Sterile Handling - Stevanato Group
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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.


 

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


 

Multi-format RTU Containers Line

The challenge

Our customer, a multinational Pharma producer, after receiving the approval for launching on the market a new family of products needed to fill them in a primary glass container of new design not commercially available. It had to be pre-sterilized and ready to use. Stevanato Group Engineering Solutions needed to develop in a very short time a line capable of processing multiple containers with extremely tight quality specifications.

The solution

Combining the competences of the various divisions, Stevanato Group Engineering Systems developed an innovative manufacturing process combining the latest developments in material handling, process control and multi-format management. Partnering with a world class manufacturer of washing and depyrogenation equipment, Stevanato Group Engineering Solutions supplied a turn key solution satisfying and exceeding the original request.

  • The new line developed by Stevanato Group Engineering Systems includes solutions that were not available before:
  • Format flexibility, with adaptive tools, capable of handling the complete range of containers without replacement or adjustment;
  • Limited format change over time achieved through the HMI, without human intervention
  • Lean layout, limiting the clean room dimensions to a minimum
  • State of the art glass handling, with no glass to glass and limited glass to metal contact
  • Optimized process, with 100% quality inspection and continuous automatic monitoring and feedback.
  • The solutions overcome the typical solutions normally available, where handling the glass in metal trays or metal pucks could affect the glass integrity.

A change over lasts a few moments, without human intervention, increasing line performance while reducing risks of contamination or mistake.

The level of automation ensures quality and flexibility, particularly when applied in a classified environment.

The line consists, among other equipment, of a denester/detrayer, of a washing machine, of a depyrogenation tunnel, of a bypassable syliconization spraying and baking unit, stoppering, capping and final packaging in Ready to Use nest and tubs.

Key Benefits

The main advantages are:

  • Highest quality
  • Low particle generation
  • Process reliability/repeatability
  • Gentle handling & NO manual operations in clean room
  • State of the Art technologies and developments, integrated in an integrated system
  • Full line and process data collection and control, thanks to its interconnected supervisory system
  • Remote line set up by software recipe
  • Shortest time to market for a full family of new product

 

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 to 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

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