Definition
ISA-88 (batch control)
ISA-88 (ANSI/ISA-88 and IEC 61512) is the international standard that structures batch control systems. It defines a physical model (enterprise, site, area, process cell, unit, equipment module, control module) and a procedural model (procedure, unit procedure, operation, phase) that decouple the recipe from the PLC code. We systematically use it on multi-recipe or multi-product projects: sequencing logic (recipe) is managed separately from machine execution (phases), which radically simplifies maintenance and accelerates the OQ and PQ phases. Without ISA-88, every new recipe requires custom code and triggers requalification. With well-implemented ISA-88, adding a recipe becomes a documented configuration operation, without modification of validated PLC code.
Related
- ISA-95
- recettes
- batch
- MES
- OQ
Further reading
ISA-88 and IEC 61512: what is the relationship?
ISA-88, IEC 61512 and S88: how they relate, what changed with the 2026 edition and how to apply the models to batch architecture.
MES, ISA-95 and ERP/PLC integration in pharma: a pragmatic architecture for Swiss sites
Pharma MES architecture: the ISA-95 grid, where Werum PAS-X, Siemens Opcenter and Rockwell PharmaSuite fit, and a concrete Swiss case of perimeter re-scoping.