bioMerieux Air IDEAL 3P User manual

Air IDEAL® 3P
User's Manual
161150-208 – I – en - 2012/10 — P/N 161150-208
LCB 71260 La Salle FRANCE
bioMérieux SA Chemin de l'Orme
69280 Marcy-l'Étoile - France
RCS Lyon 673 620 399
Tel. [phone]
Fax [phone]
www.biomerieux.com

Air IDEAL® 3P User’s Manual Revisions-1
Revisions
The list of revisions below summarizes replacements or additional pages in your
Air IDEAL 3P User’s Manual.
Version Date of
printing Modifications Page (s) modified
A 01/2001 Bilingual
(FR / EN)
All
B 04/2001 Multilingual
(FR / EN / ES / IT / DE / PT)
All
C 11/2005 Update of the manual
(FR / EN / ES)
All
D 03/2006 Update of the manual
(FR / EN / ES / IT / DE / PT)
All
E 03/2008 Environmental conditions
(FR / EN / ES / IT / DE / PT)
2-12
F - Not used -
G - Not used -
H - Not used -
I 10/2012 Addition of figure "Diameter of Petri dishes".
Modification of section:
- "Characteristics of materials".
Modification of sections:
- "Cleaning and decontamination"
- "Decontamination of the external part".
Airflow control
3-5
3-7
5-1
5-2

4501-1618 B en
Warning
The content of this manual is based on the Software release V2.
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.
IMPORTANT! Use of the instrument and manual implies acceptance of the clauses below and the
clauses set out in the regulatory booklet. Users are invited to refer to these clauses.
Trademarks
BIOMERIEUX, the blue logo, 3P, Air IDEAL 3P 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.
© 2001 -2012 bioMérieux SA
Photos: bioMérieux / Printed in France / bioMérieux SA RCS Lyon 673 620 399

Air IDEAL® 3P User’s Manual V-1
Table of contents
1How to use this manual 1-1
Finding topics and procedures ....................................................................................................................................1-1
Glossary......................................................................................................................................................................1-2
Typographic conventions ............................................................................................................................................1-3
The Air IDEAL 3P keypad ...........................................................................................................................................1-3
2Functional description 2-1
Presentation................................................................................................................................................................2-1
Operating principle ................................................................................................................................................2-1
Performance..........................................................................................................................................................2-2
Collection efficiency validated according to the ISO 14698 standard ..............................................................2-2
Physical efficiency testing approach ................................................................................................................2-2
Biological efficiency testing approach ..............................................................................................................2-2
Use in glove boxes ..........................................................................................................................................2-2
Applications...........................................................................................................................................................2-2
3Using Air IDEAL 3P 3-1
Description..................................................................................................................................................................3-1
Consumables ........................................................................................................................................................3-2
Culture media for general use .........................................................................................................................3-2
Irradiated media...............................................................................................................................................3-2
Identification of the instrument ..............................................................................................................................3-3
Front face of Air IDEAL 3P ....................................................................................................................................3-3
Rear face of Air IDEAL 3P.....................................................................................................................................3-4
Keypad ..................................................................................................................................................................3-4
Configuration for 65, 70 or 90 mm Petri dishes .....................................................................................................3-5
Tripod assembly ....................................................................................................................................................3-6
General specifications.................................................................................................................................................3-7
Environmental conditions ......................................................................................................................................3-7
Physical features...................................................................................................................................................3-7
Dimensions......................................................................................................................................................3-7
Mass ................................................................................................................................................................3-7
Materials ..........................................................................................................................................................3-7
Characteristics of materials .............................................................................................................................3-7
Technical characteristics .......................................................................................................................................3-8
Keypad ............................................................................................................................................................3-8
Display.............................................................................................................................................................3-8
Sampling grid...................................................................................................................................................3-8
User interface ..................................................................................................................................................3-8
Ergonomics......................................................................................................................................................3-8
Electrical characteristics........................................................................................................................................3-9
Functional specifications .......................................................................................................................................3-9
Flow-rate..........................................................................................................................................................3-9
Autonomy ........................................................................................................................................................3-9
Charge time .....................................................................................................................................................3-9
Sound level......................................................................................................................................................3-9
Security............................................................................................................................................................3-9
Unpacking Air IDEAL 3P...........................................................................................................................................3-10
Packing list ..........................................................................................................................................................3-10
Recommendations for installation and use ...............................................................................................................3-11
Sampling positions....................................................................................................................................................3-12
Screwing on the sampling grid..................................................................................................................................3-13
Electrical power supply .............................................................................................................................................3-14
Operation on internal battery...............................................................................................................................3-14
Low battery signals ........................................................................................................................................3-14
Charging ........................................................................................................................................................3-15

Table of contents
V-2 Air IDEAL® 3P User’s Manual
Operation using the power line ............................................................................................................................3-15
Automatic switch off.............................................................................................................................................3-15
Programming.............................................................................................................................................................3-16
Programming characteristics ...............................................................................................................................3-16
Sampling controls ................................................................................................................................................3-16
Additional information ..........................................................................................................................................3-16
Air IDEAL 3P menus............................................................................................................................................3-17
Turning on Air IDEAL 3P ...........................................................................................................................................3-18
Turning off Air IDEAL 3P...........................................................................................................................................3-18
Selection of one of the 4 pre-programmed sample volumes (Menu 1) ................................................................3-19
Programming a sample volume not in memory (Menu 2) ....................................................................................3-20
Modification of the 4 pre-programmed sample volumes (Menu 3).......................................................................3-20
Programming delayed start-up (Menu 4) .............................................................................................................3-23
Programming sequenced sampling (Menu 5) ......................................................................................................3-24
Battery autonomy test (Menu 6) ..........................................................................................................................3-25
Starting sampling ...................................................................................................................................................3-26
Stopping the motor ..............................................................................................................................................3-28
Setting Air IDEAL 3P parameters (summary diagram)..............................................................................................3-29
4Procedure 4-1
Principle ..................................................................................................................................................................... 4-1
Procedure................................................................................................................................................................... 4-1
How to obtain a good quality sample ......................................................................................................................... 4-2
Precautions of use................................................................................................................................................ 4-2
Sampling .............................................................................................................................................................. 4-2
Incubation and reading ......................................................................................................................................... 4-2
Sampling plan ............................................................................................................................................................ 4-3
Recording and evaluating results ............................................................................................................................... 4-3
5Maintenance 5-1
Preventive maintenance............................................................................................................................................. 5-1
Routine servicing........................................................................................................................................................ 5-1
Cleaning and decontamination ............................................................................................................................. 5-1
Sterilization of grids .............................................................................................................................................. 5-1
Decontamination of the external part.................................................................................................................... 5-1
Decontamination of the air circuit ......................................................................................................................... 5-1
Decontamination of the air circuit ......................................................................................................................... 5-1
Decontamination in a glove box............................................................................................................................ 5-2
Airflow control ....................................................................................................................................................... 5-2
6Troubleshooting 6-1
7Appendix 7-1
Using the reading table .............................................................................................................................................. 7-1
Information on FELLER’s law..................................................................................................................................... 7-1
Reading tables ........................................................................................................................................................... 7-2
Notes

V-3 Air IDEAL® 3P User’s Manual
List of figures
Note: Screen captures and figures are given as examples only.
2. Functional description
Figure 2-1: Principle of the impaction biocollector.......................................................................................................2-1
3. Using Air IDEAL 3P
Figure 3-1: Identification of the instrument..................................................................................................................3-3
Figure 3-2: Front face .................................................................................................................................................3-3
Figure 3-3: Rear face ..................................................................................................................................................3-4
Figure 3-4: Keypad .....................................................................................................................................................3-4
Figure 3-5 : Diameter of Petri dishes ..........................................................................................................................3-5
Figure 3-6: Sampling head and grid – 90 mm Petri dishes .........................................................................................3-6
Figure 3-7: Tripod assembly .......................................................................................................................................3-6
Figure 3-8: Air IDEAL 3P in its carrying case............................................................................................................3-10
Figure 3-9: Sampling positions .................................................................................................................................3-12
Figure 3-10: Screwing on the sampling grid..............................................................................................................3-13

Air IDEAL® 3P User’s Manual 1-1
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 main table of contents of the manual is located on pages V-1 to V-2.
It lists each chapter and the procedures and/or topics contained in the manual.
List of figures Page V-3 contains the list of figures found in this manual.
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
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.
These titles are located on the outside of the page so that you can thumb through the pages
to quickly locate a chapter or a procedure.
The footers contain the title of the manual, the name of the product and the page number.
Notes This manual contains a certain number of notes that are used to emphasize a procedure or
certain information.

How to use this manual
Glossary
1-2 Air IDEAL® 3P User’s Manual
Glossary
ABS Acrylonitrile butadiene styrene.
Aerobiocollector or
Air sampler
Instrument used to collect and count viable bacterial and fungal particles in a known and
precise volume of air.
CFU 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 Time between pressing the START button and the motor starting up.
MPN Most Probable Number of microorganisms collected. Statistical correction of the CFU
value (FELLER’s law).
NiMH Nickel Metal Hydride.
PVDF Polyvinylidene fluoride.
Ra coefficient Roughness factor of a surface. It is the arithmetic mean of all profile deviations, positive or
negative, compared to the mean line.
Sampling grid 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.
Time-delay 2 seconds required by the software to record a parameter.

How to use this manual
Typographic conventions
Air IDEAL® 3P User’s Manual 1-3
Typographic conventions
These conventions are used in the different chapters of the manual.
• Press A bullet point is used to denote an action to be performed.
ABC 123 This typography is used to represent messages which appear on the display.
The Air IDEAL 3P keypad
There are 5 keys on the Air IDEAL 3P 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 User’s Manual 2-1
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 Air IDEAL 3P aerobiocollector in order to best respond to these new needs.
Air IDEAL 3P 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.
Air IDEAL 3P 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 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 3P is calibrated at 100 L/min with an impact velocity of
less than 20 m/s. According to good sterilization practices, the sampling grids can be
sterilized in an autoclave, see section "Sterilization of grids" on page 5-1.
Operating principle
Air IDEAL 3P is an impaction aerobiocollector, used to detect the presence of viable
microorganisms 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 microorganisms 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 microorganisms collected per m3of air.
Figure 2-1: Principle of the impaction biocollector
Calibrated orifice
A
ir inlet
Nutrient medium
A
ir jets
Microorganisms
Impaction
A
ir outlet
90 or 65/70 mm diameter
Petri dishes

Functional description
Presentation
2-2 Air IDEAL® 3P User’s Manual
Performance
The performance characteristics of an aerobiocollector depend on its capacity to collect
microorganisms 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 microorganisms.
Air IDEAL 3P 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 Air IDEAL 3P.
Collection efficiency validated according to the ISO 14698 standard
Air IDEAL 3P 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 Air IDEAL 3P 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 3P 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.
Use in glove boxes
In order to be used to test glove boxes, the design and materials of
Air IDEAL 3P had to be entirely reviewed in order to optimize system air tightness.
In addition and in order to guarantee the optimal operation of Air IDEAL 3P in this
application, the system underwent a complete validation in a glove box (SKAN AG, model
ARIS glove box).
Applications
Air IDEAL 3P enables the precise and reproducible sampling of air. The volumes taken can
be set in 10 L steps up to a maximum volume of 2000 L.
This sampling range enables Air IDEAL 3P 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.
*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

Air IDEAL® 3P User’s Manual 3-1
3 Using Air IDEAL 3P
Description
Air IDEAL 3P is supplied in a carrying case. Inside the case there 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.)].
Air IDEAL 3P is available in two versions:
− for 90 mm agar plates (product No. 96302)
− for 65/70 mm agar plates (product No. 96304)
 Each reference includes:
− an Air IDEAL 3P aerobiocollector fitted with a protective cover.
− 5 sampling grids
− an AC/DC charger-adapter (see page 3-9) for the internal battery.
− 4 jack protection caps.
− a hook for suspending the instrument.
− Documentation:
• User’s manual
• Product certificate
• Adjustment certificate
• Control certificate
Note: For product No. 96303 only, a stainless steel blade is supplied for use with 70 mm diameter Petri
dishes.
 Accessories:
− 65/70 mm 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 mm plates – Kit of 10 (product No. 96301)
− Sterile box for transport and incubation of 90 mm plates – Kit of 10 (product No. 96311**)
*Availability: consult bioMérieux

Using Air IDEAL 3P
Description
3-2 Air IDEAL® 3P User’s Manual
Consumables
Air IDEAL 3P 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 Air IDEAL 3P.
The media comply with specific industrial and hospital environmental controls.
Culture media for general use
− 20 TSA 90 mm plates (product No. 43011)/100 TSA 90 mm (ref. 43019)
− 20 PCA agar 90 mm plates (product No. 43558)
− 20 Sabouraud dextrose agar 90 mm plates (product No. 43555)
− 20 Sabouraud dextrose chloramphenicol agar 90 mm plates (product No. 43596)
− 20 count-Tact agar 65 mm plates (product No. 43501)
− 20 count-Tact TSA agar 65 mm plates (product No. 43582)
− 20 count-Tact Sabouraud dextrose chloramphenicol agar 65 mm plates (product No.
43580)
Irradiated media
− 100 TSA irradiated 90 mm plates (product No. 43557)
− 20 TSA irradiated 90 mm plates (product No. 43131)
− 100 TSA with neutralizing agents 90 mm plates (product No. 43562)
− 20 Sabouraud dextrose irradiated agar 90 mm plates (product No. 43554)
− 20 Sabouraud dextrose chloramphenicol irradiated agar 90 mm plates (product No.
43595)
− 20 count-Tact irradiated agar 65 mm plates (product No. 43491)
− 100 count-Tact irradiated agar 65 mm plates (product No. 43492)
− 20 count-Tact Sabouraud dextrose chloramphenicol agar 65 mm plates (product No.
43581)
− 20 count-Tact 3P irradiated agar 65 mm plates (product No. 43691)
− 100 count-Tact 3P irradiated agar 65 mm plates (product No. 43699)

Using Air IDEAL 3P
Description
Air IDEAL® 3P User’s Manual 3-3
Identification of the instrument
Figure 3-1: Identification of the instrument
Front face of Air IDEAL 3P
Figure 3-2: Front face

Using Air IDEAL 3P
Description
3-4 Air IDEAL® 3P User’s Manual
Rear face of Air IDEAL 3P
Figure 3-3: Rear face
Keypad
Figure 3-4: Keypad
Handle
A
ir outlet
Threading
for tripod
Jack socket