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FAQ - Pharmaceutical/Life Sciences Particle Counting
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What was the specification implemented in 1986? What was the rationale for this specification? - Answer
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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