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Frequently Asked Questions (DOP Testing)

Question <--- Has DOP test been accepted by the pharmaceutical industry ? --->

<---Answer--->
  

 

                If the number of pharmaceutical houses using the test for their filters is any criterion, the answer is most certainly yes. it is also used by the FDA, and of course by many other facets of industry around the world. For example, every atomic energy commission in the free world uses DOp and the photometer for in-place filter testing, the U.S navy has a special adaption of the basic test equipment for shipboard use and it would seem by its universal acceptance that any-one with a high-efficiency air filtration system needs one to insure the integrity of their system.

 

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   Why should anyone use a laminar flow system ?
   What actually a laminar air flow system ?
   How are the High-efficiency particulate air ( HEPA filters) tested ?
   what specifications or standards apply to testing the filters in place ?
   Is this in-place filter test the same one as the filter manufacturer uses ?
   What is the procedure for in-place test?
   What does percent of penetration mean ?
   Why was 0.01% established as a significant ?
   Why can't the leak test be run with ambient air within a room ?
   If plates to obtain bacterial counts are used, must the in-place test still be run ?
   Can leaks not be detected by agar plates ?
   How about impingement devices ? 
   Is DOP aerosol harmful to the filters ?
   What happens to the DOP once it is in the system ?
   When DOP is used to test a system, does the room have to be wiped down ?
   Has DOP test been accepted by the pharmaceutical industry ?
   with reference to Fed. Std. 209b, What is the relationship of the various classes of       clean rooms( 100, 10 000, and 100 000 ) to the 0.01% figure ?
   Can a particle counter not be used to determine the class of the room ?
   But isn't a particle count important data ?
   But, why can't leak test be carried out with a particle counters ?
   What are the advantages of the DOP in-place test over attempting a leak test       with a particle counter ?
   How often should the DOP in-place test to be run ?
   What qualifications are necessary for in-place test personnel ?
   when should the HEPA filters be replaced ?
   Do all filter material makers and filter manufacturers use the same mehtods for      testing their products ?