THE CHOISE AND USE OF AN ACTIVE MICROBIAL AIR SAMPLER
The microbial air sampler must be carefully chosen because the characteristics of the instrument may impact heavily on usability, on implementing deadlines and consequently the final cost of such activities in terms of buying and managing the facility, man hours and efficiency of operations
The air sampler should be easily cleaned and sanitized and be constructed of materials compatible with the most common detergents and biocides such as isopropyl alcohol, hydrogen peroxide and sodium hypochlorite.
The air samplers with two or three aspirating heads reduce the sampling times and give the possibility to use different media at the same time (e.g. Total Bacterial Count and Yeast / molds) and to program sampling cycles at rest, in operation, at the end of shift.
Another feature is the simplicity of using the software and the ability to archiving of data that must be wide enough to allow sufficiently long work sessions and a subsequent easy download of data to a PC for the elaboration of the final report.
The air sampler must be officially calibrated by the manufacturer in accordance with current legislation.
PREPARATION OF THE MATERIAL
An important part of the preparation is the protocol (SOP) map that reports where the air samplers should be positioned according to the risk analysis that define the critical control points.
The accessories used in the microbial air monitoring should be prepared and controlled before to start the sampling activity:
- The battery of the sampler should be charged.
- All accessories involved in the sampling process (e.g. culture plates) must be properly cleaned and sanitized before entering the cleanroom.
- The operator should be dressed according to the type of involved area.
PARAMETERS TO BE CONSIDERED
The operator should transfer to the sampler all the operative parameters like name of operator, name of location, plate identification; the air sampler identification, volume of air and sequence number of the test are automatically registered by the instrument itself. The final report will issue a report directly to the user environment.
In order to make statistically relevant the air sampling activities and then the state of use of the area under analysis, it is necessary to aspirate an appropriate volume of air. In the CleanRoom the typical volume of aspirated air is 1.000 litres.
The greater the flow of air and lower will be the working time required to sample a statistically significant volume of air. In any case, never neglect the time component since, being the cleanroom and controlled contamination environments designed to treat dynamic, the air may result in variable conditions “at-rest” configuration, and with the presence of operational staff.
DATA TRANSFER AND ELABORATION
The data collected by the air sampler are exported via direct PC connection or via a USB memory key or via Bluetooth as stored in the electronics of the instrument (direct saving report in non-user-editable format in full accordance with the guidelines of 21 CFR Part 11 of the FDA).