S88 Standard

Pubblicato il 16/06/2017

S88 (short for ANSI/ISA-88) is the reference standard in batch automation and control, it provides guideline to efficiently manage the development, transformation and execution of industrial batch-recipes.

S88 Standard is about taking all the activities we perform, breaking them down into re-usable blocks of information, then selfishly (and diligently) reusing them wherever we can.

(Marc Hooybergs, Global Execution System Director at JnJ)

  • Separates the Recipe from the equipment control
  • Allows hierarchical recipe management and process segmentation
  • Improves the ability to transport a recipe from one system to another
  • Enables cross-functional alignment on terminology and methodology
  • Improves equipment/recipe long-term maintainability
  • Simplifies recipe validation and cross-site product transfers

Adopting S88 Standard guarantees both technical and business advantages, with impacts on the development process and execution of industrial batch-recipes.

  1. Quality
    • Increase yield of chemical processes
    • Increase batch-to-batch consistency
    • Ease Investigation process
    • Reduction time for site specific validation
  2. Cost
    • Savings from quality and throughput improvements
    • Revenue opportunity due to faster go-to-market
    • Reduction of non saleable batches, NPI and tech-transfer trials
  3. Throughput
    • Reduction in manufacturing doc creation time, review and testing
    • Cycle time improvements
    • Improvement due to cross-site cycle time benchmarking

OM Team supports the process of introducing S88 Standard through projects related to:

  1. Scope & Areas of Application Definition
    • Definition of project boundaries
    • Identification of ISA 88 applicable areas
    • Definition of business requirements
  2. Process/Systems Analysis & Mapping
    • Assessment
    • Data gathering of Recipe Development Process flow, Standard procedures, Documentation and system-application landscape
  3. Gap analysis and Road map definition
    • Priority identification and gap analysis
    • Definition of deployment & rollout plans
    • Definition of evaluation metrics for implementation
  4. Support to project execution
    • Redefinition of process flows, SOPs and S88 guidelines
    • Development of library and recipe templates
    • Support to pilot initiatives and full implementations

Download HERE our presentation.

Back to Pharma Industry