Definition of cleanliness classes of a Clean Room

Highlights :
Class 1 = less than 1 particle sized 0,5 µm per cubic feet and none sized 5 µm.
Class 10 = less than 10 particles sized 0,5 µm per cubic feet and none sized 5 µm.
Class 100 = less than 100 particles sized 0,5 µm per cubic feet and none sized 5 µm.
Class 1000 = less than 1000 particles sized 0,5 µm per cubic feet and less than 7 particles sized 5 µm.
Class 1000 = less than 10000 particles sized 0,5 µm per cubic feet and less than 70 particles sized 5µm.
Class 10000 = less than 100000 particles sized 0,5 µm per cubic feet and less than 700 particles sized 5µm.

Definition of cleanliness classes of a Clean Room

Highlights :
Class 4000 = less than 4000 particles sized 0,5 µm per cubic feet less than 25 particles sized 5µm (Class 100)
Class 400000 = less than 400000 particles sized 0,5 µm per cubic feet less than 2500 particles sized 5µm (Class 10000)
Class 4000000 = less than 4000000 particles sized 0,5 µm per cubic feet less than 25000 particles sized 5µm (Class 100000)

This norm is obsolete and has been replaced by the ISO 14644-1 Norm.

Definition of cleanliness classes of a Clean Room

Highlights :
Class ISO 3 = Class 1 according FS 209
Class ISO 4 = Class 10 according FS 209
Class ISO 5 = Class 100 according FS 209
Class ISO 6 = Class 1000 according FS 209
Class ISO 7 = Class 10000 according FS 209
Class ISO 8 = Class 100000 according FS 209

This European norm nullifies and replaces the NFX 44-101 Norm.

Defines the points of approval and control of the laminar flow equipment, being either a cabinet or a Clean Room.

Highlights :
Air-tightness of a filter and the joint seal : Controlled by a DOP test or any similar test. The level of penetration must not exceed 0,01%.
Flow-rate - laminarity: Controlled by a serie of velocity measurement.

Laminar flow hood	Laminar flow Clean Room
A velocity map is done using "N" lines and "n" columns throughout a plan at a distance of 20 cm from the filters. N ³ 2L/0,6             n ³ 3L/0,6 L : Absolute Filter length l : Absolute Filter width 0,3 m/s ≤ Vmoy ≤ 0,6 m/s ADS LAMINAIRE uses to choose Vmoy = 0,4 m/s ±10%	A velocity map is done with at least one point per filter throughout a plan at a distance of 1 m from the exhaust of the filters . The average velocity measured must be : Vave = 0,45 m/s ±10% for a horizontal flow Vave = 0,35 m/s ±10% for a vertical flow

Laminarity : Each measured value must not vary by more than 20% the Vave.
Vave - 20% < Vi < Vave + 20%

Particle classification: The control is done with the use of a particle counter.

Laminar flow hood	Laminar Clean Room
Only one measure is done in the middle of the work area.	At least one measure is done at a distance of 1 m from the filter plan.

We must obtain a class 100 with the FS 209 norm or a class 4000 with the NFX 44-101 norm (for laminar flow).

Highlights :
Definition of a Biohazard Safety Cabinet Type I, Type II and Type III
Analysis Method
Recall the whole of the NFX 44-102 norm plus:

	Air tightness test : No leakage up to 500 Pa for a single walled cabinet and 250 Pa for a double walled cabinet.
	Protection of the personnel (dummy test): particle count by the vaporisation of Lactobacillus in the working area. One must not count particles coming from any possible leakage of the vaporisation outside the cabinet.
	Sound level : should be lower than 65 dBA at 30 cm of the opening.
	Lighting level : must be superior to 400 Lux on the work bench.

It rules since July 2000, nullifies and replaces the NFX 44201 norm. This norm brings standardisation on the European level concerning the M.S.C.

Highlights :

	Conception : The use of a double walled M.S.C. is advised and thus, air-tightness tests are no more necessary.
	Controls and Tests : Regarding the criteria of the protection of the operator, of the environment and of the process, they are unchanged . Nevertheless, the traditional analysis methods (velocity map, particle count, dummy test) have been replaced by bacteriological tests.
	A chapter concerning the cleaning possibility, the decontamination and the sterilisation of a M.S.C. has been added.

Highlights :
Definition of a HEPA (High Efficiency Particulate Air) and a ULPA (Ultra Low Penetration Air) Filter , as well as the classification regarding the type of tests method.

Définit les méthodes d'essai (DOP, MPPS).
As Example: A HEPA filter is classified 99,999% DOP (0,3mm) or 99,995% MPPS (Most Penetrating Particle Size)

Highlights :
Definition of conception of a Lab. in relation with the confinement level (L1, L2 and L3)
Definition of the different uses.
Definition of the kind of materiel allowed inside those different laboratories

Highlights :
Defines the different configuration of surgery theatres
Defines the class of the surgery theatres on the particles aspect (with reference to the NFX 44-101norm) as well as the bacterial aspect
Defines the analysis methods: they are close the NFX 44102 norm.

Highlights :
Defines the conception of the "ETRAF"
The incoming frontal air speed must be kept between 0,4 and 0,6 m/s.

Highlights :
Defines the conception and classification of hoods.
The incoming frontal air speed must be at least equal to 0.4m/s.