ISO 14644-1:Classification of Air Cleanliness

ISO 14644-1:Classification of Air Cleanliness

ISO 14644 part 1, is a useful guideline to maintain the good manufacturing practices in sterile pharmaceutical manufacturing as well as the oral dosage forms. This document providesthe standards for the clean room classification. Revision of the guidance was started since 2007 and its drafts are already published in 2011, 2012,2014 and 2015 but none was finalized and 1999 version was applicable and expecting a new version.

Finally 2015 version is release and following are the major changes those are made in 1999 version of the ISO 14644-1.

1. Title of the ISO 14644-1 is changed from "Classification of Air Cleanliness" to "Classification of air cleanliness by particle concentration".

2. The number of sampling points in the area is no longer calculated as the square root of the surface area formula but it is now takenfrom the table given below.

Area  of cleanroom(m³) less than or equal to	Min number of sample locations to be tested(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
500	26
1000	27
>1000	Equation A

Equation A------N=27(Area)/1000

3. Formula to calculate the particle concentration(Cn) in respective classification number is no longer used and value is taken directly from the table.

4. Particles of 5 µm in ISO % class have been removed from the limit value table as given below.

Maximum concentration limits (particles M³of air) for particles equal to and larger than the considered sizes shown below:(a)
ISO Classification Number(N)	0.1 µm	0.2 µm	0.3 µm	0.5 µm	1.0 µm	5.0 µm
ISO 1	B             10	D            -2	D	D	D	E
ISO 2	100	24	10	D              -4	D	E
ISO 3	1000	237	102	35	D              -8	E
ISO 4	10000	2370	1020	352	83	E
ISO 5	100000	23700	10200	3520	832	DEF 20
ISO 6	1000000	237000	102000	35200	8320	293
ISO 7	C	C	C	352000	83200	2930
ISO 8	C	C	C	3520000	832000	29300
ISO 9	C	C	C	35200000	8320000	293000

5.0 µm should be zero according to ISO/DIS 14644-1.2 Table 1 notes;

D) Sampling and statistical limitastions for particles in low concentration make classification inappropriate.

E).. Greater than 1 micron particles make classification at this particle size inappropriate due to potential particle losses in sampling system.

F) Specify particle in association with ISO Class 5, the Marco particle descriptor M may be adapted.

5. UCL calculation is not required now: there is no need to perform an observation of all measuring points in the room any longer. Each single measuring point is considered individually and has to meet the limit value.

6. The length of tubing used in particle counter should be less than 1 meter.

7. The classification number, the air sample volumes, measuring time as well as the cancellation criterion is not changed and remains as same to the version ISO 14644-1:1999.

All SOPs and qualification protocols in pharmaceutical manufacturing related to the HVAC system and clean room management should be changed accordingly.