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The Standard
	 of Confidence
bioMérieux, Inc.
595 Anglum Road
Hazelwood, MO 63042-2320
U.S.A.
Tel: (800) 634 7656
Fax: (800) 657 3053
www.biomerieux-usa.com
©2006BIOMÉRIEUX,INC.•BIOMÉRIEUX,THEBLUELOGOANDAIRIDEALAREUSEDPENDINGAND/ORREGISTEREDTRADEMARKSBELONGINGTOBIOMÉRIEUXSAORONEOFITSSUBSIDIARIES.•PRINTEDINU.S.A.•MDI-05
bioMérieux Canada, Inc.
7815 Henri-Bourassa Boulevard West
St. Laurent (Québec)
Canada H4S 1P7
Tel: (1) 514 336 7321
Fax: (1) 514 807 0015
User friendly software
Light weight
Reproducible
air flow rate
Easy to handle
Sequential sampling
444 Ease of use
● User friendly software, easy to use in order to reduce the training effort and the risk of error­­.
● Reproducible air flow rate, calibrated by a scientifically sound metrological method.
● Sequential sampling, for "in process" monitoring.
● Light weight, with only 1.2 kg.
● Easy to handle, with its ambidextrous design and ergonomic handle.
ACCESSORIES
ref. 96 309 : 90 mm diameter additional sampling grids
ref. 96 304 : 65/70 mm diameter additional sampling grids
ref. 96 308 : Aluminium tripod with ball joint and adapter
Please consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.
SPECIFICATIONS
ref. 96 302 : air IDEAL®
3P equipped with 90 mm diameter sampling grids
ref. 96 303 : air IDEAL®
3P equipped with 65/70 mm diameter sampling grids
444 Performances through Innovation
	 air IDEAL®
3P: a New Standard of Performance
444 Pharmaceutical Solution
	 air IDEAL®
3P: Pharmaceutical Solutions for Pharmaceutical Needs
In the context of this revolution and to proactively meet customers’ needs,
bioMérieux has developed a new air sampler: air IDEAL®
3P:
● Designed to be used in isolators
● Provided with a simple and efficient procedure to decontaminate the air circuit
● Developed in partnership with external laboratories, expert in Pharmaceutical
sciences. Skan AG, Johnson Diversey and Health Protection Agency (UK).
“Pharmaceutical manufacturing evolves from
an art to a science”. FDA – 2004.
air IDEAL®
3P is a new standard in
air sampling fully transparent on its
collection efficiency following the
ISO 14698 standard:
444 Proven Efficiency
	 air IDEAL®
3P: Environmental Monitoring in Total Confidence
air IDEAL®
3P has been third party validated to provide customers with a scientifically sound air sampling
method. This validation focused on:
● Collection efficiency, following the ISO 14698 standard (physical + biological evaluation)
● Cleanability: with the validation of the air circuit decontamination
● Ability to be used in isolators.
● Physical efficiency: high level of collection for the particles
of interest: 100% of particles above 5 microns are collected
● Biological efficiency: superior performances versus the main
commercially-available air samplers.
Particles size of interest
20
40
60
80
100
120
140
160
180
2 4 6 8 10 12 14 16
Particle Size (microns)
%Efficiency
Physical efficiency of air IDEAL®
3P
Thirty years of investigation on environmental airborne particles
containing bacteria have concluded that the range of particle size is
from 5 to 15 µm with a median size of particles at ~13 µm *.
10
20
30
40
50
60
70
80
Air-samplers
Air-sampler B Air-sampler C Air-sampler D
%ofRecovery
% recovery S. epidermitis
% recovery B. subtilis
Biological efficiency of air IDEAL®
3P
• USP 28 NF 23 “chapter 1116 Microbiological Evaluation of Clean Rooms and other Controlled Environments” (2005)
• Lidwell, O. M., Noble, W. C., Dolphin, G. W. “The use of radiation to estimate the numbers of micro-organisms in airbone particles.” J. of Hyg. Camb. (1959)
• Noble, W.C. Lidwell, O.M. Kingston, D. “The size and distribution of airbone particles carrying micro-organisms”. J. of Hyg. Camb (1963)
• Mackintosh, C. A., Lidwell, O. M., Towers, A. G., Marples, R. “The dimension of skin fragments dispersed into the air during activity”. J. of Hyg. Camb (1978)
• Whyte, W. “Sterility assurance and models for assessing bacterial contamination.” Journal of Parenteral Science Technology. (1986)

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airideal_3p_brochure

  • 1. The Standard of Confidence bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320 U.S.A. Tel: (800) 634 7656 Fax: (800) 657 3053 www.biomerieux-usa.com ©2006BIOMÉRIEUX,INC.•BIOMÉRIEUX,THEBLUELOGOANDAIRIDEALAREUSEDPENDINGAND/ORREGISTEREDTRADEMARKSBELONGINGTOBIOMÉRIEUXSAORONEOFITSSUBSIDIARIES.•PRINTEDINU.S.A.•MDI-05 bioMérieux Canada, Inc. 7815 Henri-Bourassa Boulevard West St. Laurent (Québec) Canada H4S 1P7 Tel: (1) 514 336 7321 Fax: (1) 514 807 0015 User friendly software Light weight Reproducible air flow rate Easy to handle Sequential sampling 444 Ease of use ● User friendly software, easy to use in order to reduce the training effort and the risk of error­­. ● Reproducible air flow rate, calibrated by a scientifically sound metrological method. ● Sequential sampling, for "in process" monitoring. ● Light weight, with only 1.2 kg. ● Easy to handle, with its ambidextrous design and ergonomic handle. ACCESSORIES ref. 96 309 : 90 mm diameter additional sampling grids ref. 96 304 : 65/70 mm diameter additional sampling grids ref. 96 308 : Aluminium tripod with ball joint and adapter Please consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use. SPECIFICATIONS ref. 96 302 : air IDEAL® 3P equipped with 90 mm diameter sampling grids ref. 96 303 : air IDEAL® 3P equipped with 65/70 mm diameter sampling grids
  • 2. 444 Performances through Innovation air IDEAL® 3P: a New Standard of Performance 444 Pharmaceutical Solution air IDEAL® 3P: Pharmaceutical Solutions for Pharmaceutical Needs In the context of this revolution and to proactively meet customers’ needs, bioMérieux has developed a new air sampler: air IDEAL® 3P: ● Designed to be used in isolators ● Provided with a simple and efficient procedure to decontaminate the air circuit ● Developed in partnership with external laboratories, expert in Pharmaceutical sciences. Skan AG, Johnson Diversey and Health Protection Agency (UK). “Pharmaceutical manufacturing evolves from an art to a science”. FDA – 2004. air IDEAL® 3P is a new standard in air sampling fully transparent on its collection efficiency following the ISO 14698 standard: 444 Proven Efficiency air IDEAL® 3P: Environmental Monitoring in Total Confidence air IDEAL® 3P has been third party validated to provide customers with a scientifically sound air sampling method. This validation focused on: ● Collection efficiency, following the ISO 14698 standard (physical + biological evaluation) ● Cleanability: with the validation of the air circuit decontamination ● Ability to be used in isolators. ● Physical efficiency: high level of collection for the particles of interest: 100% of particles above 5 microns are collected ● Biological efficiency: superior performances versus the main commercially-available air samplers. Particles size of interest 20 40 60 80 100 120 140 160 180 2 4 6 8 10 12 14 16 Particle Size (microns) %Efficiency Physical efficiency of air IDEAL® 3P Thirty years of investigation on environmental airborne particles containing bacteria have concluded that the range of particle size is from 5 to 15 µm with a median size of particles at ~13 µm *. 10 20 30 40 50 60 70 80 Air-samplers Air-sampler B Air-sampler C Air-sampler D %ofRecovery % recovery S. epidermitis % recovery B. subtilis Biological efficiency of air IDEAL® 3P • USP 28 NF 23 “chapter 1116 Microbiological Evaluation of Clean Rooms and other Controlled Environments” (2005) • Lidwell, O. M., Noble, W. C., Dolphin, G. W. “The use of radiation to estimate the numbers of micro-organisms in airbone particles.” J. of Hyg. Camb. (1959) • Noble, W.C. Lidwell, O.M. Kingston, D. “The size and distribution of airbone particles carrying micro-organisms”. J. of Hyg. Camb (1963) • Mackintosh, C. A., Lidwell, O. M., Towers, A. G., Marples, R. “The dimension of skin fragments dispersed into the air during activity”. J. of Hyg. Camb (1978) • Whyte, W. “Sterility assurance and models for assessing bacterial contamination.” Journal of Parenteral Science Technology. (1986)