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.
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.
No “glass-to-glass” contact to preserve glass integrity and increase the mechanical strength of products
Product flexibility: machine automatically adapts from very small formats to large formats, including hybrid and customized containers
Built-in automatic process control, with embedded vision systems for the critical process steps
Quick change over time from size to size, with no or limited parts to be replaced
Industry 4.0 ready: possibility to integrate the whole line with supervisors and MES, to get full control of the line and analytical data
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.
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.
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.
The main advantages are:
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).
The machine can be easily integrated with additional modules to complete the process; in fact, it is possible to integrate the following modules:
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:
A wide expertise on visual inspection thanks to Optrel and Innoscan brands