Air IDEAL 3P Users Manual Ver I Oct 2012

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

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 Air IDEAL 3P keypad ...1-3 2

Functional 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 3

Using 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

Air IDEAL® 3P User’s Manual

V-1

Table of contents

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 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 ... 4-2 Incubation and reading ... 4-2 Sampling plan ... 4-3 Recording and evaluating results ... 4-3 5

Maintenance

5-1

Preventive maintenance... 5-1 Routine servicing... 5-1 Cleaning and decontamination ... 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 Reading tables ... 7-2 Notes

V-2

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

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Air IDEAL® 3P 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

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 page footers

and

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

How to use this manual Glossary

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.

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Air IDEAL® 3P User’s Manual

How to use this manual Typographic conventions

Typographic conventions These conventions are used in the different chapters of the manual.

• Press ABC 123

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 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

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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 3 probable number of microorganisms collected per m of air.

Calibrated orifice

Air inlet

Microorganisms Impaction

Air jets Nutrient medium 90 or 65/70 mm diameter Petri dishes Air outlet

Figure 2-1: Principle of the impaction biocollector

Air IDEAL® 3P User’s Manual

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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 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. U s e i n g l o ve b o x e s In order to be used to test glove boxes, the design and materials Air IDEAL 3P had to be entirely reviewed in order to optimize system air tightness.

of

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). Ap p l i c a t i o n s 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: HPA:

2-2

Centre Technique des Industries Aérauliques et Thermiques/Technical Center of Aeraulic and Thermal Industries Domaine Scientifique de la Doua, 69603 Villeurbanne, France Health Protection Agency - Porton Down - Wiltshire SP4 0JG Salisbury - UK

Air IDEAL® 3P User’s Manual

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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: − − − − − −

Note:

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

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* )

Air IDEAL® 3P User’s Manual

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*

*

Availability: consult bioMérieux

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)

−

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)

Irradiated media

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Air IDEAL® 3P User’s Manual

Using Air IDEAL 3P Description

Identification of the instrument

Figure 3-1: Identification of the instrument

F r o n t f a c e o f Ai r I D E AL 3 P

Figure 3-2: Front face

Air IDEAL® 3P User’s Manual

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Using Air IDEAL 3P Description

R e a r f a c e o f Ai r I D E AL 3 P

Handle

Air outlet

Threading for tripod

Jack socket

Figure 3-3: Rear face

Keypad

Figure 3-4: Keypad

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Air IDEAL® 3P User’s Manual

Using Air IDEAL 3P Description

Configuration for 65, 70 or 90 mm Petri dishes

Sampling grid for 65, 70 mm Petri dishes

Sampling grid for 90 mm Petri dishes

Count-Tact® agar plate

90 mm Petri dish

Figure 3-5 : Diameter of Petri dishes

Air IDEAL® 3P User’s Manual

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Using Air IDEAL 3P Description

Aspiration orifice

Stainless steel strip for attachment

Seal

Figure 3-6: Sampling head and grid – 90 mm Petri dishes

Tripod assembly

Figure 3-7: Tripod assembly

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Air IDEAL® 3P User’s Manual

Using Air IDEAL 3P General specifications

General specifications E n vi r o n m e n t a l c o n d i t i o n s 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) Relative humidity ...0 to 95% Maximum installation altitude... < 2 000 m Standards applicable ...See product certificate The instrument must be transported in its specific case. Physical features Dimensions Height Width Depth

Instrument alone 128 mm (5.03 in.) 146 mm (5.75 in.) 208 mm (8.18 in.)

Instrument in its case 301 mm (11.8 in.) 250 mm (9.84 in.) 400 mm (15.75 in.)

Mass Instrument alone ≈ 1,3 kg

Instrument in its case ≈ 5,6 kg

Shipping carton ≈ 7.1 kg

Materials ∗ ∗ ∗ ∗ ∗

ABS shell Polycarbonate keypad PVDF sampling grid Stainless steel mounting strips and screws Elastomer jack protection caps

Characteristics of materials − − − Note:

Shock resistance: shell and keypad. 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).

With increasing numbers of autoclaving cycles, the grids become increasingly yellow-gray, but this has no effect on grid performance.

− −

Air IDEAL® 3P User’s Manual

Surface finish: Ra coefficient of grid = 0.14 micron. Fire resistance: ABS V0 shell (highest grade of fire resistance).

3-7

Using Air IDEAL 3P General specifications

Technical characteristics Keypad −

Key control.

−

Liquid crystal display (2 x 16 characters).

−

th 1/8 of aturn screw-on sampling grid.

−

Possibility of sampling on 90 mm 65/70 mm diameter Petri dishes (specific sampling grids and fixing strips).

−

5 buttons for access to all Air IDEAL 3P functions.

−

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.

−

Ergonomic handle (right hand/left hand).

−

Possibility of stable sampling with the unit in four positions (see page 3-12).

−

Possibility of suspending Air IDEAL 3P with a hook, especially in a glove box.

−

Optionally, Air IDEAL 3P 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).

Display

Sampling grid

User interface

Ergonomics

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Air IDEAL® 3P User’s Manual

Using Air IDEAL 3P General specifications

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!

Note:

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.

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 OUTPUT... 12 VDC POWER SUPPLY complying with

0.8 A max. USA STD plug 1.5 A max.

JACK plug.

standards

INPUT... 230 VAC/50Hz

0.8 A max.

OUTPUT... 12 VDC

European STD plug

1.5 A max.

JACK plug.

Functional specifications F l ow - r a t e −

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.

−

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.

Au t o n o m y

Charge time It takes 14 hours to fully charge the battery. S o u n d l e ve l < 50 dB. Security Male plug outlet serves as the power supply sectioning device.

Air IDEAL® 3P User’s Manual

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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 explosion.

Packing list − − − − − −

an Air IDEAL 3P 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

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Air IDEAL® 3P User’s Manual