Dear Community Members
I supplied Donaldson 0.2 micron P SRF (Compressed air Sterile filter ) to a pharmaceutical facility and i have a questions regarding the the integrity test for the 0.2 micron filter ,The client use the compressed for cleaning and blowing products packaging and machines ,The Manufacturing rooms are a classified room .
1-I need to know if their are an obligation to do integrity test for the filter If yes how often the test should be done .
2-Donaldson 0.2 P SRF filter is depth filter and its integrity is tested by using a DOP test(Can any one recommend for me a devise that can do the test for the filter .
In initial pack of filter, manufacturer provided certificate for integrity test. By cost it’s not good deal to perform integrity test of compressed air 0.2 microm filter, on the basis of risk assessment FMEA you should to define filter replacement frequency in six months as a safe side because that filters efficent up to period of 12-18 months.
Dear abhijeetghongade5
I would like to thank you for your answer, ,I have another two point that still not clear for me .
1-Is there in obligation to test the filter before each batch production ?
2-Can they use an online particle Counter or a handheld one that measure down to 0.1 micron size to check the size of the particle after the filter as an alternative for DOP integrity test.
The PSRF filters are constructed from hydrophobic glassfibre…they do not meet the requirements for sterile air in pharma. Testing can be carried with a portable aerosol challenge device sold by Parker …Valairdata, it uses Ondina Oil and has a pass/fail value. It should work with the PSRF (pass when it’s intact!), but I’m not 100% certain. If the PSRF is pleated, then you’re probably OK, if it’s not pleated, then the face velocity might be too high because the area is much lower (it’s like a toilet roll), and this can result in a loss in efficiency.
I think for F&B it should be fine, in pharma, I’d be inclined to use PTFE membrane filters, because the testing corresponds closely with the requirements of PDA TR40 ‘Sterilizing Filtration of Gases’…that the filter must be validated to retain bacteria in a liquid challenge.
Regards Moz