Your Guide to Product Safety

Your guide to product safety

MEDICAL PACKAGING 2 3 First aid for smarter packaging

When we at BillerudKorsnäs describe smart packaging, we do not only mean that it satisfies the market’s expectations, wishes and requirements. Smart packaging does more. Naturally, it contributes to improved productivity and overall economy in all areas of business. It attracts the consumer, minimises transport costs and reduces environmental impact. Smarter packaging is manufactured using renewable raw materials as much as possible.

Medical packaging is a very important area of expertise at BillerudKorsnäs. Few other packaging types are so critical to human life and health – it must provide a secure barrier that preserves the purity of the product until it is used. It will be exposed to demanding sterilisation processes that must not affect the contents in any way. The material requirements are high – both papers and films must be manufactured for the specific purpose and guarantee absolute purity and product safety.

We at BillerudKorsnäs hope that this book you are now holding will give you more in-depth knowledge of the complexity of medical packaging. Supplying with care and know-how products that protect people and generate added value for a demanding market is BillerudKorsnäs’ promise. We give you first aid for smarter packaging.

2 3 Contents

1. MEDICAL MARKET TRENDS AND DRIVERS 6 4. THE BILLERUDKORSNÄS PAPER SCHOOL 44 Significant increase in the health care market______7 The basis of paper and paper production______45 The valuable raw material______46 2. MEDICAL PACKAGING 16 From tree to packaging______50 Packaging and product integration______17 The paper machine______54 Pack presentation______18

Sterilisation ______20 5. BILLERUDKORSNÄS MEDICAL PAPERS 60 Packaging machines______26 The basis of a demanding value chain______61 Product to be packed______27 Our production capacity______62 Regulations______31 Our product offer______64 Medical device direct seal market and products___ 65 3. MEDICAL KRAFT PAPER PROPERTIES 36 Medical device coating market and products_____ 66 Characteristics according to regulations______37 Hospital packaging market and products______67 Hospital wrap market and products______68 Performance packaging and products______69

4 5 6. STERILE BARRIER SOLUTIONS 72 With skill and know-how______73 Verifying performance of medical packaging______74

7. BILLERUDKORSNÄS 78 Smarter packaging______79 Serving four market segments______80 World-class packaging materials______81 Solution services______82 A global network______83 BillerudKorsnäs in facts and figures______84

4 5 CHAPTER 1

MEDICAL MARKET TRENDS AND DRIVERS

6 7 Significant increase in the health care market

The health care market stops the spread of deceases, it prolongs life and reduces mortality around the world. It also has substantial economic value. Annually, the health care market has posted higher worldwide growth than the year before. As more nations and regions lift themselves out of poverty and economic prosperity increases, more resources are invested in health care products and services. The health care market can be defined in different ways. Today, more and more products, technologies and services come under the umbrella of health care. Each supply and product organisation tends to choose its own definition of health care depending on its own circumstances and the target group for the information.

6 7 HEALTH CARE MARKET PRODUCTS – PUBLIC EXPENDITURE The traditional health care market is generally defined as being a provider of products, goods and services that are essential for life and safety. These include reusable and disposable medical devices, pharmaceuticals, diagnostics and a range of services and solutions offered to patients worldwide. Suppliers and subcontractors have to satisfy national and international laws and regulations in order to ensure product safety. The market is often financed by the public purse and is included in national, regional or local budgets.

The traditional health care market consists of products and services associated with hospital care.

8 Medical disposables

Medical devices

Dental care

Diagnostics

Ethical pharmaceuticals

8 HEALTH CARE MARKET PRODUCTS – PERSONAL EXPENDITURE There is also a fast-growing market for products that are increasingly defined as health care. The supply and sales of products we buy to feel good and to improve our personal wellbeing, are increasing sharply. Vitamins, beauty products, certain herbal medicines and hygiene products can have a preventive effect on ill health and strengthen the quality of life. These products are seldom subsidised by the state. Dental care has one foot in each area – dental care is subsidised in many countries while dental hygiene, tooth whitening and similar treatments often have to be financed by the individual.

Toiletries – toothpaste, shampoo, skin cream

10 Unsubsidised dental treatment OTC Pharmaceuticals

Vitamins

Beauty and cosmetics – make-up and perfume

Personal care – sanitary towels, diapers, condoms

10 HEALTH CARE MARKET DRIVERS With increasing prosperity, our income rises and we live longer. At the same time, the global population is increasing. An aging and growing population is consuming more medical care. Chronic diseases such as diabetes are on the rise, as is cancer, which makes us dependent on health care during more years of our life – and many more of us survive diseases than previously. The improved economy of both nations and individuals means that larger resources are being invested in health care than ever before. Changed consumption patterns in the developed countries also benefit more segments as more and more people are focusing on personal health.

STRONG GROWTH IN NEW MARKETS The developed countries (North America, Europe and Japan) account for approximately 94 percent of global spending on medical devices. This disparity is offset by stronger growth rates in developing markets which are approximately double that of their developed counterparts. This being said, any growth in the developed markets is still highly significant.

NEW TIMES As a result of the speed of technological developments, new products and services are entering the market more rapidly, which, in turn, is creating a new demand. The eye care market has experienced a large upswing in recent years in the developed countries. There is, however, a negative trend that is having a dampening effect on the developed countries’ demand of medical devices; this is related to increased downward pressure on prices, cost control and governmental expenditure.

SEVERAL FACTORS BEHIND THE RISING DEMAND Larger population Growing number of innovations Aging population Increasing incidence of chronic diseases Rising global prosperity Greater access to health care in Growing demand for eye care the growth markets

12 13 ANNUAL GROWTH IN MEDICAL PACKAGING DEMAND The relocation of device manufacturing to low cost countries means higher growth rates for packaging demand in these countries irrespective of where the devices will be used. Commodity devices with high labour content are most likely to be manufactured in low cost countries. Some examples are gauze dressings, surgical drapes and gowns. This drives demand for high volume, low cost packaging in these regions. There is also an increase in the manufacturing of higher end devices in low cost countries, mainly to satisfy growing local demand. Devices that lend themselves to highly automated production, such as disposable syringes and administration sets will still often be manufactured locally and this maintains the demand for high volume packaging in the developed regions.

MEDICAL PACKAGING MARKET MEDICAL PACKAGING MARKET VOLUME DEVELOPMENT 2006-2016 AND GROWTH 2006-2016 BY REGION

7000 2500 14%

6000 12% 2000 5000 10%

1500 4000 8% 2006 3000 6% 1000 2011

2000 4% 2016 500 CAGR 1000 2%

0 0 0% 2006 2011 2016 NA Europe Japan China Asia ROW

Volume (Mm2) CAGR (Compound Annual Growth Rate) As expected, China shows high growth on is ~ 5.5% by volume and ~ 4.3% by value. a relatively small volume with the rest of Asia, Value (€M) The medical packaging market continues excluding Japan, growing strongly as well. to demonstrate solid growth.

12 13 DISPOSABLES STOP THE SPREAD OF DISEASE One of the most important challenges facing global health is to stop the spread of serious infectious diseases. There is a good and effective recipe for this – disposable devices. When diseases are no longer spread via syringes, compresses or sutures, many lives can be saved.

KNOWLEDGE AND PROSPERITY As always, the general level of knowledge in a field is linked to its prosperity. The consumption of disposable articles has increased several times over in the Western World in the last 50 years, and this has been a significant factor as regards improved USAGE OF DISPOSABLES general health. The consumption of disposables is also increasing in the developing % 100 countries, even if non-disposable devices still dominate in many countries. Demand 90 is increasing together with rising awareness and improving economy. 80 70 EVOLUTION OF MEDICAL DEVICE STERILISATION 60 50 – CONNECTION WITH ECONOMIC PROSPERITY 40 Another important contribution to improved health and longer life is sterilisation. 30 Here, too, there is a significant connection between levels of knowledge, prosperity 20 and demand. In economically less developed countries, sterilisation is rare and non 10 disposable devices dominate the product segments. 0 1960 1970 1980 1990 2000 2010

When a country’s economic situation has improved, health care facilities often purchase Developed Countries an autoclave for sterilisation. This initial investment is extremely important for longer Developing Countries life and improved health. When a syringe made of steel is sterilised between injections, the spread of infection is halted. When a country’s economic situation has improved still further, the demand for secure sterilisation pouches with bacteria barriers increases. When a country is well developed, pre-sterilised disposables dominate the market.

14 15 As prosperity increases, governments can raise their health-care budgets and add more resources for pharmaceuticals and medical products. Using sterilised medical devices and disposables saves many lives all over the world.

14 15 CHAPTER 2

MEDICAL PACKAGING

16 17 Packaging and product integration

Purity, sterility and absolute patient safety. This is not only desirable in the production of medical devices and packaging – it is mandated in laws, directives and regulations. Medical packaging is integrated with the product, the packaging process and the sterilisation method. Every stage in the chain affects product safety – from manufacture until the package is opened and the device is finally used.

Pack Regulations presentation

Product to Packaging be packed solution

Packaging Sterilisation machine method

ILLUSTRATION: Decision model for medical packaging

16 17 Pack presentation

Medical packaging is usually divided into two groups – 2-dimensional and 3-dimensional packaging. And it is the product’s properties such as weight, form and material that determine which solution is most suitable.

MATERIAL DRIVEN SELECTION Whether it is a disposable device or a reusable instrument that is to be packaged, as well as the sterilisation method used, are of importance for the packaging decision. When choosing paper, there are different aspects to take into account – whether the package will have print on it, have high or low opacity, transparency, what strength is desirable and wich sealing method is used, and of course, what performance is required in relation to the price.

2D PACKAGING 2-dimensional packs can take the form of pouches, bags or 4-side sealed packs. Packs must provide sufficient space for the product and be able to be sealed without the package crumpling or the seams bursting. Typical material combinations include paper and film or paper and paper if the product does not need to be viewed from outside the pack. Pouches and bags are selected for lower volume production and for steam sterilisation of reusable devices. 4-side seal packs are selected for high volume products such as advanced 2D packaging – film and paper sealed to form bags wound care and surgeon’s gloves. and pouches

3D PACKAGING For products with appreciable depth, 3D packaging is the best option. A 3D pack typically consists of a thermoformable plastic bottom web sealed to a non-forming lidding material such as a medical paper. Low volume and high value products may use a pre- formed semi-rigid tray, e.g. PETG. High volume production would use a flexible film base web, thermoformed, filled and sealed on an automatic packing line.

18 19 3D packaging – formable films for bulky products.

18 19 Sterilisation

A manufactured product may appear clean to the naked eye – but it is almost always contaminated with hundreds of thousands of bacteria. To prevent these bacteria from reaching a patient, the product needs to be sterilised before use.

POROSITY – A NECESSITY For gas and steam sterilisation, the package must be porous to allow the sterilising medium to pass into and, just as importantly, out of the pack. With its good and even porosity, a medical paper is cost-effective and an excellent choice. It is important that the sterilisation process is reliable and kills the bacteria effectively, and it is equally important that the product is kept sterilised during transport and storage. This means that the paper must have barriers.

When the package has been properly sterilised, no bacteria can penetrate the surface and contaminate the device.

20 21 For a terminally sterilised medical device to be labelled sterile, the theoretical probability of there being a viable microorganism present on the device shall be equal to or less than 1x10 -6 .

20 21 STERILISATION PROCESSES There are several sterilisation methods on the market. What they all have in common is that the packages are subjected to heavy stress and strain during the process. This makes high demands on the properties and quality of the materials, and on the final package.

STERILISATION METHOD

Steam Ethylene Radiation oxide

Temperature Gamma Gas mix

Cycle time E beam Temperature

Dosage level Humidity

Cycle time

22 23 STEAM STERILISATION Steam sterilisation, also known as autoclaving, is a well-proven method of sterilisation and is convenient due to the absence of harmful gases or radiation. This property means that it is possible to have small scale autoclaves in almost any location. Re-sterilisation of reusable devices in hospitals is usually done using an autoclave. In addition, steam sterilisation is chosen for many single-use products such as gauze dressings. During steam sterilisation, the pack is subjected to high temperatures, up to 134 °C and must be porous. The paper is saturated with wet steam and repeatedly inflated and deflated over a period of time. Very high demands are made on the paper’s wet strength and the pack seals must be very strong to withstand the stress and strain of autoclaving.

ETHYLENE OXIDE/GAS STERILISATION (ETO) Ethylene oxide (ETO) is normally used when sterilising medical or pharmaceutical products that cannot withstand the high temperatures of steam sterilisation. Products containing electronic components or plastics are suitable for ETO. The temperature is The autoclaving is used at between 30 and 70 °C and, like in steam sterilisation, high demands are made on the health care facilities all over paper’s wet strength. ETO gas together with oxygen is highly explosive, which is why the world for sterilisation of very stringent safety requirements must be satisfied during the process. reusable medical devices.

IRRADIATION STERILISATION Radioactive gamma rays are used as a sterilisation method in industrial processes, normally after packing disposables such as syringes and dressings. As in ETO sterilisation, there are very rigorous safety requirements – gamma irradiation with shielding for the safety of the operators and storage of radioactive isotopes requires a lot of space. The packaging paper may not contain harmful substances as they could be released during the process and contaminate the device. For example, OBA, Optical Bleaching Agents, which are often used in publication papers, are absolutely prohibited in medical packaging papers.

22 23 The medical packaging serves as a product protector – from sterilisation to final use.

24 25 PACKAGING PROPERTIES WHEN STERILISING The materials must be durable, be of high and even quality and be certified for the sterilisation process in question. In the case of medical packaging paper, very high demands are made on surface finish in order to facilitate secure sealing and even opening. The paper must be strong in order to reduce the risk of breakage at the same time as it should have even porosity with finer pores that allow the sterilisation medium to pass through. The paper’s barriers prevent bacteria from penetrating the sterilised surface and contaminating the device. Approval as a materials supplier is conditional on the manufacturing process being certified.

Plastic and paper adapted and approved for the purpose Smooth surface of the paper for strong seals and clean peel

Right porosity with small, even pores in the paper When a package is steam Bacteria barriers to prevent contamination sterilised, it is blown up like a balloon and the paper is High strength to withstand the medium soaked at extremely high temperatures. To avoid Certified manufacturing process for product safety breakage, the package’s seal strength must be very high.

24 25 Packaging machines

There are several mechanical packaging methods in the market. Primarily two types of machines are used to package medical articles – a thermoforming machine or a 4-side seal machine.

4-SIDE SEAL MACHINE – 2D PACKAGING MACHINERY The 4-side seal machine is commonly used to pack flat 2D products. The product is placed between sheets of film and paper and all four sides are sealed in the process. This method is suitable for single articles as well as multipacks. 4-side seal machines are also used to manufacture bags and pouches for steam sterilisation.

THERMOFORMING MACHINE – 3D PACKAGING MACHINERY Thermoforming is one of the world’s most common packaging methods. Plastics are formed to pack all sorts of less bulky products with a low weight – from fresh food to consumer products such as pens, screws and electronic equipment. The method is also used very often for medical articles. The base film made of plastic is formed, and in the same process, the tray is filled with syringes, needles or dressings. The top film, here made of paper, seals the tray and the product is ready for sterilisation.

The thermoforming machine forms the trays, packs the product and seals the package in one process

The 4-side seal machine manufactures flat, 2D packaging solutions

26 27 Product to be packed

Medical devices come in many different forms and sizes. They can be made of plastic, paper, cotton and can also include liquids. Their properties determine which sterilisation method is preferable. There is a packaging solution for every device.

SYRINGES AND NEEDLES Syringes and needles are defined as an injection moulded plastic barrel and plunger with or without a needle attached. The products can also be pre-filled before packing. The items are of commodity type, manufactured in high volumes, in 3D packaging using standard low-cost packaging materials. The packaging is sterilised by either ETO or irradiation media.

Syringes and needles WOUND CARE PRODUCTS Bandages and compresses for wound care or impregnated dressings for burns are some of the most used medical devices in health care. They can be single-packed or incorporated into kits. The packaging is mainly a 2D construction and is hot or cold sealed using adhesive materials. Impregnated dressings normally require higher barrier properties in the paper and a more complex lamination with aluminium foil. Wound care products can be sterilised by any of the common techniques.

Wound care products

26 27 MEDICAL KITS Medical kits can consist of a range of items for a variety of procedures such as cardiology, dialysis, tracheotomy urology or other hospital procedures. Often the products are packed on a tray to separate the items. The packaging operation is labour intensive and the packs are sterilized by either ETO gas or irradiation.

SOLUTIONS Solutions covers a wide range of infusion and dialysis fluids which are filled into IV Bags and then overwrapped with moisture and/or gas barrier packaging. Steam Medical kits sterilisation at 121°C is the most common method of strerilisation.

ADMINISTRATION SETS Sets are designed to get a healthcare fluid into the body and consist of tubing, flow control devices and ports. They are a high volume and commodity market with thermoform-fill-seal being the typical packaging method.

CATHETERS AND TUBING Plastic and latex catheters and tubing products are used for tracheostomy, dialysis, etc. Generally, the products are very cost sensitive. The packaging process, however, Solutions is cost-effective with automatic form and fill, resulting in 3D packaging solutions. The sterilisation medium used is usually ETO or irradiation.

Catheters and tubing

28 29 GLOVES Surgical and examination gloves are standard commodity products and often produced in South East Asia close to the sources of natural latex. The products require low cost commodity packaging and usually they are sterilised by irradiation.

GOWNS AND DRAPES There is a wide range of disposable gown and drape sets on the market. Generally, the products are assembled in single packages. Because of their high bulk, hand wrapping and packaging are widely used. More and more manufacturers are choosing the 3D Gloves packaging style. The sterilisation method used is irradiation.

SURGICAL SUTURES There is a broad range of sutures in the market used for wound repair. Generally, they consist of polymer threads attached to a curved needle and often the packaging contains a liquid. This makes demands on preventing liquid loss, which why a foil lamination packaging is frequently required. Surgical sutures are mainly sterilised using ETO gas or irradiation.

Gowns and drapes

Surgical sutures

28 29 ACTIVE LIFE According to ISO 11607, medical papers must retain their barrier properties for five years from the date of manufacture.

30 31 Regulations

Packaging is very much affected by the legislation that guides manufacturers of medical products and packaging material. All the players in the chain – from paper and plastics suppliers, via the producer of the article, to its storage and use – must ensure that the products satisfy safety regulations, protect the patient’s health and save lives.

STERILE BARRIER SYSTEM DEFINITION The minimum packaging configuration that provides a microbial barrier and allows aseptic presentation of the medical device at the point of use.

MEDICAL DEVICE REGULATION IN EUROPE MDD/ Medical Device Directive (93/42/EEC) To promote the free movement of goods and services in the European Union, all the producers in the union are subject to the same legislation. Manufacturers of plastic film and paper must certify their products in accordance with the European standard EN 868 or the global standard ISO 11607. These standards guide manufacturers of articles so that they can choose safe and approved materials for their packaging. The manufacturer is responsible for ensuring that the product is safe. In the case of the hospital packaging market, e.g. autoclaving pouches and wraps, it is the manufacturer of barriers who must guarantee safety.

30 31 TASK – PRESERVE THE STERILITY OF THE PRODUCT The packaging must preserve the sterility of the product during transportation, handling and storage, until it is opened and used. The packaging material may not have a toxic effect or contaminate the product in any way during or after sterilisation. A recommended requirement is that the package’s barriers should protect the product for five years from the date of manufacture.

ISO11607-1 Packaging for terminally sterilised medical devices • Replaces EN 868-1:1997. • Is a mandated standard and must be followed to meet the requirements of the MDD 93/42/EC

ISO11607-2 Validation requirements for forming, sealing and assembly process • Processes for making seals and closure systems must be validated

ISO/PDTS 16775 Guidance on the application of ISO 11607 part 1 and 2 • Under construction by ISO/TC198/WG7 • Guidance in the implementation of ISO 11607 and what test methods are typically used to show compliance

32 33 STANDARDS FOR MEDICAL PACKAGING – EN 868 CEN STANDARD EN 868 parts 2-10 are referenced as informative documents in ISO 11607 and are optional Can be used to demonstrate compliance with parts of ISO 11607-1 Provide detailed specifications for individual materials and packaging solutions

EN 868-2 Applies to hospital wraps

EN 868-3 Applies to base paper or hospital packaging

EN 868-4 Applies to hospital packaging – bags

EN 868-5 Applies to hospital packaging – pouches and wraps

EN 868-6 Applies to base paper for medical device packaging

EN 868-7 Applies to coated papers for medical device packaging

EN 868-8 Applies to reusable sterilisation containers

EN 868-9 Applies to uncoated Tyvek

EN 868-10 Applies to coated Tyvek

32 33 OTHER RELEVANT STANDARDS FOR MEDICAL PACKAGING

ISO 9001:2000 Quality Management Systems (QMS) – Requirements • Demonstrate the ability to consistently provide products that meet customers’ and regulatory requirements • Normally sufficient to satisfy the requirements of the customer

ISO 13485: 2003 Quality Management Systems – Medical Devices – Requirements for regulatory purposes • Modifications of ISO 9001 developed to fulfill the requirements in MDD • Some manufacturers of sterile barrier systems have also chosen to be certified in accordance with ISO 13485

ISO 14001 Environmental Management • Minimise the risk to the environment from their products and processes

OHSAS 18001:1999 • Controls the occupational health and safety risk

Hygiene • E.g. BRC/IOP, focus on the risks to consumer safety Standards and product integrity and the control of hygiene in the manufacture and supply of food packaging

34 35 Product safety, absolute purity, barrier systems and sterilisation approval. There is a range of mandatory standards for medical products and packaging solutions that manufacturers must satisfy.

34 35 CHAPTER 3

MEDICAL KRAFT PAPER PROPERTIES

36 37 Characteristics according to regulations

Medical packaging paper differs from many other packaging qualities. The paper’s properties are tested and measured in accordance with a number of parameters to ensure product safety and packaging function at every stage.

Grammage Wet & Dry strength Porosity > Tensile strength > Air resistance Gurley > Burst strength

> Air resistance Bendtsen Water absorbtion Cobb/60 > Air permeance Water repellency Pore size pH Surface roughness Fluorescent spots Tear strength Chloride and sulphate content

36 37 GRAMMAGES Often, it is the product that determines the grammage necessary for safe packaging. When packaging sharp and heavy products, a higher grammage is recommended to ensure that the paper does not break during handling and storage.

POROSITY The porosity of a medical paper should be well balanced so that it allows the sterilisation medium to pass through at the same time as it protects the package from bacteria. Three methods can be used to measure porosity – all three are relevant for quality assurance. Grammages It is important to bear in mind that the measurement methods for porosity and permeance differ, as do the measurements obtained.

Air resistance – Gurley The time in seconds for 100 ml of air to pass through a paper sample of a specific area Unit: s Air resistance – Bendtsen How many milliliters of air that can pass through a paper sample of a specific area in 60 seconds Unit: ml/min Air permeance Porosity The air flow through a paper divided by the area and by the difference in air pressure between the two sides per paper Unit: um/Pa*s

PORE SIZE For medical papers, the pore size is crucial for the paper’s barrier properties and even, small pores are important for product safety. Pore size is measured by first wettening the paper with a liquid having a known surface tension. The pressure needed to force air bubbles through the interstices is then measured. The pressure together with the surfacetension of the liquid is used to calculate the size of the largest pore. Pore size Unit: um

38 39 SURFACE ROUGHNESS Surface roughness affects the package’s appearance and printability. This property is very important when the medical package has instructions for use printed on it. Good printability is also becoming increasingly valuable for brand owners wanting to emphasise their brand and its logotype in an appealing way. Surface roughness is measured by the volume of air per unit of time that passes between the edge of a measuring head and the surface in question under specific conditions and at operating pressure. Unit: ml/min Surface roughness

TEAR STRENGTH Tear strength determines how much force is needed to tear a pre-slit sample of paper. Tear strength is important for a controlled and clean opening of a package and for minimising the risk of breakage. Unit: mN

WET AND DRY STRENGTH – BURST STRENGTH The device must not be able to rupture the medical packaging paper – not even when the paper is saturated with water caused by steam from the autoclave or during gas Tear strength sterilisation. The paper must be able to withstand handling, storage and transportation without being damaged and without losing its sterility. This requires very high burst strength. Unit: kPa

Wet and dry strength – Burst strength

38 39 WET AND DRY STRENGTH – TENSILE STRENGTH The paper’s tensile strength is also important for keeping the package and product intact in both wet and dry conditions. Tensile strength also affects performance when it comes to high-speed conversion, printing and manufacturing packaging. Tensile strength is the maximum stress that a sample of paper can withstand while being stretched or pulled before breaking. Unit: kN/m

Wet and dry strength – tensile strength WATER ABSORPTION COBB/60 The paper’s barrier properties are affected by its water absorption. The capacity to resist water is important if the package unintentionally becomes wet or moist – the barriers must remain intact. Cobb is measured by dropping water on the surface and measuring the weight of the paper before and after absorption. Unit: g/m2

WATER REPELLENCY Another way of measuring water absorption, or resistance, is to place the paper sample on top of a certain amount of water and measure the time it takes for it to become Water absorption Cobb/60 saturated. Unit: s

Water repellency

40 41 PH Paper with a pH value that is too low can react aggressively with the packaged product. It can also be discoloured during sterilisation. In order to measure the pH value, the paper is dissolved in water by means of a hot extracting method. The paper’s pH value should be 7.

CHLORIDE AND SULPHATE CONTENT Chemical additives can affect the acidity of the paper, which in turn can affect the pH coating, the ink and the product itself. Acidity is measured in the same way as pH, by means of a hot extracting method with boiling water. Unit: %

OBA CONTENT – FLUORESCENT SPOTS Optical bleaching agents, which are commonly used in publication papers, give the paper a high whiteness level. However, these bleaching agents are prohibited in medical packaging paper due to the high risk of toxic contamination. The presence of OBA is easily revealed with the help of a UV-lamp. Chloride and sulphate content

OBA content – fluorescent spots

40 41 PROPERTIES FOR MEDICAL APPLICATIONS Enhanced requirements: Heat sealability and peel performance Release characteristics Hold out Reinforcement

Biocompability and toxicological attributes Heat sealabilty Cleanliness Active Life

HEAT SEALABILTY The paper’s sealing properties must be very good when it comes to safe, sterile packaging. Sealing in high temperatures (Heat Seal Coating) is a commonly used method that makes high demands on the paper. It must be able to withstand the process, which results in strong seals that keep the package intact until it is opened.

Release characteristics RELEASE CHARACTERISTICS A clean release, with as few paper fibres as possible that flake off and result in dust on the product, is just as important. Good release characteristics are in particular important to provide a uniform seal as well as safe transfer on grid-lacquered papers.

HOLDOUT Coatings and glue must be permanent. For the package’s barrier system to have a shelf- life of five years, the seals must remain intact until the product is used. The surface of the paper is crucial for a good holdout.

Holdout

42 43 REINFORCEMENT In order to give the paper better puncture resistance, thus preventing the paper from bursting, medical paper is often reinforced.

CLEANLINESS Visual appearance is one of the key elements of a medical package. Instructions must be easy to read and the pack must be perceived as clean and safe to use. Stains or any discolouring of the paper are thus not desirable. Reinforcement

BIOCOMPABILITY AND TOXICOLOGICAL ATTRIBUTES The material in contact with the device must not contain any substances known to be toxic in order to avoid any risk of a health hazard. The possibility of a breakdown of additives with different sterilisation methods must be considered.

Cleanliness

Biocompability and toxicological attributes

42 43 CHAPTER 4

THE BILLERUDKORSNÄS PAPER SCHOOL

44 45 The basis of paper and paper production

5,000 years. That’s how long humans have made use of different materials to record, draw and write down information for each other and for their descendants. Today, paper is one of the world’s most common materials and it is made from renewable resources.

THE HISTORY OF PAPER What we today define as paper was, like so many other things, invented in China. Here, the first paper was made in about 100 A.D. The oldest paper ever found also came from China and dates back to 264 A.D.

The art of papermaking spread via Persia to Europe where the Greeks learned how to make paper a few hundred years later. The Europeans used mainly rags as raw material and it would not be until the Industrial Revolution that paper made of wood fibres began to be used – mainly because the supply of rags was insufficient as a result of the sharp increase in the need for information.

The first papermaking machine was invented at the beginning of the 19th century. And even if there have been great advances in the manufacturing technology used, the basics are the same. From forest to pulp to finished paper.

44 45 The valuable raw material

For the environment, paper is a very good product. Paper is recyclable and biodegradable and it comes from a renewable raw material. When paper is burnt, biogenic carbon dioxide is released, which is absorbed by living plants in the natural cycle. Biogenic carbon dioxide does not contribute to the greenhouse effect, in contrast to fossil CO2 such as coal, oil and gas.

GROWING FORESTS ARE CRUCIAL For paper to be environmentally friendly and sustainable, the forest must be growing constantly. Responsible forestry, taking into account biological diversity, is a must for an ecosystem in balance. Large-scale replanting to replace the trees felled is an absolute prerequisite for sustainable development. It is also an absolute prerequisite for BillerudKorsnäs. As a paper manufacturer, we are always dependent on the forest being secured for our future activities.

PAPER’S FIELDS OF APPLICATION Paper is part of our daily life – every day we come into contact with paper in packaging, books, magazines and hygiene products. Paper is one of the world’s most used products.

Packaging paper Copy paper Corrugated board Tissue Sack paper Fine paper Carton board Newsprint

46 47 Medical packaging requires pure paper made of primary fibres. The right choice includes paper coming from responsibly cultivated forests.

46 47 SCANDINAVIAN FORESTRY All the wood we purchase is thoroughly checked and its country of origin is marked. Most of the wood comes from Sweden, close to our five Swedish pulp and paper mills. Swedish forestry is subject to very tough replanting laws, which are summarised in the Swedish Forestry Act from 1903. Here it is stipulated that all forest owners must replace in full all the wood they extract. For every tree felled, between two and four new trees are planted. As a result, the Swedish forests have almost doubled in the last 100 years.

GROWING FORESTS SEQUESTER MOST CO2 Slowing down the greenhouse effect and reducing the amount of carbon dioxide in the atmosphere is a major challenge for mankind. Here, active and ecological forestry can help. Felling trees and replanting has a beneficial effect on climate change since a growing forest sequesters more carbon dioxide than a forest that has remained untouched for many years.

DEVELOPMENT OF THE SWEDISH UPTAKE OF CARBON DIOXIDE IN SUPPLY OF WOOD 1930-2030 A TREE DURING ITS LIFE CYCLE

Million m3 sk Uptake of carbon dioxide 4500 4000 Harvesting 3500 Carbon sequestration 3000 2500 Carbon emission 0 2000 1500 1000 500 Plant forest Young forest Full grown forest 0 1930 1950 1970 1990 2010 2030 500 Thanks to tough legislation, the forest volume A tree’s ability to sequester carbon dioxide changes with time. in Sweden has increased with 80 percent Initially, the plant is photosyntetically inactive. As the plant grows, since 1930. The prognosis is continuous storage increases at a rapid rate. When the tree is old and stops growth. growing, sequestration is reduced.

48 49 WATER – THE SOURCE OF ALL LIFE Access to fresh water is as important for life on Earth as the oxygen we breathe. Manufacturing pulp and paper requires large volumes of fresh water and more and more environmental analysts have begun to talk about Water Footprint as a declaration of how much water is required to manufacture a certain product. In contrast to Carbon Footprint, which is a declaration of a product’s global environmental impact, Water Footprint shows the local effects. In regions where there is limited access to water, using large volumes of water is more costly for the ecosystem than in regions with large supplies of water.

WHERE WATER FLOWS BillerudKorsnäs’ mills are located close to major watercourses where the water flow is very large. At our mill in Karlsborg, the Kalix River flows at a rate that would fill Paper is a natural, recyclable an Olympic size swimming pool in less than 40 seconds. During the time it takes the and biodegradable packaging material, made from renewable mill to manufacture one ton of pulp, the water flow amounts to 30 tons. sources.

THE WATER IS PURIFIED – AND RETURNED Because we use surface water, we do not need to utilise groundwater. The water we use is purified in several steps before it is returned to its natural environment. Continuous measurements show that the fishes and animal in the watercourses are not harmed by our activities – they breed normally and the oxygen content in the water is good.

ENERGY EFFICIENCY – A NECESSITY A lot of energy is needed to manufacture paper. BillerudKorsnäs is working continuously to reduce our energy consumption and make our processes more efficient. Our main source of energy is biofuels from the forests, where branches, chips and lignin from the cellulose fibres provide us with fuel for the production of electricity and steam. The waste heat from the process is piped to the surrounding buildings via a district heating The manufacture of paper network. In this way, we reduce the dependence on electricity and oil in the areas where requires large water resources. our mills are located. A local measure with a global footprint. In Scandinavia, we have 227,000 lakes larger than 1,000 m2.

48 49 From tree to packaging

Manufacturing pulp and paper is a comprehensive process divided into several stages. It makes high demands on the production technology used and each stage affects the end result – from the forest raw material to the pulp and its path along the paper machine – to finished paper.

Forest Debarking Chipping Pulp production Cooking

Grinding Paper production Paper Transport Packaging

50 51 FIBRE PROPERTIES OF DIFFERENT PAPERS Where the tree grows, and what species, affects the properties of the fibres. Trees that grow slowly in a cold climate produce long fibres that are suitable for packaging purposes where strength and durability are important. Shorter fibres from warmer regions are an excellent choice for fine paper, which has to satisfy demands for excellent printability and efficient lamination.

KRAFT PAPER – A MIX OF BIRCH AND PINE BillerudKorsnäs’ pulp is Nordic Bleached Softwood Kraft – a balanced mix of long fibres from coniferous trees and short fibres from birch trees. Long softwood fibres give the paper wet strength, tensile strength and flexibility for demanding conversion. Shorter hardwood fibres affect the paper’s formation and pore size.

DECIDUOUS FIBRES Birch, eucalyptus, etc. > 1-1.2 mm

CONIFEROUS FIBRES Pine and spruce > 3.5-4 mm

50 51 WOOD AND PULP PREPARATION At the mill, the trees’ bark is removed in a debarking drum. The bark is used as biofuel. The trees are then reduced to chips, which are cooked in a recovery boiler. During the cooking process, the lignin is released from the cellulose and used as biofuel. The next stage is bleaching. During this process, the lignin residue is removed and the paper becomes white. Today, harmful chlorine ions are no longer used in the process and as a result, emissions of chlorine have almost ceased at the Swedish paper mills.

STOCK PREPARATION To give the paper the right properties, the stock is treated prior to production. At this stage, short and long fibres are mixed together in order to obtain the properties required THE WHOLE TREE IS in kraft paper. Large amounts of water are added together with additives such as filler ALWAYS USED and a moderate amount of sizing agents that increase printability. The pH value must 1. Large tree trunks of good be neutral, and BillerudKorsnäs does not use any harmful chemicals. When the stock quality are used for furniture is ready, it consists of 99 percent water. and in houses 2. The upper part of the trees and thinning trees are used for pulp GRINDING 3. Branch tops and lower quality The stock is ground so that the fibres combine better, which increases the strength wood are used as biofuel of the paper and the opacity of the fibres.

Strength

Tensile strength

28% 27% Bursting strength hemicellulose lignin

4% Tear strength Before and after grinding, extractives the properties of the fibres change significantly to Opacity achieve good packaging

quality. 41% Refining cellulose

52 53 Prior to pulp preparation, the trees are debarked and reduced to chips. The whole tree is always used – as timber, as pulp for paper and as biofuel.

52 53 The paper machine

A paper machine has a width of about 10 metres and a length of between 40 and 100 metres. It is divided into three sections – the forming section, the press section and the drying section. THE PAPER MACHINE

Water 99.6% Water 80% Water 60% Water 10% Water 6% Fibre 0.4% Fibre 20% Fibre 40% Fibre 90% Fibre 94%

The forming section The press The drying section The fibres are distributed section The web runs against steam on the wire by the head The web runs heated cylinders. Water is box. Water is removed from through rotating vaporised. The MG surface the wire through suction cylinders and is achieved by the drying on boxes. water is pressed the yankee cylinder. out through press felts.

54 55 The paper machine is large – between 40 and 50 metres long. The first machine was invented in the early 19th century. Since then, technology has improved substantially and, with it, the quality of paper products.

54 55 THE FORMING SECTION The stock is sprayed into the paper machine via the headbox. It then flows over a perforated web, the wire, which distributes the stock. The wire passes a number of cylinders and some of the water is drained off and the fibres are bound together. The top box improves the formation by distributing the fibres still more. After this step, the fibres can no longer move freely.

THE PRESS SECTION In the press section, the paper is dewatered still more by pressing it between two cylinders. When the paper has passed this section of the paper machine, it consists of 60 percent water. The forming section with the top box.

THE DRYING SECTION There are two drying methods that give the paper different properties. Machine Finished, MF paper, is manufactured by passing the paper through a large number of small drying cylinders, which results in both sides being identical and with a high surface roughness. In the case of medical papers, Machine Glazed, MG paper, is the best choice. Here, the web passes first a number of small cylinders and then a large Yankee cylinder. This gives the paper a very smooth finish on one side and a rougher finish on the other.

The drying section with yankee cylinder for MG kraft papers.

56 57 Before the paper has passed through the press section, it consists of 80 percent water. Two cylinders press the paper and reduce the amount to 60 percent.

56 57 SIZE PRESSING To make the paper stronger and improve its sealing and coating properties, the machine can also be equipped with a size press. Here, the paper passes thorough a small bath of liquid which impregnates the paper for enhanced surface properties. The paper can also be calendered. During calendering, the paper is pressed between rollers, which increases its stiffness and improves its surface finish.

HOLE AND SPOT DETECTOR When paper is made of fibres, a living material, its quality can vary. A hole and spot detector is used to make sure that the paper is whole, clean and free of irregularities, It is thus possible to determine whether the quality of the paper is high enough for Size pressing impregnates medical packaging. the paper.

THE END OF THE PAPER MACHINE When the paper has passed through all the sections in the paper machine, it is wound onto a tambour reel and cut in a winding machine. Then it is transported to our customers all over the world.

The hole and spot detector reveals irregularities in the paper.

58 59 With a speed of 470 metres per minute, the stock passes through the paper machine and is transformed into paper. The whole process takes about seven seconds, from the head box to the tambour reel.

58 59 CHAPTER 5

BILLERUDKORSNÄS MEDICAL PAPERS

60 61 The basis of a demanding value chain

BillerudKorsnäs’ products constitute the basis of a long demanding chain. Our papers affect performance at every stage of the medical package – from print, sealing and sterilisation to usage. Manufacturing secure medical packaging paper requires technical know-how, in- depth understanding of the market’s demands and conditions and painstaking manufacturing processes. Our products must satisfy laws and regulations.

A wide product range for medical packaging applications Certified and approved for manufacturing processes and products 40 years of experience of the medical packaging industry Corporate security and good balance sheet

Single use medical devices ”MDM” packaging sector

Medical Device Manufacturer Converters (MDM) (Printing, Hospitals BillerudKorsnäs Sheeting, Clinics Coating, Dentists Sterile Pouching) Services Supplies/ Department

Reusable medical devices ”Hospital” packaging sector

60 61 Our production capacity

BillerudKorsnäs’ medical papers are manufactured at two of our mills – Skärblacka in Sweden and Beetham in the UK. With high-tech production techniques, ongoing development work for the next generation of paper qualities, and reliable deliveries, our mills contribute to safer, cleaner and smarter packaging.

BILLERUDKORSNÄS SKÄRBLACKA Skärblacka’s large-scale production offers cost-effective and competitive paper qualities that strengthen BillerudKorsnäs’ position in the global medical market. Skärblacka is an integrated mill, thus producing both pulp and paper. The mill develops and produces strong, porous sack paper, fluting and white MG kraft paper. Here, the production apparatus for medical MG paper is equipped with the latest technology. At BillerudKorsnäs, we continue to minimise the environmental impact of our activities. Since 1970, Skärblacka mill has continually reduced emissions and today, about 95 percent of the heating energy and internal electricity production are based on biofuel from forest raw materials.

Production capacity: 400,000 tonnes/year Number of employees: 640 Products: Medical kraft paper, sack paper (brown), containerboard (fluting), market pulp

62 63 BILLERUDKORSNÄS BEETHAM Beetham’s qualities achieve the highest results when it comes to sealing strength and peel performance, which give our customers substantial added value and safe, strong packaging papers. The mill has more than 300 years of experience of producing high- quality papers. Beethem produces paper for many other demanding applications such as food packaging, baking papers and kraft papers for industrial purposes. Beetham has the capacity for small-scale production, which makes it unique, and can offer customer-specific, tailor-made solutions.

Production capacity: 45,000 tonnes/year Number of employees: 140 Products: Medical kraft paper, other speciality kraft papers

62 63 Our product offer

We produce world-class MG kraft papers. They are the basis of our two product families – BillerudKorsnäs SteriKraft and BillerudKorsnäs MediKraft.

SteriKraft® SteriKraft is our range of barrier-coated medical packaging papers, which are used for all sterilisation processes in the market. SteriKraft satisfies the demands on product safety and is certified in accordance with ISO 11607 and EN 868. SteriKraft also satisfies the criteria in ISO 11607-1, which stipulate that a package must retain its sterility for 5 years from the date of manufacture.

MediKraft® MediKraft is our range of performance medical papers with excellent runability in modern manufacturing processes. It is suitable for applications that do not require barrier properties – e.g. packaging for medical gloves. Naturally, MediKraft is also suitable and approved for sterilisation.

64 65 Medical device direct seal market and products

Manufacturers utilising direct sealing make very high demands on the paper’s surface finish, consistency and strength. The product is packed in sealing lines at high speed and the manu- facturer can seal the package using a heat or cold sealing method. The latter alternative requires a latex coating for secure sealing.

Manufacturers need paper that offers very high productivity in production in addition Medical device direct seal to secure, intact seals. This packaging process is used for products such as syringes, technology is very common needles and dressings. Gas/gamma sterilisation dominates the product segment, which for packaging of lightweight is why the paper should be certified in accordance with ISO 11607-1 and EN 8687-6. medical devices, e.g. syringes.

OUR PRODUCT OFFER TO THE SEGMENT SteriKraft G SteriKraft D SteriKraft Protect EO SteriKraft Peelclean EO SteriKraft Peelclean EOR

64 65 Medical device coating market and products

Many device manufacturers choose heat or cold seal coated papers. Heat seal coatings from solvents require pattern application to allow the passage of sterilising gases but aqueous dispersion coatings can be all over coated since they too are porous.

Coated papers can be used as lidding in 3D packaging applications but their exceptional dimensional stability and heat seal differential means they are very well suited to ultra high speed rotary packaging lines. Coated medical papers offer a secure end result. The whole paper surface must not be OUR PRODUCT OFFER TO THE SEGMENT coated – the sterilisation medium must be able to penetrate the SteriKraft CPS pores. SteriKraft S Cal SteriKraft Protect EO SteriKraft Peelcoat S

66 67 Hospital packaging market and products

Medical packaging used by hospitals and health care facilities is often in the form of pouches and reels that sterilise reusable products in an autoclave, using steam sterilisation.

High wet and dry strength and very good sealing properties are an absolute must – the package’s seams must be able to withstand the high temperatures and the steam in the autoclave. The paper’s permeability is another important property and should be optimised.

OUR PRODUCT OFFER TO THE SEGMENT SteriKraft Peelclean S-M Pouches are used when auto- claving medical reusables. SteriKraft 2011 SteriKraft S

66 67 Hospital wrap market and products

Hospital wraps are a very common product and consist of cut sheet papers. The paper is carefully folded round the device, which is then sterilised in an autoclave or with gas. The paper must have optimal permeability.

Hospital wraps are often in different colours with one colour on the inside of the packaging, and another on the outside. This system helps health care employees to keep track of which packs have been sterilised, and which are ready for use.

OUR PRODUCT OFFER TO THE SEGMENT Supadrape Supawrap Stericrepe

68 69 Performance packaging and products

BillerudKorsnäs’ performance packaging papers consists of our MediKraft range. With their high strength and stability, high productivity in modern production lines is possible. The excellent deadfold characteristics of MediKraft papers make them ideal as inner wrap for surgeon’s gloves.

MediKraft MediKraft Light

68 69 Hospital Reusable Devices – Steam Sterilisation

APPLICATION PRODUCT g/m2 PAPER CHARACTERISTICS CERTIFICATION

Film fronted pouches & rollstock BillerudKorsnäs SteriKraft S 60, 70 Optimised medical paper for steam sterilisation process ISO 11607:1 & EN 868:3

Film fronted pouches & rollstock BillerudKorsnäs SteriKraft 2011 60, 68 High seal strength balanced with a good permeability ISO 11607:1 & EN 868:3 ® High permeability combined with fast high-strength Film fronted pouches & rollstock BillerudKorsnäs SteriKraft Peelclean S-M 62, 68 ISO 11607:1 & EN 868:3 seal development

Heat seal bags BillerudKorsnäs SteriKraft S 60, 70 Optimised medical paper for steam sterilisation process ISO 11607:1 & EN 868:3

SteriKraft Reinforced high performance crepe with IPA repellency Creped sterilisation wrap (Reinforced) BillerudKorsnäs Supadrape 60 ISO 11607:1 & EN 868:2 Colours: Blue, Green

Enhanced softness high water repellency wrapping crepe Creped sterilisation wrap BillerudKorsnäs Supawrap 60 ISO 11607:1 & EN 868:2 Colours: Blue, Green, White High water repellency wrapping crepe Creped sterilisation wrap BillerudKorsnäs Stericrepe 60 ISO 11607:1 & EN 868:2 Colours: Blue, Green, White

“MDM” Packaging Single-Use Devices

APPLICATION PRODUCT g/m2 PAPER CHARACTERISTICS CERTIFICATION

Direct seal top web BillerudKorsnäs SteriKraft D 60, 70, 80 Higher seal strength version of SteriKraft G ISO 11607:1 & EN 868:6

Industry standard functionality for high volume Direct seal top web BillerudKorsnäs SteriKraft G 60, 70 ISO 11607:1 & EN 868:6 single-use medical devices ® Direct seal top web BillerudKorsnäs SteriKraft Peelclean EO 60, 70 High seal strength combined with excellent clean peel ISO 11607:1 & EN 868:6

Very high seal strength combined with clean peel Direct seal top web BillerudKorsnäs SteriKraft Peelclean EO-R 60, 70 ISO 11607:1 & EN 868:6 Compatible with a large range of films

SteriKraft Reinforced strength properties providing high puncture Direct seal top web (Reinforced) BillerudKorsnäs SteriKraft Protect EO 80, 100 ISO 11607:1 & EN 868:6 resistance and clean peel characteristics

Heat & cold seal coating BillerudKorsnäs SteriKraft S Cal 60, 70 High strength medical paper, calendered for coating efficiency ISO 11607:1 & EN 868:3&6

Heat & cold seal coating BillerudKorsnäs SteriKraft Peelcoat S 60, 70 Enhanced coating holdout with clean peel and transfer properties ISO 11607:1 & EN 868:3&6

High coating efficiency with excellent lacquer transfer and clean Grid lacquer heat seal coating BillerudKorsnäs SteriKraft CPS 60, 70 ISO 11607:1 & EN 868:6 peel properties

MediKraft ® APPLICATION PRODUCT g/m2 PAPER CHARACTERISTICS

Cold seal coating / PE Extrusion & surgical glove wrap BillerudKorsnäs MediKraft 40, 45, 50 High cleanliness MG kraft paper

PE Extrusion & surgical glove wrap BillerudKorsnäs MediKraft Light 30, 35, 40 Lightweight high cleanliness MG kraft paper MediKraft Surgical garment wrap BillerudKorsnäs Medicrepe 45 Lightweight wrapping crepe with water repellency

70 71 APPLICATION PRODUCT g/m2 PAPER CHARACTERISTICS CERTIFICATION

Film fronted pouches & rollstock BillerudKorsnäs SteriKraft S 60, 70 Optimised medical paper for steam sterilisation process ISO 11607:1 & EN 868:3 FILM FRONTED POUCHES Film fronted pouches & rollstock BillerudKorsnäs SteriKraft 2011 60, 68 High seal strength balanced with a good permeability ISO 11607:1 & EN 868:3 & ROLLSTOCK PRODUCTS

High permeability combined with fast high-strength Seal strength Film fronted pouches & rollstock BillerudKorsnäs SteriKraft Peelclean S-M 62, 68 ISO 11607:1 & EN 868:3 seal development

Heat seal bags BillerudKorsnäs SteriKraft S 60, 70 Optimised medical paper for steam sterilisation process ISO 11607:1 & EN 868:3 SteriKraft Peelclean S-M Reinforced high performance crepe with IPA repellency Creped sterilisation wrap (Reinforced) BillerudKorsnäs Supadrape 60 ISO 11607:1 & EN 868:2 Colours: Blue, Green SteriKraft 2011

Enhanced softness high water repellency wrapping crepe Creped sterilisation wrap BillerudKorsnäs Supawrap 60 ISO 11607:1 & EN 868:2 SteriKraft S Colours: Blue, Green, White Non-ISO:11607 High water repellency wrapping crepe Creped sterilisation wrap BillerudKorsnäs Stericrepe 60 ISO 11607:1 & EN 868:2 /EN:868 Products Colours: Blue, Green, White

Peel performance

APPLICATION PRODUCT g/m2 PAPER CHARACTERISTICS CERTIFICATION

Direct seal top web BillerudKorsnäs SteriKraft D 60, 70, 80 Higher seal strength version of SteriKraft G ISO 11607:1 & EN 868:6

Industry standard functionality for high volume Direct seal top web BillerudKorsnäs SteriKraft G 60, 70 ISO 11607:1 & EN 868:6 DIRECT SEAL TOP single-use medical devices WEB PRODUCTS

Direct seal top web BillerudKorsnäs SteriKraft Peelclean EO 60, 70 High seal strength combined with excellent clean peel ISO 11607:1 & EN 868:6 Seal strength Very high seal strength combined with clean peel Direct seal top web BillerudKorsnäs SteriKraft Peelclean EO-R 60, 70 ISO 11607:1 & EN 868:6 Compatible with a large range of films Reinforced strength properties providing high puncture SteriKraft Protect EO Direct seal top web (Reinforced) BillerudKorsnäs SteriKraft Protect EO 80, 100 ISO 11607:1 & EN 868:6 resistance and clean peel characteristics SteriKraft Peelclean EO-R SteriKraft Peelclean EO Heat & cold seal coating BillerudKorsnäs SteriKraft S Cal 60, 70 High strength medical paper, calendered for coating efficiency ISO 11607:1 & EN 868:3&6 SteriKraft D Heat & cold seal coating BillerudKorsnäs SteriKraft Peelcoat S 60, 70 Enhanced coating holdout with clean peel and transfer properties ISO 11607:1 & EN 868:3&6 SteriKraft G Non-ISO:11607 High coating efficiency with excellent lacquer transfer and clean Grid lacquer heat seal coating BillerudKorsnäs SteriKraft CPS 60, 70 ISO 11607:1 & EN 868:6 /EN:868 Products peel properties

Peel performance

APPLICATION PRODUCT g/m2 PAPER CHARACTERISTICS

Cold seal coating / PE Extrusion & surgical glove wrap BillerudKorsnäs MediKraft 40, 45, 50 High cleanliness MG kraft paper

PE Extrusion & surgical glove wrap BillerudKorsnäs MediKraft Light 30, 35, 40 Lightweight high cleanliness MG kraft paper

Surgical garment wrap BillerudKorsnäs Medicrepe 45 Lightweight wrapping crepe with water repellency

70 71 CHAPTER 6

STERILE BARRIER SOLUTIONS

72 73 With skill and know-how

Our goal at BillerudKorsnäs is that our customers should always get the very best out of our products. This is why we offer our customers expert technical services and solutions for optimal performance.

ONGOING DEVELOPMENT WORK Innovation is part of our tradition, as is working close to a network of packaging producers, customers and brand owners over the world. When developing the next generations of papers, we run trials at our customer’s production units and we collaborate with film producers to enhance the overall packaging solution.

WORLD-LEADING SUPPORT For efficient packaging production, it is wise to learn about the properties of our papers in order to achieve the best possible runability in production lines. We have qualified technicians in our organisation who are familiar with the market’s processes. They assist manufacturers around the globe with technical services to attain good productivity and runability.

72 73 Verifying performance of medical packaging

By using computerised methods and simulations of real conditions, BillerudKorsnäs helps producers in the medical packaging industry to develop stronger and safer packaging. We methodically analyse packaging performance as regards seal strength, peel characteristics and reliable runability.

MEASUREMENT OF SEALING SPEED Fast and reliable sealing speed is key to product safety and productivity. BillerudKorsnäs uses KOPP sealing equipment that seals the paper to the customer’s film at various speeds and temperatures. We can also adapt our tests according to the customer’s machine equipment – another important factor for sealability. Today, we know that equipment, paper and film qualities are all connected in order to achieve high productivity. Our task is to find the most compatible materials for each customer’s equipment.

SEAL STRENGTH EVALUATION When paper and film has been sealed, we evaluate the seal’s strength. Strips of film and paper are separated. The more force needed, the stronger the seal. In order to achieve a reliable result, this test is repeated at least six times and the average force is noted.

74 75 With a scientific approach and modern equipment, BillerudKorsnäs helps customers enhance sealability, seal strength and the overall performance of their packaging solutions.

74 75 The program developed by BillerudKorsnäs reveals the loose fibres of the plastic strip.

76 77 MEASUREMENT OF PEEL CHARACTERISTICS A clean peel is a necessity – fibres must not flake off the seals and contaminate the device. BillerudKorsnäs has developed a completely new method for evaluating peel characteristics, which is based on picture analysis. The plastic strip, which has been removed from the paper packaging, is scanned digitally and the loose fibres are calculated. As few loose fibres of larger sizes as possible is desirable for product safety. This evaluation is also performed repeatedly, and the average value is recorded.

A GOOD RESULT BillerudKorsnäs’ program analyses the plastic strip and counts loose fibres – the fewer loose fibres, the better the peel performance. The test on the picture shows that the larger fragments cover only 0.037 percent of the surface – a very good result for secure and safe packaging.

PROTECT PRESERVE PRESENT Sterilisation performance Maintaining a sterile Ensuring peel performance and effective sealing of barrier, seal integrity and and reliability when opening medical devices puncture resistance

76 77 CHAPTER 7

BILLERUDKORSNÄS

78 79 Smarter packaging

We challenge conventional packaging for a sustainable future by being the natural part in smarter packaging. We have come a long way from simply protecting and preserving the goods. Today, we work together with brand owners, converters and packaging partners all over the world helping them save resources, grow brands and increase profitability.

It’s both our promise to the market and a declaration of our intentions to: Be the innovative choice in the packaging industry Use renewable materials and high-performance solutions Share knowledge and work together for our customers in a global network Put packaging into a greater context to save resources, strengthen brands and increase profitability

78 79 Serving four market segments

Not all customers have the same needs, wishes and require- ments. But what they all have in common is that they demand the smartest solution and the best packaging material for their products. To satisfy the brand owners’ needs in the best possible way, we tailor our offerings to four segments.

FOOD & CONSUMER & LUXURY INDUSTRIAL MEDICAL & HYGIENE BEVERAGES GOODS

80 81 World-class packaging materials

BillerudKorsnäs’ world-class materials come from slow- OUR PRODUCT OFFER Sack Paper growing Nordic forests, known for their premium quality and high-strength fibre. This is one of the main reasons Fluting why we have become a leading producer of high- Liner performance packaging material. Kraft Paper Bags Kraft Paper Speciality

We maintain this by our complete control over the whole production process. Kraft Paper Medical More and more packaging manufacturers, brand owners and food retailers appreciate Cartonboard the value of high-quality, sustainable packaging to protect their products. Our internal processes guarantee the performance of packaging materials, minimising Liquid Packaging Board the damage and losses that lead to consumer rejection. 3D Paper

PACKAGING MATERIALS

80 81 Solution services

Not only does BillerudKorsnäs produce world-class materials, we also understand how to utilise these materials to their full potential.

This is smarter packaging. It’s built around years of knowledge, experience and world- leading techniques that guarantee packaging manufacturers and brand owners maximum performance from their packaging solution, no matter where they are located in the world. To make this possible, our extensive range of solution services has been carefully put together, focusing on the benefits each solution provides to consumers and end-users.

GAIN ACCESS TO SOLUTION SERVICES Sack Solutions Box Solutions Carton Solutions Corrugated Solutions Bag Solutions FibreForm® Solutions Sterile Barrier Solutions Material Supply/Service Your Way

82 83 A global network

To strengthen expertise and share knowledge, more than one thousand customers and packaging partners work together in this extensive network spread across more than one hundred countries.

Together with customers, BillerudKorsnäs can offer brand owners a global reach and shorter time to market while securing quality and supply. Close partnership with equipment manufacturers allows us to optimise the process for conversion, filling and packaging to maintain quality. Finally, we work closely with research institutes to ensure we are always at the very forefront of new innovation, industry standards and legal issues.

THE BILLERUDKORSNÄS NETWORK OFFERS Global reach Shorter time to market Secure quality and supply

GLOBAL NETWORK

82 83 BillerudKorsnäs in facts and figures

Our goal is to be a global leader in developing the smarter packaging solutions and materials of the future. This means closer long-term partnerships with customers, more intensive product and business development and greater flexibility. Our offering will continue to expand as we meet the demands of our customers worldwide.

Sales revenue of around SEK 22 billion 4,200 employees Sales offices in around 13 countries Europe is our main market BillerudKorsnäs is listed on the NASDAQ OMX Our production units > Beetham, UK > Karlsborg, Sweden > Gruvön, Sweden > Skärblacka, Sweden > Gävle, Sverige > Frövi, Sverige > Pietarsaari, Finland

84 85 There are so many advantages to choosing a smarter packaging solution and the benefits can be felt all the way through the value chain, from choosing the correct raw materials at the begin- ning, to protecting the patient at the end.

84 85 Widén & Co. 2017-03_496-11740

billerudkorsnas.com

BillerudKorsnäs, PO Box 703, SE-169 27 Solna, Sweden. Tel. +46 8 553 335 00