Sampling Points In Clean Rooms

The number of particles and the number of microorganisms are the most important criteria in clean rooms.

The clean room class is determined based on these two criteria. Sampling points for particle and microorganism measurements in clean rooms are specified in ISO 14644-1. In ISO 14644-1: 1999, samples were taken as much as the square root of the cleanroom area. However, the relevant standard was revised in 2015 and sampling points are given in Table 1 of ISO 14644-1: 2015.

Therefore, in clean rooms, clean room studies that take as many samples as square root of square meters are not suitable as they do not meet the requirements of the standard.

It is important for medical firms in the CE certification process to pay attention to this issue in their clean room analysis. The following table should be used for sample numbers and sampling points should be determined accordingly.

ISO 14644-1: 2015 Table 1-Minimum number of air samples to be taken depending on clean room size:
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If equal or smaller area (m2)	Minimum number of samples to be taken (NL)
2	1
4	2
6	3
8	4
10	5
24	6
28	7
32	8
36	9
52	10
56	11
64	12
68	13
72	14
76	15
104	16
108	17
116	18
148	19
156	20
192	21
232	22
276	23
352	24
436	25
636	26
1000	27
>1000	Calculated according to the following formula below

 

NL=27x(A/1000)

NL: Number of samples to be taken (If the resulting number is decimal, it is rounded to the next integer).