The list of revisions below summarizes replacements or additional pages in your
Air IDEAL 3P User’s Manual.
Version
A 01/2001 Bilingual
B 04/2001 Multilingual
C 11/2005 Update of the manual
D 03/2006 Update of the manual
E 03/2008 Environmental conditions
F - Not used -
G - Not used -
Date of
printing
Modifications Page (s) modified
All
(FR / EN)
All
(FR / EN / ES / IT / DE / PT)
All
(FR / EN / ES)
All
(FR / EN / ES / IT / DE / PT)
2-12
(FR / EN / ES / IT / DE / PT)
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
Air IDEAL® 3P User’s Manual Revisions-1
Page 4
Page 5
4501-1618 B en
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 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.
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.
Finding topics and procedures ....................................................................................................................................1-1
The Air IDEAL 3P keypad ...........................................................................................................................................1-3
Use in glove boxes ..........................................................................................................................................2-2
Culture media for general use .........................................................................................................................3-2
Identification of the instrument ..............................................................................................................................3-3
Front face of Air IDEAL 3P ....................................................................................................................................3-3
Rear face of Air IDEAL 3P.....................................................................................................................................3-4
Configuration for 65, 70 or 90 mm Petri dishes .....................................................................................................3-5
General specifications.................................................................................................................................................3-7
Mass ................................................................................................................................................................3-7
Characteristics of materials .............................................................................................................................3-7
User interface ..................................................................................................................................................3-8
Charge time .....................................................................................................................................................3-9
Unpacking Air IDEAL 3P...........................................................................................................................................3-10
Packing list ..........................................................................................................................................................3-10
Recommendations for installation and use ...............................................................................................................3-11
Screwing on the sampling grid..................................................................................................................................3-13
Electrical power supply .............................................................................................................................................3-14
Operation on internal battery...............................................................................................................................3-14
Operation using the power line ............................................................................................................................3-15
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
Stopping the motor ..............................................................................................................................................3-28
Setting Air IDEAL 3P parameters (summary diagram)..............................................................................................3-29
How to obtain a good quality sample ......................................................................................................................... 4-2
Precautions of use................................................................................................................................................ 4-2
Incubation and reading ......................................................................................................................................... 4-2
Sampling plan ............................................................................................................................................................ 4-3
Recording and evaluating results ............................................................................................................................... 4-3
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
6 Troubleshooting 6-1
7 Appendix 7-1
Using the reading table .............................................................................................................................................. 7-1
Information on FELLER’s law..................................................................................................................................... 7-1
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 3-5 : Diameter of Petri dishes ..........................................................................................................................3-5
Figure 3-6: Sampling head and grid – 90 mm Petri dishes .........................................................................................3-6
Figure 3-8: Air IDEAL 3P in its carrying case............................................................................................................3-10
Figure 3-10: Screwing on the sampling grid..............................................................................................................3-13
V-3 Air IDEAL
®
3P User’s Manual
Page 10
Page 11
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.
Air IDEAL® 3P User’s Manual 1-1
Page 12
How to use this manual
Glossary
Glossary
ABS Acrylonitrile butadiene styrene.
Aerobiocollector or
Air sampler
CFU
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.
Delayed start-up
MPN
Time between pressing the START button and the motor starting up.
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.
1-2 Air IDEAL® 3P User’s Manual
Page 13
Typographic conventions
These conventions are used in the different chapters of the manual.
How to use this manual
Typographic conventions
• 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 1-3
Page 14
Page 15
A
A
A
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 IDEAL3P 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 IDEAL3P 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 IDEAL3P 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 IDEAL3P 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 m
ir inlet
Microorganisms
Impaction
Nutrient medium
3
of air.
Calibrated orifice
ir jets
90 or 65/70 mm diameter
Petri dishes
ir outlet
Figure 2-1: Principle of the impaction biocollector
Air IDEAL® 3P User’s Manual 2-1
Page 16
Functional description
Presentation
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 IDEAL3P 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*
biological efficiency of Air IDEAL3P.
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 IDEAL3P was determined by comparison with the membrane
filtration standard operating side-by-side.
*
to validate the physical and
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 IDEAL3P 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 IDEAL3P 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 IDEAL3P 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
HPA: Health Protection Agency - Porton Down - Wiltshire SP4 0JG Salisbury - UK
Domaine Scientifique de la Doua, 69603 Villeurbanne, France
2-2 Air IDEAL® 3P User’s Manual
Page 17
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 IDEAL3P 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 IDEAL3P 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
Air IDEAL® 3P User’s Manual 3-1
Page 18
Using Air IDEAL 3P
Description
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)
3-2 Air IDEAL® 3P User’s Manual
Page 19
Identification of the instrument
Front face of Air IDEAL 3P
Using Air IDEAL 3P
Description
Figure 3-1: Identification of the instrument
Figure 3-2: Front face
Air IDEAL® 3P User’s Manual 3-3
Page 20
Using Air IDEAL 3P
A
Description
Rear face of Air IDEAL 3P
Handle
ir outlet
Threading
for tripod
Keypad
Jack socket
Figure 3-3: Rear face
Figure 3-4: Keypad
3-4 Air IDEAL® 3P User’s Manual
Page 21
Configuration for 65, 70 or 90 mm Petri dishes
Using Air IDEAL 3P
Description
Sampling grid for 65, 70 mm Petri dishes
Count-Tact® agar plate
Sampling grid for 90 mm Petri dishes
90 mm Petri dish
Figure 3-5 : Diameter of Petri dishes
Air IDEAL® 3P User’s Manual 3-5
Page 22
Using Air IDEAL 3P
Description
Stainless steel strip for
attachment
Seal
Aspiration
orifice
Tripod assembly
Figure 3-6: Sampling head and grid – 90 mm Petri dishes
Figure 3-7: Tripod assembly
3-6 Air IDEAL® 3P User’s Manual
Page 23
General specifications
General specifications
Environmental conditions
Normal storage conditions............................................................................-20° to + 50°C
Inside use in an air class zone, sterile room or glove box.
Normal conditions of use ......................................................... 0 to 40 °C (32 °F to 104 °F)
− Chemical resistance: to most standard disinfectants (70% isopropanol, hydrogen
peroxide, 70% ethanol, quaternary ammoniums).
− Thermal resistance: sampling grid that can be autoclaved using Good Sterilization
Practices (18 minutes at 134°C in water saturated vapor).
Note: With increasing numbers of autoclaving cycles, the grids become increasingly yellow-gray, but this has
no effect on grid performance.
− Surface finish: Ra coefficient of grid = 0.14 micron.
− Fire resistance: ABS V0 shell (highest grade of fire resistance).
Air IDEAL® 3P User’s Manual 3-7
Page 24
Using Air IDEAL 3P
General specifications
Technical characteristics
Keypad
− Key control.
Display
− Liquid crystal display (2 x 16 characters).
Sampling grid
− 1/8
− Possibility of sampling on 90 mm 65/70 mm diameter Petri dishes (specific sampling
grids and fixing strips).
User interface
− 5 buttons for access to all Air IDEAL3Pfunctions.
− An LCD screen is used to program the instrument and follow its operation. Messages are
in English.
− Additional information on instrument operation is given as audible signals.
th
of aturn screw-on sampling grid.
Ergonomics
− Ergonomic handle (right hand/left hand).
− Possibility of stable sampling with the unit in four positions (see page 3-12).
− Possibility of suspending Air IDEAL3P with a hook, especially in a glove box.
− Optionally, Air IDEAL3P can be mounted on a telescopic tripod equipped with a ball
joint enabling the sampling axis to be orientated through an angle of 0° to 90° (from
horizontal to vertical), and its height to be adjusted (between 0.7 and 2.50 meters).
3-8 Air IDEAL® 3P User’s Manual
Page 25
Electrical characteristics
Voltage ...................................................................................... 7.2 VDC nominal
Power supply.......................................................................................... 1 A max.
Air IDEAL 3P is designed to run on a battery (6 NiMH batteries connected in series, each
with a nominal voltage of 1.2 V).
Air IDEAL 3P can also be powered and/or recharged using one of the adapters indicated or
an equivalent one.
CAUTION! The AC-DC power supply adapter must have the following characteristics:
- Voltage: 12 VDC
- Power: 1.5 A max.
- Plug mod. Jack 12.0 x 2.1 mm
-
AC input voltage corresponding to the characteristics of the power supply in the
country where the instrument is installed.
Using Air IDEAL 3P
General specifications
Note: It is recommended to use the adapter provided with Air IDEAL 3P. You will find the details of its
characteristics below.
POWER SUPPLY UL/CSA
INPUT............................................ 120 VAC/60Hz 0.8 A max. USA STD plug
OUTPUT....................................................... 12 VDC 1.5 A max. JACK plug.
POWER SUPPLY complying with standards
INPUT................................... 230 VAC/50Hz 0.8 A max. European STD plug
OUTPUT....................................................... 12 VDC 1.5 A max. JACK plug.
Functional specifications
Flow-rate
− 100 ± 6.5 liters per minute regardless of the grid used.
− Flow-rate measured and adjusted according to the bioMérieux quality control protocol
reference 96302-protocol.
Autonomy
− More than or equal to 4 hours, enabling at least 24 consecutive 1000 l samples to be
taken.
− Specification valid for a new battery not having undergone a thermal shock or a
prolonged period of inactivity.
Charge time
It takes 14 hours to fully charge the battery.
Sound level
< 50 dB.
Security
Male plug outlet serves as the power supply sectioning device.
Air IDEAL® 3P User’s Manual 3-9
Page 26
Using Air IDEAL 3P
Unpacking Air IDEAL 3P
Unpacking Air IDEAL 3P
The instrument is supplied in a carrying case and box.
When opening the box:
• Make sure you have all the items described in the packing list.
• Keep the shipping carton in case you need to ship the instrument back to bioMérieux.
CAUTION! Any damage directly or indirectly resulting from the transport of the instrument
without adequate containers will not be covered by the warranty or maintenance
contract.
DANGER ! Do not use the instrument in an explosive atmosphere as sparks could cause an
Packing list
explosion.
− an Air IDEAL3P aerobiocollector fitted with a protective cover.
− 5 sampling grids
− a hook for suspending the instrument
− 4 jack protection caps
− an AC/DC charger-adapter (see page 3-9) for the internal battery.
− Documentation:
• User’s manual
• Product certificate
• Adjustment certificate
• Control certificate
Figure 3-8: Air IDEAL 3P in its carrying case
3-10 Air IDEAL® 3P User’s Manual
Page 27
Recommendations for installation and use
Recommendations for installation and use
• Install the instrument on a flat, perfectly horizontal surface, on its tripod or by its hook.
• Avoid locations directly exposed to sunlight, excessive heat, damp or dust.
• The instrument must not be used near strong sources of electromagnetic interference.
• Do not use the instrument with its original protective cover cap, but with a grid.
IMPORTANT! When the instrument is used for the first time, it is imperative to perform 1 battery
charge-discharge cycle.
•
Charge the battery for 14 hours.
•
Discharge the battery by performing successive sampling (see page 3-25
"Battery autonomy test (Menu 6)").
•
Recharge for 14 hours.
•
Make sure the grid holes are not blocked.
Using Air IDEAL 3P
Air IDEAL® 3P User’s Manual 3-11
Page 28
Using Air IDEAL 3P
Sampling positions
Sampling positions
Figure 3-9: Sampling positions
IMPORTANT! Air IDEAL 3P is delivered with a hook for suspending it in a glove box during
decontamination phases. Even though sampling can be done while suspended, it is
preferable to position Air IDEAL 3P along the axis of one-way flow at the air outlets.
This configuration is the worst case scenario since the air sampled has swept the
entire volume of the glove box before emerging.
Do not obstruct the air outlet during use to respect operating parameters.
3-12 Air IDEAL® 3P User’s Manual
Page 29
Screwing on the sampling grid
CAUTION! Do not insert any foreign objects into the aspiration orifice located under the grid (see
pages 3-6).
To screw on the sampling grid easily,
• Position the grid on the threading of the shell and turn it clockwise by 1/8
without forcing or pressing it.
Using Air IDEAL 3P
Screwing on the sampling grid
th
of a turn
Figure 3-10: Screwing on the sampling grid
Air IDEAL® 3P User’s Manual 3-13
Page 30
Using Air IDEAL 3P
Electrical power supply
Electrical power supply
Air IDEAL 3P operates self-sufficiently through an internal nickel metal hybrid battery pack.
Air IDEAL 3P can also run connected to a charger/adapter.
Operation on internal battery
The microprocessor manages and displays the available autonomy at all times, on the basis
of a theoretical autonomy of 4 hours for sampling cycles of 1000 liters. In the case of
sampling cycles of less than 1000 liters, it is advisable to put the battery on charge as soon
Low battery signals
CAUTION! During this battery low phase, Air IDEAL 3P remains in its normal operating condition
as the flashing symbol appears:
.
When the autonomy has expired, the following low battery signals are output:
Visual signal on the welcome message display:
Flashing symbol
Visual signal on the sample in progress display:
Flashing symbol
Audible signal each time the instrument is turned on: 2 long beeps
until the sampling cycle in progress is finished. Before performing a new sampling
cycle, recharge the battery.
3-14 Air IDEAL® 3P User’s Manual
Page 31
Charging
Using Air IDEAL 3P
Electrical power supply
To charge the battery,
• Use the charger supplied or one with the same specifications.
• During the charging phase, Air IDEAL 3P can be either switched on or switched off.
• Connect the charger to the Air IDEAL3P jack connector after removing the protection
cap.
• Connect the charger to the power outlet.
The display indicates:
The normal time required to completely recharge a discharged battery pack is 14 hours.
It is possible to perform sampling when the battery is being charged on the main power
supply.
At the end of the operation,
• Disconnect the charger from the power outlet.
• Disconnect the charger from the Air IDEAL 3P jack connector.
• Install the protection cap.
• Check that the available autonomy displayed is again 4 hours.
IMPORTANT! If Air IDEAL 3P is not used for more than 10 days, the battery must be totally
recharged (14 hours).
Operation using the power line
Connection to the power line is carried out in the same way as for charging the internal
battery.
The display indicates:
• Press the <START> or <MENU> button to return to the welcome message.
Then
• Press the <START> button to start (the volume sampled will be the last recorded).
or,
• Select the sample volume by means of MENU1 or MENU2, and then start by pressing
the <START> button.
To turn off,
• Disconnect the charger from the Jack socket of Air IDEAL 3P.
During operation on the power line, the internal battery is on charge.
IMPORTANT! During sampling with Air IDEAL 3P running off the main power supply, do not
disconnect the instrument from the main power supply as there is a risk of it
switching off and the sampling cycle in progress would be definitively lost.
Automatic switch off
In order to save the available charge on the internal battery, the unit switches off
automatically after 5 minutes of inactivity.
Air IDEAL® 3P User’s Manual 3-15
Page 32
Using Air IDEAL 3P
Programming
Programming
Air IDEAL 3P enables samplings to be programmed and monitored.
This section describes how to program the instrument.
Programming characteristics
− Sample volumes adjustable from 5 to 10 liters in 1-liter steps.
− Sample volumes adjustable from 10 to 2000 liters in 10-liter steps.
− Automatic selection of last sample volume used.
− Storage of 4 sample volumes in the memory.
− Delayed start-up (maximum 60 minutes).
• 0 to 60 seconds in 1-second steps
• 1 minute to 60 minutes in 1-minute steps
− Sequenced sampling.
Sampling controls
− Volume counter.
− Volume of air sampled remains on display after sampling is interrupted.
− Possibility of interrupting and resuming a sample in progress.
− End of sample buzzer (6 short beeps).
− Count-down of time.
Additional information
− Symbol displayed and audible alarm (2 long beeps) at the end of battery autonomy.
− Automatic stop and message displayed if the protective cover was not removed.
− Display of remaining battery life (indicative value).
− Automatic switch-off of display after 5 minutes of inactivity.
− Language: English.
3-16 Air IDEAL® 3P User’s Manual
Page 33
Air IDEAL 3P menus
Using Air IDEAL 3P
Programming
Turning on
WELCOME
MESSAGE
Last sample taken.
Remaining autonomy.
MENU 1:
Selection of one of 4 sample volumes among the 4 volumes preprogrammed in menu 3.
MENU 2: Programming 1 sample volume not in memory.
MENU 3: Modification of the 4 pre-programmed sample volumes.
MENU 4: Programming delayed start-up
MENU 5: Programming sequenced sampling.
MENU 6: Battery autonomy test.
Turning off
Air IDEAL® 3P User’s Manual 3-17
Page 34
Using Air IDEAL 3P
Turning on Air IDEAL 3P
Turning on Air IDEAL 3P
To turn on Air IDEAL 3P,
• Press <ON/OFF>.
The display indicates:
Note: The symbol is displayed if a delayed start-up is programmed.
− ZZZL corresponds to the last sample volume recorded.
XHXX corresponds to remaining autonomy.
−
If the symbol
• Recharge Air IDEAL3P.
appears:
If the last sample did not terminate correctly (sampling stopped before the end, protection
cap in place of the grid, motor blocked), the following is displayed:
In this case, press the <MENU> key to display the welcome message.
DANGER! Do not insert any foreign objects into the motor compartment when the instrument
is running.
Turning off Air IDEAL3P
To turn off Air IDEAL 3P,
• Press <ON/OFF>.
or
• Wait 5 minutes.
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Selection of one of the 4 pre-programmed sample volumes (Menu 1)
Factory programming memorizes the following 4 volumes in Air IDEAL 3P: 100, 500, 1000,
2000 liters.
To select menu 1,
• Press <MENU>.
The display indicates:
• Press the < + > button to select 1 of the 4 volumes memorized.
Using Air IDEAL 3P
Turning off Air IDEAL 3P
Example:
To select stored volume No. 2 from menu 1,
• Press < + > twice.
• Wait 2 seconds.
Note: If you did not wait for the end of the first timeout, in other words if you pressed another button before the
2 seconds, the new value selected (
YYY) is not recorded. The initial value (ZZZ) remains in memory.
The value YYY selected is recorded.
The display indicates:
There are 3 possibilities:
• Start sampling immediately by pressing the <START> button.
• Wait: the selected sampling can be started at a later time.
• Press the <ON/OFF>button to turn off the instrument. The volume selected will be
displayed the next time it is turned on.
Air IDEAL® 3P User’s Manual 3-19
Page 36
Using Air IDEAL 3P
Turning off Air IDEAL 3P
Programming a sample volume not in memory (Menu 2)
To select menu 2,
• Press <MENU> twice.
The display indicates:
To program a new volume,
• Press < + > or <- > until the desired volume is displayed.
IMPORTANT! It is imperative to press the
volume.
After a 2-second delay, the volume displayed is recorded.
The display indicates:
< + > or < - > buttonsimmediately to program a new
There are 3 possibilities:
• Start sampling immediately by pressing <START>.
• Wait: the selected sampling can be started at a later time.
• Press the <ON/OFF>button to turn off the instrument. The volume selected will be
displayed the next time it is turned on.
Modification of the 4 pre-programmed sample volumes (Menu 3)
To select menu 3,
• Press <MENU> 3 times.
The display indicates:
• Wait 2 seconds.
The display indicates:
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Using Air IDEAL 3P
Turning off Air IDEAL 3P
To program a new volume for program 1,
• Press < + > or <- > until the desired volume is displayed.
IMPORTANT! It is imperative to press the
volume.
After a 2 second delay, the volume displayed is recorded.
The display indicates:
Note: If the <MENU>, < + > or < - >, buttons are not pressed, each of the 4 pre-programmed volumes is
displayed every 2 seconds.
< + > or < - > buttonsimmediately to program a new
To program a new volume of program 2,
• Press < + > or < - > until the desired volume is displayed.
IMPORTANT! It is imperative to press the < + > or < - > buttonsimmediately to program a new
volume.
After a 2-second delay, the volume displayed is recorded.
The display indicates:
To program a new volume for program 3,
• Press < + > or < - > until the desired volume is displayed.
IMPORTANT! It is imperative to press the
volume.
After a 2-second delay, the volume displayed is recorded.
The display indicates:
< + > or < - >buttonsimmediately to program a new
Air IDEAL® 3P User’s Manual 3-21
Page 38
Using Air IDEAL 3P
Turning off Air IDEAL 3P
To program a new volume for program 4,
• Press < + > or < - > until the desired volume is displayed.
IMPORTANT! It is imperative to press the
volume.
< + > or < - >buttonsimmediately to program a new
After a 2-second delay, the volume displayed is recorded.
The display indicates:
The screen the returns to the welcome message.
Note: If the < + > or < - > buttons are not pressed, the pre-programmed volumes are sequentially displayed
without modification.
Possibility of going directly to "MENU 4", once selected volumes are modified:
END" is displayed on the screen,
When "
• Immediately press <MENU>.
Menu 4 is displayed.
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Programming delayed start-up (Menu 4)
Delayed start-up can be programmed for up to 60 minutes:
− 0 to 60 seconds in 1-second steps
− 1 minute to 60 minutes in 1-minute steps.
To select menu 4,
• Press <MENU> 4 times.
The display indicates:
To program a delay value,
• Press < + > or < - > until the desired delay value is displayed.
Using Air IDEAL 3P
Turning off Air IDEAL 3P
IMPORTANT! It is imperative to immediately press
After 2-seconds, the delay value is recorded.
The display indicates:
The screen returns to the welcome message.
The delay is recorded: the symbol
There are 3 possibilities:
• Start sampling immediately by pressing <START>.
• Wait: the selected sampling can be started at a later time.
• Press the <ON/OFF>button to turn of the instrument. The volume selected will be
displayed the next time it is turned on.
< + > or < - > to program a new volume.
appears in the welcome message.
Air IDEAL® 3P User’s Manual 3-23
Page 40
Using Air IDEAL 3P
Turning off Air IDEAL 3P
Programming sequenced sampling (Menu 5)
Menu 5 is used to sample a selected volume several times.
This sequencing is defined with 3 parameters:
− The unit volume (of each sequence).
This volume is defined with menus 1 and 2 (see pages 3-19 and 3-20).
− The number of sequences.
This number is included between 2 and 5.
− The time interval between each sequence.
It is included between 10 minutes and 4 hours, in 10-minute steps.
Total sampling time must be less than 5 hours or else an error message appears.
To select menu 5,
• Press <MENU> 5 times.
st
The following message appears and the 1
line flashes:
The unit volume is shown on the lower left and cannot be modified in this menu.
To modify the number of sequences,
• Press < + > or< - > until the desired number is displayed.
• Press <MENU> once the number of sequences is selected.
The "INT X HXX" (INTERVAL ) field flashes.
• Press < + > or < - > to define the time interval between each sequence.
IMPORTANT! Check that the remaining battery autonomy is sufficient to carry out complete
sampling (base: 10 min/1000 liters).
3-24 Air IDEAL® 3P User’s Manual
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Using Air IDEAL 3P
Turning off Air IDEAL 3P
Once sequenced sampling has been correctly programmed,
• Press the <START> button to start sampling.
The total duration of sequences and intervals must not exceed 5 hours or else an error
message appears:
Then, the screen automatically returns to Menu 5.
At this time, parameters (number of sequences/duration of the interval) must be corrected in
order to enable sampling.
IMPORTANT! A sequenced sampling is run from the specific menu, without returning to the main
menu.
If the last sampling was sequenced, the menu 5 screen is displayed when
Air IDEAL 3P is turned on.
Battery autonomy test (Menu 6)
This menu is used to verify that the battery is still compliant with specifications of new
material (autonomy ≥ 4 hours).
The battery autonomy test can be performed using a volume chosen by the operator.
1000 liters is the reference volume for verifying that specifications have been respected
(4 hours of battery life for 1000-liter samples).
If the volume generally used is, for example, 100 liters, then it is wiser to perform the test on
100 liter volumes.
To check battery autonomy:
− Note the autonomy displayed when the instrument is turned on.
− Using Menu 1, select a 1000 liter sample volume.
− Go to Menu 6.
• Press the <START> button to run the battery discharge cycle.
To select menu 6,
• Press <MENU> 6 times.
The display indicates:
The battery discharge cycle can be stopped as follows:
• Press <STOP>.
To resume at a later time,
• Press <START>.
CAUTION! If you wait more than 5 minutes, Air IDEAL 3P will turn off.
Air IDEAL® 3P User’s Manual 3-25
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Using Air IDEAL 3P
Starting sampling
Starting sampling
CAUTION! Before starting, check that Air IDEAL 3P is fitted with a sampling grid and not its
protective cover otherwise it could undergo irreversible damage which is not covered
by the bioMérieux warranty.
If the protective cover remains on Air IDEAL 3P, the following alarm message is displayed
• Remove the protection cover.
• Install the grid.
• Press <MENU>to return to the welcome message.
To start sampling,
Turn on Air IDEAL 3P,
• Press <ON/OFF>.
after several seconds and sampling stops automatically:
The display indicates:
• Press <START/STOP>.
During sampling, the display indicates:
− The
− The last sample volume recorded is automatically displayed (shown as
SAMPLE VOL display flashes during the sampling phase and the volume counter
is displayed.
ZZZL).
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Using Air IDEAL 3P
Starting sampling
A buzzer indicates the end of sampling (6 short buzzes) and the display returns to the
original message with automatic correction of the remaining battery life.
If a delayed start-up has been programmed, the display indicates:
TIMED flashes during the count-down phase.
Note: The motor stops 2 liters before the total volume has been sampled.
Last sampling not terminated:
If Air IDEAL3P was turned off during sampling, the following message appears the next
time the instrument is turned on:
CAUTION! In this case, the user will take all necessary precautions to deal with this interrupted
sampling.
• Press <MENU> to return to the welcome message.
Air IDEAL® 3P User’s Manual 3-27
Page 44
Using Air IDEAL 3P
Starting sampling
Stopping the motor
Note: It is always possible to stop a sampling operation under way by pressing <START/STOP>.
Note: If stoppage during sampling is more than 5 minutes, Air IDEAL 3P will turn off.
• Press <START/STOP>.
If the motor is stopped during the program, i.e. during the delayed start-up count-down
phase or during the sampling phase, the value displayed freezes and the display continues
to flash.
To resume sampling,
• Press <START/STOP>.
If the motor is restarted after being stopped during a program, the program will resume from
the point where it was stopped.
3-28 Air IDEAL® 3P User’s Manual
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Setting Air IDEAL 3P parameters (summary diagram)
Setting Air IDEAL 3P parameters (summary diagram)
Using Air IDEAL 3P
4 x
1 x
Menu 1 : Selection of one of
the 4 sampling volumes
among the 4 pre-programmed
Press < + > or < - > until the
desired volume in memory is
volumes.
displayed.
("Preset volume")
2 x
Menu 2 : Selection of a
sampling volume not in
memory.
Press < + > or < - > until the
desired volume is displayed.
("CHOSEN VOLUME")
3 x
Menu 3 : Modification of the 4
pre-programmed sampling
volumes
"PROGRAM 1, 2, 3 et 4
Press < + > or < - > until the
chosen volume is displayed.
Air IDEAL® 3P User’s Manual 3-29
Page 46
Using Air IDEAL 3P
Setting Air IDEAL 3P parameters (summary diagram)
4 x
Menu 4 : Programming
delayed start-up.
5 x
Menu 5 : Programming
sequences samplings.
6 x
Menu 6 : Battery autonomy
test
Select delay before starting
Press < + > or < - > until the
delay value is displayed.
Press < + > or < - > until the
desired number is displayed.
1 x
Press < + > or < - > until the
desired time is displayed.
Select number of
sequences
Select time between
sequences
3-30 Air IDEAL® 3P User’s Manual
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4 Procedure
Principle
Implementation and following of a procedure to measure aerobiocontamination corresponds
to a process based on prevention, which involves:
• Evaluating the current level and standard of hygiene and controls.
• Selecting the critical areas to be controlled.
• Establishing a reference level and an alert level for each of the critical points.
• Developing a sampling plan.
• Preparing a document for recording air sampling results.
• Preparing a plan for corrective action in case of deviation.
The result of sampling should provide information on the level of risk, global hygiene
conditions and environment.
Procedure
The procedure must be adapted to the actual conditions in which air sampling will take place
(contaminated areas, clean areas, sterile areas, etc.)
When strictly followed, the procedure guarantees good quality sampling and should include:
− Operators’ qualifications.
− Names of qualified operators.
− Hygiene of operators (clothes, hands...).
− Protocol for disinfection of the air sampler.
− Detailed steps of the procedure.
Air IDEAL® 3P User’s Manual4-1
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Procedure
How to obtain a good quality sample
How to obtain a good quality sample
Precautions of use
• Check the condition of the instrument and sampling grid.
• When unscrewing and screwing on the sampling grid avoid touching the perforated zone.
The choice of medium depends on the area to be controlled and the type of microorganism
to be isolated.
The agar in 90 mm Petri dishes, must be at least 2.5 mm thick at the center and have a flat
surface. It should not present dehydration or humidity droplets.
• During sampling, avoid any unnecessary movement, do not pass in front of the
instrument or cough etc.
• Begin by collecting from low contaminated areas.
• Collect several samples in each zone in order to obtain results that can be used for
statistical studies.
• Clean the instrument after use and sterilize sampling grids.
• Recharge the battery if necessary.
• Place the instrument in its carrying case and store it in a suitable place.
Sampling
• Turn on the instrument.
• Check the remaining battery life.
• Place the instrument on a flat surface (work bench, table...) in a vertical or horizontal
• Select the sample volume according to the critical area to be controlled.
• Remove the protective cover or the sampling grid.
• Place the Petri dish with its cover between the attachment clips and make sure it is
• Remove the Petri dish cover and place it on a clean surface.
• Screw on the sampling grid corresponding to the type of plate used.
• Perform sampling rapidly.
• The instrument indicates the end of sampling ( 6 buzzes).
• Unscrew the sampling grid.
• Carefully remove the Petri dish without touching the agar.
• Put the cover back on the Petri dish used.
• Put the protective cover back on.
• Mark the date, time and sample location on the Petri dish.
Incubation and reading
position, or set it up on its tripod.
correctly positioned.
The Petri dishes must be placed in the incubator as rapidly as possible.
After incubation, read as follows:
− Count the number of C.F.U (Colony Forming Units) which have grown and refer to the
reading table for the final result (see page 7-1).
− If results are not acceptable, proceed with colony identification to orientate corrective
action.
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Sampling plan
Procedure
Sampling plan
The sampling plan must be drawn up very carefully and followed strictly. The aim is to
guarantee that the values obtained are comparable. Any discrepancy between values
should reveal a variation in aerobiocontamination.
A sampling plan must include:
− the critical points to be controlled
− the following must be mentioned for each point controlled:
• the time and frequency,
• the microorganism(s) to be isolated,
• the media used,
• the revivification conditions,
• the sample volume,
• the number of samples per area controlled,
• the reference level and the alert level,
In practice, the alert level can be fixed at 3 times the reference level.
The person in charge of controlling the quality of air collects the results recorded.
− Results which give expected values are validated.
− If unacceptable results are obtained, corrective action may be necessary.
The document for recording results must include:
− date and time of sample,
− operator’s name,
− critical point controlled,
− the situation of the control in relation to the activity (production cycle, pre or post
operative, etc.),
− detailed stages of the procedure,
− level of internal activity (number of people present, number of lines running, etc.),
− thermohygrometric conditions (real or reference),
− microorganism to be isolated,
− culture medium used,
− incubation conditions (duration, temperature),
− date and time of incubation,
− date and time of reading,
− reference level and alert level,
− result: acceptable/unacceptable,
− decision: validation/ corrective action.
Air IDEAL® 3P User’s Manual 4-3
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Page 51
5 Maintenance
Preventive maintenance
CAUTION! No preventive maintenance needs to be performed by the user.
If an anomaly occurs on your instrument, call bioMérieux or your local distributor. Do
not open the shell of the instrument.
Dispose of the battery in a suitable container.
Routine servicing
The routine servicing operations to be carried out by the user are:
− Battery recharging.
− Cleaning and disinfection.
− Sterilization of the sampling grid.
Cleaning and decontamination
All parts, including the case (inside and outside), can be cleaned with soapy water, rinsed
and dried.
The stainless steel strip for attachment of Petri dishes can be dismantled for cleaning.
IMPORTANT! Do not use concentrated peracetic acid, acetone or chlorinated solvents (chloroform,
etc.) on the shell or keyboard.
Sterilization of grids
Air IDEAL 3P is delivered with a set of 5 grids. They can be sterilized by autoclaving at
134°C for 18 min.
bioMérieux has validated that the grid specifications and performance are not altered after
autoclaving up to:
- 40 times at 134°C for 18 minutes
- 200 times at 121°C for 20 minutes
After autoclaving 14 times or more, the grid may begin to turn yellow and may become
difficult to screw onto the instrument.
IMPORTANT! Do not sterilize under a flame.
Decontamination of the external part
All the external parts of Air IDEAL 3P can be decontaminated with most usual disinfectants
(70% isopropanol, hydrogen peroxide, 70% ethanol, quaternary ammonium).
Decontamination of the air circuit
bioMérieux has validated the bacteriological efficacy of air circuit decontamination with
ClearKlens IPA
Decontamination of the air circuit
Decontamination of the instrument according to this protocol with ClearKlens IPA (Johnson
Diversey) has been validated. A summary of this validation is available on request.
®
(Johnson Diversey).
Decontamination protocol:
• Spray twice with 70% isopropyl alcohol with the motor off: one spray at the air inlet, the
other at the outlet.
• Allow to react for 15 minutes before using the instrument.
Air IDEAL® 3P User’s Manual5-1
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Maintenance
Routine servicing
Decontamination in a glove box
Air IDEAL 3P was specially developed for use in production or control glove boxes. The
suitability of Air IDEAL3P for use in glove boxes was evaluated by the SKAN ag "Center of
Competence for Isolator Technology".
Two parameters were tested:
− The capacity of Air IDEAL3P to withstand standard decontamination cycles in gloves
boxes.
− The capacity of a standard decontamination cycle to disinfect the different types of
materials that compose the Air IDEAL 3P.
A summary of this validation is available on request.
Airflow control
The airflow control must be performed once a year from the date of the last control or
adjustment.
IMPORTANT! The airflow control must be done by a qualified person who has all the necessary
equipment to perform this task and to enter the data into the Air IDEAL 3P.
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6 Troubleshooting
Error message/signal Possible cause Recovery procedure
REMOVE PROTECTION
COVER
ERROR
TIME > 5 H
MOTOR
JAMMED
The protection cover was not removed. Install a grid.
The total duration of sequences and
intervals is too long.
Mechanical incident that blocks the
motor.
Repeat programming.
Inspect the black screen under the Petri dish
attachment strip.
Press <MENU> to return to the welcome
message.
Air IDEAL® 3P User’s Manual6-1
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Page 55
7 Appendix
Using the reading table
The following reading tables indicate the most probable number of microorganisms collected
per plate (MPN collected) with respect to the number of agglomerates of colonies counted
on the agar (CFU read).
The MPN value is calculated from the CFU count, using FELLER’s law. This statistical
correction corresponds to the random passing of bacteria through the orifices of the grid.
It quantifies for each “visited” orifice, (i.e. for each cluster counted) and as a function of the
total number of clusters counted, the most probable number of bacteria which make up the
cluster concerned, i.e. the number of bacteria having passed through the same orifice.
The application of the statistical correction assumes that the CFU count on the agar
concerns the number of colony clusters, i.e. the number of orifices with a positive impact,
without distinguishing, within a given cluster, the number of confluent colonies of which it is
made up.
In order to determine the most probable number of microorganisms collected per
cubic meter, the most probable number of microorganisms collected per plate (MPN
collected) must be multiplied by 1000 and divided by the volume sampled in liters.
Example: Volume of air sampled = 50 liters
CFU count: 120
MPN value: 159, 380905
Result expressed as the MPN collected per cubic meter = 159 x 1000 / 50 = 3188
MPN = most probable number of bacteria having passed through the orifices of the grid
N= number of orifices on the grid.
CFU = colony forming units, value obtained by the laboratory.
In the case of a sampling grid for which the passage of a particle through a given orifice of
the grid is purely random, there is a probability that, during a sampling cycle, several
particles pass through the same orifice and are therefore counted as a single and unique
CFU, while other orifices are not passed through by any particles.
The closer the CFU count obtained by the laboratory is to N, (total number of orifices on the
grid), the higher the probability is.
Moreover, the notion of probability density arises:
Example: for a given CFU value:
− there is a probability p2 that the same orifice is passed through by 2 particles
− there is a probability p3 that the same orifice is passed through by 3 particles
− there is a probability pi that the same orifice is passed through by i particles etc…
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Appendix
Reading tables
IMPORTANT! In practice, and whenever possible, to minimize statistical correction, it is
Reading tables
The probability pi decreases as i increases.
It is therefore particularly relevant to apply the statistical correction using FELLER’s law
when high CFU values are read, i.e. close to N, i.e. in the case of agar plates almost
completely saturated with colonies.
recommended to adjust the sample volume so that the CFU count does not exceed