Parshall ppt

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


Contents : Contents Interpreting S88 S88 Business Challenges The Future


Needs for Interpreting S88 : 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


Reasons to Form SP88 : 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


Spirit of S88 : Spirit of S88 S88 works with all levels of automation 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


How Does S88 Help? : 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


Improved Batch Process Metrics : Improved Batch Process Metrics 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 Throughput Cost


Successful Batch Control Defines These Elements : 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)


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


An Example Process Cell : An Example Process Cell M FT TT PT Process Cell FT


Interpretation of a Unit : Interpretation of a Unit 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 Control Module Equipment Module Unit Process Cell


What is a Unit? : What is a Unit? Mix making batch tank A Unit Not a Unit Reactor Pump Ingredient storage tank Washing machine Kitchen blender Refrigerator Dishwasher Pasteurizer 4 4 4 4 4 4 4 4 4


What is the Scope of a Unit? : 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 M FT TT PT FT Pump


Equipment and Control Modules : Equipment and Control Modules 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 Control Module Equipment Module Unit Process Cell


Physical Model is Collapsible : 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


Contents : Contents Interpreting S88 S88 Business Challenges The Future Interpreting S88 S88 Business Challenges


Packaged Systems : 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


Packaged Systems : 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


What Do We Do? : 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


Contract Manufacturing : 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


Contract Manufacturing : 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


Contents : Contents Interpreting S88 S88 Business Challenges The Future S88 Business Challenges The Future


S88 Beyond Manufacturing : 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


Final Thoughts : 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


Thank You : Thank You