The series launched in MakingPharma&Future and continued in the first online article showed that the challenges introduced by NCEs cannot be addressed simply by adopting new equipment or more advanced technologies. What needs to change is the model used to design, build and evolve GMP pilot plants throughout their lifecycle.
The Isolator Atoll Concept (IAC) was developed to address this need.
IAC is an engineering methodology for high-containment GMP pilot plants, developed to integrate the manufacturing process, containment and evolvability within a single design model.
The objective of IAC is not to define a particular plant configuration or propose a specific technological solution. Its purpose is to provide a coherent set of design principles through which the facility is conceived as an integrated system, where every decision derives from the needs of the manufacturing process and contributes to preserving its ability to evolve throughout the plant lifecycle.
The approach is based on a methodological framework built around three core principles: Integrated Process Architecture (IPA), Modular Process Architecture (MPA) and Adaptive Process Architecture (APA).
Together, these principles support three fundamental design objectives. The first is to design the system, ensuring that all design disciplines are developed from the needs of the manufacturing process. The second is to build the system, translating this model into an integrated, modular and coherent infrastructure. The third is to evolve the system, enabling the plant to adapt over time to changes in the manufacturing process, technologies and regulatory requirements while preserving continuity, coherence and performance.
IAC introduces a different approach to GMP pilot plant design. The manufacturing process becomes the primary reference for the entire project, while the infrastructure is developed to support its evolution throughout the plant lifecycle.
Integrated Process Architecture (IPA) – Design the System
IPA is the first principle of IAC.
The manufacturing process is the starting point for the entire design and becomes the common reference for all disciplines involved. Layout, building, containment, utilities, automation and qualification strategy are no longer developed as independent and sequential activities, but as elements of a single integrated design system.
This approach moves beyond the traditional logic in which the building and layout are defined in the early project stages and subsequently become constraints that limit the evolution of the manufacturing process.
With IPA, every design choice originates from the manufacturing process and contributes to preserving its ability to evolve. Integration across disciplines is therefore not a phase of the project, but an intrinsic property of IAC.
IPA delivers the Design the System principle by ensuring that all design decisions are developed according to a unified view of the facility.
Modular Process Architecture (MPA) – Build the System
MPA is the second core principle of IAC.
MPA translates the model defined by IPA into a coherent physical infrastructure.
Modularity is not simply a construction choice intended to facilitate equipment installation or replacement. It is a design criterion that organises the entire system into mutually coordinated functional units.
Each element is developed so that it can be integrated, replaced or modified without compromising the operational continuity of the facility. Modularity therefore becomes a property of the overall architecture rather than a characteristic of individual pieces of equipment.
MPA delivers the Build the System principle by turning the design model into a coherent, scalable infrastructure prepared for evolution.
Adaptive Process Architecture (APA) – Evolve the System
APA is the third core principle of IAC. APA extends the principles of integrated and modular design across the entire plant lifecycle.
The system is conceived from the outset on the assumption that the manufacturing process, available technologies and regulatory requirements will continue to evolve. Adaptability is therefore not a response to future changes, but an intrinsic property of IAC.
Each evolution is managed while preserving system continuity and limiting the impact on other design disciplines. From this perspective, change is not an exception to be managed, but a condition anticipated from the earliest design stages.
APA delivers the Evolve the System principle, allowing the facility to accompany the evolution of pharmaceutical development without requiring extensive redesign of the infrastructure.
A methodology designed to evolve
IAC proposes a new way of conceiving GMP pilot plants.
Design is no longer developed as a sequence of independent disciplines, but as an integrated process in which every decision derives from the needs of the manufacturing process. Modularity becomes the means through which continuity and reconfigurability are ensured, while adaptability is treated as a design requirement rather than a consequence of future modifications.
Together, IPA, MPA and APA form the methodological framework of IAC and define the principles on which the methodology is based. The next step is to translate these principles into operational tools and applicable design criteria, introducing the elements through which IAC is implemented in GMP pilot plant design.
THE SERIES
This article continues the series launched in MakingPharma&Future with “Pilot plants for the new era of New Chemical Entities” and developed in the first online article, which focused on the mismatch between the speed of process evolution and the rigidity of infrastructure. The next contribution examines the operational structure of IAC through the Integrated Production Unit, Reconfigurable Process Train and common infrastructures.
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