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Pharmaceutical Manufacturing
Sustainability
More Green
More Competitive
More Successful
Common Sense Sustainability
David March
Process Capital Productivity Specialist
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Sustainability is evolution by another name.
Definition: “Sustain”: To keep in existence. To maintain. To persist.
sounds like “survival” to me.
Therefore, Sustainability from an evolutionary perspective has 2
components:
1. Use of Resources
2. Adaptability
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Hurray For Darwin: Our Agenda Principals
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Definition: “Sustain”: To keep in existence. To maintain. To persist.
sounds like “survival” to me.
Therefore, Sustainability is really just evolution. Fitness based on:
Efficient Use of Resources
Adaptability
Agenda
1.
Resource Efficiency: The Atom Economy
1.
2.
3.
4.
2.
Process Resources: Process Efficiency
Support Resources: The Production Eco-System
Dealing with Waste:
Capital Efficiency
Adaptability and Agility: Success in the Marketplace
1.
2.
Time to Market: Exploiting eco-niches
Time to Adapt: Responding to change
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Agenda:
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The Atom Economy is the most direct and effective measure of process efficiency.
It compares the number of atoms going into a process to the number of atoms of good
product coming out of the process.
It counts all the atoms!
Raw materials
Energy (yes energy atoms… fuel)
Yield
Waste
LCA (Life Cycle Analysis)
It does not look at it from a cost perspective but a “mass” perspective.
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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The Atom Economy: A Definition
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In The Long Run:
Both the economics and the sustainability
of a process will be determined by its
Atom Economy
The species that uses resources most
efficiently will survive (be sustained)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
5
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From the Evolutionary Perspective
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• Pharmaceutical manufacturing is the least efficient of all chemical
industries in terms of Atom Economy (kg waste / kg product)
– Pharma Average Ratio is 200 to 1 (waste generated to product) some products as
high as 800 X
– BioPharma is worse. Typical waste to product ratios between 3,000 to 10,000 to 1
• Pharmaceuticals reported 530 Million Tons of Waste to EPA.
• Of the 170 chemicals reported to the EPA for Pharmaceuticals, the top
20 solvents represent 90% of the mass of waste generated.
• Compare with a Refinery: 97.3% Efficient
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
6
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Pharmaceutical Process Efficiency
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•
Pharmaceutical Plant Site Waste is 80% Solvent
•
Pharmaceuticals reported 530 Million Tons of Waste to EPA.
•
Solvents Represent:
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75-80% of energy usage
75-80% of the environmental impact
80-90% of the mass balance
Most solvents are not recovered because of their thermal value (similar to coal). Incinerated for
power at plant, or sold to others for incineration.
–
–
–
–
–
Natural Gas:
Coal
THF
MEK
Ethanol
54.3 MJ/kg
30.3 MJ/kg ( 48% of US Energy Generation)
32.2 MJ/kg ( 40% lower than Natural Gas)
34.0 MJ/kg
30.0 MJ/kg
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
7
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Where is the inefficiency? SOLVENTS
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Item
Recovered Energy
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Hazardous Waste Disposal
Virgin IDA Used
728,000 gallons / year
728,000 gallons / year
Price of Virgin Solvent
$ 2.50 per gallon
$ 2.50 per gallon
Sell Price of Waste
$ 0.42 per gallon
- $ 0.52 per gallon
Solvent Recovery %
92%
92%
Labor Operating Costs
$ 55,500 per year
$ 55,500 per year
Energy and Consumables
$ 39,800
$ 39,800
Initial Investment
$ 3,080,000
$ 3,080,000
Savings Per Year
$ 1,393,000
$ 4,498,000
ROI / Payback (months)
22% and 27 month payback
80% and 8 month payback
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Example Ethanol Recovery from IDA
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Pharmaceutical Manufacturers, especially Generics,
could be significantly impacted by a carbon tax:
because of the very high mass leverage (inverse
atom economy):
Almost 90% of the mass balance ends up as
Carbon Dioxide.
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
9
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HOLD ON… .Things are going to change
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A plant boundary view distorts the impact
of incineration vs recovery. As a result
most THF is incinerated rather than
recovered. (higher energy than coal)
Incineration creates energy and generates
waste (carbon dioxide)
Distillation uses energy which creates
waste (carbon dioxide and unrecoverable bottom stills)
Incineration: 0.573 kg waste/kg THF
Recovery
0.368 kg waste/kg THF
Solvent
Heat Released
MJ/kg
Carbon content
kgC/kg solvent
Ethyl Acetate
12.1
0.64
Ethanol
13.85
0.52
Methanol
9.99
0.37
Toluene
23.15
0.91
THF
17.99
0.67
Acetic Acid
5.87
0.40
Hexane
23.66
0.84
Ether
17.89
0.65
IPA
15.70
0.60
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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A Life Cycle Analysis: THF
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Broaden our perspective from plant boundary to entire life cycle.
When we recover a solvent, emissions are being avoided because there is
no need to produce that kilogram of solvent.
We need to consider not only the production of THF itself, but all the
intermediaries required throughout the process, all the way back to the
original fossil extractive source.
We must consider the entire Chemical Tree.
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
11
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Life Cycle Analysis of THF
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Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Chemical Tree (LCA) THF
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The Difference in Carbon Dioxide generation between recovery and
incineration at the plant boundary is only 0.205 kg/kg solvent (0.5730.368)
However, 78 kg of carbon dioxide was generated in producing the 1
kg of THF.
This is a 380 times difference. (78 kg / 0.205 kg)
Considering a 200 to 1 Atom Economy leverage ratio, the impact of a
carbon tax will have a 15,600 to 1 leverage impact (78 * 200)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
13
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THF Life Cycle and Carbon Dioxide
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Modules
ModulesInstalled
Installedon
onSite
Site
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
14
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Case Study
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This is all fine, good and interesting but doesn’t
apply to me because we use an aqueous
process. Our solvents are all buffers.
Sure aqueous buffers are inexpensive and easily
neutralized and disposed of… ..BUT it is wasteful
and does have an environmental impact.
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
15
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SO WHAT? I’m a big molecule Bio Person
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Energy required to create the purified water (12-18 megohm)
Energy required to treat the waste water discharge.
Energy Required to create buffer components (acids, ionic compounds)
Carbon Dioxide generated in buffer component process.
** These maybe minor in comparison to organic solvents, but they
represent waste and environmental stress.
Let’s look at the sustainability costs and implications of aqueous buffers.
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Sustainability Issues of Aqueous Solvents
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Item
Unit
Energy
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Carbon Dioxide
High Purity Water
Liters
0.32 KWh/L
0.42 lbs/L
Waste Water
Liters
0.001 KWh/L
0.001 lbs/L
Acid / Bases
Kg
1.042 KWh/Kg
1.41 lbs/Kg
Ionic Buffers
Kg
0.843 KWh/Kg
1.22 lbs/Kg
Transportation
Kg/Mile
NA
0.0376 lbs/Kg-mile
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
17
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Life Cycle Analysis of Aqueous Buffers
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Avg Solvent Usage 40 liters/min
Avg Lines 4
Yearly Solvent Consumption: 4,800,000 liters
KWh consumed: 1,630,000 KWH
Electricity Cost: $ 146,480 ( at $0.09 KWH)
Carbon Dioxide Generation: 2,275 Tons
Carbon Tax: $ 63,706 (at current $ 28 per ton)
• Estimated Capital Investment: $ 250,000
• IRR (5 years): 79%
• Payback period: 1.25 years
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
18
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Solvent Sustainability: Avg BioPharma Plant
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Estimated Yearly
Savings: $ 570,000
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Total Solvent: 80 Liters
Total Time: 20 min.
Peak Area: (ZBTR): 2.0 min.
Potential Recoverable: 91%
ROI: 254%
Desired
Fraction
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
19
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Example:
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Column
Control System
Detector
Flow Switch Manifold
Sol. 1
Sol. 2
Sol. 3
Sol. 4
Waste
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Product
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Gradient Solvent Recovery
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Besides the atoms required in the process,
production relies on a unique support ecosystem. If the eco-system is threatened,
then the species is threatened (niche)
CIP / SIP / WFI / Clean Rooms
The FDA is constantly threatening the
pharma-manufacturing eco-system.
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
21
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Eco-System Resources
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The Case For Single Use and Disposables
Technology
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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POUNDS CARBON / BATCH
SIP
CIP
Transporting Plastic
Pumping Water & Wastewater
Steel Fab. Amortized per Batch
Polymerizing Plastic per Batch
Extruding Plastic
WFI Still
Cleanroom Energy
Incinerating Plastic
TOTAL
Single Use
%
0.0 0.0%
30.5 0.2%
148.5 0.8%
3.7 0.0%
2,970.7 16.6%
799.3 4.5%
499.6 2.8%
7,308.7 40.8%
132.1 0.7%
6,029.3 33.6%
17,922.4
Stainless
%
388.5 1.0%
1,988.0 4.9%
0.0 0.0%
28.7 0.1%
7,723.8 19.2%
0.0 0.0%
0.0 0.0%
29,828.8 74.3%
204.1 0.5%
0.0 0.0%
40,161.9
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Diff.
388.5
1,957.5
-148.5
25.0
4,753.1
-799.3
-499.6
22,520.1
72.0
-6,029.3
22,239.5
Courtesy Leveen & Monge, ISPE Tampa Conference, 02 March, 2009
55% reduction in carbon footprint
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
23
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Environmental Advantages of FlexFactory:
Carbon Footprint
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Biomanufacturing Revolution
1,000L Bioreactor
1982
1,000L Bioreactor
1994
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Xcellerex 2000L Single Use
Bioreactor
TODAY
Water consumption is reduced by nearly 85%
Total carbon footprint reduced by approximately 55%.
.
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
24
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POUNDS CARBON / BATCH
SIP
CIP
Transporting Plastic
Pumping Water & Wastewater
Steel Fab. Amortized per Batch
Polymerizing Plastic per Batch
Extruding Plastic
WFI Still
Cleanroom Energy
Incinerating Plastic
TOTAL
Single Use
%
0.0 0.0%
30.5 0.2%
148.5 0.8%
3.7 0.0%
2,970.7 16.6%
799.3 4.5%
499.6 2.8%
7,308.7 40.8%
132.1 0.7%
6,029.3 33.6%
17,922.4
Stainless
%
388.5 1.0%
1,988.0 4.9%
0.0 0.0%
28.7 0.1%
7,723.8 19.2%
0.0 0.0%
0.0 0.0%
29,828.8 74.3%
204.1 0.5%
0.0 0.0%
40,161.9
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Diff.
388.5
1,957.5
-148.5
25.0
4,753.1
-799.3
-499.6
22,520.1
72.0
-6,029.3
22,239.5
Courtesy Leveen & Monge, ISPE Tampa Conference, 02 March, 2009
We still generate a lot of waste:
Chromatography resins
Filtration
All must be decontaminated
Single use bags
and disposed of.
Gowning
Spent Media
Biomass
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
25
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Environmental Advantages of Single Use:
Carbon Footprint
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Recovering Hydrogen and Energy from Pharmaceutical Waste
Syngas Polishing System
Waste Feed System
Steam/CO2 System
Scrubber System
.d o
Waste
Syngas Preheater
Scrubbed Syngas
P
T
T
Carbon
Bed
T
FM
Demister
Mat
HEPA
Filter
P
Steam
In
T
Medwaste
Feed Screw
P
Spray
Tower
T
Steam/CO2
Reformer
T
T
Steam
In
T
Screw-Conveying Kiln
CO2
T
Chiller
T
P
Double Gate
Lockhopper
T
Product
Syngas
Vane
Vacuum
Pump
T O2
Variable-speed
Motor-drive
Pump
Caustic
Sterilzed
Solids
Receiver
Payback about 3 years.
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
26
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Steam Reforming-Hydrogen and Syngas Generator
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New biopharma plants are too expensive and capital is tied up too long
unproductively.
Solutions:
1. Single Use Disposables
2. Controlled Environment Modules
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Capital Efficiency
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Biomanufacturing Revolution
1,000L Bioreactor
1982
1,000L Bioreactor
1994
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Xcellerex 2000L Single Use
Bioreactor
TODAY
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Individual Unit Operation Clean Modules
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People are the biggest source of contamination. Keep them out of unit ops.
Gowning dramatically reduced
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Working with Controlled Environment Modules
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Plant Footprint:
Conventional vs. Xcellerex FlexFactory
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for 4 x 2000L lines, cell vial to purified API bulk
MEDIA
LOCKERS/
GOWNING
U.S.P.
BUFFER
EQUIP.
PREP
U.S.P.
LABS
LOCKERS/
GOWNING
FlexFactory™
PROCESSING
SUITE
C.I.P./
S.I.P.
OFFICES
D.S.P.
CLEAN
UTILITIES
WASH
LABS
D.S.P.
WAREHOUSE
PLANT
UTILITIES
OFFICES
WAREHOUSE
PLANT
UTILITIES
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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•
•
•
•
Capital Cost Reduced by 65%
Major investment delayed until product is ready.
Water consumption is reduced by nearly 85%
Gowning Costs decrease by 40%; Modular CEM architecture enables
independent operation of each unit process. Operators can move freely
up and down lines or across lines, without extra gowning and degowning.
• Increase in Sq Ft Efficiency---A single FlexFactory line can produce
multiple drugs — at the same time!
• Total carbon footprint reduced by approximately 55%.
• Final COGS reduced by 30% or more.
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Operating Benefits
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The ability to effectively change and to quickly take
advantage of new opportunities.
For Pharma this means:
Time to Market
&
Flexible Manufacturing
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Adaptability and Agility
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From
3-5 Years
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To
12-18 Months
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Time to Market is Everything
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*Pharma
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Modularization* –Past 20 Years
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What was built… process room
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Interlock
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What was designed… Cut-away Section
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Modular Process Solutions
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What was built… on the high seas
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5:30 PM Friday Night
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Modules Lifted on to Pad
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8:00 AM Monday
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Flexibility and Adaptability
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Standard Unit Ops, Single Use Technology and
Modular Construction Provides Improved Flexibility
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Seed reactor
(Wave System20 shown)
N-1 reactor
(Xcellerex XDR-200 shown)
Chromatography
Production reactor
(Xcellerex XDR-2000 shown)
0.2u Filtration
(BioFlash , GEAKTA-Ready) (Sartorius Sartopore shown)
Disposable centrifuge Depth filtration
(Centritech Cell I shown)
(Millipore POD shown)
Ultra-diafiltration
(GE Hollow Fiber shown)
Virus Filtration
Buffer/Media Prep
Buffer/Process Storage
(Pall DV20 shown)
(Xcellerex XDM-500 shown)
(Hyclone Labtainer shown)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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• Survival of the Fittest:
– Most Efficient Use of Resources
• Solvent Usage
• Single Use Technology
– Ability To Adapt
• Time to Market
• Standard Unit Ops
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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Sustainability Recap
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Thank You
And
Good Luck
For more information please contact:
David March
704-559-5348
damarch@ra.rockwell.com
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
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