Filter integrity test
Filter integrity test
(OP)
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
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





RE: Filter integrity test
RE: Filter integrity test
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.
RE: Filter integrity test
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.
RE: Filter integrity test
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.
RE: Filter integrity test
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).
RE: Filter integrity test
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.