Simulation and Optimization of Pharmaceutical Operations. Simulation and Optimization of Pharmaceutical Operations 1

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1 Simulation and Optimization of Pharmaceutical Operations Simulation and Optimization of Pharmaceutical Operations 1

2 Agenda Why simulate? How to simulate? Simulation in practice Conclusions Simulation and Optimization of Pharmaceutical Operations 2

3 Why Simulate? Simulation and Optimization of Pharmaceutical Operations 3

4 Why Simulate? Why do we need to simulate operations? Because we need crucial figures and System or changes to system do not exist yet System is too complex for equations and spreadsheets Field experimentation is too expensive or time consuming Real-life testing is unsafe, dangerous or leads to disaster And also because Modern computers are fast, powerful and cheap There are many nice software packages out there! Scheduling for operations is a great source of complexity! Simulation and Optimization of Pharmaceutical Operations 4

5 Why Simulate? Production scheduling in a pharmaceutical plant can easily become a threat to mental health Multiple products Multiple packages Changeovers Limited footprint Client orders Existing equipment Equipment availability Best lot sizes? Best sequencing? Deliver on time? Reduce costs? Cleaning times and much more! Simulation and Optimization of Pharmaceutical Operations 5

6 Why Simulate? What about integrating all system aspects into one model? Combination of process expertise and planning know-how Faster and error-free calculations Convenient way to manipulate schedules and validate feasibility Oh! By the way This is called simulation and it can be used to: Select, size and validate new equipment Identify ongoing operations bottleneck(s) Reduce/eliminate undesired waiting times Test alternative production sequences (this list is definitely not exhaustive!) Simulation and Optimization of Pharmaceutical Operations 6

7 Why Simulate? To have a global view on complex industrial systems Layouts, routes, dimensions, stationary and mobile equipment characteristics, technical data HISTORICAL PROCESS DATA Cycle times, schedules, resource availability, logic, routing and operational constraints, reliability DESIGN SPECIFICATIONS SIMULATION MODEL OPERATIONS KNOWLEDGE Performance diagnosis Effective and ultimate throughput Equipment utilization rates Meaningful and custom statistics Trend and pie charts, histograms Simulation and Optimization of Pharmaceutical Operations 7

8 Why Simulate? To provide fact-based strategic insights when in matters ENGINEERING PROJECTS Conceptual model Model with basic data Update model with existing data Enriched model, what if analysis Troubleshooting with model Expand or modernize with existing model De-bottlenecking and fine tuning Continuous improvement ONGOING OPERATIONS Simulation and Optimization of Pharmaceutical Operations 8

9 How to Simulate? Simulation and Optimization of Pharmaceutical Operations 9

10 How to Simulate? Mankind has been creative when it comes to simulation Here is a short classification of relevant simulation techniques: Deterministic Stochastic Static Algebraical equations Markov chains Monte-Carlo Dynamic Differential equations (process simulation) Discrete events simulation (operations simulation) Dynamic: time-dependant model, decisions based on current system state Stochastic: model uses random values and probabilities Simulation and Optimization of Pharmaceutical Operations 10

11 How to Simulate? Principles of discrete events simulation in 3 words! Discrete Events Simulation System updated at countable number of times System states and flows constant between events Absence of smooth and continuous transition Changes in a state, flow, record, schedule, etc. Beginnings and endings of cycles Arrivals and departures of resources Scheduled activities Model evolves from one event to the other An event can create a cascade of upcoming events Simulation executes the time-ordered list of events Simulation and Optimization of Pharmaceutical Operations 11

12 SIMULATION USEFULNESS SIMULATION FOCUS How to Simulate? Process design Operations design Thermodynamics Fluid mechanics Heat and mass transfer (Bio)chemical reactions PID / control loops Flow of bulk materials and parts Transport and kinematics Interactions and variability Tasks and resources coordination Reliability and maintenance Design unit operations Establish flows and compositions Calculate utilities and requirements Find how to ensure unit operations Establish overall system throughput Assess impact of resources availability Simulation and Optimization of Pharmaceutical Operations 12

13 How to Simulate? Ingredients of a discrete events simulation model that are common in the pharmaceutical industry Components for mass balance of fluid/bulk process Components for logistics, movement and materials handling Plant-wide components Tanks, pipes, valves, flow control Conveyors, feeder bins, stockpiles Batching cycles and filling processes Changeover, cleaning, queuing for CIP Trucks loading and unloading AGV, forklift, and cart deliveries Staging, palletizing and warehousing Personnel interactions with process Weekly/daily production schedules Operators and task coordination Equipment reliability & maintenance Simulation and Optimization of Pharmaceutical Operations 13

14 How to Simulate? Model outputs can be customized and provide decision-ready facts that are easy to interpret Gantt-style effective schedules On-time order fulfillment scorecards Equipment utilization rates with breakdown Filling line throughput Evolution of work-in-progress inventories Simulation and Optimization of Pharmaceutical Operations 14

15 How to Simulate? A structured, scientific and rigorous methodology is needed to guide simulation studies: 1 DATA & INFO. COLLECTION Discover assets and operations Obtain data and knowledge 2 MODEL SPECIFICATION Understand how system works Describe how it will be modelled 3 MODEL DEVELOPMENT Implement in simulation package Verify and validate model 4 SYSTEM OPTIMIZATION Test improvements Increase performance Simulation and Optimization of Pharmaceutical Operations 15

16 Simulation in Practice Simulation and Optimization of Pharmaceutical Operations 16

17 Simulation in Practice Production scheduling is crucial to ensure: For the Client: on-time order fulfillment For the company: Maximum use of installed equipment and personnel Minimization of waste The challenge is to answer the basic questions: What is the required equipment capacity to fulfill orders on-time? What is the maximum volume that can be accommodated? What is the optimal production schedule? Equipment selection and process scheduling are inter-related: To select equipment, one needs to know the desired production schedule To establish a production schedule, one needs to know what equipment to use Simulation and Optimization of Pharmaceutical Operations 17

18 Simulation in Practice Simulation-aided iterative scheduling strategy Obtain client s ordered volumes EXECUTE SIMULATION Analyze and interpret results Edit lot sizes and production sequences Validate production schedule Traditional scheduling process Iterative simulationaided process Update product characteristics Update equipment specifications yes Optimization opportunities identified? no Production scheduling completed Simulation and Optimization of Pharmaceutical Operations 18

19 Simulation in Practice Old School Simulation Methods: Excel spreadsheets used to schedule unit operations (both manufacturing and transverse support) Simulation and Optimization of Pharmaceutical Operations 19

20 Simulation in Practice Old School Simulation Methods: Include hourly clean and black utility estimates Simulation and Optimization of Pharmaceutical Operations 20

21 Simulation in Practice Old School Simulation Results: Hourly utility requirements Overall facility utility sizing Simulation and Optimization of Pharmaceutical Operations 21

22 Simulation in Practice Old School Simulation Issues: Excel sheets become large with many background calculations (crashing) Changes / scenario investigation tedious Copy / paste schedule Re-align process steps Introduce new sheets? How many CIPs was that? Simulation and Optimization of Pharmaceutical Operations 22

23 Simulation in Practice Today s Simulation Methods: Process analysis / optimization Scenario investigation Utility sizing CIP allocation Comprehensive buffer & media strategies Hourly utility usage Multi-product campaign scheduling for the year Simulation and Optimization of Pharmaceutical Operations 23

24 Simulation in Practice Today s Simulation Results: Simulation and Optimization of Pharmaceutical Operations 24

25 Simulation and Optimization of Pharmaceutical Operations 25

26 Simulation in Practice Optimal schedule for installed equipment and fixed demand Equipment characteristics, production volumes and deadlines are known Use the methodology to determine the best production sequence Minimize waiting and down times to reduce costs Maximize production capacity with installed equipment Equipment characteristics are known Unknown: how much can be produced Increase volumes and optimize schedule iteratively until no more marginal capacity Modify equipment for fixed demand, maintain optimality Future or desired production volumes are known Unknown: required equipment to ensure on-time fulfillment Add the least equipment possible and maintain schedule optimality Simulation and Optimization of Pharmaceutical Operations 26

27 Conclusions Simulation and Optimization of Pharmaceutical Operations 27

28 The Final Words Production scheduling is a challenging endeavour Designing or modernizing a facility is even more challenging Fundamental problem: optimal scheduling and equipment selection are interdependent Operations simulation supports this optimization task Representation of schedules, tasks, flowrates, storage, human interventions, etc. Selection, sizing and validation of equipment requirements Reduction of waiting and down times Benefits of simulation for pharmaceutical processes Centralized, consensual and cross-discipline model Reduced calculation time and risk of error Increased decision-making power Simulation and Optimization of Pharmaceutical Operations 28

29 Questions? Simulation and Optimization of Pharmaceutical Operations 29

30 Thank you for your attention! FOR MORE INFORMATION: Vincent Béchard Discrete Event Simulation Designer Office: #57221 John Black Senior Process Engineer Office: #52154 Richard Fecteau VP, Business Development Office: #54406 Simulation and Optimization of Pharmaceutical Operations 30

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