This document discusses a new air sampler called the air IDEAL® 3P developed by bioMérieux to meet pharmaceutical needs. It has the following key features: 1) Designed to be used in isolators and has a simple procedure to decontaminate the air circuit. 2) Meets the ISO 14698 standard for transparent collection efficiency, with 100% collection of particles above 5 microns. 3) Was third party validated for high collection efficiency of biological particles compared to other air samplers, as well as cleanability of the air circuit.

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)