The Secret Life of S88 (S88 as Seen by Users)

1. The Secret Life of S88(S88 as Seen by Users) Jim Parshall Eli Lilly and Company

2. Contents Interpreting S88 S88 Business Challenges The Future The Secret Life of S88

3. Needs for Interpreting S88 • Standards serve countless companies in many different industries • Must be written to cover the broadest ground • Nature of standards prevents lengthy examples or interpretation details • S88.01 is not a compliance standard • It makes suggestions or provides examples • It does not list requirements The Secret Life of S88

4. Reasons to Form SP88 • No universal model existed for batch control • Users had a very difficult time communicating their batch processing requirements • Engineers found it very hard to integrate solutions from different vendors • Engineers and users had a difficult time configuring batch control solutions The Secret Life of S88

5. Spirit of S88 • S88 isn’t just a standard for software, equipment, or procedures • It’s a way of thinking, a design philosophy • Understanding S88 will help you better design your processes and manufacture your products S88 works with all levels of automation The Secret Life of S88

6. How Does S88 Help? 1. Modularity allows for easier global replication and better return on investment 2. Isolates equipment from recipes 3. Design concepts make validation easier 4. S88-aware solutions help track product and process data 5. Gathering requirements from customers and conveying requirements to vendors is easier 6. Provides guidelines on how to recover from abnormal events The Secret Life of S88

7. Improved Batch Process Metrics Throughput Cost • Reduced batch cycle time • Increased production rate • Faster changeover time • More scheduled recipes • Reduced downtime • Faster process development time • Faster new product launches • Reduced raw material loss • Improved batch consistency • Better equipment utilization • Less time to add or modify recipes • Lower engineering cost • Lower data capture cost • Better data availability The Secret Life of S88

8. Successful Batch Control Defines These Elements • Instructions on how to make a product (recipes) • The physical tools needed to make a product (equipment entities) • Methods to link recipes to equipment entities (control activities) The Secret Life of S88

9. A Recipe Phases are the workhorses. Other levels simply group, organize, and direct phases. Make Toothpaste Procedure Unit Procedures Make Paste Make Gel Swirl Prepare Tank Add Ingredients React Operations Add Water Add Fillers Add NaF Phases The Secret Life of S88

10. Material Selection Material Charging Pressure Control Mix Unit Temperature Control Discharge and Recirc Equipment Module Pump Control Module An Example Process Cell Process Cell FT M PT TT FT The Secret Life of S88

11. Interpretation of a Unit Process Cell Unit Equipment Module Control Module • Batching cannot occur without units; batching occurs in units • A unit runs a recipe to • Combine ingredients • Perform a reaction • Add value to your product or interim product • Don’t narrow your definition of a unit to just a vessel • In-line mixer • Pasteurizer The Secret Life of S88

12. What is a Unit? Not a Unit A Unit Mix making batch tank 4 Pasteurizer 4 Reactor 4 Pump 4 Ingredient storage tank 4 Washing machine 4 Kitchen blender 4 Refrigerator 4 Dishwasher 4 The Secret Life of S88

13. Pressure Control Temperature Control Discharge and Recirc Material Selection Material Charging Mix What is the Scope of a Unit? • Applying the S88 concept is much easier when equipment dedicated to a single unit is considered part of the unit • If a dedicated unit resource is not permanently associated with the unit, a lot of unneeded overhead is involved to use it FT M PT TT Pump FT The Secret Life of S88

14. FT Material Charging Equipment Module Material Selection Control Module Equipment and Control Modules Process Cell Unit Equipment Module Control Module • Equipment modules group devices for performing one or more specific processing activities • Control modules “connect” software to the process through actuators and sensors with all elements treated as a single entity • Equipment modules run portions of a recipe; control modules do not The Secret Life of S88

15. Unit Equipment Module Control Module Physical Model is Collapsible • A control module does not have to be part of an equipment module to be part of a unit • A unit can “own” control modules directly • A process cell must contain at least one unit Process Cell The Secret Life of S88

16. Contents Interpreting S88 Interpreting S88 S88 Business Challenges S88 Business Challenges The Future The Secret Life of S88

17. Packaged Systems • In bulk chemical operations, equipment entities (tanks, valves, pumps, etc.) are combined and integrated with control systems • S88 works well when end-user assembles stainless steel and integrates to form a working system • The application of S88 has been much more focused on these type of operations The Secret Life of S88

18. Packaged Systems • Fill/finish-type operations found in the consumer products industries can benefit greatly from S88 • Equipment from these operations are typically purchased from various OEMs • Integration into a common S88 framework is difficult The Secret Life of S88

19. What Do We Do? • Spec out equipment phases and have integrator or “system OEM” link equipment entities via recipes? • A two-tier S88-aware architecture • How about using S88.02 functions? • S88 software links recipes to equipment control at a level other than phase • S88 solution providers educate, assist, and influence OEMs to follow an S88 methodology The Secret Life of S88

20. Contract Manufacturing • Interpretation of supply chain is changing • Contract manufacturing organizations (CMO) are growing and evolving • Used in food industry for years • Concept fairly new in pharmaceuticals • Product “owners” may evolve into R&D and marketing organizations • Manufacturing will evolve to third-parties • Sales already partly transforming to third-parties The Secret Life of S88

21. Contract Manufacturing • Product “owners” will deal with general and site recipes • Product manufacturers will deal with master and control recipes • Properly transforming a general recipe into a master recipe will become even more critical The Secret Life of S88

22. Contents Interpreting S88 S88 Business Challenges S88 Business Challenges The Future The Future The Secret Life of S88

23. S88 Beyond Manufacturing • Theme park rides/attractions/shows • Instead of making a product according to some recipe, people are being entertained according to some sequence • Anyone visited Alien Encounter at Disney’s Magic Kingdom? • Power generation • Thinking of power in batches does not seem to make sense, but state-based procedural control could be an asset to a power plant • Moving baggage at an airport The Secret Life of S88

24. Final Thoughts • S88 being a standard with international influence is a big selling point • Make sure your vendors are aware of S88 • Don’t underestimate the benefits of making your operator’s lives better • Make the process better • Don’t trash the old system just yet • You may always have to sell S88 - even after projects are complete • An S88 solution is one element in a total system of manufacturing The Secret Life of S88

25. Thank You