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Biopharmaceutical Silicone Tube

Typical application fields
◆Aseptic filling and fluid transportation ◆Bioreactor pipeline◆Pharmaceutical and biotechnology processes◆Disposable system◆Pipeline assemble
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Product Description

Product Features

◆To be produced in cleaning room

◆Pharmaceutic grade platinum cured silicone tube, low dissolved matter

◆Low working temperature scope:-60°C -- 200°C

◆Can be sterilized by high temperature and high pressure\EO\gamma ray

◆High smooth inner surface which can inhibit fluid adsorption

◆Complete control from raw material to products leaving factory, and batch  can be traced

◆No animal derived ingredients

◆High flexibility


Typical application fields

◆Aseptic filling and fluid transportation ◆Bioreactor pipeline◆Pharmaceutical and biotechnology processes◆Disposable system◆Pipeline assemble

Physical and mechanical properties

Properties

Test Standards

       Indicators

Hardness: SHOREA hardness tester by 3 seconds

GB/T531.1-2008

55±5

Tensile strength  MPa

GB/T528-2009

≥9

Elongation at break 100%

GB/T528-2009

≥400

Tear strength KN/m

GB/T529-2008

≥60

Density


1.08±0.02

Biocompatibility Verification

Verification Items

Report No.

Regulation Standards

Bacterial endotoxin test

SSMT-R-2021-00069-01A

Chinese pharmacopoeia 2020 part  IV 1143

In vitro hymolysis test, rabbit blood

SDWH-M201501816-1

EN ISO 10993-4:2009

Skin sensitization test:Test of max dose in guinea pigs


P

2015032522

ISO 10993-10:2010


Intradermal reaction test

P2015032522

ISO 10993-10:2010


Cytotoxicity test

Y2010030527

ISO10993.5-2009/Extraction method

Extract research report

RP-200518-001(01)

PF 45(2)USP-1663;National drug packing material standard\Chinese pharmacopoeia 2015 version,etc.

Size & specification

Product Code

ID

(mm)  (inch)

OD

(mm)  (inch)

Thickness

(mm)   (inch)

Length(m)

sup-cspt-0063-0188

1.59    1/16

4.76    3/16

1.59    1/16

15/50

sup-cspt-0094-0219

2.38    3/32

5.56    7/32

1.59    1/16

15/50

sup-cspt-0125-0250

3.18    1/8

6.35    1/4

1.59    1/16

15/50

sup-cspt-0125-0313

3.18    1/8

7.95    5/16

2.38    3/32

15/50

sup-cspt-0125-0375

3.18    1/8

9.53    3/8

3.18    1/8

15/50

sup-cspt-0156-0281

3.96    5/32

7.14    9/32

1.59    1/16

15/50

sup-cspt-0156-0406

3.96    5/32

10.31  13/32

3.18    1/8

15/50

sup-cspt-0188-0313

4.76    3/16

7.95    5/16

1.59    1/16

15/50

sup-cspt-0188-0375

4.76    3/16

9.53    3/8

2.38    3/32

15/50

sup-cspt-0250-0313

6.35    1/4

7.95    5/16

0.79    1/32

15/50

sup-cspt-0250-0375

6.35    1/4

9.53    3/8

1.59    1/16

15/50

sup-cspt-0250-0438

6.35    1/4

11.11   7/16

2.38    3/32

15/50

sup-cspt-0250-0500

6.35    1/4

12.7    1/2

3.18    1/8

15/50

sup-cspt-0313-0438

7.95    5/16

11.11   7/16

1.59    1/16

15/50

sup-cspt-0313-0500

7.95    5/16

12.7    1/2

2.38    3/32

15/50

sup-cspt-0375-0500

9.53    3/8

12.7    1/2

1.59    1/16

15/50

sup-cspt-0375-0563

9.53    3/8

14.3    9/16

2.38    3/16

15/50

sup-cspt-0375-0625

9.53    3/8

15.88   5/8

3.18    1/8

15/50

sup-cspt-0500-0688

12.7    1/2

17.47  11/16

2.38    3/32

15/50

sup-cspt-0500-0750

12.7    1/2

19.05   3/4

3.18    1/8

15/50

sup-cspt-0625-0875

15.88   5/8

22.22   7/8

3.18    1/8

15/50

sup-cspt-0750-1000

19.05   3/4

25.4     1

3.18    1/8

15/50

sup-cspt-0750-1125

19.05   3/4

28.57   9/8

4.76    3/16

15/50

sup-cspt-0750-1250

19.05   3/4

31.75   5/4

6.35    1/4

15/50

sup-cspt-1000-1375

25.4     1

34.92  11/8

4.76    3/16

15/50

sup-cspt-1000-1500

25.4     1

38.1    3/2

6.35    1/4

15/50


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