Filter integrity test

[sohini]

Sir,

I am associated with environmental control of Pharma Industry. Our Drug authority did not mention the Class of cleanliness of proceess rooms for Oral Solid Dosage. Only they have asked for supply of 5 micron filtered air with 20 air changes per hour.
Now, they are asking integrity test of 5 micron filter & particle count of the room.
What standard or process should I follow to for the above?
Please reply & oblige

 

[imok2]

The MERV (minimum eff. reporting value) would be (9-12) with an average dust spot efficiency of 40-75% and a particle size of 1.0 to 3 microns. This should be sufficient. Ashrae std 52.2

 

[MedicineEng]

Regarding the filter integrity test you will be better off if you outsource this function to a specialized laboreatory/service provider.
The equipment for these tests are quite expensive and the calibration/training of these also. Unless you have dozens of filters to inspect you will save money if you outsource this.
Nevertheless, assure that they know what they are doing.
REgarding hte standard for thiese tests, I suggest that you google. For sure you will find which standard shopuld you comply with. In case of doubt, ask your drug authority to which standard it wants that the filters tested against.

 

[MintJulep]

ASHRAE 52.1 and 52.2 are for testing filter media only.

Integrity tests and room counts imply that your customer is interested in the performance of the installed system.

If your customer knows to ask for this, he probably also thinks he knows what standard he wants used. Why not ask him instead of a bunch of random anonamous strangers.

However, ANSI/AIHA Z9.5 and ISO 14644-2 would probably be a good place to start.

 

[quark]

There is no integrity testing for 5 micron filters or you won't find anything, if you do it. You will get efficiency certificates from the manufacturer, as stated above. You should note that the filters are type tested.

You can test the filters for integrity if you are using atleast EU-8 or better filters. Generally, OSD facilities should be class 100000 at rest condition. You can do the testing as per ISO 14644-2 as suggested by MintJulep.

Drug authorities never specify the kind of filtration you require. There may be some misunderstanding. Discuss it clearly before you land up into problems.

 

[MedicineEng]

Correct. As far as I know that depends on the class of the room that you are working with. If ISO9 or below, filter integrity test is not mandatory andopnly filter maintenance is required.
If ISO8 or better then filter integrity test is highly recomended and expected (even if as far as I know, not mandatory, but please don't quote me on this without confirm).

 

[hmm97]

I think your client likes to know if there is any leakage around the filter or not. Such test includes spraying aeosel before filter and measuring number of particles after the filter. Special tecnicians know the detail how to do this. As a designer you must provide proper ductwork on two sides of the filter to make the test possible.
The type of filter should be at least 45% (see above) or I would simply put a 90% efficient filter with proper (specia) housing there.