Inside the Azzurra Solution — Interview with Claudio Bechini and Cinzia Butini

Redesigning aseptic filling with a robotic, regulatory-first approach

Azzurra, the robotic aseptic fill-finish platform by Pharma Integration, represents a collaborative response to long-standing challenges in aseptic filling technology.

Claudio Bechini, Co-Founder & Managing Director, and Cinzia Butini, VP of Engineering, discussed how Azzurra overcomes these challenges by offering a truly holistic solution with collaboration playing a key role in its success.

What long-standing challenges in aseptic filling technology does Azzurra aim to solve, and why have these persisted for so long in the industry?

The aseptic filling industry has long faced recurring challenges: high capital costs, extended delivery timelines, complex installations, and lengthy qualification processes, which in some cases result in non-compliance.

Many of these challenges stem from a reliance on custom machines, often tailored to meet specific, moment-in-time user requirements. While customization can be effective short-term, it comes at the cost of longer development times, fragmented system design, and a lack of standardization, which ultimately compromises both quality assurance and operational reliability.

Another key issue is that drug product manufacturers often choose to procure equipment—such as filling machines, isolators, and control systems—from multiple suppliers. This creates integration challenges, prolonged CQV timelines, and additional regulatory burden, especially when these components haven’t been designed to function as a single, unified system from the outset.

These issues have persisted largely because legacy equipment providers continue to follow fabrication-led, project-based business models, rather than delivering standardized, prequalified platforms. As a result, the industry struggles to scale efficiently, mitigate risk, or respond with the agility needed to accelerate speed to patients.

Azzurra, on the other hand, was developed as a direct and deliberate response to these long-standing limitations. Its design reflects a completely different philosophy: one that prioritizes standardization, flexibility, and regulatory alignment from the very beginning.

It’s more than a machine: it’s a complete, fully integrated solution.

Azzurra is described as ‘more than a machine’. What makes it a holistic technology solution rather than just another piece of equipment?

Azzurra is the result of a deliberate and collaborative effort to rethink aseptic filling from the ground up. It was never intended to be just a high-performing piece of equipment, but as a holistic technology solution, developed through Quality by Design principles. It addresses not only the mechanical act of filling, but the entire ecosystem that surrounds it—from compliance and qualification, to installation, speed to market, and ultimately, patient safety.

Its design is rooted in regulatory compliance as a primary objective, shaped through close collaboration with international regulatory authorities. This early engagement allowed us to build a system that not only meets, but anticipates compliance requirements, helping manufacturers go to market faster and more safely, without having to fix integration or qualification gaps later on.

Azzurra includes a fully robotic machine that performs denesting/detraying, filling, stoppering/plungering, capping, and renesting/retraying, all integrated within an isolator, VHP generator, on-board HVAC, and unified control systems—tested together as a single monobloc unit at the factory. This unified, prequalified design ensures that everything functions seamlessly as a whole, reducing complexity, accelerating installation, and supporting robust contamination control strategies.

What makes Azzurra a truly holistic technology solution, not just a machine, is the combination of integrated pre-testing before dispatch, monoblock delivery with plug-and-play facility integration, production flexibility, and full regulatory alignment supported by comprehensive GMP documentation. It brings together technical innovation, manufacturing efficiency, and regulatory readiness to serve the needs of the drug product industry and, ultimately, deliver better outcomes for patients.

How does the monobloc design and robotic automation of Azzurra improve sterility assurance and reduce contamination risks compared to legacy systems?

Azzurra was designed to elevate sterility assurance by primarily focusing on ensuring compliance and product quality. The integration of Quality by Design (QbD) principles and robust risk assessments has allowed us to identify and eliminate potential weak points commonly present in legacy systems. Its monobloc architecture integrates all essential components—including the robotic process unit, isolator, control systems, and VHP generator—into a single, factory-assembled unit that is fully tested before dispatch. Much like receiving a car that’s already been tested on the track and arrives ready to drive, Azzurra is delivered exactly as it was pre-tested: no disassembly, no re-integration, just plug and play. This preserves the integrity of the setup, and removes the risks and delays typically associated with reassembly. The result is a solution that not only reduces installation time and qualification effort but also ensures that the system performs reliably as a whole.

The platform operates as a fully automated, aseptic gloveless, and humanless system, removing the need for aseptic human intervention altogether. All critical operations, from line setup to format changes and EM plate handling, occur within a closed environment, minimizing contamination risk and ensuring consistency.

Azzurra’s unique isolator design, featuring no base plate, allows for optimal robot positioning and improves airflow dynamics, enhancing first air compliance and further supporting aseptic integrity. Additionally, it has a genuinely compliant No-Touch-Transfer (NTT) Tub debagging system that incorporates a Grade B intermediate Zone, which is VHP decontaminated and has full EM monitoring. This level of control significantly reduces the dependency on extensive cleanroom classification and validation activities, making the entire process more robust and efficient.

Together, the monobloc design and robotic automation create a platform that not only improves sterility assurance but also reduces operational complexity and contamination risks in a way that legacy systems simply cannot match.

Azzurra is part of both the FDA Emerging Technology Program and EMA’s Quality Innovation Group. How has this early engagement with regulators influenced its design and adoption?

Early and proactive engagement with regulators has been a fundamental pillar of Azzurra’s development, not a box to check at the end, when design decisions are already fixed and any compliance issues or risks are typically passed on to the pharmaceutical company. From the beginning, we adopted a “regulatory-first” design philosophy, meaning that compliance and product quality were not treated as outcomes to be validated later, but as core design drivers.

Being part of both the FDA Emerging Technology Program and the EMA Quality Innovation Group is an industry first for a platform of this kind. It reflects our commitment to shifting the paradigm: instead of placing the burden of compliance and qualification on the customer, we took full ownership of designing a solution that would be regulatory-ready from day one.

Throughout the development process, we engaged with multiple regulatory authorities to ensure that Azzurra would meet—and in many cases anticipate—global compliance requirements. This approach allowed us to integrate features that simplify Annex 1 alignment, support Contamination Control Strategies, and deliver robust quality assurance.

For example, one of the key areas of focus by the Regulators has been on the debagging unit operation. As a consequence of our engagement with them, and the extensive use of various risk assessment tools, the Azzurra Debagger design is industry leading.

Ultimately, this strategy puts the customer, and the patient, at the center. By designing a system that’s already aligned with regulatory expectations, we help manufacturers accelerate time to market, reduce risk, and focus their efforts where it matters most: delivering safe, high-quality therapies.

How does Azzurra support the generation of a Contamination Control Strategy (CCS) in line with Annex 1 expectations?

The design of Azzurra has been developed with Annex 1 compliance as a central objective from the very beginning. During the early stages of development, a Quality Risk Assessment using the FMEA method was conducted to identify potential failure modes. The insights gained from this assessment directly influenced the design, with targeted actions taken to mitigate identified risks.

In parallel, a Hazard Analysis Critical Control Point (HACCP) methodology was applied to evaluate and monitor all Critical Control Points (CCPs) related to potential sources of contamination. This dual-risk-based approach ensures that contamination risks are proactively addressed within the system itself, rather than left to the customer to resolve post-installation.

As a result, Azzurra’s documentation package includes both HACCP and FMEA risk assessments, structured in a clear, modular format that supports and simplifies the development of a CCS by the customer. Because the platform is standardized and based on known, prequalified design elements, customers don’t start from scratch: they receive a system that is already aligned with regulatory expectations and supported by a documentation set ready to feed directly into their qualification and contamination control processes.

With increasing demand for in-country and rapid deployment solutions, how does Azzurra address the need for transportability and fast qualification?

Azzurra was specifically designed to address these exact needs. The monobloc structure enables fast and straightforward transport. It’s compact, standardized, and engineered for plug-and-play installation at the facility.

Because we factory-test the entire system as a whole before shipment, we dramatically reduce the installation and CQV burden on site. There’s no need to coordinate multiple suppliers or re-integrate systems post-delivery. This means customers can deploy capacity quickly, even in-country, and begin operations faster with greater regulatory confidence.

Ultimately, Azzurra supports a more agile, global manufacturing model—whether it’s for pandemic response, localized production, or emerging therapies that require rapid deployment.

The Azzurra platform was born from a triad collaboration between machine specialists, facility designers, and regulators. What lessons can the industry learn from this model of co-creation?

The development of the Azzurra platform shows that breaking long-standing inefficiencies in pharmaceutical manufacturing requires a fundamentally different approach, one rooted in early and structured collaboration.

This triad model, bringing together robotic filling machine specialists (Pharma Integration), facility design and project delivery experts (PM Group), and international regulators, demonstrated that collaboration works and accelerates innovation.

By aligning engineering, facility design, and compliance from the very beginning, the team was able to eliminate redundancies, shorten timelines, and deliver a solution that is technically advanced, regulatory-compliant, and operationally efficient.

The industry needs more of this co-creation approach. Not just for equipment, but for how we build the future of pharmaceutical manufacturing.