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Frequently Asked Questions (DOP Testing)

Question <--- Can a particle counter not be used to determine the class of the room ? --->

<---Answer--->
 


    All the particle counter can do is give a reading of the number of particles per cubicfoot at any one point at one time. It doesn't indicate what the particles are, or where they come from. the stepwise checkout of a clean room should be first to run the DOp test to find the significant leaks and eliminate them. If the subsequent introduction of personnel and equipment causes generation of particaulate matter which may be of concern to the successful operation of the room one more step to be taken.

A sample of the room air should be taken with a millipore-type filter after which the particles collected may be sized and counted, but and this is the most important- they may now be identified. This identification will enable the room operator to establish the source of contamination is harmful to the work being done. No particle counter in existence can do this for you. As a matter of fact, to quote from paragraph 60 Fed, STd, 209a referring to the DOP test," .... in most instances, this type of facility check will be more meaningful than any attempt to amke an actual aprticle count, due to the extremly low particle concentrations expected, plus the difficulty of taking a representative sample in a laminar air flow stream".

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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 ?