Getinge ISOTEST, User Manual

Page: 10 / 74

GETINGE-LA CALHENE ISOTEST | User manual
NTA 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page
10
/
74
4. GENERAL OPERATION AND RANGE OF APPLICATIONS
The ISOTEST isolator is a sealed enclosure which allows its user to perform
biodecontamination of various surfaces inside the isolator by chemical means in a closed
circuit. The unit is designed and equipped so as to be able to be biodecontaminated using
hydrogen peroxide, H
2
O
2
.
APPLICATION : Rigid-wall isolator for the performance of sterility tests.
The isolator is equipped with a ventilation and filtering module that maintains an overpressure
inside the sterile volume while guaranteeing minimum air renewal with HEPA-filtered air. The
isolator is furthermore equipped with transfer systems allowing the insertion and removal of
sterile equipment and/or products. Handling systems allow the operator to perform operations
inside the sterile contained environment from the outside.
These instructions are valid for the ISOTEST (Rigid-wall stainless-steel isolator with fixed
glass window and door) operating with overpressure and biodecontaminated with hydrogen
peroxide, H
2
O
2
. It consists of a stainless-steel biodecontamination airlock with interlocked
doors (inflatable seals), a working isolator for performing the sterility test (using a Millipore
Equinox pump or equivalent), and a ventilation/filtering system.