Getinge ISOTEST User Manual

GETINGE-LA CALHENE ISOTEST | User manual
NTA 3015/78 C
Approuvé informatiquement / Electronic signature
DEX | Page 60/
74
11. DEFINITION OF THE TECHNICAL TERMS
Work station
(or work isolator)
Sealed volume in which the work is performed.
STERITRACE II Hydrogen peroxide sterilizer (H
2
O
2
).
Open loop
The sterilizer only takes care of the sterilant intake, the outlet
is provided by the isolator extractor.
Closed loop
The sterilizer takes care of the sterilant intake and outlet in the
enclosure.
Dust accumulation
class
Classification for comparing the airborne contamination levels
of one enclosure with another.
Biodecontamination
Sterilization of surfaces using a sterilant in vapour phase.
DPTE® transfer system
Secure transfer system with a double door. The safest method
for introducing and eliminating sterile and/or toxic products
without breach of containment.
DPTE® ALPHA
Cell clamp / cell door assembly. Fixed part of the DPTE®
mounted on the isolator wall.
DPTE® BETA
Container clamp / container door / container body assembly.
Mobile part of the DPTE® (for example a container).
DPTE-BetaBag
TM
System for evacuating waste with no risk of contaminating the
environment.
Tubing System
The tubing system has been designed to allow dynamic sterile
transfer of equipment or products from inside the isolator to
the outside, in a semi-continuous way without breach of
containment.
Production phase
Work campaign
Aeration phase
Isolator / airlock aeration to eliminate sterilant vapours.
RFID
Radio Frequency Identification. Radio frequency
identification is a method for remotely storing and recovering
data using markers called RFID tags or RFID transponders.
RFID tags are small objects, such as self-adhesive labels,
which can be affixed or added to objects or products or even
implanted in living organisms. RFID tags consist of an
antenna associated with an electronic chip which allows them
to receive and reply to radio requests emitted by the
transceiver. These electronic chips contain an identifier and,
optionally, additional data.

Getinge ISOTEST Specifications

General

Brand	Getinge
Model	ISOTEST
Category	Test Equipment
Language	English