Getinge ISOTEST User manual

ISOTEST
USER MANUAL

GETINGE-LA CALHENE ISOTEST | User manual
NTA 3015/78 C Approuvé informatiquement / Electronic signature
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74
Title :
ISOTEST
Document type :
User manual
Customer reference : GLC reference:
Customer : Number of pages : 74
Version : C Date: 07.07.2010
REVISION HISTORY
Date Version Description Written by
22.12.2009 A
First issue (09/186) E. Delombaerde
12.02.2010 B
General update (10/037) S. Chauvin
07.07.2010 C
Issue of software modifications (10/163)
− Addition of:
 “Start loading” button
 “Waiting production phase”
 a screen to select batch number
E. Delombaerde
Date Written by Reviewed by Approved by
07.07.2010 E. Delombaerde S. Chauvin D. Papin

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CONTENTS
Page
1.
IDENTIFICATION................................................................................................................ 5
1.1.
ISOLATOR BRAND AND DESCRIPTION................................................................ 5
1.2. VERSION OF THE ISOLATOR AND THE SOFTWARE.......................................... 5
1.3. MANUFACTURER'S NAME AND ADDRESS .......................................................... 6
2.
COMPLIANCE REPORT .................................................................................................... 7
3.
SAFETY NOTES................................................................................................................. 8
3.1.
DEFINITIONS AND WARNINGS.............................................................................. 8
3.2. GENERAL................................................................................................................. 9
4.
GENERAL OPERATION AND RANGE OF APPLICATIONS............................................. 10
5.
SAFETY INFORMATION .................................................................................................... 11
6.
COMMISSIONING .............................................................................................................. 13
7.
EQUIPMENT DESCRIPTION ............................................................................................. 14
7.1.
OVERVIEW............................................................................................................... 14
7.2. OPERATOR INTERFACE ........................................................................................ 16
7.3. WORK STATION ...................................................................................................... 17
7.4. BIODECONTAMINATION AIRLOCK........................................................................ 18
7.5. STERITRACE II STERILIZER INTERFACE............................................................. 19
7.6. HANDLING ............................................................................................................... 20
8.
OPERATION ....................................................................................................................... 23
8.1.
TRANSFER SYSTEM............................................................................................... 23
8.2. PROCESS ................................................................................................................ 25
8.3. STOPPING A CYCLE BY THE USER...................................................................... 43
8.4. EMERGENCY AERATION ....................................................................................... 44
8.5. PRINTING................................................................................................................. 45
8.6. PROCESS ALARMS................................................................................................. 51
8.7. RECIPE..................................................................................................................... 52
8.8. CLEANING................................................................................................................ 55

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9.
INSTRUCTIONS FOR THE TOOLS AND ACCESSORIES ............................................... 56
9.1.
DPTE-BETA BAG
TM
.................................................................................................. 56
9.2. TUBING SYSTEM..................................................................................................... 56
10.
OPTION LIST ...................................................................................................................... 59
10.1.
CONTROL SYSTEM................................................................................................. 59
10.2. ACCESSORIES ........................................................................................................ 59
10.3. CONSUMABLES ...................................................................................................... 59
11.
DEFINITION OF THE TECHNICAL TERMS ...................................................................... 60
APPENDICES ..................................................................................................................... 61
Appen ix 1 "Hy rogen peroxi e pro uct sheet" .......................................................................................... 1 page
Appen ix 2 "Hy rogen peroxi e safety ata sheet" ..................................................................................... 11 pages

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1. IDENTIFICATION
1.1. ISOLATOR BRAND AND DESCRIPTION
ISOTEST Rigid-wall isolator for the performance of sterility tests
(European version)
1. . VERSION OF THE ISOLATOR AND THE SOFTWARE
The isolator is identified by its serial number and by the software version indicated on the
operator panel (see technical manual, configuration chapter).

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1.3. MANUFACTURER'S NAME AND ADDRESS
GETINGE-LA CALHENE
1, rue du Comté de Donegal
41102 Vendôme cedex – France
 [phone]
 [phone]
www.getinge-lacalhene.com
Isolator serial
number
Operator panel and
PLC program
version number

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. COMPLIANCE REPORT
− EMC directive no. 89/336/EEC modified by directives 91/263/EEC, 92/31/EEC, 93/68/EEC,
92/31/EEC.
− Low voltage directive no. 73/23/EEC.
− Test voltage (stan ar test): as per EN 61 010-1, 2001 issue.
− Overvoltage classification II, pollution level 2
− Electrical safety: as per EN 61 010-1, 2001 issue.
− Electromagnetic compatibility:
 Emission according to EN 61000-6-4, 2007 issue
 Immunity according to EN 61000-6-2, 2005 issue
− Personal protective equipment (gloves) directive no. 89/686/EEC.

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3. SAFETY NOTES
3.1. DEFINITIONS AND WARNINGS
DANGER
Means that failure to apply the correct safety measures will result
in death or serious injury.
WARNING
Means that failure to apply the correct safety measures may
result in death or serious injury.
CAUTION
Means, when placed next to a warning triangle, that failure to
apply the correct safety measures may result in mild injury.
CAUTION Means, when not placed next to a warning triangle, that failure to
apply the correct safety measures may result in material damage.
IMPORTANT Means that, if the COMMENTS in question are not taken into
account, an unwanted result or status may be obtained.
COMMENTS
In these documents, "COMMENTS" are used to draw the
reader's attention to important information concerning the product
or a specific part of the document.
Means that the reader should consult the user manual to find out
the usage procedures and limitations

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3. . GENERAL
WARNING
This equipment uses hydrogen peroxide, electricity and
compressed air.
Failure to observe the recommendations and instructions
included in this manual may result in serious injury or
considerable material damage. Only qualified personnel
completely familiarised with all the safety rules and the
installation, operation and maintenance procedures set forth in
the various manuals is authorised to work on this equipment.
The correct and safe operation of this equipment requires
installation, use and maintenance in accordance with good
engineering practices.
CAUTION
This equipment should only be used for the purposes indicated
by its manufacturer. Unauthorised modifications and the use of
spare parts and accessories that are not sold or recommended
by the equipment manufacturer may result in fires, electric
shocks and injuries.
IMPORTANT
This manual must be kept within reach nearby the equipment,
and a copy must be sent to every user. All measurement and
testing operations to be performed on the live equipment must
comply with the applicable work safety regulations in the
country in question. It is advisable to use suitable tools. Before
installation and commissioning, please take the time to read the
safety instructions and the warnings included in this manual, as
well as all the warning labels affixed to the equipment. Please
make sure that these warning labels are always readable and
replace any missing or damaged labels.
Qualified personnel
In this manual, "qualified person" refers to a person who is
familiar with the installation, assembly, starting-up and use of
the equipment, as well as with the risks incurred.
Use of the
equipment
according to its
destination
The equipment should only be used for the applications
specified in the manual, with devices and components
recommended and approved by Getinge-La Calhène

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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 (Rigi -wall stainless-steel isolator with fixe
glass win ow an oor) 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.

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5. SAFETY INFORMATION
DANGER
Do not use the ISOCYT isolator in an explosive atmosphere.
Only use "HYDROCYDE" hydrogen peroxide with a concentration
of 35 % as recommended by Getinge-La Calhène
WARNING
The ISOCYT isolator makes use of hazardous toxic products. The
user must take all necessary steps before the proper authorities to
have this new equipment included in their safety analysis study.
The technicians who will use these machines must have previously
undergone a specific adapted training process.
When handling hydrogen peroxide, please consult the product
toxicity sheet (see appen ix).
It is compulsory to wear gloves and goggles when handling
hydrogen peroxide.
Only persons who have been trained in using the ISOCYT isolator
are authorised to perform biodecontamination cycles.
In the event of a leak of hydrogen peroxide in liquid or gaseous
form during a biodecontamination cycle, the operators must
press the "EMERGENCY AERATION" button twice in less than
8 seconds and evacuate the hazard area.
An emergency / evacuation procedure must be in place for this
purpose.
During the biodecontamination phase, the isolators must be
connected to an extractor linked directly to the outside of a building
to allow aeration.
Make sure that the extractors, generally located on the roof, are
protected against rain and high winds and sufficiently separated
from passage areas and other heating, ventilation and A/C air
intakes.
The isolator pipes may only be removed after carrying out after the
auxiliary isolator aeration phase, taking all necessary precautions in
order to compensate for the risk of residual H
2
O
2
in the pipes.

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WARNING
All maintenance operations must be performed after aerating
the circuits that contain hydrogen peroxide in gaseous form
and purging the circuits in which the sterilant is in liquid form.
It is compulsory to rinse with water when removing a
component on the injection circuit.
CAUTION
It is advisable to install hydrogen peroxide detectors in the
room where the isolator is installed (acceptable exposure
threshol : 1 ppm – 1.4 mg/m³).
It is advisable to install a luminous signal to show when a
biodecontamination phase is in progress to warn operators
who want to access the room (contact available on the
terminal block).
CAUTION
The outer door of the biodecontamination airlock SHOULD
NEVER be used as a support for setting any type of object,
even on a temporary basis. This may affect the adjustment of
the door, compromising its seal.
DANGER
Before opening the inner door, it is advisable to make sure
that no objects on the work top will interfere with its opening.
It is also imperative for the operator handling the door to
make sure that the second operator (using the other station)
has been warned and has not placed his hands under the
door. When opening, use one hand to hold the handle,
making sure to operate the door under optimum conditions.
Failure to observe this instruction may result in injuries to the
operator due to impact with the door or his hands getting
caught between the door and an object placed on the work
top.
CAUTION
When closing one of the two doors (inner oor an outer oor
of the bio econtamination airlock), it is advisable to check that
no objects will get caught between the door and the seal. This
may cause a leak-tightness fault. The leak test before a
biodecontamination cycle may fail in this case, making it
impossible to use the device.

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6. COMMISSIONING
− Set the master switch to position 1.
− Check that the operator panel switches on. The welcome view appears automatically:

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7. EQUIPMENT DESCRIPTION
7.1. OVERVIEW
Number Designation
1 Work station
2 Sleeves and gloves
3 Quick biodecontamination airlock
4 H
2
O
2
container
5 Red/green LEDs for door opening authorisation
6 Touch-sensitive operator interface
3
5
1
4
6

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Number Designation
1 Ventilation / Filtration
2 Control-command
3 Biodecontamination airlock
4 Built-in STERITRACE II hydrogen peroxide sterilizer
3
1
4

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7. . OPERATOR INTERFACE
Number Designation
1 Master power switch
2 EMERGENCY AERATION push-button
3 Touch screen
3
1

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7.3. WORK STATION
Number Designation
1 Steritest pump
2 DPTE® S transfer system
3 Basket hanging bars
4 Sleeve and glove
DANGER
Special precautions must be taken when opening the inner door.
Consult chapter 5 – Information and Safety.
3
1
4

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7.4. BIODECONTAMINATION AIRLOCK
Number Designation
1 Transfer trolley
2 Biodecontamination airlock door
3 Sealing gaskets
4 Inner door
5 Basket
6 Inspection window
IMPORTANT To help when loading the baskets in the transfer trolley, a preparation
trolley can be placed in front of the airlock.
4
5
1
6
3

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7.5. STERITRACE II STERILIZER INTERFACE
Number Designation
1 Needle-positioning lever (perforation of the cap of the vial)
2 Vial container
3 Hydrogen peroxide vial
3
1

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7.6. HANDLING
Before each sterilization cycle, Getinge-La Calhène recommends checking the integrity of
the isolator gloves. The method consists of:
− conducting a test by raising the oxygen level to assess glove performance (GLT
testing evice – operator manual NT 3020/1)
If the result of the test is "not correct", the glove must be replaced.
The procedure for replacing a glove without breach of containment is as follows:
Installation of gloves for an isolator under positive pressure
− Pull the glove (2) to be replaced inside out into the sleeve (1).
− Remove the tightening ring (3).
− Position the new glove (5) parallel to the cuff ring (4) aligning the axis of the thumb
with the seal of the sleeve.
− Install the new glove (5) on the cuff ring (4) up from the bead (6) of the glove to be
replaced.
− Place the tightening ring (3) around the glove behind the bead (6).
− Position the bead (6) of the glove and the tightening ring (3) on the end of the cuff
ring groove (4).
− Remove the glove (2) from the sleeve (1).
− Extract the glove (2).
1
3
4
5
6
1
3
4
6