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Millistak+HC AppGd_textC.qxd - Millipore

Millistak+HC AppGd_textC.qxd - Millipore

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7. To ensure that all air and condensate<br />

are effectively removed, adjust<br />

V2, V4, V5 and V7 as required,<br />

so that a wisp of steam and a<br />

continuous drip of water can be<br />

seen exiting from each valve.<br />

8. When the temperature downstream<br />

of the product filter, as measured<br />

by temperature gauge T1,<br />

exceeds 123 °C, start the timer.<br />

The sterilization time should be<br />

at least 30 minutes (or longer,<br />

as established during validation).<br />

During the sterilization phase,<br />

both pressure and temperature<br />

should be recorded regularly.<br />

9. At completion of the sterilization<br />

cycle, close the steam supply<br />

valve V1 and slowly open V8<br />

to introduce compressed gas<br />

into the system.<br />

Millistak+ HC Filters Application Guide<br />

Caution: Make sure that the system<br />

remains under positive pressure (as<br />

indicated by pressure gauges P1 and<br />

P2) and that the pressure differential<br />

across the filter does not exceed<br />

350 mbar (5 psid).<br />

10. Allow for steam purge from all<br />

bleed valves and close valves<br />

V2 and V4, to increase the<br />

flow of gas through the system.<br />

Maintain the minimum gas flow<br />

required to cool the system,<br />

until the temperature gauge T1<br />

indicates approximately 30 °C.<br />

11. In the following order, close valves<br />

V7, V6 and V5. Keep V8 and V3<br />

open, to maintain positive pressure<br />

into the sterile filter system while it<br />

is not in use.<br />

12. After steam sterilization, repeat the<br />

procedures for flushing and testing<br />

the assembled stack, described<br />

above.<br />

25

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