bioMerieux SAMPL'AIR LITE Manuel Utilisateur page 50

SAMPL'AIR LITE
7.7.2 Determination of target, alert, and action levels
Once the critical points are defined in each area to be controlled, target, alert, and actions levels must be
determined. Appropriate corrective actions must be taken as soon as the action level is reached.
The method for the target level determination should be defined in a quality insurance procedure, and be
mentioned in the Quality Process Certificate.
Example for the identification of risk levels:
Reference area
Area 1
Area 2
Area 3
It is then the aim of the person in charge through his experience and knowledge, to assess the acceptable level
of contamination in various areas. He/ she will also have to determine the corrective actions (removing filters,
new waste management, and new organisation of services ...) to reduce the impact of the contamination levels,
and improve the environment management.
Within a quality insurance process, preventive monitoring and maintenance must prevail against curative
actions.
7.7.3 Control plan establishment
Once the reference plan is determined, a control plan should be described in order to validate the hygiene level.
The users depending on their aims can develop different sampling plans.
Sampling plan may be:
 A routine sampling plan for a global prevention.
 A specific sampling (Areas at risk...)
 A sampling to measure the incidence of an unforeseen phenomenon (Impact of
 or any other process if needed.
Whatever the aims are, protocol, sampling locations, and duration of sampling should be clearly defined to
compare and analyse the results.
Finally a quality control sheet (such as the one given in appendices of this manual) should be filled in to gather
any useful information.
It is important to specify on this sheet any parameter that might have an impact
!
!
!
on the result (Level of personal activity, rebuilding works, air recycling system,
sampling area ...)
Air contamination control can be obtained only if concurrently an effort for staff training is made.
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MANUEL UTIILSATION / USER'S MANUAL
Target level
Total Flora Yeast and
molds
rebuilding work, removing of filtration filters...)
Alert level
Total Flora Yeast and
molds
MA107501
Action level
Total Flora Yeast and
molds