IN0169 GB MOFF 2009 08 BB

Bormed offers peace of mind – solutions for healthcare

Borealis and Borouge are leading

providers of innovative, value creating

plastics solutions. With more than 40

years of experience in polyolefins and

using our unique Borstar® technology,

we focus on the infrastructure,

automotive and advanced packaging

markets across Europe, the Middle

East and Asia. Our production facilities,

innovation centres and service centres

work with customers in more than

170 countries to provide materials

that make an essential contribution to

society and sustainable development.

We are committed to the principles

of Responsible Care® and to leading

the way in ‘Shaping the Future with

Plastics’™.

Borealis is owned 64% by the

International Petroleum Investment

Company [IPIC] of Abu Dhabi and

36% by OMV, Central Europe’s

leading oil and natural gas group.

With EUR 6.6 billion revenue in sales

in 2008 and 5,400 employees, the

company is headquartered in Vienna

and has manufacturing operations in

Austria, Belgium, Finland, Germany

and Sweden. It also has special,

compounding units in Brazil, Italy and

the United States.

The company’s main products are

polyolefins and base chemicals.

Polyolefins are the collective name for

polyethylene and polypropylene. Base

chemicals comprise feedstocks and

olefins, phenol and aromatics as well

as melamine and plant nutrients.

Borouge is a joint venture established

in 1998 between Borealis and the

Abu Dhabi National Oil Company

[ADNOC], one of the world’s leading

oil companies. Headquartered in Abu

Dhabi, the United Arab Emirates,

its state-of-the-art, world-scale

petrochemical complex is located

at Ruwais, where it is currently

implementing a multi-billion-dollar

expansion.The project, called

Borouge 2, is due for completion in

2010 and will triple the company’s

polyolefin production capacity.

For more information:

www.borealisgroup.com

www.borouge.com

About Borealis and Borouge

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

Contents

www.borealisgroup.com I www.borouge.com4

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

as Borstar®, Borealis and Borouge continue to enhance the solutions capability of

their comprehensive polypropylene [PP] and polyethylene [PE] product portfolio.

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

through Innovation’. For us, plastics are not a commodity. We believe that by

understanding and working with partners throughout the value chain, we can

develop innovative, sustainable solutions that meet our customers’ needs.

Water

Access to water and sanitation – more

than 1 billion people have no access to

fresh water, and due to climate change,

up to 3 billion people may live in water

scarce regions within the next 20 years.

Energy

Energy access – boosted by

diversification of supply, development

of renewable resources and security/

interconnection requirements for

existing networks.

Climate

Climate change – to limit CO2 emissions

and keep global warming under control.

We have more than 30 years of

experience proving cuttingedge

plastics solutions to the

healthcare industry, recently

including materials from our

innovative Borstar® technology.

Because we care

5

Communication

Communication – to extend, secure and

strengthen communication networks

that are critical to our modern economy

and quality of life.

Health

Healthcare – provide access and an

acceptable level of healthcare for a

growing and aging global population.

Food

Food – to protect and deliver safe food

from “farm to fork” across regions.

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

which lead to:

CO• 2 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•

Enhanced food preservation and delivery•

Safer, more convenient and affordable medical devices for the healthcare sector •

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.

We believe that ‘Value

Creation through Innovation’

is the path to success.


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


20502000 20201900

1.6 bn

6.0 bn

7.5 bn

9.2 bn

Why is the healthcare market unique?

Figure 1: World population growth 1900 – 2050

9


The healthcare sector will continue to grow. The developed countries of Western

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

strongest growth opportunities. In developing countries, population and gross

domestic product [GDP] growth, accessibility to medical products and services

along with government policies that are driving healthcare expenditures will all

contribute to a boost in healthcare spending.

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.

Globally, pharmaceutical/medical regulations range from very stringent to more

flexible, depending on the country and the application. In most developed

countries, the approval processes have to ensure that devices, containers,

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,

healthcare products made from polymers must be composed of raw materials

that assure the stability of the internal contents and protect the content against

potentially adverse elements such as air, moisture, impact and temperature.

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,

no change in its construction or composition is permitted without documenting

the change, evaluating its effect on the total product safety and informing the

relevant authorities.

Pharmaceutical packaging

is expected to grow more

than 5% annually worldwide,

with the biggest share in

the Asian countries.

Demand for healthcare

products is increasing

mainly due to shifting

demographics and lifestyles.

Regulatory requirements for

healthcare products ensure

the safety of the end user.

Regulations will continue

to intensify, especially in

the emerging markets.

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•

11

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

challenging needs by providing the security, functionality and traceability

features required by this very specialized market.

Our BormedTM polyolefins

meet regulations.

% o

f p

op

ula

tio

nag

e 60

an

d o

ver

35

30

25

20

15

10

5

0EuropeAsiaAfrica

20002050

Aging 60 +increasinglyimportant

Figure 2: Percentage of population age 60 and over


Bormed offers peace of mind

DEDICAtED mAtErIALsBroad grade range•

Regulatory compliance •

[EP and USP]

US DMF registered•

Special production and quality control [QC] •

precautions to provide superior product

consistency, high quality and purity

ADDItIOnAL suPPOrtRegular updates •

[EP and USP compliance]

Regular updates DMF files•

Long-term traceability •

[QC data and retained sample]

Extended technical support•

Extensive application experience •

InnOvAtIOnSolutions provider•

Strong company commitment•

Pilot capabilities•

Use of the latest proprietary technologies•

Partnership with value chain•

sECurIty OF suPPLyLong-term commitment•

Prenotification before deletion •

or modification

Prioritisation in planning•

Higher stock levels•

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.

We are committed to producing polypropylene and polyethylene of the highest

quality and meeting the strict requirements of our customers.

Our high-quality materials are

designed to meet the strict

requirements of our customers.


Market segmentationFrom 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.


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.

The healthcare market can be segmented into:

Pharmaceutical and diagnostic packaging •

Medical devices•

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.

17

PE: 50%

Other: 5%

PET: 13%

PS: 8%

PP: 16%

PVC: 8%

Figure 4: Healthcare market by plastic type

Other: 5%

Glass: 8%

Alu: 12%

Paper: 20% Plastics: 55%

Figure 3: Healthcare market by material type

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].


PP and PE each have their own specific property benefits.

Polypropylene

Lowest density •

Higher transparency •

Higher dimensional stability •

Steam sterilisability at 121°C•

High stiffness •

Polyethylene

Easier to sterilise with radiation•

Lower friction•

Good low temperature impact •

strength

High variety in stiffness •

(depending on density)

Very high purity in LDPE•

Polyolefins provide many

advantages over competing

materials, including versatility,

ease of processing, sterilisability

and cost competitiveness.

The healthcare industry

remains a niche market despite

significant growth expectations.

In a globalised economy, only

a selected, dedicated group

of suppliers is willing to meet

the demanding requirements

of this worldwide industry.

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•

The consumption of plastics for these medical markets is steadily increasing

and is mainly driven by substitution of other materials and overall growth

of healthcare products. The use of polyolefins for healthcare applications is

expected to grow by more than 5% per year in the coming years.

19

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

single-use syringes

Catheters

Filters for artificial kidneys

Pen injector

Blister

sachets

Fluid bags for parenteral and enteral solutions

Bottles and ampoules

Pharmaceutical and diagnostics packaging

Inhalers

medical devices

Packaging powder, tablets and pills

small bottles and caps

Film laminated against medical paper or PO nonwovens

Peelablepouch

secondary overwrap


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


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

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

Liquid products require final sterilisation by steam, and the choice of material

is as essential as the conversion technique used. However, it is also important

to define other properties such as transparency, inertness and softness [easy

emptying or dosing] as this will determine the choice of the material to be used.

Our innovative solutions for

bottles and ampoules offer

weight reduction and higher

sterilisation temperature.


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•

Packaging of nutrition solutions [enteral solutions of glucose, vitamins, lipids, •

amino acids]

PP based fluid bag concepts involve several components,

Primary bag•

Connectors and ports•

Valves•

Tubing•

Secondary overwrap•

Our polyolefin film solutions

for flexible fluid bags offer

transparency, collapsibility

and design flexibility, thus

providing an advantage over

alternative solutions.

Bags and tubingsPolyolefin [PO] based liquid bags along with blown plastic containers, are

alternative solutions to the more traditional PVC bags and glass bottles. The use

of PVC is still very popular in many countries, but due to perceived environmental

concerns, PVC has become subject of much criticism. Non-PVC bags are

continuing to replace PVC in many applications and regions. Flexible bags provide

ease of use and safety versus glass bottles.

Flexible bags made of

polyolefins are easy to use

and safe for the end-user.

25

PP bags PvC bags PO bottles Glass bottles

strengths Capability to collapse allows airless withdrawal

Transparency Simple production process [few production steps and high degree of automation]

Longer shelf life for oxygen sensitive products [amino acids, fat solutions]

Transparency allowing visual inspection of content prior to use

Flexibility High process and cost efficiency

High temperature stability [aseptic filling at T < 300°C

System safety Easy joining with ports/tubes [solvent dipping]

System safety

Flexibility Traditional material [widespread use]

Mechanical strength

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

Weaknesses Many and cost intensive production and assembly steps

Use of plasticizers [traditionally phthalates]

Lower transparency Heavy weight

HSE [health safety and environmental concerns]

Subject to breaking

Energy intensive production

High transportation costs


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 activity of the packed ingredient thus providing consumer

safety and must meet strict requirements:

Long shelf life•

- Good compatibility with the packed content [no interaction]

Resistance to damage [avoiding leakage in order to provide low scrap rates] •

- High mechanical strength [contents up to 1 litre]

- Good seal toughness and strong seals with port systems

- Good puncture resistance

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•

The primary bag protects the

active ingredient inside and

must meet rigid requirements.

Puncture and tear resistance,

transparency, safe and easy

handling and cost efficiency are

just a few of the requirements

of our primary bags.

Borealis is focusing on

developing the next generation

of sterilisable and transparent

soft polypropylene for flexible

bags enabling the development

of more cost competitive

systems and fostering

future growth.

Barrier protection against moisture [to protect during steam sterilisation process]

or oxygen [to protect oxygen sensitive ingredients] is provided by the primary

package or the secondary overwrap.

The tubing needs to be flexible, sterilisable without becoming sticky or brittle and

needs to provide resistance to kinking and coil recovery.

Bag, tubing and connectors/ports are selected to be joined together by heat

sealing or HF welding techniques. Each component meets specific technical

requirements and is composed of specific raw materials as illustrated on page 26.


Packaging of powder, tablets and pillsThe 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

Density[g/cm3]ISO 1183

E-modulus 300µm blister film [MPa] ISO 527

0 3000

Water vapour transmission rate DIN 53122 100 µm film [g/[m2 x24h]]

PP 0.905 0.70

PvC 1.40 2.40

Ps 1.05 14

PEt 1.34 6.8

400 2200

1500 2800

1300 3000

2200 – 2400

Polyolefins are an extremely

good moisture barrier as

compared to other polymers.

Polyolefins are an ideal material

for packaging solid medicines.

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].•

have a high chemical inertness.•

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.

The low density and the high water barrier properties of polypropylene

allow thickness reductions while maintaining the same performance level,

which makes PP a cost efficient alternative to other polymers in a number of

applications.


Blister packagingBlister 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 pouchesSachets, 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.


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].

Hours200 4000

HE2581-PHUnimodal PE

Figure 5: Bottle EsCr-F50

Weight of bottle [g]40 4535

Bar

120

110

100

90

80

70

60


Figure 6: melt pressure

Hours20 40 600 80


Figure 7: EsCr – Bell test – F50

Bar500300 700

cm

80

60

40

20

0


Figure 8: spiral flow 2mm thick – 230 ̊C

small bottles and caps

33

Blow moulding

Increased ESCR [400%]•

Less swell [15%]•

Bottle weight reduction [10%]•

Higher production rate [10%]•

Less energy consumption [5%]•

Applications

Bottles for diagnostics and •

pharmaceuticals

Containers up to 10 l•

Injection moulding

Increased ESCR [400%]•

Improved processing [80%]•

Potential for •

- Weight reduction

- Shorter cycle time

- Energy savings

Applications

Containers and closures for •

diagnostics and pharmaceuticals

Increased security

Improved profitability

Full compliance with EP 3.1.3 and 3.1.5


Sti

ffn

ess/

So

ftn

ess:

Fle

xura

l Mo

du

lus

[MPa

] 1600

1400

1200

1000

800

600

400

200

070503010-10-30-50 90 150130110

Temperature Utilization Range [°C]

PP HomoPP Block

PP Raco low C2-contentHDPE 955 kg/m³

PP TerpolymerPP Raco high C2-content

Soft PPLDPE 923 kg/m³

Figure 9: stiffness/softness

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.

35

More and more, polyolefins are

the material of choice for cost

competitive, chemically inert,

high-quality, versatile solutions for

medical diagnostic applications.

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.

The right choice of material is essential to secure the device and its content,

thereby safeguarding the life of the patient. Patients carry their devices

everywhere and normally, the medical devices are used at warm temperatures,

however transport and assembly of the devices can be made at lower

temperatures. Therefore, temperature band is especially crucial for the material

choice.


Recent investments in our world-class Innovation Headquarters in Linz,

Austria, will enable us to better serve our international customer base.

Innovation supports business growth

37


We win

through

commitment

and

innovationBorealis 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

soft to high-stiffness materials].

Both Business Units Moulding and Film and Fibre have a strong commitment to

the medical and pharmaceutical industry. We are driving our product and service

offerings in order to fully respond to the unmet needs of the flexible and rigid

healthcare packaging chain.

Our continuous focus on research

and development as well as

the evolution of our Borstar®

technology will help keep us on

the leading edge of innovation.

We win

through

commitment

and

innovation


Bormed solutions for the healthcare industryBormed products meet a variety of application needs.

41


Bormed solutions for film applications

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

most suitable for the intended use.

BormedTM RE806CF is

produced using Borstar® and

SiriusTM catalysts, providing

superior purity with low

volatiles and extractables.

Product in the spotlight:Bormed rE806CF offers best-in-class transparencyBormed RE806CF is designed to produce cast films that offer best-in-class

optical performance, sealability and sterilisation resistance. Bormed RE806CF

is a medium ethylene random copolymer without slip or anti-blocking agents.

In comparison to other random copolymer grades, Bormed RE806CF offers

an exceptional combination of heat resistance, sterilisability, optical properties,

sealability and excellent transparency.

Figure 10: Comparison of different types of polypropylene

Property unitPP homo-polymers

PP random copolymers

PP heterophasic copolymers

PP random heterophasic copolymers

E-modulus

DIn 53357mPa

Penetration energy Dynatest

DIn 53373J/mm

Haze

Astm D1003%

Gloss

DIn 67530–

temperature

utilization range °C

Water vapour transmission

rateg/m2*d

300 – 500

10 – 20

1 – 2

100 – 125

-8°C – 130°C

0.9 – 1.2

600 – 900

6 – 10

2 – 4

80 – 100

4°C – 142°C

0.8–1.1

450 – 600

15 – 25

25 – 40

10 – 30

-25°C – 135°C

1.4 – 1.6

180 – 450

23 – 35

4 – 25

15 – 80

-35°C – 130°C

1.5 – 1.7

mE

CH

An

ICs

OP

tIC

sO

tH

Er

Pr

OP

Er

tIE

s

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 50µm thick mono layer cast films]

unit rE806CF rB801CF rD804CF rD808CF

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


0 100

FB 8230

LDPE 0.3

LDPE 1.0

LDPE 2.0

LDPE 4.0

LLPE

LPDE/LLDPE blends

25 50 75[µm] Film thickness

2.5mm

Figure 12: Achievable thickness ranges

1 2 543

Fraction [%]

BimodalConventional

Taste, odour, smoke, migration

Processability lubricant

Mechanicalstrengthtie molecules

Processability,melt strength, swell, orientation development

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

properties [stiffness- toughness balance]

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.

The broad molecular weight distribution [MWD] gives excellent bubble

stability over a wide thickness range.

45

BormedTM FB8230 offers

excellent toughness, seal

strength and puncture

resistance to medical bags,

semi-bulk packaging and

various laminate structures.

BormedTM FB8230 offers a

unique combination of process

efficiency and film performance.

LDPE [0.3]

C4-LLDPE

CB-LLDPE

3% EBA

7% EBA

FB8230

40 µm FB8230

Dart drop [g]0 100 200 300 400 500

Figure 14: unique combination of process efficiency and film performance

Hot tack force

Processability

Dart drop

MD tear

TD tearStiffness

Tensile strength

BormedTM FB8230LDPEC4LLDPE

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.

Figure 13: Low temperature dart drop of 70 µm films

Films produced with Bormed FB8230 are further characterised by a matt

surface and a soft, silky feel. A further benefit of high purity is provided by

the absence of slip, anti-blocking or process additives.


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 JHDPE L J JPP 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

16,015,014,013,012,011,010,09,08,07,06,0

43210 5 7 23211815119

Weeks

Non-Irr.1 mm

Irr. at 38 kGy1 mm

Non-Irr.2 mm

Irr. at 38 kGy1 mm

25

Figure 16: Influence of radiation rF830mO – yellowness index – Ageing at 80°C

kJ/m

2

10

8

6

4

2

0

Radiation PPStandard PP

731Non-Irr. 5 9

Figure 15: Charpy impact strength notched at 23°C – Accelerated ageing at 80°C

10

9

8

7

6

5

4

3

2

1

0

kJ/m

2

Month

0 1 2 3 4 5 6 8 11 16 18 21 24 27 30 33 42 48 54 60

0 kGy38 kGy

Figure 17: Charpy notched 23 ºC – HD810mO


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

which possesses this technology

and which is in full compliance

with the regulations. Apart from

a better dimensional stability as

well in steam sterilisation it also

offers better transparency with low

extractables.

Conclusion: The used sterilisation

method is an essential part which

needs to be taken into account

at the start of the development of each medical device or pharmaceutical/

diagnostic package to determine the right material.

0 XX XX

Tc

HDT

Stiffness

BNT PPNormal PP

Figure 18: PP Borstar technology with Bnt technologyHigh purity of LDPE products

from Borealis’ Bormed™

product line prevent

contamination of medicine.


monograph 3.2.2 – Polyolefins for

pharmaceutical packaging

Very little descriptive•

Refers to food-contact •

regulations

Does not recommend anti-•

static

Of little value – most materials •

comply to it

monograph 3.1.3 – Polyolefins

for parenteral and ophthalmic

solutions

Includes PE and PP•

Specific on chemical analyses •

and additives

Most used in pharmaceutical •

world

specific monographs for LDPE,

PP and HDPE

3.1.4 = for LDPE containers and •

closures for preparations for

parenteral and ophthalmic use

3.1.5 = for HDPE containers •

and closures for preparations

for parenteral and ophthalmic

use

3.1.6 = for PP containers and •

closures for preparations for

parenteral and ophthalmic use

BFs: Blow, fill and seal process

Bnt: Borealis Nucleation Technology

DmF: Drug Master File

EBm: Extrusion blow moulding

Enteral: Drug/medicine that is

administered by using any part of the

gastrointestinal tract, meaning orally

[tablets, capsules, drops], gastric

feeding tube, inhalation, etc

EP: European Pharmacopeia

EsCr: Environmental stress crack

resistance

EtO: Ethylene oxide

EvOH: Ethylene-vinyl alcohol

copolymer

HDt: Heat deflection temperature

IBm: Injection blow moulding

IsBm: Injection stretch blow moulding

mWD : Molecular weight distribution

Ophthalmic: Medicine that is

administered via the eye

Parenteral/Iv solutions: Medicine

that is administered by using other

means than the gastrointestinal tract,

meaning by injection or infusion. This

can be intravenous, intramuscular,

subcutaneous or transdermal [under or

through the skin], peritoneal [dialysis]

QC: Quality control

usP: US Pharmacopeia

Glossary

51

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

assume no responsibility regarding the consequences

of its use or for any printing errors. It is the customer’s

responsibility to inspect and test our products in order

to satisfy himself as to the suitability of the products

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.

Contact us

Contact us with your inquiries. Our

devoted Bormed team will be happy to

help you.

[email protected]

IN01

69/G

B M

O 2

009

06 B

B

©

200

9 B

orea

lis A

G

©

200

9 B

orou

ge P

te L

td

For more information

please contact us at [email protected]

or visit www.borealisgroup.com/healthcare

and www.borouge.com

Borealis AG I IZD Tower

Wagramer Strasse 17 – 19 I A -1220 Vienna I Austria

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

Documents

IN0169 GB MOFF 2009 08 BB