Shorten New Bio Product Development using ISA-88 and ISA-95

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1 Shorten New Bio Product Development using ISA-88 and ISA-95 dr. Dmitriy Borodin ir. Wim De Bruyn M.Sc. Bert Van Vreckem University College Ghent Production Information systems lab Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 1

Bert Van Vreckem University College Ghent Production Information

2 New Bio-Product Development from scratch Common Vision on NBPD: NBPD is the complete process of bringing a new bioproduct to market. NBPD process: idea generation product design detail engineering Companies typically see NBPD as the first stage in generating and commercializing new products within the overall strategic process of product life cycle management used to maintain or grow their market share. Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 2

NBPD process: idea generation product design detail engineering Companies typically see NBPD as the first stage in

4 Designing a new bio-chemical facility: Challenges The process makes the product : difficult to change the process after approval Chemical scientists have short time-frame for optimizing the process of promising a new molecule Engineers have to quickly design and construct new production lines and facilities for the new product Production process should be properly reflected in the software: MES, ERP, process automation tools Validation of all models & systems: software tests, GAMP V-model Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 4

production lines and facilities for the new product Production process should be properly reflected in the software: MES, ERP, process automation

6 Piping&Instumentation Diagram Provided by experienced engineers in the field using best practices Doesn t contain any measurable data for the real production facility How to test it out? Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 6

for the real production facility How to test it out?

7 Validation Documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. Includes the qualification of systems and equipment. A requirement for Good Automated Manufacturing Practices (GAMP) "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 7

meeting its pre-determined specifications and quality attributes." (FDA 1987).

Traditional Qualification Process An adaptation of the typical V-Model Validation: GAMP

GAMP V-model Wim De Bruyn, Dmitriy Borodin,

9 Validation: GAMP V-model Operational & Performance (OPQ) Validation Process An adaptation of the typical V-Model Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 9

10 Business Impact Low Medium High Risk Levels Risk Likelihood Level ONE High Medium Low Level TWO Level THREE Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 10

11 How should NBPD go ideally? Simulate and develop standardized model of the production facility on a PC Identify pitfalls, bottlenecks, weaknesses Perform Change Management on the simulated model: resolve problems and bottlenecks Validate the standardized process model using GAMP V-model Transfer already validated Standardized model to process automation tools, MES and ERP systems Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 11

Perform Change Management on the simulated model: resolve problems and bottlenecks Validate the standardized process

12 How to shorten the NBPD? Calculate the production indicators (e.g. impact of sizing): what-if analysis Model the facility work and behavior: predictability of the production process, debottlenecking on the early design phase Make the facility model format compatible with the MES, ERP, process automation tools models: faster and easier model transfer from one system to another Optimize validation: moving towards standardized model => validate only one model Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 12

the early design phase Make the facility model format compatible with the MES, ERP, process automation tools models: faster and easier

13 Which tools and standards can make it possible? contain a very rich library of materials, operations and units quick testing pretesting and simulation before to test the real implementation Powerful analysis tool Simulation software ISA-88 ISA-95 standards Base components are standardized, tested and already verified by the supplier. You can go to a multitier validation which means that only the configuration and the functional and operational tests have to be executed. GAMP Interfaces BatchML B2MML Allow integration with existing production information systems (ERP, MES, ) Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 13

Simulation software ISA-88 ISA-95 standards Base components are standardized, tested and already verified by the supplier.

14 ISA-88 and ISA-95 Standards BatchML and B2MML interfaces ISA-88 + BatchML: abstracting the physical design towards a development of a software configuration. It enables the optimized multi-product, multi-line plants to short new product development and production extension from a pilot to the full-scale production. The equipment functioning is separated from the recipe procedure => enhanced flexibility. The modularity and consistency properties are introduced by the breakdown and terminology of equipment entities and procedural elements. ISA-95 + B2MML: defines boundaries between the enterprise systems and the control systems => enables to answer such questions as which tasks can be executed by which function? and what information must be exchanged between applications? BatchML and B2MML (XML-schemas) are interfaces (bridge, data transfer method) between software and the data structures of ISA- 88 and ISA-95 Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 14

The equipment functioning is separated from the recipe procedure => enhanced flexibility.

External Origin (environment attributes) Internal Origin (simulation tool attributes) Simulation Tools: SWOT analysis Helpful to achieving the objective (Strengths) Harmful to achieving the objective

15 External Origin (environment attributes) Internal Origin (simulation tool attributes) Simulation Tools: SWOT analysis Helpful to achieving the objective (Strengths) Harmful to achieving the objective (Weaknesses) Simulation is cheaper than lab experiments and pilot plant Build and simulate further on existing examples and frameworks Rich library of reactors, methods, recipes S Big market for green field bio-tech installation Existing users of the system are positive To include even more standard unit data (more brends) O High level of bio-process knowhow is required to use the simulation software efficiently (a technological mistake can cost a fortune) Incompatibility with some platforms and operating systems (e.g. MacOS, Windows 64 bit) W Other competitive products Really Integrated products and solutions Standards (e.g. ISA-88 and ISA-95) T Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 15

green field bio-tech installation Existing users of the system are positive To include even more standard unit data (more brends) O High level of bio-process knowhow is required to use the simulation

Simulation tools: benefits case (Toumi et al.

slide Wim De Bruyn, Dmitriy Borodin, Bert

New Bio-Product Development: Impact of Simulation together with ISA-88&ISA-95 Wim De

19 Conclusions Nowadays, it is vital to respond quickly to market demand; the time required to launch a new product on the bio-pharmaceutical market is very long and shortening this track is extremely important. The approach adopted matches this requirement. The use of best practices, standards and simulation significantly improve the implementation of a full scale production from a pilot. It improves productivity, increases efficiency, eliminates waste, optimizes stock levels and cuts costs. Therefore risks are reduced, changes are managed easily and precious time is saved in a new bio-product introduction. Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 19

The use of best practices, standards and simulation significantly improve the implementation of a full scale production from a pilot.

20 References Toumi, A., Jürgens, C., Jungo, C., Maier, B. A., Papavasileoiu, V. & Petrides, D. P. (2010) Design and Optimization of a Large Scale Biopharmaceutical Facility Using Process Simulation and Scheduling Tools. Pharmaceutical Engineering, March/April 2010, pp De Bruyn, W., Van Vreckem, B. MES roll-out in a regulated environment. Reducing the costs of validation based on risk assessment. Proceedings of the WBF European Conference (2006) Vinson, J. The Value of Batch Process Design in a Chemical Engineering Education. White Paper Aspen Technology, Inc. (2008) Scholten, Bianca (2007). Integrating ISA-88 and ISA-95. ISA Expo Houston, Texas, USA Wim De Bruyn, Dmitriy Borodin, Bert Van Vreckem Copyright 2011 WBF. All rights reserved. 20

Proceedings of the WBF European Conference (2006) Vinson, J. The Value of Batch Process Design in a Chemical Engineering Education. White Paper Aspen Technology, Inc.

processes 1 This survey report is written within the PWO Project: Production scheduling of batch

processes 1 This survey report is written within the PWO Project: Production scheduling of batch REPORT SURVEY SCHEDULING SOFTWARE* 1 Pieter Caluwaerts, Wim De Bruyn, Luiza Gabriel, Bert Van Vreckem University College Ghent Hogeschool GENT. GENT BELGIUM Pieter.Caluwaerts@hogent.be, Wim.Debruyn@hogent.be,