Solmed® TubeFlex 4502 tubing

Solmed® TubeFlex 4502 tubing
JM BioConnect developed together with Renolit, a new generation of tubing especially designed for
the pharmaceutical and biotech industry, Solmed® TubeFlex 4502 tubing. The Solmed® TubeFlex 4502
tubing is made in a complete controlled cleanroom environment using the cleanest biological compatible material TPE
® which is already widely used within the industry. The Solmed® TubeFlex 4502
tubing is autoclavable, resistant for gamma radiation, weldable (by commercial sterile tube welders)
and sealable. Further it is successfully tested and validated as pump tubing and is resistant upto > 3 bar.
COMPOUND
CODE study and extractable: study is 4502
A
complete validation
completed and available for our customers.
Solmed Tubeflex 4502 TECHNICAL DATA
PRODUCT
:
MAIN POLYMERS
:
Recommended
tube sealing
method:
MAIN APPLICATION
AREAS
Solmed® Tubeflex
Thermoplastic Elastomer
:Biotechnology
Heat sealing, impulse
sealing,
sterile docking fluid transfer
systems,
biopharmaceutical
Recommended sterilization method
: Gamma, ETO, UV
Maximum recommended sterilization temperature
: 121°C
Maximum recommended sterilization dose : 50 kGy
Recommended pH range
: 2-13
PHYSICAL PROPERTY*
DIMENSION
PROCEDURE
Appearance
: Slightly frosted VALUE
Formulation characteristics
: Ultra low extractable, high purity, high flexibility and free of animal derived
oils. D-638
Tensile strength at break
MPa
12 ingredients and
ASTM
Pump performance
: KrosFlo® Research II pump (0-600 rpm)
Recommended continuous use
: up to 60 hour at 160 rpm
Elongation
at break
%
1800
ASTM D-638
Flow rate stability at 200 rpm
: better than 93%; tested for 48h.
Flow rate stability at 600 rpm
: better than 87%; tested for 7h.
Tensile
moduluson
at tubing
100%size
elongation
1.2
D-638
Tests conducted
3/8” x 9/16”MPa
: (9.5 x 14.3 mm); gamma
radiated atASTM
>50 kGy.
Shore A
-
Tubeflex
4502 Tubing
Cold brittleness
Tubing Catalog #
°C
ID X OD (metric mm)
Density
JMBTF45020300S
JMBTF45020300B
JMBTF45020400S
Water
vapor transmission
JMBTF45020400B
rate
(23°C,
100% RH)
JMBTF45020401S
JMBTF45020401B
3,2 x 6,4
JMBTF45020701S
Haze
JMBTF45020701B
15
15
6,4 x 11,1
cm3.m-2.day-1.bar-1
1/4 x 3/8
1/4 x 7/16
cm3.m-2.day-1.bar-1
6,4 x 12,7
9,5 x 14,3
JMBTF45020800S
JMBTF45020800B
12,7 x 15,9
12,7 x 17,5
12,7 x 19,1
100
350
1/4 x 1/2
%
9,5 x 12,7
Water absorption (100% RH)
JMBTF45020802S
JMBTF45020802B
1/8 x 1/4
0.9
3/16 x 3/8
9,5 x 15,9
JMBTF45020801B
g.cm-3
4,8 x 9,5
JMBTF45020702S
JMBTF45020702B
Burst
Pressure (23 °C)
JMBTF45020801S
ASTM D-746
m/Coil
0.08 15
Steam
sterilization shrinkage
JMBTF45020600S
7,9 x 12,7
JMBTF45020600B
121
°C, 30 minutes
JMBTF45020700S
JMBTF45020700B
< -40
ID X OD (fractions)
g.m-2.day-1
3/16 x 5/16
JMBTF45020501B
CO2
permeability (23°C; 0% RH)
JMBTF45020502S
JMBTF45020502B
ASTM D-2240
4,8 x 7,9
JMBTF45020500S
O2
permeability (23°C; 0%RH)
6,4 x 9,5
JMBTF45020500B
JMBTF45020501S
60
5/16 x 1/2
%
MPa
3/8 x 9/16
3/8 x 5/8
1/2 x 5/8
1/2 x 11/16
15
15
�1
3/8 x 1/2
%
15
15
15
30
15
< 0.2
15
0.54
1/2 x 3/4
15
15
15
Packing Qty
ASTM
D-792
Single
Bulk (20)
Single
ASTM
F-1249
Bulk (20)
Single
Bulk (20)
Single
ASTM
D-3985
Bulk (20)
Single
Bulk (20)
ASTM
F-2476
Single
Bulk (20)
AUTOCLAVE
Single
Bulk (20)
Single
Bulk (20)
Single
ASTM
D-1003
Bulk (20)
Single
ASTM
D-570
Bulk (20)
Single
Bulk (20)
ASTM
D-1599
Single
Bulk (20)
Single
Bulk (20)
AllJMBTF45020900S
above tests: tubing size 3/8” x 9/16” (9.5 x 14.3 mm); gamma radiated at >50 kGy.
Single
15,9 x 22,2
5/8 x 7/8
15
JMBTF45021000S
JMBTF45021000B
19,1 x 25,4
3/4 x 1
5
Single
Bulk (20)
JMBTF45021001S
JMBTF45021001B
19,1 x 28,6
3/4 x 1 1/8
5
Single
Bulk (20)
JMBTF45021002S
JMBTF45021002B
19,1 x 31,8
3/4 x 1 1/4
5
Single
Bulk (20)
JMBTF45021100S
JMBTF45021100B
25,4 x 34,9
1 x 1 3/8
5
Single
Bulk (20)
JMBTF45020900B
Bulk (20)
JM BioConnect bv
Maidstone 50 • 5026 SK Tilburg • The Netherlands
T +31 40 2901570 • F +31 40 2901579 • [email protected] • www.jmbioconnect.com
CL2149 Datasheet EU.indd 1
22-12-2009 15:13:57
Solmed® TubeFlex 4502 validation & technical data
Pharmacopoeia compliancy and biocompatibility:
- USP <88> class VI; 121 °C, 1 hour
- ISO 10993-4 Hemolysis
- USP <85> Bacterial Endotoxins – LAL
- ISO 10993-5 Cytotoxicity
®
- USP <661> plastic containers
- ISO 10993-6 Implantation
test
- European Pharmacopoeia tests 3.1.6
- ISO 10993-10 Irritation and Sensitization
- Japanese Pharmacopoeia tests
- ISO 10993-11 Acute Systemic Toxicity
RecommendedCODE
tube sealing method
:
Heat sealing, impulse sealing, sterile docking
COMPOUND
:
4502
- ISO 10993-18 Chemical Characterization
Solmed Tubeflex 4502 TECHNICAL DATA
Recommended sterilization method
:
Gamma,
PRODUCT
:
Solmed®
TubeflexSteam, ETO, UV
Maximum
recommended
sterilization
temperature
:
121°C
MAIN
POLYMERS
:
Thermoplastic
Elastomer
Copies of the test reports are available upon request.
Maximum
recommended
:
50 kGysystems, biopharmaceutical fluid transfer
MAIN
APPLICATION
AREASsterilization dose
:
Biotechnology
Recommended pH range
:
3 to 11
Appearance
:
Slightly frosted
COMPOUND CODE
: 4502
® :
Formulation
characteristics
PRODUCT
: Solmed TubeflexUltra low extractable, high purity, high
flexibility.
Free of animalPROCEDURE
derived ingredients and oils.
PHYSICAL
PROPERTY*
DIMENSION
VALUE
MAIN
POLYMERS
: Thermoplastic Elastomer
MAIN APPLICATION AREAS
: Biotechnology systems, biopharmaceutical fluid transfer
Tensile strength at break
MPa
Pharmacopoeia
compliancy
and
biocompatibility:
Physical Property*
Dimension
- ISO 10993-4
Hemolysis
Elongation
at break
%
-Tensile
ISO 10993-5
Cytotoxicity
strength at break
MPa
- ISO 10993-6
test
Tensile
modulusImplantation
at 100% elongation
MPa
Elongation
at break
%
- ISO 10993-10
Irritation and Sensitization
- ISO 10993-11
Acute Systemic ToxicityShore
A
Tensile
modulus atChemical
100% elongation
MPa
- ISO 10993-18
Characterization
- USPbrittleness
<88> class VI; 121 °C, 1 hour
Cold
°C
Shore A
-
- USP <85> Bacterial Endotoxins – LAL
- USPbrittleness
<661> plastic containers
Density
Cold
°Cg.cm-3
- European Pharmacopoeia tests 3.1.6
- Japanese
Pharmacopoeia
Water
vapor
transmission tests
g.m-2.day-1
Density
g.cm-3
Copies
of the
test RH)
reports are available upon request.
rate
(23°C,
100%
12
Value
12
60
Procedure
1800
ASTM D-638
1.2
ASTM D-638
1800
1.2
ASTM D-638
ASTM D-638
ASTM D-638
60
ASTM D-2240
< -40
ASTM D-746
ASTM D-638
ASTM D-2240
< -400.9
ASTM
D-792
ASTM D-746
0.9 0.08
ASTM
F-1249
ASTM D-792
Water vapor transmission g.m-2.day-1
0.08 ASTM F-1249
rate
(23°C, 100% RH)
O2 permeability
(23°C; 0%RH)
cm3.m-2.day-1.bar-1
100
ASTM D-3985
2
O
permeability
(23°C;
0% RH)
cm3.m-2.day-1.bar-1
100 350
ASTM D-3985
Pump
performance
Krossflow R II (0-600
RPM)
CO2
permeability
(23°C;
0% RH)
cm3.m-2.day-1.bar-1
ASTM
F-2476
Recommended
continuous
use
up
to
60
hour
at
160
RPM
CO2 permeability (23°C; 0% RH)
cm3.m-2.day-1.bar-1
350 ASTM F-2476
Flow rate
stability at
200 RPM
Steam
sterilization
shrinkage
% better than 93%; tested
� 1 for 48h.
AUTOCLAVE
Flow
rate
stability
at
600
RPM
better
than
87%;
tested
for
7h.
121
°C,
30
minutes
Steam sterilization shrinkage
%
1
AUTOCLAVE
Tests conducted
121°C,
30 minuteson tubing size 3/8” x 9/16” (9.5 x 14.3 mm); gamma radiated at >50 kGy.
Haze
%
30
ASTM D-1003
Haze
Water absorption (100% RH)
Water absorption (100% RH)
%
%
30
%
ASTM D-1003
< 0.2
< 0.2
This technical information consists of typical product data and should not be used as a specification 2009/09.
Burst Pressure (23 °C)
Burst Pressure (23°C)
MPa
MPa
0.54
0.54
ASTM D-570
ASTM D-570
ASTM D-1599
ASTM D-1599
The data contained in this document are provided in good faith for the sake of general information. It is deemed to be accurate
at the time of going into press. The purchaser or user is required to verify with our technical services whether any specific
application is appropriate. Freedom of possession, use or marketing under intellectual property rights or legal provisions or
All
above
size
3/8”
x 9/16”
(9.5
x 14.3
gamma
radiatedradiated
at should
>50 kGy.
All
abovetests:
tests:tubing
tubing
3/8”
9/16”
(9.5
x mm);
14.3
gamma
at >50
regulations,
whether
national
or size
local,
must
bexduly
considered
before
use.mm);
Under no
circumstances
any
SolmedkGy.
film,
tubing or compound be used in any cosmetic, reconstructive or any other temporary or permanent bodily implant application.
This technical information consists of typical product data and should not be used as a specification 2009/09.
The data contained in this document are provided in good faith for the sake of general information. It is deemed to be accurate at the time of going into press.
The purchaser or user is required to verify with our technical services whether any specific application is appropriate. Freedom of possession, use or marketing
under intellectual property rights or legal provisions or regulations, whether national or local, must be duly considered before use. Under no circumstances
should any Solmed film, tubing or compound be used in any cosmetic, reconstructive or any other temporary or permanent bodily implant application.
JM BioConnect is a registered tradename from JM Separations BV, 21-12-2009.
JM BioConnect bv
JM
bv HG Eindhoven • The Netherlands
P.O.BioConnect
Box 6286 • 5600
Maidstone
50 • 5026
Tilburg
• The Netherlands
T +31 40 2901570
• FSK
+31
40 2901579
• [email protected] • www.jmbioconnect.com
T
+31
40 2901570• •BTW
F +31
40 2901579
• [email protected]
• www.jmbioconnect.com
KvK
0987654321
12345678
• Bank
987654321
CL2149 Datasheet EU.indd 2
22-12-2009 15:13:57