The general requirements of Certification to ISO 14644-1:
1. Measure, calculate, and record the area of the ISO 5 laminar flow hood (LAF). The number of particle monitoring points necessary is the square root of the area in meters squared.
2. The area of the background ISO 7 area is the total room area minus the ISO 5 area. The number of samples required for the ISO 7 is the square root of the ISO 7 area in m2.
3. Sample points must be equidistant and at work height, irrespective of the activity at the sample location. The intention of the certification process is to determine if the filtration system is operating in accordance with a defined standard and has no bearing on product or process risk (at this point).
4. Samples are taken in a grid pattern at the identified locations and the PASS / FAIL criteria calculated for ISO 14644-1.
5. The exercise is repeated for the background ISO 7 area. The room’s geometry may make it difficult to determine the sample points. In this case, an equal area formula can be done (i.e. 1 sample every x m2).
6. A final report is created and marks the end of the certification process. For details of calculations performed, refer to the ISO14644-1 document.
The steps above can be done in either an operational or at-rest state. Once this is done, a baseline has been set in accordance with ISO 14644.”