Getinge ISOTEST, User Manual

Page: 29 / 74

GETINGE-LA CALHENE ISOTEST | User manual
NTA 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page
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74
8.2.2. Cycle progress
"The goal of steps 1 to 4 is to prepare the isolator during initial commissioning or after
a cleaning or maintenance operation with breach of containment ( operation
recommended once per month ). The isolator is not sterile at the start of this phase,
and is sterile at the end. Steps 5 to 14 describe the sequence of phases during routine
production.
Step 1:
−
Preparing the isolator for biodecontamination.
The operations are as follows :
Make sure that the inside of the isolator is clean and free from objects ( stainless-
steel baskets, vials, equipment, etc. ). Tools designed to remain inside the isolator
( scales, etc. ) can remain there. Objects that are left inside the isolator may risk
compromising the quality of the biodecontamination, since the biodecontamination
cycle parameters have been validated with the isolator empty.
Make sure that the gloves and sleeves are installed correctly.
Take a sleeve support and position it in the
sleeve and on the RGI 300 by "separating"
the spring-mounted ring.
"Slip" the cuff ring onto the sleeve support
until it comes to a stop against the bead.
"Hitch" the sleeve up as far as possible to
uncover all its surfaces.
Do the same for the other sleeve supports.
Perform these steps in the opposite order to
remove the sleeve supports.
Make sure a dummy container or a multipurpose container is properly connected to
each DPTE® system and that the doors of all the DPTE® systems are open.
Make sure the outer door of the biodecontamination airlock is closed.