Airborne particles

GOOD MANUFACTURING PRACTICE (cGMP)
1

hi all

I want to take airborne particles test in my nitrogen system PQ,the results will show the effect of final filter ,i think it is necessary to take the test,because the nitrogen is critical for our products,but i can not find the pass limit.

any reply?

thanks!

2

Hi

I think u r using 0.2 micron filter at final stage.
U can apply the limits which are related to Compressed Air (ISO 8573-1)

B’coz nowhere it was not mentioned for the limits of particle count in Nitrogen gas.

Thatswhy u can use the compressed air limits based on the applicablity.

3

So you are doing filter qualification not nitrogen PQ. Since their are no limits, wouldn’t you do developmental testing? I.e. particulate level without filter…then particulate level with the filter. Still don’t understand why you would test this because a .2 micron filter should suffice and should already be qualified.

4

[quote=baobei]hi all

I want to take airborne particles test in my nitrogen system PQ,the results will show the effect of final filter ,i think it is necessary to take the test,because the nitrogen is critical for our products,but i can not find the pass limit.

any reply?

thanks![/quote]

Dear Baobei,

Generally, airborne particle count test, does for cleanrooms. In this case, you check for 0.5 & 5 micron particles which are greater than 0.3 micron.

But, as part of Nitrogen test, you can do “Particulate Matter”, not airborne particulate count. Still If you want to do it as part of Nitrogen PQ as it is critical to your product, then apply the same Grade limits for this Airborne particle count.

I hope, this will clarify your query. Let me know, if something is there…

With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com

5

Dear All

It is logically absolutely right that any type of gas which is entering in the cleanroom such as nitrogen , oxygen , carbondioxide and methane should be finally filtered by 0.2 micron to filter the particulate matters and microbial count.It must meet the ISO 8573-1 for cleanroom

But as for the case of nitrogen, it must be tested with the following criteria.

  1. Purity of Nitrogen should be 99.999%
  2. oxygen level in ppm
  3. total hydrocarbon in ppm
  4. Carbon dioxide in ppm
  5. Carbon monooxide in ppm
  6. Moisture contents in ppm

the above test should be done becuase nitrogen is used normally for pre and post purging of empty and filled container respectively.

The above test should be included in the PQ of nitrogen systems

Thanks

6

[quote=Ahsan Khan]Dear All

It is logically absolutely right that any type of gas which is entering in the cleanroom such as nitrogen , oxygen , carbondioxide and methane should be finally filtered by 0.2 micron to filter the particulate matters and microbial count.It must meet the ISO 8573-1 for cleanroom

But as for the case of nitrogen, it must be tested with the following criteria.

  1. Purity of Nitrogen should be 99.999%
  2. oxygen level in ppm
  3. total hydrocarbon in ppm
  4. Carbon dioxide in ppm
  5. Carbon monooxide in ppm
  6. Moisture contents in ppm

the above test should be done becuase nitrogen is used normally for pre and post purging of empty and filled container respectively.

The above test should be included in the PQ of nitrogen systems

Thanks[/quote]

Nice and precise reply

7

Dear All,
I think baobei is talking about testing for particulate matter in the nitrogen used inside his cleanroom, and im thinkin that he is looking for the acceptance criteria.
The acceptance criteria here will be the total particulate limit for the hyigenic class the nitrogen will be used within

8

Mr> Khan

Good Reply

Regards

A.Aziz