FAQ - Conteo de partículas en producción farmacéutica y ciencias de la vida

Pregunta
What was the specification implemented in 1986? What was the rationale for this specification?

Respuesta

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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