Advanced Configurable Process Plants (ACPP) for Continuous API Production

Batch processes currently dominate API development in which formulators must run multiple Design of Experiments (DoE) cycles, each requiring separate setup, cleaning, and validation. This linear approach leads to higher development costs, delayed market entry, excess resource consumption and inconsistent product quality, due to batch variations.

However, the continuous production model that solves these problems has become much more accessible and affordable for API manufacturers with the advent of Advanced Configurable Process Plant (ACPP) technology and Dec Group is a leader in this emerging field.

The MTP solution

Dec Group’s Module Type Package (MTP) for semi-continuous and continuous API production brings plug‑and‑produce modularity to API workflows. By breaking the end‑to‑end process into interoperable units, manufacturers can assemble, reconfigure, and scale their production cycles within days, rather than months.

ACPPs are revolutionizing the way operations are integrated, enabling manufacturers to connect multiple operations seamlessly and efficiently. Self-contained and pre-automated modular units can be skid-mounted and swiftly configured to meet specific process requirements, drastically reducing the time to market for production plants. Each module is dedicated to a single unit operation (reactor, crystallizer, filter. washer, dryer, etc.) allowing equipment to remain within the module, and for the whole unit to be relocated or repurposed as necessary.

This modular approach allows for quick adjustments, minimizing downtime by enabling the swift replacement of modules for routine maintenance.

Ease of integration

The ACPP framework offers unparalleled flexibility, allowing companies to add, remove or rearrange modules with minimal effort. Each module comes with a dedicated MTP file that contains essential data on functionality, structure, piping and instrument diagrams (P&ID), ensuring easy connection and smooth integration into the entire process.

Each module features a decentralized controller compatible with the Process Orchestration Layer (POL). Standardized MTP metadata enables “plug‑and‑produce” commissioning, so modules automatically register with the enterprise supervisory system.

ACPP Benefits:

Adopting ACPP strategy delivers potentially game-changing benefits, particularly for small to medium sized producers or those in emerging markets.

These include:

• Multi-modular production systems: easy to configure and reconfigure.
• Rapid production changeovers: no need for re-commissioning and validation once qualified.
• Fully portable: solutions that eliminate geographical limitations.
• Simple connection: to common utilities and easy docking with other modules.
• Full automation: systems designed to work under SCADA or DCS for 24-hour autonomous operation.
• Flexibility: self-contained modules connecting via standardized interfaces allow rapid creation of a bespoke API continuous production solution.
• Seamless Digital Integration:
• Enhanced Quality & Compliance: Continuous flow reduces hold‑times and contamination risk. Fully integrated CIP/SIP routines ensure GMP‑grade cleaning between runs, while real‑time PAT tools deliver continuous monitoring and documentation.
• Scalability: It’s possible to start with a benchtop MTP train for R&D, then scale up by adding identical production‑scale modules—preserving process performance and regulatory continuity.

End-to-end

Favored by leading chemical, fine chemical, and pharmaceutical companies, MTP systems align with established Namur and DIN standards and are attracting interest from America’s FDA.

The Modular ACPP API Production is a key component of Dec’s comprehensive True End-to-End product portfolio, encompassing everything from the bulk handling of raw materials to the final dosage form.

As pharma transitions towards a future of decentralized small and medium-scale API production, ACPPs stands out as a game-changer, offering unmatched efficiency and flexibility in a dynamic market.

Resources

Click on Dec Group ACPP solution for further information.
Click on Dec webinar “New World” Processing with Advanced Configurable Process Plants to learn more about ACPP technologies.