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

The Secret Life of S88The Secret Life of S88(S88 as Seen by Users)(S88 as Seen by Users)

Jim ParshallJim Parshall

Eli Lilly and CompanyEli Lilly and Company

April 18, 2000The Secret Life of S88 2World Batch Forum 2000 / Atlantic City

ContentsContents

InterpretingS88

S88 BusinessChallenges

The Future


Needs for Interpreting S88Needs for Interpreting S88

Standards serve countless companies in Standards serve countless companies in many different industriesmany different industries Must be written to cover the broadest groundMust be written to cover the broadest ground Nature of standards prevents lengthy examples Nature of standards prevents lengthy examples

or interpretation detailsor interpretation details S88.01 is not a compliance standardS88.01 is not a compliance standard

It makes It makes suggestionssuggestions or provides or provides examplesexamples It does not list requirementsIt does not list requirements


Reasons to Form SP88Reasons to Form SP88

No universal model existed for batch controlNo universal model existed for batch control Users had a very difficult time communicating Users had a very difficult time communicating

their batch processing requirementstheir batch processing requirements Engineers found it very hard to integrate Engineers found it very hard to integrate

solutions from different vendorssolutions from different vendors Engineers and users had a difficult time Engineers and users had a difficult time

configuring batch control solutionsconfiguring batch control solutions


Spirit of S88Spirit of S88

S88 works with alllevels of automation

S88 isn’t just a standard for software, S88 isn’t just a standard for software, equipment, or proceduresequipment, or procedures

It’s a way of thinking, a design It’s a way of thinking, a design philosophyphilosophy Understanding S88 will help you better Understanding S88 will help you better design your processes and manufacture design your processes and manufacture your productsyour products


How Does S88 Help?How Does S88 Help?

1.1. Modularity allows for easier global Modularity allows for easier global replication and better return on investment replication and better return on investment

2.2. Isolates equipment from recipesIsolates equipment from recipes

3.3. Design concepts make validation easierDesign concepts make validation easier

4.4. S88-aware solutions help track product and S88-aware solutions help track product and process dataprocess data

5.5. Gathering requirements from customers and Gathering requirements from customers and conveying requirements to vendors is easierconveying requirements to vendors is easier

6.6. Provides guidelines on how to recover from Provides guidelines on how to recover from abnormal eventsabnormal events


Improved Batch Process MetricsImproved Batch Process Metrics

Reduced batch cycle Reduced batch cycle timetime

Increased production Increased production raterate

Faster changeover Faster changeover timetime

More scheduled More scheduled recipesrecipes

Reduced downtimeReduced downtime Faster process Faster process

development timedevelopment time Faster new product Faster new product

launcheslaunches

Reduced raw Reduced raw material lossmaterial loss

Improved batch Improved batch consistencyconsistency

Better equipment Better equipment utilizationutilization

Less time to add or Less time to add or modify recipesmodify recipes

Lower engineering Lower engineering cost cost

Lower data capture Lower data capture cost cost

Better data Better data availabilityavailability

ThroughputThroughput CostCost


Successful Batch Control Successful Batch Control Defines These ElementsDefines These Elements

Instructions on how to make a product Instructions on how to make a product (recipes)(recipes)

The physical tools needed to make a The physical tools needed to make a product product (equipment entities)(equipment entities)

Methods to link recipes to equipment Methods to link recipes to equipment entities entities (control activities)(control activities)


A RecipeA Recipe

MakeToothpaste

UnitUnit

ProceduresProcedures

OperationsOperations

PhasesPhases

ProcedureProcedure

Make Paste

PrepareTank

Add Water

Make Gel Swirl

AddIngredients

React

Add Fillers Add NaF

Phases are the workhorses.Other levels simply group,

organize, and direct phases.

Phases are the workhorses.Other levels simply group,

organize, and direct phases.


An Example Process CellAn Example Process Cell

Mix

DischargeandRecirc

Pressure Control

Temperature Control

Material Charging

Material Selection

M

FT

TTPT

Pump

ControlModule

EquipmentModule

Unit

ProcessCell

FT


Interpretation of a UnitInterpretation of a Unit

Batching cannot occur without units; Batching cannot occur without units; batching occurs batching occurs inin units units

A unit runs a recipe toA unit runs a recipe to Combine ingredientsCombine ingredients Perform a reactionPerform a reaction Add value to your product or interim productAdd value to your product or interim product

Don’t narrow your definition of a unit to Don’t narrow your definition of a unit to just a vesseljust a vessel In-line mixerIn-line mixer PasteurizerPasteurizer

ControlModule

EquipmentModule

Unit

ProcessCell


What is a Unit?What is a Unit?

Mix making batch tankMix making batch tank

A UnitA UnitNot a Not a UnitUnit

ReactorReactor

PumpPump

Ingredient storage tankIngredient storage tank

Washing machineWashing machine

Kitchen blenderKitchen blender

RefrigeratorRefrigerator

DishwasherDishwasher

PasteurizerPasteurizer


DischargeandRecirc

Pressure Control

Temperature Control

Mix

Material Charging

Material Selection

What is the Scope of a Unit?What is the Scope of a Unit?

Applying the S88 concept is much easier Applying the S88 concept is much easier when equipment dedicated to a when equipment dedicated to a singlesingle unit unit is considered part of the unitis considered part of the unit

If a dedicated unit resource is not If a dedicated unit resource is not permanently associated with the unit, a lot permanently associated with the unit, a lot of unneeded overhead is involved to use itof unneeded overhead is involved to use it

M

FT

TTPT

FT

Pump


Equipment and Control ModulesEquipment and Control Modules

Equipment modules group devices for performing Equipment modules group devices for performing one or more specific processing activitiesone or more specific processing activities

Control modules “connect” software to the Control modules “connect” software to the process through actuators and sensors with all process through actuators and sensors with all elements treated as a single entityelements treated as a single entity

Equipment modules run portions of a recipe; Equipment modules run portions of a recipe; control modules do notcontrol modules do not

Material Charging Equipment Module

FT

Material Selection Control Module

ControlModule

EquipmentModule

Unit

ProcessCell


Physical Model is CollapsiblePhysical Model is Collapsible

A control module does not have A control module does not have to be part of an equipment to be part of an equipment module to be part of a unitmodule to be part of a unit

A unit can “own” control A unit can “own” control modules directlymodules directly

A process cell must contain at A process cell must contain at least one unitleast one unit

ControlModule

EquipmentModule

Unit

ProcessCell


ContentsContents

InterpretingS88


The Future

InterpretingS88



Packaged SystemsPackaged Systems

In bulk chemical operations, equipment In bulk chemical operations, equipment entities (tanks, valves, pumps, etc.) are entities (tanks, valves, pumps, etc.) are combined and integrated with control combined and integrated with control systemssystems

S88 works well when end-user assembles S88 works well when end-user assembles stainless steel and integrates to form a stainless steel and integrates to form a working systemworking system

The application of S88 has been much more The application of S88 has been much more focused on these type of operationsfocused on these type of operations


Packaged SystemsPackaged Systems

Fill/finish-type operations found in the Fill/finish-type operations found in the consumer products industries can benefit consumer products industries can benefit greatly from S88greatly from S88

Equipment from these operations are Equipment from these operations are typically purchased from various OEMstypically purchased from various OEMs

Integration into a common S88 Integration into a common S88 framework is difficultframework is difficult


What Do We Do?What Do We Do?

Spec out equipment phases and have Spec out equipment phases and have integrator or “system OEM” link integrator or “system OEM” link equipment entities via recipes?equipment entities via recipes?

A two-tier S88-aware architectureA two-tier S88-aware architecture How about using S88.02 functions?How about using S88.02 functions?

S88 software links recipes to equipment control S88 software links recipes to equipment control at a level other than phaseat a level other than phase

S88 solution providers educate, assist, and S88 solution providers educate, assist, and influence OEMs to follow an S88 methodologyinfluence OEMs to follow an S88 methodology


Contract ManufacturingContract Manufacturing

Interpretation of supply chain is changingInterpretation of supply chain is changing Contract manufacturing organizations Contract manufacturing organizations

(CMO) are growing and evolving(CMO) are growing and evolving Used in food industry for yearsUsed in food industry for years Concept fairly new in pharmaceuticalsConcept fairly new in pharmaceuticals

Product “owners” may evolve into R&D Product “owners” may evolve into R&D and marketing organizationsand marketing organizations Manufacturing will evolve to third-partiesManufacturing will evolve to third-parties Sales already partly transforming to third-partiesSales already partly transforming to third-parties


Contract ManufacturingContract Manufacturing

Product “owners” will deal with general and Product “owners” will deal with general and site recipessite recipes

Product manufacturers will deal with master Product manufacturers will deal with master and control recipesand control recipes

Properly transforming a general recipe into a Properly transforming a general recipe into a master recipe will become even more criticalmaster recipe will become even more critical


ContentsContents

InterpretingS88


The Future


The Future


S88 Beyond ManufacturingS88 Beyond Manufacturing

Theme park rides/attractions/showsTheme park rides/attractions/shows Instead of making a product according to some Instead of making a product according to some

recipe, people are being entertained according recipe, people are being entertained according to some sequenceto some sequence

Anyone visited Anyone visited Alien EncounterAlien Encounter at Disney’s at Disney’s Magic Kingdom?Magic Kingdom?

Power generationPower generation Thinking of power in batches does not seem to Thinking of power in batches does not seem to

make sense, but state-based procedural control make sense, but state-based procedural control could be an asset to a power plantcould be an asset to a power plant

Moving baggage at an airportMoving baggage at an airport


Final ThoughtsFinal Thoughts

S88 being a standard with international S88 being a standard with international influence is a big selling pointinfluence is a big selling point

Make sure your vendors are aware of S88Make sure your vendors are aware of S88 Don’t underestimate the benefits of Don’t underestimate the benefits of

making your operator’s lives bettermaking your operator’s lives better Make the process betterMake the process better Don’t trash the old system just yetDon’t trash the old system just yet You may always have to sell S88 - even You may always have to sell S88 - even

after projects are completeafter projects are complete An S88 solution is one element in a total An S88 solution is one element in a total

system of manufacturingsystem of manufacturing

Thank YouThank You

Documents

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