LCB AI3PTRA User Manual
Solution
airIDEAL
®
3P
TM
Traceability
AeroBioCollector
User's Manual
96307 - G – en - 2010/07 — P/N 4501 - 1716
Manufactured par:
Distributed by:
LCB 71260 La Salle France
bioMérieux S.A. 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
http://www.biomerieux.com
Revisions
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 2011/01 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
airIDEAL
®
3P™ Traceability AeroBioCollector User's Manual Revisions-1
Warning
IMPORTANT! Use of the instrument and manual implies acceptance of the clauses
The content of this manual is based on the Software release 0.9
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 S.A. products, software or services which are not available in the
country of release; this shall not mean that bioMérieux S.A. intends to market
such products, software or services in such country
To request copies of publications or for any technical request, contact
bioMérieux S.A. or your local distributor.
below and the 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
bioMérieux, the blue logo, 3P, airIDEAL and Count-Tact are used, pending
and/or registered trademarks belonging to bioMérieux S.A. or one of its
subsidiaries.
Any other name or trademark is the property of its respective owner.
© 2010 bioMérieux S.A.
Photos: bioMérieux / Printed in France / bioMérieux S.A. 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
The airIDEAL 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 ......................................................................................................................2-4
Applications....................................................................................................................................... 2-4
Description.............................................................................................................................................. 2-5
Consumables ....................................................................................................................................2-6
Culture media for general use .....................................................................................................2-6
Irradiated media........................................................................................................................... 2-6
Identification of the instrument .......................................................................................................... 2-7
Front face of the airIDEAL 3P Traceability...................................................................................... 2-7
Rear face of the airIDEAL 3P Traceability ...................................................................................... 2-8
Keypad .............................................................................................................................................. 2-8
Configuration for 65, 70 or 90 mm Petri dishes ................................................................................. 2-9
Tripod assembly .............................................................................................................................. 2-10
General specifications........................................................................................................................... 2-11
Environmental conditions ................................................................................................................ 2-11
Physical features ............................................................................................................................. 2-11
Dimensions................................................................................................................................ 2-11
Mass .......................................................................................................................................... 2-11
Materials .................................................................................................................................... 2-11
Characteristics of materials .......................................................................................................2-11
Technical characteristics ................................................................................................................. 2-12
Electrical characteristics.................................................................................................................. 2-13
Functional specifications ................................................................................................................. 2-13
airIDEAL
®
3P™ Traceability AeroBioCollector User's Manual I-1
Table of contents
Using airIDEAL 3P Traceability 3-1
3
Unpacking airIDEAL 3P Traceability.....................................................................................................3-1
Recommendations for installation and use .............................................................................................3-2
Cleaning and decontamination procedure...............................................................................................3-2
Sterilization of grids ...........................................................................................................................3-3
Decontamination of the external part.................................................................................................3-3
Decontamination of the air circuit ...................................................................................................... 3-3
Decontamination in a glove box ........................................................................................................3-3
Sampling positions..................................................................................................................................3-4
Screwing on the sampling grid ................................................................................................................3-5
Electrical power supply ...........................................................................................................................3-6
Operation on the battery.................................................................................................................... 3-6
Low battery signals ...................................................................................................................... 3-6
Charging ......................................................................................................................................3-7
Operation using mains power............................................................................................................3-8
Automatic standby.............................................................................................................................3-8
Automatic switch off ..........................................................................................................................3-8
Operation in slave mode .........................................................................................................................3-9
Operation in manual mode......................................................................................................................3-9
Programming.....................................................................................................................................3-9
Programming characteristics .......................................................................................................3-9
Sampling controls ........................................................................................................................ 3-9
airIDEAL 3P Traceability menus......................................................................................................3-10
Turning on airIDEAL 3P Traceability ...............................................................................................3-11
Standby ...........................................................................................................................................3-12
Turning off airIDEAL 3P Traceability.............................................................................................3-12
Selection of one of the 4 pre-programmed sample volumes (Menu 1) ............................................ 3-12
Programming a sample volume not in memory (Menu 2)................................................................ 3-14
Modification of the 4 pre-programmed sample volumes (Menu 3)................................................... 3-15
Programming delayed start-up (Menu 4) ......................................................................................... 3-18
Programming sequenced sampling (Menu 5)..................................................................................3-20
Battery autonomy test (Menu 6) ......................................................................................................3-22
Starting sampling ...............................................................................................................................3-23
Stopping the motor ..........................................................................................................................3-25
Setting airIDEAL 3P Traceability parameters (summary diagram)...................................................3-26
Navigation using <+> and<-> keys........................................................................................................3-28
I-2 airIDEAL® 3P™ Traceability AeroBioCollector User's Manual
Table of contents
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.................................................................................................................4-3
Incubation and reading......................................................................................................................4-3
Sampling plan ......................................................................................................................................... 4-4
Recording and evaluating results............................................................................................................4-5
5 Maintenance 5-1
Preventive maintenance .........................................................................................................................5-1
Routine servicing ....................................................................................................................................5-2
Cleaning ............................................................................................................................................ 5-2
Decontamination of the external part.................................................................................................5-2
Decontamination of the air circuit ...................................................................................................... 5-2
Decontamination in a glove box ........................................................................................................ 5-2
Sterilization of the sampling grid .......................................................................................................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 .................................................................................................................7-2
Reading tables ........................................................................................................................................ 7-3
Notes
airIDEAL® 3P™ Traceability AeroBioCollector User's Manual I-3
Note: Screen captures and figures are given as examples only.
2 Functional description
Figure 2-1: Principle of the impaction biocollector .......................................................................2-2
Figure 2-2: airIDEAL 3P Traceability in its carrying case...........................................................2-5
Figure 2-3: Identification of the instrument...................................................................................2-7
Figure 2-4: Front face .................................................................................................................. 2-7
Figure 2-5: Rear face................................................................................................................... 2-8
Figure 2-6: Keypad ...................................................................................................................... 2-8
Figure 2-7: Sampling head and grid – 65, 70 or 90 mm Petri dishes ........................................... 2-9
Figure 2-8: Tripod assembly ...................................................................................................... 2-10
List of figures
3 Using airIDEAL 3P Traceability
Figure 3-1: Sampling positions ....................................................................................................3-4
Figure 3-2: Screwing on the sampling grid................................................................................... 3-5
I-4 airIDEAL
®
3P™ Traceability AeroBioCollector User's Manual
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
List of figures
The table of contents of the manual is located on pages I-1 to I-3.
It lists each chapter and the procedures within each chapter.
The list of figures for the manual is located on page I-4.
Warnings
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!).
Page headers and
page footers
Notes
Apart from the first page of every chapter, each page of the manual includes a
page header and a footer.
Each page header includes the chapter title and the title of a procedure or its
corresponding description.
The footers contain the title of the manual, the name of the product and the
page number.
This manual contains a certain number of notes that are used to emphasize a
procedure or certain information.
airIDEAL
®
3P™ Traceability AeroBioCollector User's Manual 1-1
How to use this manual
Glossary
Glossary
ABS Acrylonitrile butadiene styrene.
AeroBioCollector or
Air sampler
CFU
Delayed start-up
Li-ion
MPN
PVDF Polyvinylidene fluoride.
Ra coefficient
RUID "Remote User Interface Device"
Sampling grid
airIDEAL 3P Traceability, instrument used to collect and count viable bacterial
and 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.
Time between pressing the
Lithium ion
Most Probable Number of micro-organisms collected. Statistical correction of
the CFU value (FELLER’s law).
Roughness factor of a surface. It is the arithmetic mean of all profile deviations,
positive or negative, compared to the mean line.
Remote control containing the user interface.
Perforated and calibrated plastic device. The number of orifices, their diameter
and arrangement, guarantee a CFU count (positive clusters) and a flow of air
corresponding to the motor setting.
START button and the motor starting up.
Solution
airIDEAL 3P Traceability
Time-delay
1-2 airIDEAL® 3P™ Traceability AeroBioCollector User's Manual
airIDEAL 3P Traceability (AeroBioCollector) + RUID (remote control) +
airIDEAL 3P Traceability software.
Two seconds required by the software to record a parameter.
How to use this manual
Typographic conventions
Typographic conventions
These conventions are used in the different chapters of the manual.
• 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.
The airIDEAL 3P Traceability keypad
There are 5 keys on the instrument keypad. (See page 2-8 of the manual).
In this manual, the keys are referred to by their individual names, enclosed in
angle brackets "< >".
1
2
3
airIDEAL
®
3P™ Traceability AeroBioCollector User's Manual 1-3
4
5
2 Functional description
Presentation
“Pharmaceutical manufacturing evolves from an art to a science”.
This sentence alone from the FDA Guideline “Pharmaceutical cGMP for the 21st
century – 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 airIDEAL 3P Traceability AeroBioCollector in
Principle of use
order to best respond to these 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
micro-organisms in less demanding work environments such as agribusiness.
In addition and in order to continue its universal application,
airIDEAL 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 airIDEAL 3P Traceability is calibrated at 100 l/min
with an 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 3-3.
1
2
3
4
airIDEAL 3P Traceability can operate in 2 modes:
• Slave mode: using airIDEAL 3P Traceability with the RUID.
• Manual mode: autonomous operation using the keypad.
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.
airIDEAL® 3P™ Traceability AeroBioCollector User's Manual 2-1
5
Functional description
A
A
A
Presentation
Operating prin ciple
airIDEAL 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
ir inlet
Micro-organisms
Impaction
Nutrient medium
90 or 65 mm diameter
Petri dishes
ir outlet
3
of air.
Calibrated orifice
ir jets
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.
airIDEAL 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
Domaine Scientifique de la Doua, 69603 Villeurbanne, France
HPA : Health Protection Agency - Porton Down - Wiltshire SP4 0JG Salisbury - UK
2-2 airIDEAL® 3P™ Traceability AeroBioCollector User's Manual
Functional description
Presentation
Collection efficiency validated according to the ISO 14698 standard
airIDEAL 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 sideby-side.
1
2
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, airIDEAL 3P Traceability was evaluated for recovery of a
mixture 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.
airIDEAL® 3P™ Traceability AeroBioCollector User's Manual 2-3
3
4
5
Functional description
Presentation
Use in glove boxes
In order to be used to test glove boxes, the design and materials of
airIDEAL 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).
Applications
airIDEAL 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.
2-4 airIDEAL® 3P™ Traceability AeroBioCollector User's Manual
Functional description
Description
Description
airIDEAL 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. 96302)
− for 65/70 mm agar plates Count-Tact
®
(product no. 96303)
∗ For each product no., please refer to the packing list provided with the
instrument.
1
2
3
Figure 2-2: airIDEAL 3P Traceability in its carrying case
∗ 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
(product No. 96301).
− Sterile box for transport and incubation of 90 mm plates – Kit of 10
(product No. 96311
*
).
4
5
*
Availability: consult bioMérieux
airIDEAL® 3P™ Traceability AeroBioCollector User's Manual 2-5
Functional description
Description
Consumables
airIDEAL 3P Traceability is adapted to all types of Petri dishes available on the
market: 65, 70 and 90 mm.
Moreover, the use of a large range of ready-to-use culture media – irradiated or
classic – developed and manufactured by bioMérieux, the reference in this field,
enables you to obtain the best possible performance from the instrument.
The media comply with specific industrial and hospital environmental controls.
Culture media for general use
− TSA 20 x 90 mm plates (product No. 43011) / GTS 100 x 90 mm plates
(product no. 43018 and product no. 43019)
− PCA agar 20 x 90 mm plates (product no. 43558)
− Sabouraud Dextrose agar 20 x 90 mm plates (product no. 43555)
− Sabouraud Dextrose Chloramphenicol agar 20 x 90 mm plates (product no.
43596)
− Count-Tact
− Count-Tact TSA agar 20 x 65 mm plates (product no. 43582)
− Count-Tact Sabouraud Dextrose Chloramphenicol agar 20 x 65 mm plates
(product no. 43580)
®
agar 20 x 65 mm plates (product no. 43501)
Irradiated media
− Irradiated GTS 3P agar 20 x 90 mm plates (product no. 43711)
− Irradiated GTS 3P agar 100 x 90 mm plates (product no. 43169)
− Irradiated GTS 3P agar with neutralizers 20 plates (product no. 43811)
− Irradiated GTS 3P agar with neutralizers 100 plates (product no. 43819)
− Irradiated Count-Tact 3P agar 20 x 65 mm plates (product no. 43691)
− Irradiated Count-Tact 3P agar 100 x 65 mm plates (product no. 43699)
− irradiated Sabouraud Dextrose agar 20 x 90 mm plates (product no. 43554)
− Irradiated Sabouraud Dextrose 3P agar with neutralizers 20 plates (product
no. 43814)
− Irradiated Sabouraud Dextrose Chloramphenicol agar 20 x 90 mm plates
(product no. 43595)
− Irradiated Count-Tact Sabouraud Dextrose 3P agar with neutralizers 20
plates (product no. 43812)
− Irradiated Count-Tact Sabouraud Dextrose Chloramphenicol agar with
neutralizers 20 x 65 mm plates (product no. 43581)
2-6 airIDEAL® 3P™ Traceability AeroBioCollector User's Manual
Functional description
Description
Identification of the instrumen t
Figure 2-3: Identification of the instrument
Front face of the airIDEAL 3P Traceability
1
2
3
airIDEAL® 3P™ Traceability AeroBioCollector User's Manual 2-7
Figure 2-4: Front face
4
5
Functional description
A
Description
Rear face of the airIDEAL 3P Traceability
Handle
ir outlet
Threading
for tripod
Jack socket
Figure 2-5: Rear face
Keypad
+
ON
2-8 airIDEAL® 3P™ Traceability AeroBioCollector User's Manual
OFF
START
STOP
MENU
-
Figure 2-6: Keypad
Functional description
A
Description
Configuration for 65, 70 or 90 mm Petri dishes
Sampling grid for 65 or 70 mm Petri dishes
®
65 or 70 mm (Count-Tact
) Petri dish
Stainless steel strip
for attachment
Seal
1
Sampling grid for 90 mm Petri dishes
2
90 mm Petri dish
spiration orifice
3
4
Figure 2-7: Sampling head and grid – 65, 70 or 90 mm Petri dishes
airIDEAL® 3P™ Traceability AeroBioCollector User's Manual 2-9
5
Functional description
Description
Tripod assembly
Figure 2-8: Tripod assembly
2-10 airIDEAL® 3P™ Traceability AeroBioCollector User's Manual
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