ISA-88 Explained: The Batch Manufacturing Standard

Batch processes — from pharmaceuticals to specialty chemicals to food production — are complex by nature. Unlike continuous manufacturing, where equipment runs in steady state, batch operations involve recipes, sequences, and equipment reuse across different products. To bring order to this complexity, the automation community developed ISA-88, also known as the Batch Control Standard.

What Is ISA-88?

ISA-88 is an international standard (ANSI/ISA-88) created by the International Society of Automation. Its purpose is to provide a common language and structure for batch manufacturing. In short, it standardizes how we describe recipes, equipment, and control logic so that engineers, software, and operators are all speaking the same terms.

Core Concepts of ISA-88

1. Recipes

At the heart of ISA-88 is the recipe. The standard breaks recipes into clear levels:

• General Recipe – technology-independent description of how a product is made.
• Site Recipe – adapts the general recipe to the capabilities of a specific facility.
• Master Recipe – defines the detailed instructions for execution on a particular line.
• Control Recipe – the actual execution instance, created when production runs.

This hierarchy separates what needs to be made from how it is executed, which improves flexibility and reusability.

2. Modular Equipment Model

ISA-88 introduces a modular way to describe equipment:

• Enterprise / Site / Area – organizational context.
• Process Cell – the collection of equipment required to produce batches.
• Unit – the core element that performs operations (e.g., a reactor, mixer, dryer).
• Equipment Module – subfunctions of a unit (e.g., heating system, agitator).
• Control Module – the lowest level, such as valves, pumps, sensors.

This model makes it easier to scale systems, integrate new equipment, and structure automation code consistently.

3. Separation of Procedure and Equipment

A defining principle of ISA-88 is separating recipes (procedures) from equipment. The same recipe logic can run on different units, and the same equipment can execute different recipes. This modularity prevents duplication, simplifies validation (critical in regulated industries), and reduces engineering effort.

Why ISA-88 Matters

• Consistency: Provides a universal framework for describing batch processes, reducing miscommunication between engineering, operations, and IT.
• Flexibility: Makes it easier to adapt recipes to new equipment or facilities.
• Efficiency: Standardized structures shorten engineering time and simplify system integration.
• Regulatory compliance: In industries like pharmaceuticals, the traceability and structured documentation ISA-88 enables are critical for meeting FDA or EMA requirements.
• Future readiness: ISA-88 concepts are embedded in modern MES and automation systems, making them essential knowledge for digital transformation.

ISA-88 and Today’s Manufacturing Systems

Most major automation vendors — from Siemens and Rockwell to Emerson and ABB — design their batch management platforms around ISA-88. Manufacturing Execution Systems (MES) also use its terminology for recipe management and scheduling. For companies moving toward smart manufacturing and Industry 4.0, understanding ISA-88 ensures smooth integration between process design, automation, and enterprise systems.

Key Takeaway

ISA-88 isn’t just a standard for control engineers — it’s a framework that aligns production, engineering, and IT in batch manufacturing. By separating recipes from equipment, defining a clear equipment hierarchy, and standardizing batch logic, it gives manufacturers the flexibility to scale, comply, and innovate with confidence.

About MDCplus

Our key features are real-time machine monitoring for swift issue resolution, power consumption tracking to promote sustainability, computerized maintenance management to reduce downtime, and vibration diagnostics for predictive maintenance. MDCplus's solutions are tailored for diverse industries, including aerospace, automotive, precision machining, and heavy industry. By delivering actionable insights and fostering seamless integration, we empower manufacturers to boost Overall Equipment Effectiveness (OEE), reduce operational costs, and achieve sustainable growth along with future planning.