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

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The Secret Life of S88 (S88 as Seen by Users) Jim Parshall Eli Lilly and Company Contents Needs for Interpreting S88 Standards serve countless companies in many ... – PowerPoint PPT presentation

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Title: 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
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

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

5
Spirit of S88
  • S88 isnt just a standard for software,
    equipment, or procedures
  • Its 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
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

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

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)

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
10
An Example Process Cell
Process Cell
FT
M
PT
TT
FT
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
  • Dont narrow your definition of a unit to just a
    vessel
  • In-line mixer
  • Pasteurizer

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
13
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
14
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

15
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

16
Contents
Interpreting S88
Interpreting S88
S88 Business Challenges
S88 Business Challenges
The Future
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

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

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

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 RD and
    marketing organizations
  • Manufacturing will evolve to third-parties
  • Sales already partly transforming to third-parties

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

22
Contents
Interpreting S88
S88 Business Challenges
S88 Business Challenges
The Future
The Future
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 Disneys 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

24
Final Thoughts
  • S88 being a standard with international influence
    is a big selling point
  • Make sure your vendors are aware of S88
  • Dont underestimate the benefits of making your
    operators lives better
  • Make the process better
  • Dont 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

25
Thank You
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