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Frequently Asked Questions (DOP Testing)

Question <--- 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 ?        --->

<---Answer--->
  

 

             There is no relationship at all. For example- a clean room with no one in it might be class 100, while the addition of personnel will send it into other higher categories. however, suppose the filters supplying a room were thoroughly checked for leaks, and all significant leaks were sealed, this room is operating at maximum efficiency with respect to the filters, and since the filters are mechanical in nature, there is nothing the opertor can do to change conditions in this area.

The achievement of a particualr class would relate to the number of air changes per hour as well as the scavenging design of the system.


   Federal Standard 209D Class Limits

   Federal Standard 209E Class Limits

   ISO Standard 14644-1 Class Limits

   Comparison between selected equivalent classes of FS 209 and ISO
    14644-1

   Airborne classification in the EU GGMP


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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 ?