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

GETINGE-LA CALHENE ISOTEST | User manual
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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

GETINGE-LA CALHENE ISOTEST | User manual
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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.