in0169 gb moff 2009 08 bb
DESCRIPTION
Borealis' latest publication on its healthcare applications. For more information please contact [email protected] visit www.borealisgroup.com/healthcareTRANSCRIPT
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.
www.borealisgroup.com I www.borouge.com6
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
www.borealisgroup.com I www.borouge.com8
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
www.borealisgroup.com I www.borouge.com10
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
www.borealisgroup.com I www.borouge.com12
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.
www.borealisgroup.com I www.borouge.com14
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.
www.borealisgroup.com I www.borouge.com16
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].
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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
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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
www.borealisgroup.com I www.borouge.com22
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.
www.borealisgroup.com I www.borouge.com24
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
www.borealisgroup.com I www.borouge.com26
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.
www.borealisgroup.com I www.borouge.com28
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.
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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.
www.borealisgroup.com I www.borouge.com32
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
HE2581-PHUnimodal PE
Figure 6: melt pressure
Hours20 40 600 80
HE7541-PHUnimodal PE
Figure 7: EsCr – Bell test – F50
Bar500300 700
cm
80
60
40
20
0
HE7541-PHUnimodal PE
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
www.borealisgroup.com I www.borouge.com34
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.
www.borealisgroup.com I www.borouge.com36
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
www.borealisgroup.com I www.borouge.com38
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
www.borealisgroup.com I www.borouge.com40
Bormed solutions for the healthcare industryBormed products meet a variety of application needs.
41
www.borealisgroup.com I www.borouge.com42
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
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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
www.borealisgroup.com I www.borouge.com44
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.
www.borealisgroup.com I www.borouge.com46
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].
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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
www.borealisgroup.com I www.borouge.com48
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.
www.borealisgroup.com I www.borouge.com50
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.
IN01
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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