Elaborating A Sampling Plan And Interpreting Results - bioMerieux SAMPL'AIR LITE Manuel Utilisateur

SAMPL'AIR LITE

7.7 Elaborating a sampling plan and interpreting results

The sampling plan establishment and the aerobiocontamination evaluation are part of a HACCP plan (Hazard
Analysis Critical Point). It is a voluntary, autonomous process based on prevention.
The user has to evaluate the contamination level to be met in order to insure that the critical point is reached
(place, product process) and controlled.
The aerobiocontamination management requires a multidisciplinary team whose aim is to define the areas at
risk, the preventive actions, the sampling points, their frequency, the control specifications (target, alert and
action levels), and the corrective measures to be taken.
Prior to results interpretation, control specifications must be defined. The control specifications are based on
existing referentials (GMP, APSEC, usual Standards....), or referentials created thanks to the inherent data. The
international ISO/14698-1 standard about air quality, recommends a recording of contamination levels, at least
for several weeks, in order to create a reference and assess target, alert, and action levels.
7.7.1 Determination of control specifications
Referential for clinical environment:
According to the ASPEC recommendations (Association for the prevention and study of contamination), it is
possible to determine 4 areas at risk. The risk levels of these areas are linked to the patients' fragility, and to
the risk due to the type and duration of the medical act.
Risk level of a medical act in clinical environment:
Risk due to the patient's
condition
1
2
3
4
Control specifications for aerobiocontamination in very high risk and high-risk areas:
Micro-organisms CFU*/ m
Target level
Alert level
Action level
Referential for pharmaceutical environment:
The table below gives a summary of the aerobiocontamination rates according to clean rooms class, as defined
in the "Good Manufacturing Practice" in Pharmaceutics:
GMP Classes / Categories
Contamination (recommended limits)
UFC* / m
* CFU: Colony Forming Unit
The sampling places should be determined according to critical points identified in a precise area.
With a mapping of the area to be controlled, critical points may be identified.
MANUEL UTIILSATION / USER'S MANUAL
Risk due to the medical act
1
1
2
3
4
High risk area
High risk area
3
Molds CFU*/ m
500 1
100 1
10 <1
3
<1
2 3
2 3
4 6
6 9
8 12
Very high risk area
Very high-risk area
3
Micro-organisms CFU*/ m
10
5
<1
A B
10
4
4
8
12
16
3 3
Molds CFU*/ m
1
1
<1
C D
100 200
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