FAQ - 制药和生命科学领域粒子监测

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问题
What was the specification implemented in 1986? What was the rationale for this specification?
答案

The original limits were 10,000 and 1,000 counts per container at 10 and 25 um. Why they were that limit I do not know. However, it is based upon the maximum amount of contaminants a body can take. Whether this was tested at an animal level (where limits are given as counts / ml/ body weight) and then interpreted to give average human levels again this is only conjecture.

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