Download ISO 14644 2015 - Pharmig x.pdf PDF

TitleISO 14644 2015 - Pharmig x.pdf
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Page 17

Change A – particle locations #3
• The new method is based on hypergeometric distribution.

 Opposite to binomial distribution.

 Samples are drawn randomly without replacement from a finite

 Each location can be treated independently with a 95% level of
confidence that at least 90% of the cleanroom will comply with
the maximum particle limit for the intended class.

 Confidence an be increased if desired.

 No calculations are required to determine the number of
locations - there is a ‘look-up table’ (Table 1 - the only reference
for all sizes of particle from ISO 1 to ISO 9).

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