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Borealis and Borouge are leading Borealis is owned 64% by the Borouge is a joint venture established
providers of innovative, value creating International Petroleum Investment in 1998 between Borealis and the
plastics solutions. With more than 40 Company [IPIC] of Abu Dhabi and Abu Dhabi National Oil Company
years of experience in polyolefins and 36% by OMV, Central Europe’s [ADNOC], one of the world’s leading
using our unique Borstar technology,
®
leading oil and natural gas group. oil companies. Headquartered in Abu
we focus on the infrastructure, With EUR 6.6 billion revenue in sales Dhabi, the United Arab Emirates,
automotive and advanced packaging in 2008 and 5,400 employees, the its state-of-the-art, world-scale
markets across Europe, the Middle company is headquartered in Vienna petrochemical complex is located
East and Asia. Our production facilities, and has manufacturing operations in at Ruwais, where it is currently
innovation centres and service centres Austria, Belgium, Finland, Germany implementing a multi-billion-dollar
work with customers in more than and Sweden. It also has special, expansion.The project, called
170 countries to provide materials compounding units in Brazil, Italy and Borouge 2, is due for completion in
that make an essential contribution to the United States. 2010 and will triple the company’s
society and sustainable development. The company’s main products are polyolefin production capacity.
We are committed to the principles polyolefins and base chemicals.
of Responsible Care and to leading
®
Polyolefins are the collective name for For more information:
the way in ‘Shaping the Future with polyethylene and polypropylene. Base www.borealisgroup.com
Plastics’™. chemicals comprise feedstocks and www.borouge.com
olefins, phenol and aromatics as well
as melamine and plant nutrients.
Contents
04 Because we care
14 Market segmentation
50 Glossary
4 www.borealisgroup.com I www.borouge.com
Because we care
Climate change – to limit CO2 emissions Access to water and sanitation – more Energy access – boosted by
and keep global warming under control. than 1 billion people have no access to diversification of supply, development
fresh water, and due to climate change, of renewable resources and security/
Over the past 30 years, Borealis and Borouge have established market-leading
positions in the healthcare industry throughout Europe, the Middle East and Asia
and are committed to customer success through innovation and sustainable
technological developments. Through advanced processing developments such
We have more than 30 years of as Borstar ®, Borealis and Borouge continue to enhance the solutions capability of
their comprehensive polypropylene [PP] and polyethylene [PE] product portfolio.
experience proving cuttingedge
plastics solutions to the Our mission is to be the leading provider of innovative, value creating plastics
solutions. Therefore, we will continue along our chosen path of ‘Value Creation
healthcare industry, recently
through Innovation’. For us, plastics are not a commodity. We believe that by
including materials from our understanding and working with partners throughout the value chain, we can
innovative Borstar technology.
®
develop innovative, sustainable solutions that meet our customers’ needs.
5
Communication – to extend, secure and Healthcare – provide access and an Food – to protect and deliver safe food
strengthen communication networks acceptable level of healthcare for a from “farm to fork” across regions.
that are critical to our modern economy growing and aging global population.
For each of these challenges, Borealis and Borouge deliver customised solutions
We offer
differentiated
products
and are
committed
to innovation
7
Why is the
healthcare market
unique?
9.2 bn
7.5 bn
6.0 bn
1.6 bn
Pharmaceutical packaging The healthcare sector will continue to grow. The developed countries of Western
is expected to grow more Europe, the United States and Japan continue to account for more than 70%
of the demand, although developing countries led by China will provide the
than 5% annually worldwide,
strongest growth opportunities. In developing countries, population and gross
with the biggest share in domestic product [GDP] growth, accessibility to medical products and services
the Asian countries. along with government policies that are driving healthcare expenditures will all
contribute to a boost in healthcare spending.
demographics:
elderly persons
mainly due to shifting flexible, depending on the country and the application. In most developed
countries, the approval processes have to ensure that devices, containers,
demographics and lifestyles.
closures, labels, tubing and other accessories comply with regulatory standards
and norms. Regulation for healthcare products has intensified in recent years
and will continue to do so in emerging markets. To fulfill regulatory requirements,
Regulatory requirements for healthcare products made from polymers must be composed of raw materials
that assure the stability of the internal contents and protect the content against
healthcare products ensure
potentially adverse elements such as air, moisture, impact and temperature.
the safety of the end user.
They should not be sensitive to degradation nor interact with its content during
the entire shelf life. Size, shape and design must provide ease of use, safety,
tamper evidence and child resistance. Once a healthcare product is registered,
Regulations will continue
no change in its construction or composition is permitted without documenting
to intensify, especially in the change, evaluating its effect on the total product safety and informing the
the emerging markets. relevant authorities.
11
35
Aging 60 +
30
increasingly
age 60 and over
% of population
25 important
20
15
10
2000
5
2050
0
Africa Asia Europe
The need for global supply will intensify the regulatory environment in the
developing countries very quickly to match or even exceed the already strict
regulations found in Western Europe, the United States and Japan. These
demanding requirements impose superior quality and traceability standards on all
of the raw materials used in the end product.
Bormed offers
peace of mind
Bormed includes both polyethylene and polypropylene grades for rigid and
flexible products, ensuring a consistent approach to the medical and healthcare
market, independent of conversion technology or polymer type.
The broad Bormed grade range meets the technical requirements of a wide
variety of end-uses, including packaging of parenteral, ophthalmic and enteral
solutions, medical devices as well as pharmaceutical and diagnostic products.
Besides its superior technical performance, the Bormed product range meets
the challenging service requirements of the healthcare industry.
Our high-quality materials are
designed to meet the strict We are committed to producing polypropylene and polyethylene of the highest
requirements of our customers. quality and meeting the strict requirements of our customers.
14 www.borealisgroup.com I www.borouge.com
Market
segmentation
From a global polyolefin perspective, the healthcare market remains
a small niche segment despite above-average growth expectations.
The long term commitment, security of supply, extended traceability,
applying higher quality standards and production support, skilled and
experienced technical services, and strong innovation capabilities
are resulting in a dedicated range of materials for healthcare
applications. In times of globalisation, only a few polymer suppliers
are willing to meet the demanding needs of this industry.
15
• Medical devices
Several polymer types are used for various healthcare and medical products,
depending on the required features. Polypropylene [PP] accounts for 16% and
polyethylene [PE] for 50% of the total use of plastics for medical applications
[Fig. 4].
Other: 5% Other: 5%
Alu: 12%
PS: 8%
PVC: 8%
Figure 3: Healthcare market by material type Figure 4: Healthcare market by plastic type
18 www.borealisgroup.com I www.borouge.com
Polyolefins provide many The consumption of plastics for these medical markets is steadily increasing
advantages over competing and is mainly driven by substitution of other materials and overall growth
of healthcare products. The use of polyolefins for healthcare applications is
materials, including versatility,
expected to grow by more than 5% per year in the coming years.
ease of processing, sterilisability
and cost competitiveness. The use of polyolefins is increasing proportionally more than competing materials due to
• Chemical inertness
• Sterilisability
• Cost competitiveness
In a globalised economy, only • Higher dimensional stability • Good low temperature impact
The healthcare market can be divided into the following market segments:
Pharmaceutical and
diagnostics packaging Medical devices
Blister Inhalers
Sachets Catheters
Small
bottles
and caps
20 www.borealisgroup.com I www.borouge.com
Complete
solutions for a
variety of
applications
Polyolefins are able to meet the special requirements of the healthcare industry:
• Environmentally friendly
Depending on what is packed [solids, liquids or sterile liquids] and the requirements of
• Injection blow moulding [IBM], delivering high accuracy of the neck finish for
optimal closing
to the bottle
* ISBM is only used for PP, however this can be done in one machine or by doing the stretching and blow moulding
using cold pre-forms, which need to be pre-conditioned.
23
Our innovative solutions for Liquid products require final sterilisation by steam, and the choice of material
bottles and ampoules offer is as essential as the conversion technique used. However, it is also important
to define other properties such as transparency, inertness and softness [easy
weight reduction and higher
emptying or dosing] as this will determine the choice of the material to be used.
sterilisation temperature.
LE6609-PH
• Primary bag
• Valves
• Tubing
• Secondary overwrap
Flexible PO based films can be used for fluid bags in several end-applications:
Strengths Capability to collapse Transparency Simple production Longer shelf life for
allows airless process [few production oxygen sensitive
withdrawal steps and high degree products [amino acids,
of automation] fat solutions]
Weaknesses Many and cost intensive Use of plasticizers Lower transparency Heavy weight
production and [traditionally phthalates]
assembly steps
Energy intensive
production
High transportation
costs
26 www.borealisgroup.com I www.borouge.com
Overwrap
Configuration
• Easy peel
• sterilisation resistance
• O2 barrier
REQUIREMENTS
• Heat resistant outside layer like
PP homopolymer
• Soft PP
• Inside = peelable PP
IV bag
Configuration
• Softness
• seal toughness
• sterilisation resistance
REQUIREMENTS
• Heat resistant outside layer like PP
homopolymer
• Soft PP
• Inside = peelable PP
• High dimensional
• Easy to process
• Good stiffness
Tubing
• Softness
• Sterilisation resistance
• Kink resistance
• Coil resistance
• No sticking to overwrap
27
Puncture and tear resistance, • Resistance to damage [avoiding leakage in order to provide low scrap rates]
transparency, safe and easy - High mechanical strength [contents up to 1 litre]
handling and cost efficiency are - Good seal toughness and strong seals with port systems
• Film flexibility enables ability to collapse during use [avoiding venting during
• Cost efficiency
Borealis is focusing on Barrier protection against moisture [to protect during steam sterilisation process]
or oxygen [to protect oxygen sensitive ingredients] is provided by the primary
developing the next generation
package or the secondary overwrap.
of sterilisable and transparent
soft polypropylene for flexible The tubing needs to be flexible, sterilisable without becoming sticky or brittle and
bags enabling the development needs to provide resistance to kinking and coil recovery.
Polyolefins are an extremely The low density and the high water barrier properties of polypropylene
good moisture barrier as allow thickness reductions while maintaining the same performance level,
which makes PP a cost efficient alternative to other polymers in a number of
compared to other polymers.
applications.
1500 2800
PVC 1.40 2.40
1300 3000
PS 1.05 14
2200 – 2400
PET 1.34 6.8
Polyolefins
Blister packaging
Blister packs have been used for many years. They consist of a thermoformed
semi-rigid plastic base with multiple “blisters“ to contain individual pills [forming
web]. This is sealed to a lidding foil [top web].
The forming web protects the product against moisture, gas, oxygen and
provides long shelf life and high efficiency packaging. The lidding foil is typically
coated with a heat seal layer and may involve paper, aluminium or polymer
materials to provide additional functionality such as child resistance or tear
resistance.
Key requirements for forming webs are superior clarity, chemical resistance,
thermoformability, rigidity, dimensional stability and sealability to a wide range of
lidding materials.
120
HE2581-PH
Unimodal PE 110
100
Bar
90
80
HE2581-PH
70
Unimodal PE
60
0 200 400 35 40 45
Hours Weight of bottle [g]
80
HE7541-PH
Unimodal PE
60
cm
40
20
HE7541-PH
Unimodal PE
0
0 20 40 60 80 300 500 700
Hours Bar
Figure 7: ESCR – Bell test – F50 Figure 8: Spiral flow 2mm thick – 230 ˚C
The use of bottles and caps to pack solid medicines is in competition with blister
packages. Both have their advantages and disadvantages, and it also depends on
the habits in the different countries. For pills, tablets and powders, which need
to be taken in larger quantities, it is obvious that a bottle with a cap can bring
an easier solution. These bottles and closures are mainly produced with HDPE,
which today offers new possibilities by using the latest technology.
Actual bimodal polymerisation processes are able to shape the molecular weight
distribution [MWD] of a polyolefin, which provides material advantages in
processing as well as in properties resulting in higher security as well as energy
and weight savings.
Applications Applications
• Bottles for diagnostics and • Containers and closures for
pharmaceuticals diagnostics and pharmaceuticals
• Containers up to 10 l
Increased security
Improved profitability
Full compliance with EP 3.1.3 and 3.1.5
34 www.borealisgroup.com I www.borouge.com
Medical devices
The disposable syringe was one of the first and is still today one of
the most used medical devices made from polypropylene. The risk of
contamination by infectious diseases due to insufficient cleaning or
sterilisation made it necessary to produce disposable medical devices.
1600
Stiffness/Softness: Flexural Modulus [MPa]
1400
1200
1000
800
600
400
200
0
-50 -30 -10 10 30 50 70 90 110 130 150
Temperature Utilization Range [°C]
Figure 9: Stiffness/Softness
35
The versatile properties of polypropylene and polyethylene along with their cost
competitiveness and easy shaping during conversion make them the first choice
in applications such as catheters, needle hubs, needle protectors, inhalers, filter
housings, artificial kidneys and blood collection systems.
More and more, polyolefins are The right choice of material is essential to secure the device and its content,
the material of choice for cost thereby safeguarding the life of the patient. Patients carry their devices
everywhere and normally, the medical devices are used at warm temperatures,
competitive, chemically inert,
however transport and assembly of the devices can be made at lower
high-quality, versatile solutions for temperatures. Therefore, temperature band is especially crucial for the material
medical diagnostic applications. choice.
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Innovation
supports
business growth
Recent investments in our world-class Innovation Headquarters in Linz,
Austria, will enable us to better serve our international customer base.
37
38 www.borealisgroup.com I www.borouge.com
We win
through
commitment
and
innovation
Borealis is a leading provider of unique polymer and application solutions to the
flexible and rigid packaging industry. The company´s mission is to be THE leading
provider of innovative, value creating plastics solutions. This commitment is
based upon three key cornerstones:
Bormed solutions
for the healthcare
industry
Bormed products meet a variety of application needs.
41
42 www.borealisgroup.com I www.borouge.com
PP random
PP homo- PP random PP heterophasic
Property Unit heterophasic
polymers copolymers copolymers
copolymers
E-Modulus
MPa
DIN 53357
Mechanics
Haze
%
ASTM D1003
Optics
Gloss
–
DIN 67530
80 – 100 100 – 125 10 – 30 15 – 80
Temperature
OtHEr PrOPErtIEs
°C
Utilization range
4°C – 142°C -8°C – 130°C -25°C – 135°C -35°C – 130°C
produced using Borstar® and optical performance, sealability and sterilisation resistance. Bormed RE806CF
is a medium ethylene random copolymer without slip or anti-blocking agents.
Siriustm catalysts, providing
In comparison to other random copolymer grades, Bormed RE806CF offers
superior purity with low an exceptional combination of heat resistance, sterilisability, optical properties,
volatiles and extractables. sealability and excellent transparency.
43
Processability Mechanical
Bimodal lubricant strength
Conventional tie molecules
1 2 3 4 5
Fraction [%]
Figure 11: BiModality illustration – combination of processing efficiency [more film in less time] and mechanical
FB 8230
2.5mm
LDPE 0.3
LDPE 1.0
LDPE 2.0
LDPE 4.0
LLPE
LPDE/LLDPE blends
0 25 50 75 100
[µm] Film thickness
3% EBA
7% EBA
FB8230
40 µm FB8230
Films with superior mechanical performance and high seal strength can be
achieved. Superior film stiffness, strength, tear resistance and impact strength
can be obtained versus commercial LLDPEs and LDPE.
Processability
Tensile MD tear
strength
Stiffness TD tear
Bormed TM FB8230
BormedTM FB8230 offers LDPE
C4LLDPE
excellent toughness, seal
strength and puncture Figure 14: Unique combination of process efficiency and film performance
Today, steam sterilisation, gas treatment [mainly with EtO] and radiation are
the most common used methods for sterilisation of disposables and devices.
It is important to know in advance which sterilisation method will be used when
developing a new device or package as this will highly influence the material
choice.
LDPE L J J
HDPE L J J
PP J J L
Sterilisation by radiation, either by using a radioactive source or via electron
acceleration, has become one of the leading sterilisation techniques for
disposables. However, radiation can have a drastic influence on the material
properties. In the case of low and high density polyethylene we see very
little change in the properties even when materials are radiated up to 50 kGy.
However, a low dose of radiation on polypropylene will cause degradation –
highly reactive radicals will be formed which can be active for a very long period
resulting in a material which becomes very brittle and a device or package which
cannot be used at the moment it is needed.
When the product is made from PP and it is sterilised by radiation, then radiation
stable PP needs to be chosen. Normal PPs will degrade and eventually discolour,
though this may not happen immediately. However depending on storage
condition and time, the material will become too brittle resulting in a failing
product.
Borealis has been offering materials which resist radiation for many years.
Bormed HD810MO has been used by our customers for more than 15 years,
while Bormed RF830MO is a more recent development. Both materials have
been tested internally and comparisons have been made between radiated and
non-radiated specimens either by accelerated aging for several months or by
aging at room temperature for a period of 5 years [see Figure 17].
47
10
Radiation PP
8 Standard PP
kJ/m2
4
0
Non-Irr. 1 3 5 7 9
Figure 15: Charpy impact strength notched at 23°C – Accelerated ageing at 80°C
16,0
15,0
14,0
13,0
12,0
11,0
10,0
9,0
8,0
7,0
6,0
0 1 2 3 4 5 7 9 11 15 18 21 23 25
Weeks
10
0 kGy
9
38 kGy
6
kJ/m2
0
0 1 2 3 4 5 6 8 11 16 18 21 24 27 30 33 42 48 54 60
Month
Steam sterilisation has no influence on the material but it can influence the
dimensional stability of the final product. During steam sterilisation care needs
to be taken even with final products made from polypropylene. Apart from the
material also the shape of the product, the speed in heating up and cooling down
the autoclave, the internal and external tension on the product, how the final
products are loaded/standing in the autoclave will as well determine if the final
product will keep its dimensional stability. The melting temperature and even
better the crystallisation temperature of the material are a strong indication if the
dimensional stability can be kept during the steam sterilisation.
Tm* Tc*
• Higher stiffness
• Better transparency
0 XX XX
Glossary
Monograph 3.2.2 – Polyolefins for • 3.1.5 = for HDPE containers IBM: Injection blow moulding
pharmaceutical packaging and closures for preparations
ISBM: Injection stretch blow moulding
for parenteral and ophthalmic
• Very little descriptive
use MWD : Molecular weight distribution
• Refers to food-contact
• 3.1.6 = for PP containers and Ophthalmic: Medicine that is
regulations
closures for preparations for administered via the eye
• Does not recommend anti- parenteral and ophthalmic use
Parenteral/IV solutions: Medicine
static
that is administered by using other
• Of little value – most materials means than the gastrointestinal tract,
BFS: Blow, fill and seal process
comply to it meaning by injection or infusion. This
BNT: Borealis Nucleation Technology can be intravenous, intramuscular,
subcutaneous or transdermal [under or
DMF: Drug Master File
Monograph 3.1.3 – Polyolefins through the skin], peritoneal [dialysis]
for parenteral and ophthalmic EBM: Extrusion blow moulding
QC: Quality control
solutions
Enteral: Drug/medicine that is
USP: US Pharmacopeia
• Includes PE and PP administered by using any part of the
gastrointestinal tract, meaning orally
• Specific on chemical analyses
[tablets, capsules, drops], gastric
and additives
feeding tube, inhalation, etc
• Most used in pharmaceutical
EP: European Pharmacopeia
world
ESCR: Environmental stress crack
resistance
Specific monographs for LDPE,
EtO: Ethylene oxide
PP and HDPE
EVOH: Ethylene-vinyl alcohol
• 3.1.4 = for LDPE containers and
copolymer
closures for preparations for
parenteral and ophthalmic use HDT: Heat deflection temperature
51