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)