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Can't Touch This! The Three W's of Barrier Isolator Technology

Can't Touch This! The Three W's of Barrier Isolator Technology

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A<br />

Different <strong>Isolator</strong> Applications<br />

„Open <strong>Isolator</strong>s“ for continuous aseptic Operations<br />

• Classifications:<br />

Filling:<br />

Capping:<br />

Support Area:<br />

ISO 5 / Grade A<br />

ISO 7 / Grade C<br />

ISO 8 / Grade D<br />

D<br />

4 Pa<br />

E<br />

A<br />

40 Pa<br />

ISO 5<br />

• VHP sterilization for ISO 5 / Grade A<br />

- stopper bowls included in VHP sterilization<br />

- CIP / SIP for filling equipment<br />

4-6Pa.<br />

30Pa.<br />

• Caps and capping equipment:<br />

- no sterilisation<br />

- controlled disinfection<br />

B<br />

B<br />

30 Pa<br />

ISO 5<br />

20Pa.<br />

• Environmental Monitoring:<br />

- particles 0.5µm, 5.0µm<br />

- viable air monitoring<br />

-surfaces (RODAC)<br />

- Temp, diff. pressure, relative humidity<br />

-10 Pa<br />

0<br />

a-<br />

e<br />

-10Pa.<br />

D<br />

C<br />

H<br />

F<br />

10Pa.<br />

G<br />

E<br />

F<br />

G<br />

D<br />

10 Pa<br />

ISO 7<br />

C<br />

Andockstation<br />

f╧r Stopfen<br />

2270<br />

Hubs╠ule<br />

Stopfen<br />

2295<br />

G<br />

12

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