ELECTRONIC SUPPLEMENTARY MATERIAL
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1.1
Methods
Goal and scope
The system boundaries for the +PLUSPAK™ and glass bottle are shown in Fig. S1.
1.2
Life cycle inventory analysis
Bottle materials supply chain
The +PLUSPAK bottle consists of a pharmaceutical-grade polypropylene vial, rubber stopper, and
polypropylene cap; the glass bottle consists of a glass vial, rubber stopper, and a crimp seal made of aluminum and
polypropylene (Fig. S2 and Table S1). +PLUSPAK contains only virgin materials. The glass bottle contains 1030 % glass cullet (with 20 % recycle content assumed as default for this analysis), all from internal rework at the
manufacturer thus ensuring full manufacturer control over the composition. The bottle components (vials, caps, and
either rubber stoppers or crimp seals) are manufactured by supply chain vendors in several countries. In the main
analysis, all the electricity usage is assumed to be European since most of the components are manufactured in
Europe. A sensitivity analysis considers the effect of bottle component manufacturing in China or the U.S.
The bottle components are then transported via a combination of truck and freight ship to three GE
Healthcare facilities for assembly and filling: Cork, Ireland; Shanghai, China; and Oslo, Norway (the Norway
facility currently only assembles glass bottles).
The burdens associated with the production of the scrap, rejected bottles, broken or frozen bottles, and
bottles to be recycled at end of life are included in the study, but their refurbishment is ignored in the main
comparative analysis as they are sent to an external recycler for reprocessing and the recycled materials used by
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another manufacturer. An alternate scenario is also considered in which recycling impacts are allocated using a
market-based approach (as described in the end-of-life section of this paper).
Assembly and filling
The glass vial bodies are depyrogenated (heat treated) prior to filling, whereas the +PLUSPAK vials do not
require this process step (although for ease of manufacturing the +PLUSPAK vials do pass through the
depyrogenation equipment but with the heat turned down to a minimum setting). The bottles are then filled with
contrast media, closed and sealed. Autoclaving is used as a final sterilization process for both bottle types.
Following a quality check, the bottles are labeled and packaged. The glass bottles are packaged in a double-walled
corrugated board box that includes dividers for additional protection; the +PLUSPAK bottles are packaged in singlewalled corrugated board boxes without dividers.
Transport and use
The bottles are distributed to different global markets including but not limited to the U.S., Europe, China,
India, and Korea where they are used and disposed of. The transport is via air freight, transoceanic freight, and road.
A detailed model was created based on the countries to which the product is shipped from each manufacturing
facility, the amounts shipped from each facility, and the transportation modes used. Air and transoceanic freight
distances were calculated for each transport leg. Domestic distribution distances via road transport within China
were based on a rounded average of 1000 km.
The shelf-life of contrast media is the same in both bottle types and both are stored at the same temperature.
Before administering the contrast media, the bottles are typically placed in an incubator to bring the contrast media
to body temperature prior to injection. Slightly more energy is needed for the glass bottle as it is heavier and has a
higher specific heat capacity. The study also accounts for the contrast media itself, including the additional contrast
media needed due to breakage and freezing of some bottles caused by cold weather during transport.
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Cut-off criteria
Cut-off criteria are often used in LCA practice for the selection of processes or flows to be included in the
system boundary. The processes or flows below these cut-offs or thresholds are excluded from the study. Several
criteria are used in LCA practice to decide which inputs are to be considered, including mass, energy, and
environmental relevance. In this study, every effort is made to include all the flows associated with the processes.
During the interpretation phase, processes or flows with less than 1 % contribution to the total environmental impact
– as calculated by the ReCiPe (H) impact assessment method (Goedkoop et al. 2009) – are considered negligible and
excluded from further study.
Excluded data
Typically in an LCA, some aspects are excluded due to redundancy or statistical insignificance. In this
study, the following aspects are excluded: (1) assembly and filling process that are the same for both +PLUSPAK
and glass bottles; (2) shrink wrap used to wrap multiple shipping containers (same for both); (3) pallets used to
move shrink wrapped boxes (same for both); (4) infrastructure of GE Healthcare manufacturing facility (same for
both); and (5) human activities such as driving to and from work.
Assumptions
The following assumptions are made: (1) the reference flows using a functional unit of 96 mL are one 100
mL bottle, two 50 mL bottles, one-half of a 200 mL bottle, and one-fifth of a 500 mL bottle; residual contrast media
left in the bottles after all doses are delivered is assumed to be thrown away; (2) GE Healthcare makes all bottle
sizes except the 500 mL glass bottle. The weights of secondary packaging and shipping container for the 500 mL
glass bottle are extrapolated based on the data for other glass bottle sizes. Distribution transport distances are
assumed to be the same as the 200 mL bottle.
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2
Results and discussion
Life cycle impact assessment
Table S2 shows the life cycle midpoint impacts for the comparison of the 100 mL polymer and glass
bottles.
End-of-life
The study results using the cut-off allocation method indicate that +PLUSPAK is environmentally
favorable compared to the glass bottle regardless of the end-of-life disposal method used for either bottle type (Table
4). Recycling is generally the least impactful disposal option for both +PLUSPAK and glass, and pre-shred,
autoclave and incineration is generally the most impactful disposal option for both bottle types.
The results are also evaluated using the market-based approach, in which the level of material utilization in
the market for the recycled materials determines how the environmental burdens and benefits of recycling are
calculated and distributed between the production systems. The current demand for recycled polypropylene is high
and the market is considered to be fully utilized (Block 2011; Resource Recycling 2012). The recycling of the
+PLUSPAK bottle is therefore modeled by crediting the system for the displaced virgin polypropylene. In the case
of the glass bottles, the current recycling rate in Europe is estimated at 68 % (CEE Packaging 2012; FEVE - The
European Container Glass Federation 2012). The model therefore includes a credit for displacing 68 % virgin glass,
and the remaining 32 % is assumed to be sent to municipal incineration (there is no energy recovery from glass).
Incineration of polypropylene and rubber using the market-based approach is modeled by crediting the
system for the recovered heat and electricity (ecoinvent Centre 2010). The incineration of the glass vial or the
aluminum crimp seal does not include any credit as there is no energy recovery.
The market-based results (Table 4) indicate that +PLUSPAK is environmentally favorable compared to the
glass bottle regardless of the end-of-life disposal method used for either bottle type. Recycling is generally the least
impactful disposal option for both +PLUSPAK and glass. Recycling of the bottles can be particularly beneficial if
there is a high demand for post-consumer polypropylene and glass. Pre-shred, autoclave and incineration is
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generally the most impactful disposal method for glass, whereas municipal treatment is generally the most-impactful
disposal method for +PLUSPAK using the market-based approach.
Fig. S3 shows the sensitivity of the model results to end-of-life disposal method for both the cut-off and
market-based allocation approaches. This comparison looks at the worst-case disposal treatments for +PLUSPAK
(pre-shred, autoclave and incineration for cut-off approach; municipal treatment for market-based approach) with
the best-case treatment for glass bottle (recycling for both cut-off and market-based approaches). The results of this
worst-best case comparison indicate that +PLUSPAK has lower life cycle impacts compared to the glass bottle in all
impact categories regardless of disposal method or allocation approach.
Sensitivity analyses
Bottle size: The study compares different bottle sizes on a functionally equivalent “per dose” basis – two 50
mL bottles, one 100 mL bottle, half of a 200 mL bottle, and one fifth of a 500 mL bottle. The +PLUSPAK bottle
outperforms the glass bottle for each bottle size (Fig. S4). The 500 mL bottle has the lowest impacts per dose and the
50 mL bottle has the highest impacts per dose for both bottle types. This can be attributed to the need for less bottle
material and packaging (per dose) for the larger bottle sizes.
Secondary packaging configuration: +PLUSPAK and glass bottles are packaged in various configurations
depending on the GE Healthcare facility they are shipped from and the markets they are shipped to (Table S3). For
both bottle types, multi-pack packaging configurations are considerably less impactful than single-pack
configurations since less packaging materials are required per functional dose (Table 3). When multi-pack secondary
packaging configurations are used, +PLUSPAK exhibits lower environmental impacts compared to the glass bottle
in all impact categories considered. The differences are less clear when single-pack secondary packaging
configurations are used (due to the much higher proportion of secondary packaging materials per functional dose).
Manufacturing electricity grid mix: The European electricity grid is used as default in the main analysis
since most of the bottle components are manufactured in Europe. Sensitivity analyses are conducted with the
Chinese and U.S. grids for the glass bottle and with the Chinese grid for +PLUSPAK (only manufactured in Europe
and China). The Chinese grid results in slightly higher impacts for most of the impact categories for both bottle
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types (Table S4). +PLUSPAK still exhibits lower impacts in all impact categories regardless of manufacturing
electricity grid mix.
Glass bottle recycled content: The glass bottle contains about 10-30 % cullet, which is less than the average
borosilicate glass. Although increasing the cullet beyond 10-30 % is not within the material specification for this
product, a more typical 60 % cullet content would reduce the energy required during the glass manufacturing
process, resulting in up to 20 % reduction in the impact of the glass bottle (Table S4). The comparison is still found
to be favorable for +PLUSPAK.
+PLUSPAK scrap rate: The glass bottle manufacturing process has a higher scrap rate than +PLUSPAK
bottle manufacturing based on data provided by bottle suppliers. Sensitivity to this parameter is evaluated by
comparing both bottle types using the highest reported scrap rate for the glass bottle (Table S4). +PLUSPAK has
lower environmental impacts compared to the glass bottle even with the higher scrap rate.
Mode of distribution transport: Sensitivity to air freight is examined by replacing all of the air transport
with ocean freight for both bottle types. This change can reduce impacts by up to 30 % for +PLUSPAK and up to
20 % for the glass bottle, but +PLUSPAK is still favorable compared to glass (Table S4).
Contrast media: Several different contrast media are used with +PLUSPAK and glass bottles for both X-ray
and MRI procedures. The type of contrast media has negligible impact on the study results, and the results for MRI
application (results not shown) are proportionally the same as for X-ray.
Choice of impact assessment method: Sensitivity of the comparison is tested by using the IMPACT 2002+
method. The results are favorable for +PLUSPAK in all but the carcinogens category, primarily due to aromatic
hydrocarbons in the industry average polypropylene data set. To further test this finding, the comparison is
conducted again using the USEtox method. The USEtox results do not coincide with the IMPACT 2002+ results,
but instead are in agreement with the findings of the ReCiPe method. It should be noted that the IMPACT 2002+
method is older than either ReCiPe or USEtox and that newer versions of the method use the USEtox
chararacterization factors for toxicity.
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Limitations
Note that a comparative life cycle assessment should not be the sole basis used to determine environmental
superiority or equivalence, as additional information may be necessary to overcome some of the inherent limitations
in the life cycle impact assessment. Even if a study has been critically reviewed, the impact assessment results are
relative expressions and do not predict impacts on category endpoints, threshold exceedance, or risks. It is further
recognized that there are other tools available for environmental assessment such as risk assessment, environmental
impact assessment, and others. Life cycle assessment was chosen as the best environmental tool to cover the goal
and scope of this product comparison. The ability of LCA to consider the entire life cycle of a product makes it an
attractive tool for the comparative assessment of potential environmental impacts.
References
Block
DG (2011) Recycled Resin Prices Still Rising in First Quarter. Available from
http://www.ptonline.com/articles/recycled-resin-prices-still-rising-in-first-quarter. Accessed May 1 2012
CEE Packaging (2012) No improvement in glass recycling. Available from http://ceepackaging.com/2012/05/02/noimprovement-in-glass-recycling/. Accessed May 1 2012
ecoinvent Centre (2010), ecoinvent data v2.2. ecoinvent reports No. 1-25, Swiss Centre for Life Cycle Inventories,
Dübendorf, available from: http://www.ecoinvent.org
FEVE - The European Container Glass Federation (2012) Good practices in collection and closed-loop glass
recycling in Europe. Available from http://www.feve.org/images/stories/pdf2012/goodpractices-collectionclosed-loop%20glass%20recycling%20in%20europe%20-%20report.pdf. Accessed May 1 2012
Goedkoop M, Heijungs R, Huijbregts M, De Schryver A, Struijs J, van Zelm R, (2009) ReCiPe 2008: A life cycle
impact assessment method which comprises harmonised category indicators at the midpoint and the
endpoint level, VROM–Ruimte en Milieu, Ministerie van Volkshuisvesting, Ruimtelijke Ordening en
Milieubeheer. Available from http://www.lcia-recipe.net.
Resource Recycling (2012) PetroChem Wire: Recycled polypropylene prices rise in March. Available from
http://resource-recycling.com/node/2629. Accessed May 1 2012
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Table S1 Component materials and weights of +PLUSPAK and glass bottles
+PLUSPAK
Bottle component
Vial
Cap
Stopper
Bottle size
50 mL
100 mL
200 mL
500 mL
-
Weight (grams)
11.9
16.3
26.1
44.1
4.8
3.7
Material
Comment
Polypropylene
Polypropylene
Synthetic rubber
Same for all sizes
Same for all sizes
Material
Comment
Glass bottle
Bottle component
Vial
Crimp seal
Bottle size
50 mL
100 mL
200 mL
500 mL
Weight (grams)
55
95
170
290
-
3
Type 1 glass
(10-30 % cullet)
52 % Aluminum;
48 % Polypropylene
Synthetic rubbers
Stopper
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Source = GE Healthcare and suppliers
Type 1 glass is a borosilicate glass commonly used in pharmaceutical products
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Same for all sizes
Same for all sizes
Table S2 Comparison of +PLUSPAK and glass bottle (100 mL bottle, X-ray contrast media)
Glass bottle
+PLUSPAK
+PLUSPAK impact vs.
glass bottle
0.401
0.185
46 %
kg CFC-11eq
4.31E-8
1.24E-8
29 %
Human toxicitya
kg 1,4-DBeq
0.111
0.041
37 %
Photochemical oxidant
formationa
kg NMVOC
1.70E-3
6.29E-4
37 %
Particulate matter formationa
kg PM10eq
8.07E-4
1.93E-4
24 %
Ionizing radiationa
kg U235eq
0.072
0.031
43 %
Ecosystemsb
species.yr
5.28E-9
2.07E-9
39 %
Resourcesb
economic unit
2.11
1.24
59 %
Cumulative energy demand
MJ
7.05
3.90
55 %
Impact category
Unit
Climate changea
kg CO2eq
Ozone depletiona
a
b
ReCiPe Midpoint (H)
ReCiPe Endpoint (H/A)
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Table S3 Packaging configurations for +PLUSPAK and glass bottles shipped from Shanghai, China and Cork, Ireland to Rest of World (ROW) and to U.S.
Bottle
size
Secondary
package
Weight
(gram)
Shipping
container
Weight
(gram)
Comment
+PLUSPAK
100 mL
10 x 100 mL
104
6 x 10 x 100 mL
377
Multi-pack, from Shanghai to ROW (default)
100 mL
10 x 100 mL
82
-
-
Multi-pack, from Shanghai to US (no shipping container)
100 mL
10 x 100 mL
98
-
-
Multi-pack, from Cork to US (no shipping container)
100 mL
1 x 100 mL
14
1 x 1 x 100 mL
339
Single-pack, from Shanghai to ROW
100 mL
1 x 100 mL
12
1 x 1 x 100 mL
460
Single-pack, from Cork to ROW
Glass bottle
100 mL
10 x 100 mL
323
6 x 10 x 100 mL
495
Multi-pack, from Shanghai to ROW (default)
100 mL
10 x 100 mL
448
-
-
Multi-pack, from Shanghai to US (no shipping container)
100 mL
10 x 100 mL
233
-
-
Multi-pack, from Cork to US (no shipping container)
100 mL
1 x 100 mL
18
1 x 1 x 100 mL
428
Single-pack, from Shanghai to ROW
100 mL
1 x 100 mL
20
1 x 1 x 100 mL
433
Single-pack, from Cork to ROW
Source: GE Healthcare
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Table S4 Sensitivity analysis results, shown as percent of impact in each impact category relative to the default glass 100 mL bottle (defaults: EU grid mix;
20% cullet; mix of air and ocean for distribution transport).
Climate
change
Ozone
depletion
Human
toxicity
Photochemical
oxidant
Particulate
matter
Ionizing
radiation
Ecosystems
Resources
CED
100 %
100 %
100 %
100 %
100 %
100 %
100 %
100 %
100 %
Glass - EU (default)
100 %
100 %
100 %
100 %
100 %
100 %
100 %
100 %
100 %
Glass – US
103 %
99 %
98 %
103 %
104 %
85 %
102 %
103 %
101 %
Glass – China
109 %
98 %
93 %
111 %
117 %
71 %
106 %
104 %
100 %
+PLUSPAK - EU (default)
46 %
29 %
37 %
37 %
24 %
43 %
39 %
59 %
55 %
+PLUSPAK – China
47 %
29 %
36 %
38 %
26 %
39 %
40 %
59 %
55 %
Glass – 10 % cullet
103 %
103 %
104 %
103 %
105 %
104 %
102 %
104 %
103 %
Glass – 20 % cullet (default)
100 %
100 %
100 %
100 %
100 %
100 %
100 %
100 %
100 %
Glass – 30 % cullet
97 %
97 %
96 %
97 %
95 %
96 %
98 %
96 %
97 %
Glass – 60 % cullet
89 %
88 %
85 %
88 %
82 %
86 %
90 %
87 %
87 %
+PLUSPAK – 5 % scrap (default)
46 %
29 %
37 %
37 %
24 %
43 %
39 %
59 %
55 %
+PLUSPAK – 50 % scrap
54 %
30 %
43 %
43 %
28 %
52 %
45 %
73 %
69 %
Glass - mix of air and ocean (default)
100 %
100 %
100 %
100 %
100 %
100 %
100 %
100 %
100 %
Glass - air replaced with ocean
83 %
80 %
98 %
80 %
89 %
97 %
89 %
82 %
86 %
+PLUSPAK - mix of air and ocean (default)
46 %
29 %
37 %
37 %
24 %
43 %
39 %
59 %
55 %
+PLUSPAK - air replaced with ocean
38 %
19 %
36 %
28 %
19 %
41 %
34 %
50 %
49 %
Glass 100 mL bottle (default)
Electricity grid mix:
Glass recycle content:
+PLUSPAK scrap rate:
Distribution transport:
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Figure captions
Fig. S1 System boundaries for +PLUSPAK and glass bottle life cycle assessment
Fig. S2 A: 100 mL glass bottle (left) and +PLUSPAK polymer bottle (right); B: rubber stoppers for glass bottle (left) and
for +PLUSPAK polymer bottle (right); C: aluminium and polypropylene crimp seal for glass bottle; D: polypropylene cap
for +PLUSPAK bottle
Fig. S3 Sensitivity of the comparison to end-of-life treatment using cut-off and market-based allocation methods. Results
are full product life cycle for the default 100 mL +PLUSPAK or glass bottle for X-ray contrast media. The cut-off
allocation results compare the best-case treatment for glass (recycling) with the worst-case treatment for +PLUSPAK
(preshred, autoclaving, and incineration). The market-based allocation results compare the best-case treatment for glass
(recycling) with the worst-case treatment for +PLUSPAK (municipal waste)
Fig. S4 Life cycle results for different bottle sizes (50 mL, 100 mL, 200 mL, 500 mL). Results are normalized relative to
the 50 mL glass bottle (100 %)
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