what are the reason and remedes for following?
If during area qualification in Class D Particle count of 0.5u n 5.0u both are out of limit.
For class d , number of particles/cubic meter is not defined in table during operation.
You can measure the particle count in rest condition to check the area is under control or not.
yes im talking about at rest during area qualification.at rest OSD falls under Class D.
so my q is that if both .5 and 5.0 are out of range whats the reason behind?
More Simplify why 0.5 u partucles increase in area what is the route casue n remedy?
Y 5.0particles increase route case n remedy?
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What is used for gowning?
cloth primry uniform then parashot 2ndr gowning
Source of contamination may be system,process,person.
if 0.5 u particles are out of range source of contamination is Defects in HEPA e.g loose,leakage,damaged.
if 5.0 u particles are out reason is general cleaning problem,area,equipments,personl movments,etc
Particle count goes out of limit means, there is more particles in the area than the defined limit.
One of the main reason is your air cleanliness (Air changes per hour) is not proper.
More in detail, particles are coming through supply or generated in the area from machine, process and man movement is not going to return and remain in the area, that is the reason it is out of limit.
If, your Air changes per hour and supply and return flow is proper, generated goes to return and how area is remain clean.
Your particle count is going out of limit means, it may also chances that your microbial test fail.
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HEPA filter controls both size of particle.if u find particle count limit of b grade area is under limit but it is out of limit under LAF then it may be HEPA related issue.ensure the differential pressure of LAF is within limit.check the velocity of LAF.
There should be no obstacles in front of return riser.ensure all return riser is working.
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