Samson 3349 Mounting And Operating Instructions page 86

Aseptic angle valve with usp-vi diaphragm, valve with pneumatic actuator and positioner, valve combined with pneumatic piston actuator and positioner
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Detailed conditions and results of migration test on PTFE membrane
Overall migration (OM)
The maximum limit on the overall migration (OML) has been tested and measured in accordance with the following
table:
Simulant
10% ethanol
4% acetic acid
Vegetal oil
Specific migration (SM)
The maximum limits on the specific migration (SML) of substances authorized by the Regulation GB 4806.6
4806.9
5
have been tested and measured in accordance with the following tables:
PTFE= Polytetrafluoro- Ethylène
Simulant
4% acetic
acid
Detailed conditions and results of migration test on metallic parts in steel 1.4435 / 316 L
Overall migration (OM)
The maximum limit on the overall migration (OML) has been tested and measured in accordance with the following
table:
Simulant
10% ethanol
4% acetic acid
95% ethanol
Isooctane
*The OL 95% and ISO test conditions correspond to conventional fatty medium substitution test conditions (2 h at 100°C). These
conditions are quoted in the European standard ISO 1186-1 (2002)
Specific migration (SM)
The maximum limit on the specific migration (SML) of substances authorized by the Regulation GB 4806.9
tested and measured in accordance with the following table:
Simulant
4% acetic acid
SAMSON REGULATION S.A.S.
Bruno Soulas
Head of Strategy and Development
SAMSON REGULATION S.A.S. · 1, rue Jean Corona · 69120 Vaulx-en-Velin, France · samson@samsongroup.com
14-12
Duration
Temperature
2 h
Back flow temperature
2 h
Back flow temperature
2 h
Back flow temperature
Polymer name
Duration
Temperature
Back flow
2h
temperature
Duration
Temperature
2h
Back flow temperature
2h
Back flow temperature
3.5h
*60°
1.5h
*60°
Duration
Temperature
Back flow
2h
temperature
Ratio surface /
volume (dm
/dl)
2
1
1
1
SML
No
CAS No
(mg/kg)
87
9002-84-0
0.05
Results
Item
(mg/kg)
As
<0.01
Cd
<0.002
Cr
0.01
Ni
0.02
Pb
0.01
Ratio Surface /
volume (dm
2
/dl)
1
1
1
1
Results
Item
(mg/kg)
As
<0.01
Cd
<0.002
Cr
0.01
Ni
0.02
Pb
0.01
SAMSON REGULATION S.A.S.
Joséphine Signoles-Fontaine
Head of QSE Department
OML
Results
(mg/dm
)
(mg/dm
)
2
2
10
1.9
10
1.8
10
0.2
5
and GB
Status
OK
SML
Status
(mg/kg)
< 0.04
OK
< 0.02
OK
< 2.0
OK
< 0.5
OK
< 0.05
OK
OML
Results
(mg/dm
2
)
(mg/dm
2
)
10
1.0
10
1.2
10
0.5
10
0.4
5
has been
SML
Status
(mg/kg)
< 0.04
OK
< 0.02
OK
< 2.0
OK
< 0.5
OK
< 0.05
OK
EB 8048-2 EN
4

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