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Bormed

offers peace of mind – solutions for healthcare


About Borealis and Borouge

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

08 Why is the healthcare market unique?

12 Bormed offers peace of mind

14 Market segmentation

20 Complete solutions for a variety of applications

36 Innovation supports business growth

40 Bormed solutions for the healthcare industry

50 Glossary
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Because we care

Climate Water Energy

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/

up to 3 billion people may live in water interconnection requirements for

scarce regions within the next 20 years. existing networks.

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

Providing access to adequate healthcare for the world’s rapidly growing


and aging population is one of the major global challenges today.

We are addressing the healthcare challenge by delivering convenient


and affordable medical materials to healthcare providers.

Communication Health Food

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.

and quality of life.

For each of these challenges, Borealis and Borouge deliver customised solutions

which lead to:

• CO2 emissions cut across the value chain

• Access to fresh water and sanitation

• Secure energy supply – from power and gas networks to pipelines

• Wired or wireless and broadband communications


We believe that ‘Value • Enhanced food preservation and delivery
Creation through Innovation’ • Safer, more convenient and affordable medical devices for the healthcare sector
is the path to success.
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We offer
differentiated
products
and are
committed
to innovation
7

“With the high-class Bormed product range, we offer our customers


a long-term commitment and stability with the continuous development
of customer-oriented solutions for the global markets.”
Mark Garrett,
Chief Executive, Borealis

“Bormed dedicated polyolefins are answering the needs of our


customers for security of supply, product consistency and quality,
compliance with international norms, superior level of service and
innovation.”
Lorenzo Delorenzi,
Executive Vice President Polyolefins, Borealis
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Why is the
healthcare market
unique?
9.2 bn

7.5 bn

6.0 bn

1.6 bn

1900 2000 2020 2050

Figure 1: World population growth 1900 – 2050


9
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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.

The demand for pharmaceutical packaging is boosted by changes in global

demographics:

• The global population will continue to expand

• The world population is aging, with an increasing percentage of middle-age and

elderly persons

• A continuous increase in allergies and lifestyle-linked diseases

• An increasing awareness of the signs of disease

• Increasing world health expenditures

In mature markets, growth of plastics in healthcare will predominantly be led


by advances in raw materials. These improvements will provide better cost
efficiencies, improved aesthetics, barrier protection, security, ease of use and
compliance features.
Demand for healthcare
products is increasing Globally, pharmaceutical/medical regulations range from very stringent to more

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

Figure 2: Percentage of population age 60 and over

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 dedicated polyolefins for the healthcare industry respond to


Our BormedTM polyolefins challenging needs by providing the security, functionality and traceability
meet regulations. features required by this very specialized market.
12 www.borealisgroup.com I www.borouge.com

Bormed offers
peace of mind

Dedicated materials Additional support


• Broad grade range • Regular updates
• Regulatory compliance [EP and USP compliance]
[EP and USP] • Regular updates DMF files
• US DMF registered • Long-term traceability
• Special production and quality control [QC] [QC data and retained sample]
precautions to provide superior product • Extended technical support
consistency, high quality and purity • Extensive application experience

Security of supply Innovation


• Long-term commitment • Solutions provider
• Prenotification before deletion • Strong company commitment
or modification • Pilot capabilities
• Prioritisation in planning • Use of the latest proprietary technologies
• Higher stock levels • Partnership with value chain
• Global supply
13

To meet the challenging needs of healthcare products, Borealis offers a


dedicated range of Bormed polyolefin products.

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.
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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

The use of polyolefins for healthcare applications is


expected to grow by more than 5% per year in the future.
This is due to substitution of other materials [i.e. glass,
aluminium] and the overall growth of healthcare products.
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In order to meet the needs and requirements of the healthcare market, we


must understand the different applications and their functionality as well as the
respective trends and drivers.

The healthcare market can be segmented into:

• Pharmaceutical and diagnostic packaging

• Medical devices

From a regulatory requirement perspective, the pharmaceutical and diagnostic


packaging market can be divided into primary packaging that is in direct contact
with the active substance and includes blister packs, fluid bags, pouches, bottles,
vials and ampoules. Secondary packaging includes every part of the total concept
or medical device that is not in direct contact with the packed drug or fluid [e.g.
an overwrap].

At present, primary packaging products are subject to stricter regulations than


secondary packaging.

However, components of the secondary packaging can migrate through the


primary material into the packed medicine. It is known that the secondary
packaging can have a negative influence on the quality and stability of the
total system, and therefore it can be expected that regulations for secondary
packaging will also become more demanding in terms of validation,
documentation and traceability.
17

Each of these end-uses has specific and demanding functionality requirements,


which implies the use of a wide variety of materials such as glass, metal, paper
and polymers [Fig. 3].

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%

Glass: 8% PET: 13%

Alu: 12%
PS: 8%

PVC: 8%

Paper: 20% Plastics: 55% PP: 16% PE: 50%

Figure 3: Healthcare market by material type Figure 4: Healthcare market by plastic type
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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

its many advantages:

• Chemical inertness

• Versatility, broad property window

• Advanced quality and design possibilities

• Easy processability by multiple converting technologies

• Sterilisability

• Cost competitiveness

• Free of solvents and softeners

PP and PE each have their own specific property benefits.

The healthcare industry Polypropylene Polyethylene


remains a niche market despite • Lowest density • Easier to sterilise with radiation

significant growth expectations. • Higher transparency • Lower friction

In a globalised economy, only • Higher dimensional stability • Good low temperature impact

a selected, dedicated group • Steam sterilisability at 121°C strength

of suppliers is willing to meet • High stiffness • High variety in stiffness


(depending on density)
the demanding requirements
• Very high purity in LDPE
of this worldwide industry.
19

The healthcare market can be divided into the following market segments:

Pharmaceutical and
diagnostics packaging Medical devices

Bottles and Single-use Secondary


ampoules syringes overwrap

Fluid bags Pen injector Peelable


for pouch
parenteral
and enteral
solutions

Packaging Filters for Film


powder, artificial laminated
kidneys against
tablets and
medical
pills paper or PO
nonwovens

Blister Inhalers

Sachets Catheters

Small
bottles
and caps
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Complete
solutions for a
variety of
applications

Our polypropylene and polyethylene grades are used to


produce a wide range of products with superior technical
properties. These high-quality products are designed
to meet our customers’ strictest requirements.
21
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Pharmaceutical and diagnostic packaging

Bottles and ampoules


For pharmaceutical and diagnostic products, bottles and ampoules are commonly
used to pack, transport, distribute and administer solid and liquid preparations.
Glass is still a very popular material because of its inertness and good barrier
to the environment. However its weight and brittleness are disadvantages and
pose a risk to medical personnel or end-users during handling, transport or
administration. Polymers have also proven to be advantageous in the production
of bottles and ampoules and have gradually taken market share from traditional
materials.

Polyolefins are able to meet the special requirements of the healthcare industry:

• Easy to shape into different forms

• Very high barrier against water and water vapour

• High chemical inertness

• Low density, resulting in lower packaging weight

• Environmentally friendly

Depending on what is packed [solids, liquids or sterile liquids] and the requirements of

the content, polyolefin bottles can be produced using different techniques:

• Extrusion blow moulding [EBM], including BFS technology

• Injection blow moulding [IBM], delivering high accuracy of the neck finish for

optimal closing

• Injection stretch blow moulding [ISBM*], delivering additional characteristics

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.

LDPE HDPE Soft PP Rigid PP

EBM/BFS LE6607-PH HE2581-PH RB801CF RB845MO

LE6609-PH

IBM HE2581-PH RB801CF RB845MO

ISBM 1-step RB801CF RB845MO

2-step RD808CF RD804CF


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Our polyolefin film solutions Bags and tubings


for flexible fluid bags offer Polyolefin [PO] based liquid bags along with blown plastic containers, are
alternative solutions to the more traditional PVC bags and glass bottles. The use
transparency, collapsibility
of PVC is still very popular in many countries, but due to perceived environmental
and design flexibility, thus concerns, PVC has become subject of much criticism. Non-PVC bags are
providing an advantage over continuing to replace PVC in many applications and regions. Flexible bags provide

alternative solutions. ease of use and safety versus glass bottles.

PP based fluid bag concepts involve several components,

• Primary bag

• Connectors and ports

• Valves

• Tubing

• Secondary overwrap

Flexible PO based films can be used for fluid bags in several end-applications:

• Infusion bags [IV bags, parenteral solutions]

• Bags for peritoneal dialysis and fluid collection


Flexible bags made of
• Packaging of nutrition solutions [enteral solutions of glucose, vitamins, lipids,
polyolefins are easy to use
amino acids]
and safe for the end-user.
25

PP bags PVC bags PO bottles Glass bottles

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]

Transparency allowing Flexibility High process and cost High temperature


visual inspection of efficiency stability [aseptic filling
content prior to use at T < 300°C

System safety Easy joining with ports/ System safety


tubes [solvent dipping]

Flexibility Traditional material Mechanical strength


[widespread use]

Design flexibility allows


multi-chamber systems
with peelable seal for
mixing prior to use

Weaknesses Many and cost intensive Use of plasticizers Lower transparency Heavy weight
production and [traditionally phthalates]
assembly steps

HSE [health safety Subject to breaking


and environmental
concerns]

Energy intensive
production

High transportation
costs
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Overwrap
Configuration
• Easy peel

• convenience for user

• sterilisation resistance

• O2 barrier

REQUIREMENTS
• Heat resistant outside layer like
PP homopolymer

• Soft PP

• Inside = peelable PP

IV bag
Configuration
• Softness

• no interaction with active ingredient

• seal toughness

• sterilisation resistance

REQUIREMENTS
• Heat resistant outside layer like PP
homopolymer

• Soft PP

• Inside = peelable PP

Connectors and valves


• Sealing to the film

• High dimensional

• Stability also after steam sterilisation

• Weldability to the pouch and tubings

• Easy to process

• Good stiffness

Tubing
• Softness

• Sterilisation resistance

• Kink resistance

• Coil resistance

• No sticking to overwrap
27

The primary bag protects the


The primary bag protects the activity of the packed ingredient thus providing consumer
active ingredient inside and
safety and must meet strict requirements:
must meet rigid requirements. • Long shelf life

- Good compatibility with the packed content [no interaction]

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

- Good puncture resistance


just a few of the requirements
of our primary bags. • Good tear resistance [ability to hang on a hook without tearing]

• Chemical and physical purity

• Excellent transparency before and after sterilisation resistance

• Film flexibility enables ability to collapse during use [avoiding venting during

withdrawal of the fluid]

• Safe and easy handling

• 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.

of more cost competitive


Bag, tubing and connectors/ports are selected to be joined together by heat
systems and fostering sealing or HF welding techniques. Each component meets specific technical
future growth. requirements and is composed of specific raw materials as illustrated on page 26.
28 www.borealisgroup.com I www.borouge.com

Packaging of powder, tablets and pills


The packaging of solid pharmaceuticals [pills, tablets, powders] involves a variety
of packaging formats including blisters, small bottles and pouches/sachets. The
main requirement is to protect the medicine from atmospheric influences and
to guarantee its shelf life. Also convenience is an important functionality of the
packaging. When powder, pills or tablets are administered by the patient the
packaging should be easy to open and easy to dose however should provide
child-resistant functionality.

Increasing demands for pack functionality, drug safety and environmentally


friendly systems and cost efficiency drive the development of innovative
solutions. One of the key factors for choosing a material for the packaging of solid
medicines is to protect it from the environmental humidity as plenty of medicines
start to lose functionality in contact with water. Polyolefins have an extremely
good barrier to moisture compared to other polymers although there are still
major differences between polyethylene and polypropylene.
29

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.

Density E-Modulus Water vapour


[g/cm3] 300µm blister film transmission rate
ISO 1183 [MPa] DIN 53122 100 µm film
ISO 527 [g/[m2 x24h]]
0 3000
400 2200
PP 0.905 0.70

1500 2800
PVC 1.40 2.40

1300 3000
PS 1.05 14

2200 – 2400
PET 1.34 6.8

Due to the many advantages of polyolefins we find a lot of polyolefins as


packaging materials for solid medicines in the shape of blisters, bottles, closures,
tubes, pouches, tubes.

Polyolefins

• are easy to shape by moulding, extrusion or thermoforming.

• have a competitive cost picture.

• have a wide range of properties.

• are environmentally friendly [waste handling by incineration].

Polyolefins are an ideal material • have a high chemical inertness.


for packaging solid medicines.
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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.

The most traditional material for blister packaging is calendered PVC in


thicknesses between 150 – 300 µm. The search for more environmentally friendly
and more cost competitive alternatives to PVC though has led to an increasing
use of PP as forming web.
31

Sachets and pouches


Sachets, pouches and strip packs are used for the packaging of powdered drugs
and medicine as well as liquids and gels. The significant growth of this packaging
format is mainly driven by the push for single unit dosing packs and on-the-go
consumption.

Unit dose packaging supports the growth of pharmaceutical consumption in


developing markets. It also has a positive effect on pharmaceutical packaging
volume growth because more packaging material is needed for a given volume of
pharmaceuticals.

A wide variety of film structures are used depending on functionality


requirements such as barrier properties, seal strength and optical properties.

High barrier film structures are often based on aluminium laminates or


multilayer films including a barrier layer such as EVOH or polyester. The choice
of barrier material depends on the barrier requirements, costs and whether
transparency is needed. Polyethylene or polypropylene are often used as sealing
material in such laminate structures. The material choice is influenced by the
required seal strength and seal integrity and depends on whether and which
sterilization technique is used. Excellent seal strength is needed even if powder
contamination occurs in the seal area.
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Small bottles and caps

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]

Figure 5: Bottle ESCR-F50 Figure 6: Melt pressure

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.

This typically brings benefits to moulding applications. Borealis’ Bormed range


has two HDPE materials produced with the bimodal process that offer these
advantages: HE7541-PH for injection moulding and HE2581-PH for blow
moulding or injection blow moulding [see page 33].
33

Blow moulding Injection moulding


• Increased ESCR [400%] • Increased ESCR [400%]

• Less swell [15%] • Improved processing [80%]

• Bottle weight reduction [10%] • Potential for

• Higher production rate [10%] - Weight reduction


- Shorter cycle time
• Less energy consumption [5%]
- Energy 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
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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]

PP Homo PP Raco low C2-content PP Terpolymer Soft PP


PP Block HDPE 955 kg/m³ PP Raco high C2-content LDPE 923 kg/m³

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.

Changes in the requirements of medical devices, such as high transparency,


sterilisation by steam and radiation as well as highly complicated moulds and
shapes encouraged polyolefin producers to develop new materials. Due to the
new possibilities, we see major growth in polyolefins used in medical devices,
replacing classic materials and engineering polymers. There has also been an
increase of polyolefins being used for the booming diagnostic market because of
their need for products with high chemical inertness and versatility.

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
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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:

 Proprietary Borstar ® technology – a leading technology for manufacturing


polyolefins

 Creative, innovative and experienced people and top-notch talents

 Leading-edge hardware in polymerisation, material and analytical testing,


and application/processing for simulation tests
39

The recent investments in an expanded word-class Innovation Headquarters in


Linz, Austria, are a clear indication that Borealis and Borouge are committed to
serving their European customer base. By making use of synergies between
our Business Units, we offer concentrated know-how as well as the latest
technology for accelerated processes to produce large sample sizes.

We apply fundamental research in order to make our customers’ products a


commercial success. The international working environment with international
teams for international customers ensures we deliver what we promise and a bit
more.

In addition to our Innovation Headquarters, our two other Innovation Centres,


located in Porvoo, Finland, and Stenungsund, Sweden, help us create product,
application and technology innovations that give us the edge. We believe it is
very important to work closely with our customers and external partners in the
value chain to make sure that our cutting-edge products continue to create value
for our customers.

The continuous evolution of our proprietary Borstar technology is crucial to


keeping Borealis’ innovation pipeline ahead of the competition.

Using proprietary Sirius™ catalyst in the Borstar polypropylene [PP] production


technology adds novel characteristics to PP. This technology platform allows
for production of superior polypropylene that will contribute to product
differentiation and productivity improvements.

Innovations are focused on unique combinations of properties and offer


differentiation through a step change in purity and improved optical properties
combined with optimum sealability and efficient processability in moulding, film
processes and PPs with outstanding mechanical features [from transparent, very
Our continuous focus on research soft to high-stiffness materials].

and development as well as


Both Business Units Moulding and Film and Fibre have a strong commitment to
the evolution of our Borstar®
the medical and pharmaceutical industry. We are driving our product and service
technology will help keep us on offerings in order to fully respond to the unmet needs of the flexible and rigid
the leading edge of innovation. healthcare packaging chain.
40 www.borealisgroup.com I www.borouge.com

Bormed solutions
for the healthcare
industry
Bormed products meet a variety of application needs.
41
42 www.borealisgroup.com I www.borouge.com

Bormed solutions for film applications

The basic properties of different polypropylene types determine which PP type is


most suitable for the intended use.

PP random
PP homo- PP random PP heterophasic
Property Unit heterophasic
polymers copolymers copolymers
copolymers

E-Modulus
MPa
DIN 53357
Mechanics

600 – 900 300 – 500 450 – 600 180 – 450

Penetration energy Dynatest


J/mm
DIN 53373
6 – 10 10 – 20 15 – 25 23 – 35

Haze
%
ASTM D1003
Optics

2 – 4 1 – 2 25 – 40 4 – 25

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

Water vapour transmission


g/m2*d
rate
0.8–1.1 0.9 – 1.2 1.4 – 1.6 1.5 – 1.7

Figure 10: Comparison of different types of polypropylene

Product in the spotlight:


Bormed RE806CF offers best-in-class transparency
Bormedtm RE806CF is Bormed RE806CF is designed to produce cast films that offer best-in-class

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

A novel feature that relates to the excellent retention of transparency


after sterilisation, a feature that could, up to now, only be achieved with
low ethylene random copolymers such as Bormed RD804CF.

Bormed RE806CF combines the transparency before and after sterilisation of


a low C2 random grade, with the low sealing temperature of a high ethylene
random copolymer. Bormed RE806CF is produced using the Borstar technology
combined with proprietary Sirius catalysts. This provides superior purity in terms
of low volatiles and extractables. Furthermore, Bormed RE806CF is a reactor
grade which has a positive effect on its chemical purity.

Typical polymer properties Unit RE806CF RB801CF RD804CF RD808CF

MFR [230°C/2.16] g/10min 12 1.9 8 8

Flexural Modulus MPa 900 750 1000 700

Melting temperature °C 143 140 151 140

Vicat soft temperature °C 130 125 139 125

Typical film properties [measured on


Unit RE806CF RB801CF RD804CF RD808CF
50µm thick mono layer cast films]
Tensile Modulus MPa 500 450 600 400

Haze % <0.5 <0.5 <0.7 <0.5

Haze after sterilisation [121°C/30 min] % 2.9 8 1.5 7

Dynatest penetration energy J/mm 20 25 17 30

Seal initiation temperature °C 117 115 121 115


44 www.borealisgroup.com I www.borouge.com

Bormed FB8230 combines process efficiency with film strength!


FB8230 is a dedicated Bormed LLDPE produced by using Borstar technology.
This gives a broad molecular weight distribution. The low molecular weight
fraction contributes to the excellent processability on blown film technologies.
The high molecular weight provides superior mechanical properties.

Processability Mechanical
Bimodal lubricant strength
Conventional tie molecules

Taste, odour, Processability,


smoke, migration melt strength, swell,
orientation development

1 2 3 4 5
Fraction [%]

Figure 11: BiModality illustration – combination of processing efficiency [more film in less time] and mechanical

properties [stiffness- toughness balance]

The broad molecular weight distribution [MWD] gives excellent bubble


stability over a wide thickness range.

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

Figure 12: Achievable thickness ranges


45

BormedTM FB8230 offers a


LDPE [0.3]
unique combination of process C4-LLDPE

efficiency and film performance. CB-LLDPE

3% EBA

7% EBA

FB8230

40 µm FB8230

0 100 200 300 400 500


Dart drop [g]

Figure 13: Low temperature dart drop of 70 µm films

High production efficiencies can be obtained as a result of the stable processing


[fewer bubble breaks], the absence of melt fracture and the lower melt pressure
versus conventional LLDPEs.

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

Hot tack force


Dart drop

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

resistance to medical bags,


Films produced with Bormed FB8230 are further characterised by a matt
semi-bulk packaging and surface and a soft, silky feel. A further benefit of high purity is provided by
various laminate structures. the absence of slip, anti-blocking or process additives.
46 www.borealisgroup.com I www.borouge.com

Bormed solutions for moulding applications

Bormed grades are suitable for different sterilisation techniques


Bacteriological contamination is one of the major concerns when nursing a
patient resulting in the need to use sterile devices and/or medicines. Producing
under controlled condition can highly reduce the risk of bacteriological
contamination, however product sterility can only be assured by final sterilisation.

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.

General purpose materials:

Steam sterilisation EtO Radiation

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

Non-Irr. Irr. at 38 kGy Non-Irr. Irr. at 38 kGy


1 mm 1 mm 2 mm 1 mm

Figure 16: Influence of radiation RF830MO – Yellowness index – Ageing at 80°C

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

Figure 17: Charpy notched 23 ºC – HD810MO


48 www.borealisgroup.com I www.borouge.com

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.

Despite the lower melting temperature of LDPE it is common to steam sterilise


bottles and ampoules made from LDPE at a lower temperature during a longer
period. Bormed LE6607-PH and Bormed LE6609-PH can successfully be used
with steam sterilisation with restricted temperature levels. Bormed LE6609-PH
makes it possible to exceed a sterilisation temperature of 110ºC resulting in a
reduction of sterilisation time.

Tm* Tc*

LDPE 115°C 100°C

HDPE 125°C 115°C

PP homopolymer 165°C 115°C

PP block copolymer 160°C 112°C

PP random copolymer 150°C 105°C


*= typical values
49

The crystallisation temperature [Tc] is the temperature where the material


starts to solidify or to liquidify – so the higher the Tc the easier the product
will stand the steam sterilisation. The Tc of a polypropylene can be highly
influenced by nucleation. Several efficient nucleators are commonly known.
However, they have the disadvantage of migrating into the liquids, especially
after steam sterilisation. With our propriety catalyst and our Borstar technology
we are able to nucleate PP very efficient without adding an external nucleator.
Borealis Nucleation Technology [BNT] is the most homogeneous and strongest
nucleation available because it is done via the catalyst and not via external
chemicals during extrusion.

As a consequence this results in a very homogeneous morphology of the


material which gives an increased crystallisation temperature of +15°C creating
a better dimensional stability during steam sterilisation. This way of nucleation is
not extractable by commonly used extraction methods.

Advantages of PP Borstar technology with BNT technology

• Faster cycle time

- Higher crystallisation temperature

- Faster crystallisation time

• Better dimensional stability [even shrinkage]

• Higher stiffness

• Higher HDT [vapour sterilisation]

• Better transparency

• Full regulatory approval

Bormed HD850MO is a material


BNT PP
which possesses this technology
Normal PP
and which is in full compliance
Tc
with the regulations. Apart from
a better dimensional stability as
HDT well in steam sterilisation it also
offers better transparency with low
extractables.
Stiffness

0 XX XX

High purity of LDPE products Conclusion: The used sterilisation


Figure 18: PP Borstar technology with BNT technology
method is an essential part which
from Borealis’ Bormed™
needs to be taken into account
product line prevent at the start of the development of each medical device or pharmaceutical/
contamination of medicine. diagnostic package to determine the right material.
50 www.borealisgroup.com I www.borouge.com

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

Contact us Disclaimer The information contained herein is to


our knowledge accurate and reliable as of the date of
publication. Borealis and Borouge extend no warranties
and make no representations as to the accuracy or
completeness of the information contained herein, and
Contact us with your inquiries. Our
assume no responsibility regarding the consequences
devoted Bormed team will be happy to of its use or for any printing errors. It is the customer’s
help you. responsibility to inspect and test our products in order
to satisfy himself as to the suitability of the products
Bormed@borealisgroup.com for the customer’s particular purpose. The customer
is also responsible for the appropriate, safe and legal
use, processing and handling of our products. Nothing
herein shall constitute any warranty [express or implied,
of merchantability, fitness for a particular purpose,
compliance with performance indicators, conformity
to samples or models, non-infringement or otherwise],
nor is protection from any law or patent to be inferred.
Insofar as products supplied by Borealis and Borouge
are used in conjunction with third-party materials, it is
the responsibility of the customer to obtain all necessary
information relating to the third‑party materials and
ensure that Borealis and Borouge products, when
used together with these materials, are suitable for
the customer’s particular purpose. No liability can be
accepted in respect of the use of Borealis and Borouge
products in conjunction with other materials. The
information contained herein relates exclusively to
our products when not used in conjunction with any
third‑party materials.
The product[s] mentioned herein are not intended for
use as medical implant material or implantable medical
devices. Nothing herein shall constitute any warranty of
merchantability or fitness for a particular purpose. It is the
customers’ responsibility to inspect and test our products
in order to satisfy themselves as to the suitability of
the products for the customers’ particular purpose.
Customers are responsible for the appropriate, safe and
legal use, processing and handling of our products

Borstar and Responsible Care are a registered


trademark of Borealis A/S.
Bormed, sirius and Shaping the Future with Plastics
are trademarks of Borealis A/S.
© 2009 Borouge Pte Ltd
© 2009 Borealis AG
IN0169/GB MO 2009 06 BB

For more information
please contact us at Bormed@borealisgroup.com
or visit www.borealisgroup.com/healthcare
and www.borouge.com

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Tel + 43 1 22 400 000 I Fax + 43 1 22 400 333

Borouge Pte Ltd I Sales and Marketing Head Office


1 George Street 18 – 01 I Singapore 049145
Tel + 65 6275 4100 I Fax + 65 6377 1233