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Automation in pharmaceutical industry, Leiden Oct 8th 2009.
0
Raf Reintjens
Competence manager process intensificationDSM Pharmaceutical ProductsGeleen, The [email protected]
Transition frombatch to continuous processing
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
1Content
• Introduction
• Why switch to continuous?
• Barriers to transition
• About process intensification
• How can PI help to make the transition?
• The pharma plant of the future
• Conclusions
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
2Introduction
Life Science Products
Coal
Fertilizers
Petrochemicals
Performance Materials
Bioterials / Biologics
Chemical engineering
Polymer technology
Fine chemical synthesis
Material science
Mechanical engineering
Modern Biotechnology
Technological competences1902 1930 19701950 1990 2000 2010
DSM’s evolution
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
A Century of successful transitions
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
3Why switch to continuous?
Pharma industry is experiencing economic, social and environmental pressures
• Decreasing growth rate• Increasing cost for healthcare• New API molecules become more complex• Low manufacturing efficiency (waste, energy)
• Long development time• Increasing competition from generics
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
4Why switch to continuous?
Batch
• Segmented individual steps • Processing a specific quantity• Multi purpose equipment• Quality managed by repetition
and testing
Continuous
• Integrated synchronized operations• Continuous flow of product
• Equipment dedicated for purpose• Quality managed by design and
process control of steady state
Benefits
- Lower cost level (operational, invest)
- Increased productivity (small plant, low hold-up)
- Shorter through put time (less inventory)
- Consistent quality (less off-spec, less byproducts)
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
5Why switch to continuous?
Historical change of course
1900 1950 2000 2050
batch
continuous
automotive
petrochemical
electronics
pharma
• Efficiency and cost pressure (competition) have driven the transition in other processing industries
• Pharma is experiencing pressures and starts exploring continuous processing
• Managing quality in continuous processing made significant progress (6sigma)
Sep 2007
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
6Barriers to transition
Regulatory - Barriers are perceived, FDA stays tough on criteria but opens up to new solutions
Culture - Conservative attitude towards continuous processing mode
Education - Skill-base of personnel is batch oriented
Technology - Existing continuous processing technologies are oriented on dedicated bulk production
Equipment - Existing batch multi purpose plants will be standing idle- Industrial equipment for new technologies is not available or too expensive
Process Intensification helps removing barriers
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
7About process intensification
Process intensification is…..
The effective use of a set of innovative technologies aiming at:Driving a chemical process from the equipment limits to the limits of chemistry and physics
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
8About Process Intensification
PI competence development at DSM
FeasibilityNeeds
Stimulate external developments
academic, PPP, suppliers
Monitor and select
Develop promising technologies
Partner with suppliers
Information feedback
Learning curve
Business projects
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
9How can PI facilitate the transition
How to switch to continuous operation?
Integral Process & Plant Design• Identify the required functionalities
• Understand what drives them
• Understand how they interact
• Take a science based holistic view
PI technologies (modular)• Highly productive (small, safe, fast)
• Flexible (function, capacity)
• Reconfigurable (high OSF)
• Broad toolbox (reactive, DSP)
Process control• Secure steady state (design space)
• Use predictive models
• Incorporate PAT (real time release)
• Reliability, redundancy, accuracy
Chemistry• Choice of route
• Intrinsic kinetics
• Catalysis
• New domains (operating window)
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
10How can PI facilitate the transition
Transition through hybrid state
Partly continuous
- For discrete section
- Start-up / shutdown
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
11How can PI facilitate the transition
Example continuous nitration
extraction decomposition
Business needs- Intrinsic safety- High productivity- High selectivity- GMP production
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
12How can PI facilitate the transition
centrifugalextractors
distillationcolumns
Micro reactor
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
13The pharma plant of the future
Con
vers
ion
For
mul
atio
n
Sha
ping
Pac
kagi
ng
Process control
PI equipment
PI technologies
MIT-Novartis
Continuous operation� All process steps integrated (short throughput time)
� Quality by design (hardware, control)
� Low operational cost (manpower, utilities)
APPI
Automation in pharmaceutical industry, Leiden Oct 8th 2009.
14Conclusions
• Continuous processing provides significant benefits that can help the pharma industry to face the current challenges.
Thanks for your attention
• Process intensification facilitates the transition from batch tocontinuous processing. Small modular PI equipment can satisfy the need for versatility and flexibility
• Process control and PAT technologies will play an important role in quality management.