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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
April 18, 2000The Secret Life of S88 3World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 4World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 5World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 6World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 7World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 8World Batch Forum 2000 / Atlantic City
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)
April 18, 2000The Secret Life of S88 9World Batch Forum 2000 / Atlantic City
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.
April 18, 2000The Secret Life of S88 10World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 11World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 12World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 13World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 14World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 15World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 16World Batch Forum 2000 / Atlantic City
ContentsContents
InterpretingS88
S88 BusinessChallenges
The Future
InterpretingS88
S88 BusinessChallenges
April 18, 2000The Secret Life of S88 17World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 18World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 19World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 20World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 21World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 22World Batch Forum 2000 / Atlantic City
ContentsContents
InterpretingS88
S88 BusinessChallenges
The Future
S88 BusinessChallenges
The Future
April 18, 2000The Secret Life of S88 23World Batch Forum 2000 / Atlantic City
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
April 18, 2000The Secret Life of S88 24World Batch Forum 2000 / Atlantic City
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