The Secret Life of S88 (S88 as Seen by Users) S88 As We (Users) See It 3/31/2017 The Secret Life of S88 (S88 as Seen by Users) Jim Parshall Eli Lilly and Company James H. Parshall

Contents Interpreting S88 S88 Business Challenges The Future S88 As We (Users) See It 3/31/2017 Contents Interpreting S88 S88 Business Challenges The Future The Secret Life of S88 April 18, 2000 James H. Parshall

Needs for Interpreting S88 S88 As We (Users) See It 3/31/2017 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 term “S88-compliant” does not make sense. “S88-aware” or “S88-consistent” would appear to be more appropriate. The Secret Life of S88 April 18, 2000 James H. Parshall

Reasons to Form SP88 No universal model existed for batch control S88 As We (Users) See It 3/31/2017 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 All of these problems led to expensive batch control systems that often did not meet all of the needs of the users and were difficult to maintain. So the S88 Committee put together a roadmap that outlined a two-part standard. Part 1, S88.01, is about models and terminology, and part 2, S88.02, is about data structures and guidelines for languages. S88.01 was released on October 23, 1995. As of today, S88.02 has not been released. The Secret Life of S88 April 18, 2000 James H. Parshall

S88 As We (Users) See It 3/31/2017 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 Identify your needs better. Make recipe development easier. Help reduce the time it takes to reach full production levels with a new system or for each new product. S88 a framework of terminology and methodology for modular batch automation. The Secret Life of S88 April 18, 2000 James H. Parshall

S88 As We (Users) See It 3/31/2017 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 Benefit from the replication of recipes and equipment control code. Can duplicate equipment functionality with minimal changes, significantly reducing time needed to implement subsequent projects. Good S88 design will allow validation of procedures and equipment independently. Documenting/validating such a system is also tough. Makes recipes difficult, if not impossible, to maintain. If recipes are kept at a higher level they are more flexible. The person who knows what process changes are required -scientists, process engineers, or lead operators- can make the changes directly. When there is a problem with a product, can be difficult to understand what was being done in the process at a given time. S88 software tracks the state of the batch in a log that can be integrated with a data historian or warehouse. Since common terminology and models help us know what questions to ask, S88 helps better define the manufacturing process. Working with more than one vendor is also easier. If everyone follows S88, we are much more likely to have better success integrating products from different vendors. In the long term, as vendors become more comfortable with S88, we should experience quicker turnaround time on systems and projects. Recovering from abnormal events is one of the most difficult parts of batch control. In many non-S88 installations, automatic recovery is not implemented and operators and/or engineers are needed to get equipment and the recipe back in sync. The Secret Life of S88 April 18, 2000 James H. Parshall

Improved Batch Process Metrics S88 As We (Users) See It 3/31/2017 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 These benefits existed prior to S88. Lower cost of capturing data, including less time to record batch data Data availability is better: A larger quantity of higher-quality data is accessible for analysis The Secret Life of S88 April 18, 2000 James H. Parshall

Successful Batch Control Defines These Elements S88 As We (Users) See It 3/31/2017 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 April 18, 2000 James H. Parshall

A Recipe Make Toothpaste Make Paste Make Gel Swirl Prepare Tank Add S88 As We (Users) See It 3/31/2017 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 April 18, 2000 James H. Parshall

An Example Process Cell S88 As We (Users) See It 3/31/2017 An Example Process Cell Material Charging Material Selection Pressure Control Process Cell Mix FT M Unit PT Temperature Control TT Discharge and Recirc Equipment Module Control Module Pump FT The Secret Life of S88 April 18, 2000 James H. Parshall

Interpretation of a Unit S88 As We (Users) See It 3/31/2017 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 Pasteurizers are typically three-section plate heat exchangers, and they can be large enough to hold hundreds of gallons of mix at any one time as part of a continuous process. Even so, we really didn’t consider our pasteurizer to be a vessel. Whether or not you might think of a pasteurizer as a reactor, it certainly adds value to the product. After all, what real market value is there for unpasteurized ice cream? (Well, to pathologists, physicians, and lawyers there might be a lot of market value to unpasteurized ice cream.) Starting, running, and stopping a pasteurizer are no trivial tasks. Using a recipe to operate a pasteurizer is certainly valid, even though the “running” portion of the recipe is active much longer than the “starting” or “stopping” portions. The Secret Life of S88 April 18, 2000 James H. Parshall

What is a Unit? Not a Unit A Unit Mix making batch tank 4 Pasteurizer S88 As We (Users) See It 3/31/2017 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 A dishwasher is a great example of a unit since it more or less runs a recipe, and we consider cleaning dishes and silverware as adding value. (If you disagree, that’s fine; but please don’t invite us over for dinner.) Kitchen blender 4 Refrigerator 4 Dishwasher 4 The Secret Life of S88 April 18, 2000 James H. Parshall

What is the Scope of a Unit? S88 As We (Users) See It 3/31/2017 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 Material Charging Material Selection Pressure Control Mix FT Examples include agitators, inlet or outlet valves, and instrumentation It is probably best to keep equipment not dedicated to a single unit separate or to include it as part of an equipment or control module. M Temperature Control PT TT Discharge and Recirc Pump FT The Secret Life of S88 April 18, 2000 James H. Parshall

Equipment and Control Modules S88 As We (Users) See It 3/31/2017 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 Material Charging Equipment Module FT Material Selection Control Module The Secret Life of S88 April 18, 2000 James H. Parshall

Physical Model is Collapsible S88 As We (Users) See It 3/31/2017 Physical Model is Collapsible Process Cell 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 Unit Equipment Module Control Module The Secret Life of S88 April 18, 2000 James H. Parshall

Contents Interpreting S88 Interpreting S88 S88 Business Challenges S88 As We (Users) See It 3/31/2017 Contents Interpreting S88 Interpreting S88 S88 Business Challenges S88 Business Challenges The Future The Secret Life of S88 April 18, 2000 James H. Parshall

S88 As We (Users) See It 3/31/2017 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 April 18, 2000 James H. Parshall

S88 As We (Users) See It 3/31/2017 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 A single piece of equipment (an ice cream freezer, freeze dryer), often considered a unit, needs to be integrated with other equipment (pint filler, tablet compression machine) to make the best use of S88 concepts The Secret Life of S88 April 18, 2000 James H. Parshall

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 April 18, 2000

Contract Manufacturing S88 As We (Users) See It 3/31/2017 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 Some pharmaceutical companies now use contract employees to augment their sales forces The Secret Life of S88 April 18, 2000 James H. Parshall

Contract Manufacturing S88 As We (Users) See It 3/31/2017 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 April 18, 2000 James H. Parshall

Contents Interpreting S88 S88 Business Challenges S88 Business S88 As We (Users) See It 3/31/2017 Contents Interpreting S88 S88 Business Challenges S88 Business Challenges The Future The Future The Secret Life of S88 April 18, 2000 James H. Parshall

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 April 18, 2000

S88 As We (Users) See It 3/31/2017 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 Eliminating unnecessary paperwork or automating a manual process frees operators up for more important and value-added tasks. Our operators hated paperwork and the manual keying of data. When we eliminated some of it, they loved us even more. If you're in a union environment, you may have some specific challenges to overcome when eliminating tasks, but sell hard. Ben & Jerry's never, ever considered firing or laying off someone just because we could eliminate a job or a portion of a job, so our operators were easy to work with on these productivity improvements. For us, improving our operators' (our customers') work lives was what excited us the most. About two weeks after successfully starting our system, we attended a conference. Since we had left the "old" batch control system in place, we told our operators that if the new system failed while we were gone, just go back to using the old system until we return. They paid us the highest possible compliment by replying, "But we don't want to use the old system.” Don’t just look at this from a technical standpoint; realize the business side of this statement as well. Two of the biggest business challenges that manufacturing companies face today are successfully planning production and conforming to the plan. The fallout from handling these activities poorly includes missed shipment dates and underutilizing plant resources, which results in second-rate customer service metrics and higher manufacturing costs. A prerequisite to good production planning and conforming to the plan is a solid production execution. Irrespective of good production planning software or well-trained employees, inherent variability in your processes can create havoc. S88 techniques and solutions can help reduce the variability in your batching operations, allowing you to better predict the time and resources needed to execute an order. The Secret Life of S88 April 18, 2000 James H. Parshall

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