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0102

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Helix Medical Europe GmbH

Liebigstraße 2--8 Tel.: +49 (0) 631 53 41-75 00 info@helixmedical.de 67661 Kaiserslautern Fax: +49 (0) 631 53 41-76 00 www.helixmedical.de

Pharmaceutical grade silicone stoppers are ideal for a tight, reliable seal when used with glass tubes, vials and flasks. These platinum-cured silicone stoppers have full traceability down to the raw material, contain no peroxide residues and are autoclavable. HelixMark® silicone stoppers are available in 14 standard sizes. Typical hardness: 50 Shore A

The HelixMark® biomedical / pharmaceutical grade silicone gaskets are made with our proprietary molding process and engineered geometry to promote crevice-free and protrusion-free processing. The gaskets have exceptional biocompatibility and contain no contami-nants or leachables. Clamp gaskets can be sterilized by autoclave, ethylene oxide or gamma radiation within the user’s validated cycles and exposure levels. Typical hardness: 80 Shore A

HelixMark® platinum-cured silicone productsoffer an extensive array of product types andsizes – available off the shelf.

· Platinum-cured USP Class VI· ISO 13485 Certified· ISO 8 Cleanrooms

● Standard Tubing● Peristaltic Pump Tubing● Braided Reinforced Tubing● Close Tolerance Tubing● PharmaFocus™-Tubing● Color Stripe Tubing● Stoppers and Gaskets

HelixMark® products have been developed as a result of 30 years of manufac-turing experience and are fabricated from silicones made by industry leaders, including Dow Corning and Wacker. We apply a medical device quality system to all product lines and include material certification and lot traceability documents with every product.

13 8 25

15 10 25

17 13 25

19 14 25

20 16 25

24 18 25

26 20 25

27 23 25

32 26 25

37 30 25

41 33 25

45 37 25

50 42 25

64 54 25

000

00

0

1

2

3

4

5

6

7

8

9

10

12

45639100

45639101

45639102

45639103

45639104

45639105

45639106

45639107

45639108

45639109

45639110

45639112

45639190

45639199

REFmmmm mm

ISO FDA USP EPBOTTOMDIAMETER

TOP DIAMETER HEIGHT

STOPPERSIZE

Typical data are average data and may vary. • Packaged 12 per zip bag in boxes. • Material certification and lot traceability documents included in every box.*

45639005

45639007

45639010

45639015

45639020

45639025

45639030

45639040

45639060

ISO FDA USP EP

REFmm

12.70

19.05

25.40

38.10

50.80

63.50

76.20

101.60

152.40

Mini

Mini

Standard

Standard

Standard

Standard

Standard

Standard

Standard

Typical data are average data and may vary. • Packaged 25 per zip bag in boxes. • Material certification and lot traceability documents included in every box.*

INSIDEDIAMETERTYPE

®

HelixMark®

Silicone Stoppers

Other custom extrusions and services available:

• Spooling

• Multi-Lumen

• Profiles

• Tip trimming

• Cut to length

• Punching

• Helix Black Tube

• Radiopaque tubing with pad printing

®®

Making a world of difference

• Proprietary striping and colouring

* Typical data are average data and values may vary. Typical data shall not be used as product specification. • Not for implantation • Nonsterile.

Germany

HelixMark® Silicone Clamp Gaskets

HelixMark_Brochure_E_121113_v3.indd 1 12.11.13 14:34

ISO ISO 10993-1 FDA FDA 21CFR 177-2600 USP USP-KLASSE VI EP EP 3.1.9(EP) EP 3.1.9 without appearance of solution

SPECIFICATION

Silastic® is a registered trademark of Dow Corning.

Superior Pumping PerformanceHelixMark® peristaltic pump tubing, manufactured with platinum-cured Wacker silicone material, meet the strength and durability requirements associated with peroxide-cured tubing. Peristaltic pump tubing undergoes a stabilization process, providing superior strength, performance and longer life. Typical hardness: 60 Shore A

Great variety of standard tubingBiomedical / pharmaceutical grade standard silicone tubing is offered in a full range of sizes in two choices of silicone elastomer: Dow Corning Silastic® and Wacker Elastosil®. All of our HelixMark® standard silicone tubing is platinum-cured and contains no additives, plasticizers or peroxide components. With the ability to operate at elevated temperatures, our products will not oxidize or deteriorate. Rigorous testing, including expanded biocompatibility, provides highest quality and safety for the most demanding biomedical / pharmaceutical industry standards. In addition all products offer full traceability down to the raw material. HelixMark® standard tubing can be sterilized with autoclave, ethylene oxide or gamma radiation within the user’s validated cycles and exposure levels. Typical hardness: 50 Shore A and 60 Shore A

mm mm mm REF REF

45630101

45630102

45630103

45630104

45630105

45630106

45630107

45630108

45630109

45630110

45630111

45630121

45630122

45630123

45630124

45630125

45630126

45630127

45630128

45630129

45630130

45630131

45630132

45630133

45630134

N/A

45634140

49300528

45634142

45634143

45634144

49300529

45634146

45634147

49300530

45634149

45634150

45634151

45634152

45634153

45634154

45634155

45634156

45634157

45634158

45634159

45634160

49300531

45634162

45634163

49300532

45634165

ISO FDA USP EP ISO FDA USP (EP)Dow Corning

Silastic® Wacker

Typical data are average data and may vary. • 15.00 m coils • Packaged double bagged in boxes. • Material certificate and lot traceability documents included in every box.*

TYPICAL PROPERTIES AS CUREDSpecific Gravity [g/cm³] 1.16 1.16Durometer Hardness [Shore A pts] 50 60Tensile Strength [MPa] 10.16 9.8Tear Strength [kN/m²], Die B ASTM D624 45,9 38Elongation[%] 903 700

OUTSIDE DIAMETER

INSIDEDIAMETER

WALL THICKNESS

0.31 0.64 0.17

0.51 0.94 0.22

0.64 1.19 0.28

0.76 1.65 0.45

1.02 2.16 0.57

1.47 1.96 0.25

1.58 2.41 0.42

1.58 3,18 0.80

1.98 3.18 0.60

2.64 4.88 1.12

3.35 4.65 0.65

3.18 6.35 1.59

4.78 7.95 1.59

4.78 9.53 2.38

6.35 9,53 1,59

6.35 11,13 2,39

6,35 12.70 3.18

7.94 12.70 2.38

9.53 12.70 1.59

9.53 14.30 2.39

9.53 15.88 3.18

12.70 17.48 2.39

12.70 19.05 3.18

15.88 22.23 3.18

15.88 23.83 3.98

19.05 25.41 3.18

mm mm REFmm

ISO FDA USP (EP)

#112 45635015#13 45635023 45635027 45635037#14 45635043#119 45635045 45635051 45635063 45635070#16 45635079#120 45635082 45635093#25 45635104#15 45635108#15TW 45635110#123 45635112#17 45635130#24 45635133#24TW 45635136#26 45635139#26TW 45635141#18 45635160#35/121 45635163#185 45635166#36/122 45635191#73 45635194#73TW 45635197#70/190 45635200#186 45635230#82 45635243#82TW 45635245#88 45635248#184 45635262#189 45635270#187 45635288#191 45635310#92 45635420#92TW 45635428

Typical data are average data and may vary. TW = Thick Wall (variance between competition pump numbers), 7.5 m coils • Packaged double bagged in boxes. • Material certification and lot traceability documents included in every box.*

FIT PUMPTUBE SIZE

0.51 3.71 1.60 0.79 3.99 1.60 0.99 1.60 0.31 1.50 2.52 0.51 1.60 4.80 1.60 1.60 6.38 2.39 2.01 3.02 0.51 2.52 3.53 0.51 3.00 4.01 0.51 3.18 6.38 1.60 3.18 7.95 2.39 4.01 5.44 0.72 4.78 7.98 1.60 4.78 9.55 2.39 4.78 9.86 2.54 4.78 11.13 3.18 6.35 9.55 1.60 6.35 11.13 2.39 6.35 11.43 2.54 6.35 12.70 3.18 6.35 13.21 3.43 7.95 11.15 1.60 7.95 12.73 2.39 7.95 15.98 4.02 9.53 14.30 2.39 9.53 15.89 3.18 9.53 16.38 3.43 9.53 19.03 4.75 12.01 20.03 4.01 12.70 19.05 3.18 12.70 19.56 3.43 12.70 22.20 4.75 15.88 22.23 3.18 15.88 25.38 4.75 16.00 24.03 4.02 19.05 28.55 4.75 25.40 34.90 4.75 25.40 35.56 5.08

OUTSIDE DIAMETER

INSIDEDIAMETER

WALL THICKNESS

HelixMark®

Standard SiliconeTubing

HelixMark®

Peristaltic Pump Tubing

High performance under high pressureManufactured with our proprietary process incorporating strong polyester braiding between extrusions of platinum-cured silicone, our durable reinforced tubing with the identifiable blue spiral is ideally suited for increased pressure and high temperature appli-cations. HelixMark® braided reinforced silicone tubing can be sterilized by autoclave, ethylene oxide or gamma radiation within the user’s validated cycles and exposure levels. Typical hardness: 65 Shore A

HelixMark® Braided ReinforcedSilicone Tubing

ISO FDA USP EP

mm mm bar REF

45636020

45636030

45636040

45636045

45636050

45636060

45636070

45636080

45636090

45636100

Typical data are average data and may vary • 7.5 m coils • Packaged double bagged in boxes. • Material certification and lot traceability documents included in every box.*

INSIDEDIAMETER MIN BURST

OUTSIDE DIAMETER

15.00

15.00

15.00

15.00

15.00

15.00

15.00

15.00

15.00

15.00

9.27

11.35

13.21

15.04

16.64

20.32

24.51

27.94

31.37

34.54

3.18

4.75

6.35

7.92

9.53

12.70

15.88

19.05

22.23

25.40

45631121

45631122

45631124

45631125

45631129

45631130

45631131

45631132

45631133

ISO FDA USP EP

REFmm mm mm

Typical data are average data and may vary. • 15.00 m coils • Packaged double bagged in boxes. • Material certification and lot traceability documents included in every box.*

INSIDEDIAMETER

OUTSIDE DIAMETER

WALL THICKNESS

3.18

4.76

6.35

6.35

9.53

9.53

12.70

12.70

15.88

6.35

7.95

9.53

11.13

14.29

15.88

17.48

19.05

22.23

1.59

1.60

1.59

2.39

2.38

3.18

2.39

3.18

3.18

Precision for demanding requirementsBiomedical / Pharmaceutical grade platinum-cured silicone tubing, manufactured with Dow Corning Silastic®, provides superior flow properties. HelixMark® close tolerance silicone tubing ensures minimal dimension variation, making this product appropriate for exacting applications. It can be sterilized with autoclave or ethylene oxide as well as by gamma radiation within the user’s validated cycles and exposure levels. Typical hardness: 50 Shore A

HelixMark® Close Tolerance Silicone Tubing

The right testing.The platinum-cured silicone elastomer used for our PharmaFocus™ tubing has been designed specifically to fit the needs of the pharmaceutical marketplace. This silicone undergoes a battery of biocompatibility tests appropriate for pharmaceutical appli-cations, reducing the costly extended implant studies typically performed on biomedical grade silicones. The result is a more economic silicone tubing that delivers consistent quality and the right level of assurance.The right source.Applying 30 years of silicone manufacturing experience, Helix Medical consistently strives to meet our number one goal: to instill confidence into every product we make. The drive to provide peak levels of assurance to our customers compels us to meet the highest standards available for our production areas.The right tubing.PharmaFocus™ platinum-cured silicone tubing is available in eleven sizes. Typical hardness: 50 Shore A

Organize lines at a glanceHelixMark® color stripe silicone tubing is available in three choices of color striping: red, green and white. Whether you want to recognize your lines at a glance by application, tubing size or functional area, HelixMark® color stripe tubing gives you the flexibility to create your own system. Add non-stripe and custom colors to create a system as complex as necessary. Typical hardness: 60 Shore A

HelixMark® Color Stripe Tubing

®

HelixMark® PharmaFocus™ Tubing

REFmm mm mm

ISO FDA USP EP

45632521

45632522

45632523

45632525

45632526

45632527

45632530

45632532

45632533

45632535

45632536

3.18 6.35 1.59

4.78 7.95 1.59

4.78 9.53 2.38

6.35 11.13 2.39

6.35 12.71 3.18

7.95 12.71 2.38

9.53 15.88 3.18

12.71 19.06 3.18

15.88 22.23 3.18

19.06 25.41 3.18

25.41 38.12 6.36

OUTSIDE DIAMETER

INSIDEDIAMETER

WALL THICKNESS

Typical data are average data and may vary. • 15.00 m coils • Packaged double bagged in boxes. • Material certification and lot traceability documents included in every box.*

Typical data are average data and may vary. Please contact customer service for tolerances and custom size requests.*

45630621

45630623

45630626

45630627

45630630

45630632

REF

45630721

45630723

45630726

45630727

45630730

45630732

REF

45630821

45630823

45630826

45630827

45630830

45630832

REFmm mm mm

INSIDE DIAMETER

OUTSIDE DIAMETER

WALL THICKNESS

3.18 6.35 1.59

4.78 9.53 2.38

6.35 12.70 3.18

7.95 12.70 2.38

9.53 15.88 3.18

12.70 19.05 3.18

RedStripe

Green Stripe

WhiteStripe

HelixMark_Brochure_E_121113_v3.indd 2 12.11.13 14:34