Pressure differential between rooms

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hi,

Is anyone able to tell me the minimum differential pressure required between rooms in a GMP grade D cleanroom facility?

Thanks,

Josie

2

Hi Josie,

To the best of me knowledge grade D room (iso 9) pressure difference just need to be over zero (5 will do).

hope it helps
oded

3

Hi Josie, to what standard are you preparing the area? PICs, WHO, etc.
Small section from the WHO Technical Report Series, No 937,Annex 2;

4.5.15 In considering room pressure differentials, transient variations, such
as machine extract systems, should be taken into consideration.

Note: The most widely accepted pressure differential for achieving containment
between two adjacent zones is 15 Pa, but pressure differentials
of between 5 Pa and 20 Pa may be acceptable. Where the design pressure
differential is too low and tolerances are at opposite extremities, a flow
reversal can take place. For example, where a control tolerance of ± 3 Pa is
specifi ed, the implications of the upper and lower tolerances on containment
should be evaluated.
4.5.16 The pressure differential between adjacent rooms could be considered
a critical parameter, depending on the outcome of risk analysis. The limits
for the pressure differential between adjacent areas should be such that there
is no risk of overlap, e.g. 5 Pa to 15 Pa in one room and 15 Pa to 30 Pa in
an adjacent room, resulting in no pressure cascade, if the first room is at the
maximum tolerance and the second room is at the minimum tolerance.

Hope this is of some help.

4

Hi Jose
Within GMP, where room differential pressure is the stated method of contamination control, then minimum acceptable room differential is 15Pa.

Because of individual instrument manufacturing tolerances and the tolerance that must be given to the engineers balancing the air flow, it is practically impossible to work to less.

Regulators accept this.

Alex Kennedy

5

Dear Josie,

For differential pressure between critical areas must be NLT 12 pa and delta p between less critical areas it must be more than 5 pascals.

[quote=Josie]Hi,

Is anyone able to tell me the minimum differential pressure required between rooms in a GMP grade D cleanroom facility?

Thanks,

Josie[/quote]