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Current market trends in aseptic fill-finish are now forcing pharmaceutical companies to adopt agile manufacturing strategies and embrace new technologies to meet the actual requirements for a highly variable production process. Central goal is to achieve flexible production in a safe, aseptic environment, implementing cost-saving solutions with a space-efficient design.

In aseptic processing, operators are the primary source of contamination. Although human operators figure in a potentially risky activity in sterile areas, pharma manufacturing remains predominantly human. Therefore, one of the focal topics for pharmaceutical manufacturing today is how to improve the use of robotic automation in a gloveless, isolated environment. The ideal outcome is the creation of a digitally controlled aseptic process with little to no human intervention.

To address this issue, in many pharmaceutical industries, conventional filling systems are now progressively implemented with robots.  However, these robots are typically used for only one step of production, i.e. for simple moving of vials from station-to-station or for removing the cover from a tub of nested containers. However, these attempts generally represent only half-steps towards utilizing the full potential of robots.

To achieve the aim of reaching the maximum possible improvement in safety and productivity the full fill/finish process should be completely based on robotics operating in a closed, gloveless, isolator environment.

INJECTA can meet these fundamentals, tracing the roadmap for a real and complete fill-finish process modernization. Its fully isolated robotic filling system is designed as a whole, an integrated system utilizing all robotic capabilities. Kawasaki’s seven-axis robot arms are made in st. st. and designed for the lowest particle shedding. They are resistant to positive/negative and high pressures and fully compatible for decontamination using H2O2 vapors. 

INJECTA’s specialized robots not only provide precise, consistent handling activities, but also offer a high level of flexibility: they are completely digitally controlled with Industry 4.0 capability. No human interventions are required: all activities/issues are solved through robot interactions.

If flexibility is crucial for high-value and medium-low production batches, INJECTA is naturally born to be flexible. Its filling system can accommodate a wider range of containers (tub, nest and trays) and components (vials, syringes and cartridges) with minimal or no size changeover.  Further to this, its flexible methods of production allow both the bulk processing of vials and the processing of Ready-To-Fill components. It can easily combine robotized in-nest or de-nesting operations before filling or after stoppering.

INJECTA inbuilt “combi” configuration guarantees a whole, contained integrated production system with no use of interchangeable production modules to adjust production processes. Injecta is flexible and precise in terms of quality. It works with multiple primary packaging components. Its design is intrinsically modular and meets multiple requirements from small-scale clinical trial batches up to medium high production levels.

INJECTA supports a completely automated fill/finish process without the need for gloves and glove ports, guaranteeing a greater level of sterility. Single-use materials such as ready-to-use primary containers, disposable inner/outer bags, etc. are used and disposed of within the system. Its advanced design allows faster setup and efficient product changeover, involving therefore a faster VHP cycle development with respect to conventional isolated lines. Results are a reduced filling line downtime, expanding capacity and increasing flexibility.

We can finally state that the robotic technology is a real new challenge in terms of greater accuracy, innate modularity, flexibility, and reliability. The risk for microbial contamination generated by operating personnel is virtually eradicated by its advanced aseptic production system. Gloveless solutions drastically remove the potential for human contamination and guarantee a greater level of sterility.

INJECTA’s gloveless isolated robotic filling system intrinsically entails all these benefits. It represents our approach to INDUSTRY 4.0 requirements and reinforces our vision: to create value for customers by means of advanced technology, process improvement and service support.

 

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