can be combined together to reach different product specifications on the various types of primary packaging containers (vial, cartridge, syringe or hybrid).

SG Engineering System Division has designed and manufactured flexible production lines for Ready-To-Use containers, able to process multiple-format products both in terms of container type (vial, cartridge, syringe or hybrid) and size.


Glass primary packaging is rapidly evolving both in terms of products and complexity: we build our lines to be flexible and to easily adapt to new formats and product specifications

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No “glass-to-glass” contact to preserve glass integrity and increase the mechanical strength of products

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Product flexibility: machine automatically adapts from very small formats to large formats, including hybrid and customized containers

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Built-in automatic process control, with embedded vision systems for the critical process steps

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Quick change over time from size to size, with no or limited parts to be replaced

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Industry 4.0 ready: possibility to integrate the whole line with supervisors and MES, to get full control of the line and analytical data

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