The exclusively developed 3P Peel-Pouches & Rolls with Multi-X Film

The unique Multi-X fi lm provides an extremely

strong and durable seal while peeling cleanly to

ensure safe presentation of sterilized products.

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6

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A well-designed and correctly used steriliza-tion pack provides for effective sterilization and safe handling and storage of all items until the moment they are used. A pack must remain sealed against bacteria and facilitate aseptic presentation of the packaged product.

Steriking® Multi-X minimizes packaging failures

Steriking® Multi-X maintains mechanical strength and provides a clean peel

Wipak Medical´s unique multilayer fi lm, Steriking® Multi-X, features excellent sealing characteristics without compromising the fi ber-free opening.

Steriking® Multi-X fi lm maintains its mechanical strength and does not crystallize easily. The performance of Steriking® Multi-X is far superior to that of conventional fi lms.

Steriking® Multi-X is a multilayer fi lm with fi ve very fi ne layers, which makes it very tough and durable. The polyester (PET) outer layer provides high heat resistance. The interme-diate layers together with the sealing layerof polypropylene (PP) offer advanced seal-ing and peeling properties with superior tear strength.

Before heat exposureSteriking® Multi-X and con-ventional fi lms appear similar

After heat exposure Steriking® Multi-X demonstrates no change in crystallization grade of PP

1. PET - Outer layer2. TIE - Adhesive layer3. PP - Middle layer, elasticity4. PP - Bulk layer, mechanical strength5. PP - Middle layer, profi le stability 6. PP - Sealing layer, against paper

Crystallization gradeMettler calorimeter %

20

18

16

14

12

10

8

6

4

2

0

Steriking® Multi-X no heatexposure

Steriking®

Multi-Xautoclaved

Conventional fi lmautoclaved

The Ster ik ing® c lean peel l ine consists of the ordinary heat-seal pouches and rol ls , with or without gussets, as wel l as the sel f-seal pouches.

After heat exposureConventional fi lm demon-strates a clear increase in crystallization grade of PP

Packaging failures are usually the result of either 1) bursting during sterilization or 2) fi lm tear and/or paper shear when opening a package.

Conventional fi lms frequently crystallize when exposed to high temperatures during sealing and sterilization processes. When crystallized, the fi lm is brittle and breaks easily.

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MD = Machine direction CD = Cross direction

= Steriking fi lms

= Conventional fi lms

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Steriking® Multi-X with improved fi lm toughness and fl exibility

Top-quality raw materials and highly advanced product and production technologies have produced a new lightweight amorphous fi lm, Steriking® Multi-X. It is very elastic, tough and durable.

The fl ex-crack test wrinkles the material during 900 cycles. This stress on packaging is far greater than in standard packaging practices and sterilization processes, thus causing damage and pinholes in the material. Pinholes in packing materials compromise the bacteria barrier properties.

Comparison of test results clearly shows the superiority of the Steriking® Multi-X.

When the results of typical fi lm performance tests are compared, Steriking® Multi-X and conventional fi lms do not differ greatly.

However, the high strength and toughness of Steriking® Multi-X are demonstrated by testing the elasticity and by testing practical peel performance.

Steriking® packs with Multi-X demonstrate superior clean peel characteristics.

The Ster ik ing® c lean peel l ine consists of the ordinary heat-seal pouches and rol ls , with or without gussets, as wel l as the sel f-seal pouches.

Note:1. The peeling performance tests are conducted with ready-made pouches. When making packages out of a roll material, the user has to pay careful attention to heat sealing conditions in order to facilitate the open-ing of the packs.

2. Steriking® pouches and rolls are marked with a symbol indicating the recommended peeling direc-tion for correct opening of the pack.

300

250

200

250

100

50

0

Flex-crack challenge testPinholes/m2

Conventional fi lm

Steriking®

Multi-X

75

70

65

60

55

MD MDCD CD

Tensile strengthISO 527-3 (N/mm2) after autoclaving

Steriking® Multi-X Conventional fi lm

150

140

130

120

110

100

90

80

70

60

MDMD CD CD

Elongation at break ISO 527-3 (%) after autoclaving

Steriking® Multi-X Conventional fi lm

1600

1400

1200

1000

800

600

400

200

0

MD MDCD CD

Modulus of elasticityISO 527-3 (N/mm2) after autoclaving

Steriking® Multi-X Conventional fi lm

60

50

40

30

20

10

0

Sealing time 0.5 sec

Sealing time 0.9 sec

Peeling performanceMaterial tear (%) after autoclaving

Conventional fi lm

Conventional fi lm

Steriking®

Multi-XSteriking®

Multi-X

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EN 868-3 (1999)

Grade 60 g

Grade 70 g

Tensile strength dry MD kN/m ≥ 4.40 6.71 7.00

CD kN/m ≥ 2.20 3.27 3.80

Tensile strength wet MD kN/m ≥ 0.90 1.28 1.50

CD kN/m ≥ 0.45 0.68 0.90

Tear strength mN ≥ 550 690 790

Water repellency sec ≥ 20 26 42

Air permeance µm/Pa*sec

≥ 3.4 9 6

Steriking® Multi-X maintains superior seal strength

Steriking® high-weight medical paper

Steriking® supplementary design qualities

Prevacuum sterilization processes present a great challenge to packaging. Packs should not burst open during autoclaving. Steriking® superior packaging saves the time and costs that repacking and resterilization of the items to most vigorous autoclaving process, yet it provides a clean, fi ber-free peel when opening the packs.

The seal strengths of the Steriking® Multi-X packaging are higher than those required in the international standards and norms, and 40-60% higher than those of other products.

All international standards for medical papers state a surface weight of 56 g per m2 as a minimum. Steriking® packaging exceeds that requirement,

providing greater safety. The improved barrier and water repellent properties, as well as the mechanical strength of Steriking® 70 g grade, are indisputable.

The green seal allows closure integrity to be checked visually

When sealed, the green fi lm turns to a darker green, which makes it simple to visually check potential defects in the sealing area. The packed item is easily recognizable through the transparent fi lm.

Reliable chemical process indicators

Steriking® process indicators provide clear evidence of processing. Their contrasting color changes are very clear and easy to read. Their performance conforms to the requirements of international standards and norms.

Safe printing layout eliminates ink contamina-tion risk

The indicator and other imprints are subjected to the same sterilization conditions as the packaged product.

On the pouches, the indicators are positioned outside the sealed packing area; and on the reels, they are within the seal area. Risk of ink contamination is eliminated.

70 gram paper 60 gram paper O.R. textile

Performance comparison

0,5 1 1,5 2 2,5 3 3,5

Other products, average

Steriking fl at packs Steriking gusseted packs

EN 868-5 (1999)

Heat seal strength requirements (N/15mm)

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Visual check of the seal When sealed, the fi lm turns to darker green allowing a visual check of the seal integrity.

Clean peel Steriking® seals facilitate clean, fi ber-free open-ing allowing aseptic presentation of the product. Pouches feature a specially designed peel-off seal which makes opening easy.

Strong seals The seal strength values of Steriking® packages are much higher than required in the norms and standards to avoid bursting during autoclaving and handling. Several narrow parallel seams (Multiline) make the seal extremely strong and contribute the Clean Peel.

Sealed edgesHeat-sealed upper corners prevent dust from collecting at the opening seal which reduces the risk of contamination when opened.

Easy handling Thumb notches at each end of the pouch make it easy to fi ll and open the pack.

Safe print designAll the indicators and text imprints are outside the actual packing area to avoid the risk of ink contamination.

Manufacture traceabilityEach package carries a lot code that allows traceability of the production history. The code states the manufacture year and month (YYMM).

Process indicators Clearly contrasting color changes make it easy to distinguish between processed and unprocessed products.

Exclusive materials Strong and fl exible multilayer plastic fi lm and high-weight medical grade paper guarantee superior bacteria barrier and mechanical strength of the pack.

Compliant with norms and standardsSteriking® sterile barrier systems comply with the international norms and standards EN ISO 11607 and EN 868. CE mark is labelled on the transport cartons.

10 Points for Steriking®

Unique 3P Packaging Range with three process-indicators

The exclusively developed see-through packages have built-in process indicators for steam, EO and FO sterilization. The 3P-indicator feature offers approved user convenience. The color change demonstrates that the pack has been exposed to the sterilization process and clearly distinguishes between processed and unprocessed packs.

Our indicators provide contrasting color changes

• Each invidual indicator imprint corresponds to 100 mm2 in size according to the EN 868-5 (1999) requirement and has a full coverage of color for easy reading. • All print is outside the packing area to eliminate ink con tamination risks. • Indicator imprints are subject to the same sterilization

conditions as the packaged product.

EOtime, temperature, humidity and gas concentration from white to gold

FOtime, temperature, humidity and gas concentration from pink to green

STEAMtime, temperature and saturated steam from red to brown

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