Case Study
DCS Recipe Layer Optimisation and MES Migration — DeltaV Redesign and Syncade to PharmaSuite, Large-Scale Mammalian Facility
The Challenge
Every qualified parameter had to be preserved exactly.
A large-scale mammalian biologics manufacturing joint venture facility in Switzerland — producing monoclonal antibodies at commercial scale — initiated a programme to optimise and evolve its automation and MES architecture. The facility was running on an established Emerson DeltaV and Syncade platform across the full manufacturing scope — USP, CIP, SIP, downstream processing and BMS. With manufacturing programmes developing and operational experience accumulating, the decision was made to increase flexibility at the DeltaV recipe layer and transition the MES from Syncade to Rockwell PharmaSuite — giving the facility a more modular, independently maintainable recipe architecture and an MES platform with the open-content structure to support long-term manufacturing evolution.
The engineering challenge was precise and non-negotiable: the DeltaV recipe layer had to be redesigned to deliver greater flexibility and maintainability — but every qualified parameter had to be preserved exactly. This was not a revalidation programme. The process knowledge and qualified operating ranges embedded in the existing recipes were the facility’s validated manufacturing baseline and could not be altered. The redesign had to deliver a better recipe architecture while maintaining identical qualified process parameters throughout.
Simultaneously, the MES migration from Syncade to Rockwell PharmaSuite required working with a third-party PharmaSuite vendor to configure the new system correctly against the redesigned DeltaV recipe layer — which meant translating the complete process and recipe architecture into interface requirements the vendor could act on, across USP, CIP, SIP, DSP and BMS, before a single engineering batch ran.
The Scope
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Current state mapping — full recipe and process architecture analysis
Before any redesign work began, Rockstone’s Process Automation Engineers conducted a comprehensive mapping of the existing Syncade recipe authoring and DeltaV configuration across the entire facility scope — USP, CIP, SIP, downstream processing and BMS. Every process step, every recipe instruction, every qualified parameter and every DeltaV interface was documented — creating a precise picture of the existing architecture, the qualified process baseline that had to be preserved, and the recipe logic to be rebuilt at the DeltaV layer.
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DeltaV recipe layer redesign — greater flexibility, identical qualified parameters
The DeltaV recipe layer was redesigned across the full facility scope — every process recipe rebuilt as ISA-88 phase logic at the DCS level, designed around the actual equipment and process requirements of each manufacturing area. CIP and SIP sequences were rebuilt as discrete ISA-88 phases. USP process steps — bioreactor control, DO cascade, nutrient feed management and harvest sequences — were redesigned as properly structured DeltaV recipe phases. DSP steps including chromatography, viral filtration and UF/TFF were rebuilt with standardised DeltaV recipe structures. Throughout the redesign, every qualified parameter — every set point, every control range, every alarm limit forming part of the validated process — was carried forward exactly. The objective was a better recipe architecture, not a different process.
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PharmaSuite MES implementation and interface specification with third-party vendor
Rockwell PharmaSuite was implemented as the new MES — recipe management, electronic batch records, weigh and dispense module and batch execution across the full facility scope. Rockstone translated the complete process and recipe architecture into precise interface requirements for the third-party PharmaSuite vendor — every communication point between PharmaSuite and DeltaV, every data exchange between the MES batch record and the DCS execution layer, across USP, CIP, SIP, DSP and BMS. This three-way coordination was the most demanding aspect of the programme — MES migrations encounter their most significant issues at the DCS-MES interface, and Rockstone’s role was to ensure every interface was defined, documented and tested before qualification started.
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Engineering batches through commercial production
Rockstone supported the facility through engineering batches into commercial production — present during batch execution, identifying and resolving any minor issues arising from the new recipe configuration or the DeltaV-PharmaSuite interfaces in real time. Every adjustment identified during engineering batches was implemented, tested and documented under change control before the next batch ran.
The Outcome
- Every qualified parameter preserved exactly
- Migrated Syncade to PharmaSuite on a live platform
- Zero interface deviations in commercial production
The programme demonstrated a capability that is technically demanding but commercially essential for any mature GMP facility: the ability to evolve and optimise the automation architecture — increasing flexibility and long-term maintainability — without touching the qualified manufacturing baseline that the facility’s regulatory position depends on. Commercial production ran on the new platform following engineering batch validation with no deviations attributable to the DCS recipe redesign or the DCS-MES interface.