LCB AI3PTRA1 User Manual
Air IDEAL®3P
TM
www.biomerieux.com
Traceability
Solution
AeroBioCollector
User's Manual
96307 - I – en - 2013/09 — P/N 161150 - 190
Distributed by :
LCB 71260 La Salle France
bioMérieux SA Chemin de l'Orme
69280 Marcy-l'Étoile - France
RCS Lyon 673 620 399
Tel. 33 (0)4 78 87 20 00
Fax 33 (0)4 78 87 20 90
7BRevisions
The list of revisions below summarizes replacements or additional pages in your User’s
Manual
Version
Date of
printing
Modifications Pages modified
A 2001/01 Bilingual
(FR / EN)
B 2001/04 Multilingual
(FR / EN / ES / IT / DE / PT)
C 2005/11 Update of the manual
(FR / EN / ES)
D 2006/03 Update of the manual
(FR / EN / ES / IT / DE / PT)
E 2008/03 Environmental conditions
(FR / EN / ES / IT / DE / PT)
F 2010/10 Addition of a remote user interface device (RUID)
to ensure sampling traceability.
G 2011/04 Regulatory modifications:
FCC (USA) and IC (Canada).
All
All
All
All
2-12
All
Pages 2-7, 2-8, 2-11, 2-13
Pages 3-2 and 5-1
H 2011/11 Airflow control 5-1
I 2013/09 Modification of spelling:
- airIDEAL
®
3PTM Traceability
becomes
- Air IDEAL®3PTM Traceability.
Software version change from V9 to V10.
Modification of agar plate references: 96302
becomes 410175 and 96303 becomes
410174.
Deletion of ref 43018
Modification of serial number label
Addition of figure "Diameter of Petri dishes".
Modification of section:
- "Characteristics of materials".
Modification of sections:
- "Cleaning and decontamination procedure"
- "Decontamination of the external part".
All
Warning
3-1
3-2
3-2
3-4
3-6
5-1
5-2
Air IDEAL
®
3P™ Traceability Solution AeroBioCollector User's Manual Revisions-1
Warning
IMPORTANT! Use of the instrument and manual implies acceptance of the clauses below and the
The content of this manual is based on the Software release 10.
This manual is periodically updated. The updates shall be included in the new releases of
the Software.
Information supplied in this manual may be subject to modifications before the products
described become available.
This manual may contain information or references relating to certain bioMérieux SA
products, software or services which are not available in the country of release; this shall not
mean that bioMérieux SA intends to market such products, software or services in such
country
To request copies of publications or for any technical request, contact bioMérieux SA or your
local distributor.
clauses set out in the regulatory booklet. Users are invited to refer to these clauses.
DANGER! To ensure user safety, the instrument must be used in accordance with this manual.
Trademarks
BIOMERIEUX, the blue logo, 3P, Air IDEAL and Count-Tact are used, pending and/or
registered trademarks belonging to bioMérieux, or one of its subsidiaries, or one of
its companies.
ClearKlens IPA is a trademark belonging to Johnson Diversey.
Any other name or trademark is the property of its respective owner.
© 2010 - 2013 bioMérieux SA
Photos: bioMérieux / Printed in France / bioMérieux SA RCS Lyon 673 620 399
Table of contents
1 How to use this manual ........................................................................................................................ 1-1
Finding topics and procedures ......................................................................................................................................1-1
Glossary .......................................................................................................................................................................1-2
Typographic conventions ..............................................................................................................................................1-3
Air IDEAL®3P™ Traceability keypad ............................................................................................................................1-3
2 Functional description .......................................................................................................................... 2-1
Presentation .................................................................................................................................................................2-1
Principle of use .........................................................................................................................................................2-1
Operating principle ...................................................................................................................................................2-2
Performance .............................................................................................................................................................2-2
Collection efficiency validated according to the ISO 14698 standard ...................................................................2-3
Physical efficiency testing approach .....................................................................................................................2-3
Biological efficiency testing approach ...................................................................................................................2-3
Use in glove boxes ...............................................................................................................................................2-3
Applications ..............................................................................................................................................................2-3
3 Using Air IDEAL®3P™ Traceability ...................................................................................................... 3-1
Description ....................................................................................................................................................................3-1
Consumables ............................................................................................................................................................3-2
Culture media for general use ..............................................................................................................................3-2
Irradiated media ....................................................................................................................................................3-2
Identification of the instrument ..................................................................................................................................3-2
Front face of the Air IDEAL®3P™ Traceability ..........................................................................................................3-3
Rear face of the Air IDEAL®3P™ Traceability ..........................................................................................................3-3
Keypad .....................................................................................................................................................................3-4
Sampling grid ................................................................................................................................................................3-4
Configuration for 65, 70 or 90 mm Petri dishes ........................................................................................................3-4
Tripod assembly .......................................................................................................................................................3-5
General specifications ..................................................................................................................................................3-6
Environmental conditions..........................................................................................................................................3-6
Physical features ......................................................................................................................................................3-6
Dimensions ...........................................................................................................................................................3-6
Mass .....................................................................................................................................................................3-6
Materials ...............................................................................................................................................................3-6
Characteristics of materials ..................................................................................................................................3-6
Technical characteristics ..........................................................................................................................................3-7
Electrical characteristics ...........................................................................................................................................3-8
Functional specifications...........................................................................................................................................3-8
Unpacking Air IDEAL®3P™ Traceability .......................................................................................................................3-9
Recommendations for installation and use ...................................................................................................................3-9
Sampling positions .....................................................................................................................................................3-11
Screwing on the sampling grid ....................................................................................................................................3-12
Electrical power supply ...............................................................................................................................................3-12
Operation on the battery .........................................................................................................................................3-12
Low battery signals .............................................................................................................................................3-13
Charging .............................................................................................................................................................3-13
Operation using mains power .................................................................................................................................3-14
Automatic standby ..................................................................................................................................................3-14
Automatic switch off ................................................................................................................................................3-14
Operation in slave mode .............................................................................................................................................3-15
Operation in manual mode .........................................................................................................................................3-15
Programming ..........................................................................................................................................................3-15
Programming characteristics ..............................................................................................................................3-15
Sampling controls ...............................................................................................................................................3-15
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual I-1
Table of contents
Air IDEAL®3P™ Traceability menus ...................................................................................................................... 3-16
Turning on Air IDEAL®3P™ Traceability ................................................................................................................ 3-17
Standby .................................................................................................................................................................. 3-18
Turning off Air IDEAL®3P™ Traceability ................................................................................................................ 3-18
Selection of one of the 4 pre-programmed sample volumes (Menu 1) .................................................................. 3-18
Programming a sample volume not in memory (Menu 2) ...................................................................................... 3-19
Modification of the 4 pre-programmed sample volumes (Menu 3) ......................................................................... 3-20
Programming delayed start-up (Menu 4) ............................................................................................................... 3-22
Programming sequenced sampling (Menu 5) ........................................................................................................ 3-23
Battery autonomy test (Menu 6) ............................................................................................................................. 3-25
Starting sampling ....................................................................................................................................................... 3-26
Stopping the motor ................................................................................................................................................ 3-28
Setting Air IDEAL®3P™ Traceability parameters (summary diagram) ....................................................................... 3-29
Maintenance Menu .................................................................................................................................................... 3-31
Navigation using < + > and< - > keys .................................................................................................................... 3-31
4 Procedure ............................................................................................................................................... 4-1
Principle ....................................................................................................................................................................... 4-1
Procedure .................................................................................................................................................................... 4-1
How to obtain a good quality sample ........................................................................................................................... 4-2
Precautions of use ................................................................................................................................................... 4-2
Sampling in manual mode ....................................................................................................................................... 4-2
Incubation and reading ............................................................................................................................................ 4-2
Sampling plan .............................................................................................................................................................. 4-3
Recording and evaluating results ................................................................................................................................. 4-3
5 Maintenance ........................................................................................................................................... 5-1
Preventive maintenance .............................................................................................................................................. 5-1
Routine servicing ......................................................................................................................................................... 5-1
Cleaning and decontamination procedure ............................................................................................................... 5-1
Sterilization of grids ................................................................................................................................................. 5-1
Decontamination of external parts ........................................................................................................................... 5-2
Decontamination of the air circuit ............................................................................................................................. 5-2
Decontamination in a glove box ............................................................................................................................... 5-2
Airflow control .......................................................................................................................................................... 5-2
6 Troubleshooting .................................................................................................................................... 6-1
7 Appendix ................................................................................................................................................ 7-1
Using the reading table ................................................................................................................................................ 7-1
Information on FELLER’s law ...................................................................................................................................... 7-1
Reading tables ............................................................................................................................................................. 7-2
I-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
List of figures
Note: Screenshots and figures are given as examples only.
2. Functional description
Figure 2-1: Principle of the impaction biocollector ............................................................................................................2-2
3. Using Air IDEAL®3P™ Traceability
Figure 3-1: Air IDEAL®3P™ Traceability in its carrying case ............................................................................................3-1
Figure 3-2: Identification of the instrument .......................................................................................................................3-2
Figure 3-3: Front face .......................................................................................................................................................3-3
Figure 3-4: Rear face ........................................................................................................................................................3-3
Figure 3-5: Keypad ...........................................................................................................................................................3-4
Figure 3-6: Diameter of Petri dishes .................................................................................................................................3-4
Figure 3-7: Sampling head and grid – 65, 70 or 90 mm Petri dishes ................................................................................3-5
Figure 3-8: Tripod assembly .............................................................................................................................................3-5
Figure 3-9: Sampling positions .......................................................................................................................................3-11
Figure 3-10: Screwing on the sampling grid ...................................................................................................................3-12
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual II-1
Apart from the first page of every chapter, each page of the manual includes a page header
Each page header includes the chapter title and the title of a procedure or its corresponding
1 How to use this manual
IMPORTANT! Please read the "General safety and regulatory information" booklet provided with the
instrument.
Finding topics and procedures
This manual is divided into 7 chapters.
Table of contents
The table of contents of the manual is located on pages I-1 to I-2.
It lists each chapter and the procedures within each chapter.
List of figures
Warnings
Page headers and
page footers
The list of figures for the manual is located on page II-1.
Different types of warnings are used throughout the manual:
- for safety reasons (DANGER!),
- to ensure that the instruments are maintained in good working condition (CAUTION!),
- for regulatory reasons (WARNING!) or,
- for optimum performance of operations, procedures, etc. (IMPORTANT!).
and a footer.
description.
The footers contain the title of the manual, the name of the product and the page number.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 1-1
How to use this manual
instrument used to collect and count viable bacterial and
organisms collected. Statistical correction of the CFU
arithmetic mean of all profile deviations, positive or
their diameter and
arrangement, guarantee a CFU count (positive clusters) and a flow of air corresponding to
(AeroBioCollector) + RUID (remote control) +
Glossary
Glossary
ABS
AeroBioCollector or
Air sampler
CFU
Acrylonitrile butadiene styrene.
Air IDEAL®3P™ Traceability,
fungal particles in a known and precise volume of air.
Number of Colony Forming Units read on the agar plate.
The number of CFU corresponds to the number of clusters that have grown on the agar.
Delayed start-up
Li-ion
MPN
PVDF
Ra coefficient
Time between pressing the START button and the motor starting up.
Lithium ion
Most Probable Number of microvalue (FELLER’s law).
Polyvinylidene fluoride.
Roughness factor of a surface. It is the
negative, compared to the mean line.
RUID "Remote User Interface Device"
Remote control containing the user interface.
Sampling grid
Solution Air IDEAL®3P™
Traceability
Time-delay
Perforated and calibrated plastic device. The number of orifices,
the motor setting.
Air IDEAL®3P™ Traceability
Air IDEAL®3P™ Traceability software.
Two seconds required by the software to record a parameter.
1-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
•
Typographic conventions
These conventions are used in the different chapters of the manual.
How to use this manual
Typographic conventions
Press
PROGRAM 1
A bullet point is used to denote an action to be performed.
This typography is used to represent messages which appear on the display.
Air IDEAL®3P™ Traceability keypad
There are 5 keys on the instrument keypad. (See page 3-4 of the manual).
In this manual, the keys are referred to by their individual names, enclosed in angle brackets
"< >".
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 1-3
2 Functional description
Presentation
"Pharmaceutical manufacturing evolves from an art to a science".
This sentence alone from the FDA Guideline “Pharmaceutical cGMPs for the 21
A Risk-Based Approach” summarizes the current revolution in the Pharmaceutical industry.
Conscious of these changes and remaining attentive to its customers, bioMérieux decided to
improve its Air IDEAL
new needs.
The instrument was thus developed and validated in order to provide a tool to the
pharmaceutical industry that would guarantee a scientifically proven method of air sampling.
This instrument evidently remains perfectly suited to the enumeration of airborne microorganisms in less demanding work environments such as agribusiness.
In addition and in order to continue its universal application,
Air IDEAL®3P™ Traceability is still available in two versions:
− one for the use of culture media in 90 mm diameter Petri dishes,
− the other designed for use with 65 or 70 mm plates.
The aspiration flow-rate of Air IDEAL
impact velocity of less than 20 m/s.
According to good sterilization practices, sampling grids can be sterilized in an autoclave,
see "Sterilization of grids" on page 5-1.
®
3P™ Traceability AeroBioCollector in order to best respond to these
st
century –
®
3P™ Traceability is calibrated at 100 l/min with an
Principle of use
Air IDEAL®3P™ Traceability can operate in 2 modes:
• Slave mode: using Air IDEAL
• Manual mode: autonomous operation using the keypad.
®
3P™ Traceability with the RUID.
The present manual describes how to use the instrument in manual mode;
for use of the instrument in slave mode, please refer to the RUID User
Manual.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 2-1
Functional description
Calibrated orifice
Air inlet
Nutrient medium
Air jets
Micro-organisms
Air outlet
90 or 65/70 mm diameter
Presentation
Operating principle
Air IDEAL®3P™ Traceability is an impaction AeroBioCollector used to detect the presence
of viable micro-organisms in the environment to be tested, by precise sampling of a given
volume of air.
Air is taken up with a turbine through a grid surface. The acceleration of airflow results in the
impaction of airborne micro-organisms on the agar. Passage of the air through the grid filters
out particles, thereby facilitating the enumeration of CFU (colony forming units) after
incubation of the medium.
A reading and statistical correction table is used to convert the number of CFU to the most
probable number of micro-organisms collected per m
Impaction
3
of air.
Petri dishes
Figure 2-1: Principle of the impaction biocollector
Performance
The performance characteristics of an AeroBioCollector depend on its capacity to collect
micro-organisms in the air without compromising their viability during impaction on the agar.
This property can be obtained only with a perfect compromise between the high aspiration
velocity leading to effective collection, and a sufficiently low impaction velocity to guarantee
the revivification of collected micro-organisms.
Air IDEAL
®
3P™ Traceability was developed in close cooperation with aeraulics experts in
order to optimize this ratio.
Since the industry has increasing needs for scientifically proven methods, bioMérieux
commissioned two recognized independent organizations
∗
to validate the physical and
biological efficiency of the instrument.
∗
CETIAT: Centre Technique des Industries Aérauliques et Thermiques/Technical Center of Aeraulic and Thermal Industries
HPA : Health Protection Agency - Porton Down - Wiltshire SP4 0JG Salisbury - UK
2-2 Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual
Domaine Scientifique de la Doua, 69603 Villeurbanne, France
Collection efficiency validated according to the ISO 14698 standard
Functional description
Presentation
Air IDEAL
®
3P™ Traceability was third party validated by the Health Protection Agency
(UK) to meet the requirements of ISO 14698-1 for the control of clean rooms. Both the
physical and biological efficiencies of the equipment have been validated according to this
standard.
Physical efficiency testing approach
The physical efficiency of an air sampler for collecting airborne bacteria is evaluated by
comparison with a membrane filter sampler. Uniform particles of different diameters
containing bacterial spores of Bacillus subtilis var niger were generated in a controlled room.
The physical efficiency of the instrument was determined by comparison with the membrane
filtration standard operating side-by-side.
Biological efficiency testing approach
Air sampler inefficiency can either be due to a failure of the sampler to capture particles
containing micro-organisms (physical loss), or to inactivation of viable micro-organisms
during collection, so that formation of visible colonies on agar will not occur (biological loss).
To address this point, Air IDEAL
of Bacillus subtilis (standard indicator for physical loss) and Staphylococcus epidermidis
(standard indicator for biological loss).
The ratio of S. epidermidis / B. subtilis for the test samplers was divided by the ratio
obtained with the reference standard membrane filter sampler to give a comparative
biological efficiency.
®
3P™ Traceability was evaluated for recovery of a mixture
Use in glove boxes
Applications
In order to be used to test glove boxes, the design and materials of
Air IDEAL
®
3P™ Traceability had to be entirely reviewed in order to optimize system air
tightness.
In addition and in order to guarantee the optimal operation of the instrument in this
application, the system underwent a complete validation in a glove box (SKAN AG, model
ARIS glove box).
Air IDEAL
®
3P™ Traceability enables precise and reproducible air sampling.
The volumes taken can be set in 10 l steps up to a maximum volume of 2000 l.
This sampling range enables the instrument to be used in all types of environments, from
sterile zones to more contaminated surroundings and in all applications, e.g. qualification of
sterile rooms or daily monitoring.
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 2-3
3 Using Air IDEAL®3P™ Traceability
Description
Air IDEAL®3P™ Traceability is supplied in a carrying case. Inside the case is a rigid lid
which can be used as a small work surface [dimensions 22.7 x 13.9 cm
(8.9 in. x 5.4 in.)].
The instrument is available in two versions:
− for 90 mm agar plates (product no. 410175)
− for 65/70 mm agar plates Count-Tact
∗ For each product number, please refer to the packing list provided with the instrument.
®
(product no. 410174)
∗ Accessories:
− 65/70 mm Count-Tact diameter additional sampling grid (product No. 96304).
− 90 mm diameter additional sampling grid (product No. 96309).
− Aluminum telescopic tripod with ball joint (product No. 96308).
− Sterile box for transport and incubation of 65/70 mm Count-Tact plates – Kit of 10
− Sterile box for transport and incubation of 90 mm plates – Kit of 10
Figure 3-1: Air IDEAL®3P™ Traceability in its carrying case
(product No. 96301).
*
(product No. 96311
).
*
Availability: consult bioMérieux
Air IDEAL®3P™ Traceability Solution AeroBioCollector User's Manual 3-1
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