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and should, therefore, be periodically tested (typically every 6 months). The purpose with
the test is to measure any leaks in the filter (or housing), and not, to document the
filtration efficiency “this is the filter suppliers responsibility, as they must supply individual
molecular contamination, which is not controlled with traditional HEPA air filtration. AMC
can be in the form of gases, vapors or aerosols that is the result of outdoor air,
and bio-effluents from clean room personnel. The AMC control is required to eliminate
toxic, odor and irritants particles for operating personnel safety and health and must be
using ANSI standards, good engineering practice, and compliance testing procedures,
o Outside air intake located upstream of exhaust point when considering local
prevailing wind conditions.
• Cross contamination
intermediate product or finished product with another starting material or product during
manufacture. It has been proven that one of the major reasons for cross contamination is
the air handling units and extraction systems. Inadequate procedure for personnel and
equipment and insufficiently clean equipment is another key reason. Cross contamination
could be minimized by
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