0113010203 EN Helix Medical Europe GmbH Liebigstraße 2--8 Tel.: +49 (0) 631 53 41-75 00 [email protected]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 products offer an extensive array of product types and sizes – 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 REF mm mm mm ISO FDA USP EP BOTTOM DIAMETER TOP DIAMETER HEIGHT STOPPER SIZE 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 REF mm 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.* INSIDE DIAMETER TYPE ® 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
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HelixMark Silicone Clamp Silicone Stoppers · HelixMark® silicone stoppers are available in 14 standard sizes. Typical hardness: 50 Shore A The HelixMark® biomedical / pharmaceutical
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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.
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
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.*
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.*