How can decided em sampling location in aseptic area?plz rpl if any know

(Jignesh darji) #1

I need help for selection of em sampling locationfor for new plant,any guideline for selection of new location preparation,and how can i decided frequency for sampling

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(Wendy Jimenez) #2

Hello, first you will need to determine the amount of sampling points per room. The ISO 14644 part 1 (2015) annex A, provide explain how to calculate the locations based on the square meters of each room.
The ISO 14644 part 2 (2015), provide a guide on the justification of sampling locations.
Both stardards will be very helpfull for you.

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(이정민) #3

Hello Wendy, I have a question about your reply : the ISO 14644 (2015) is still available ? I remember this guideline was updated and there is no exactly way to decide the number of sampling point per room…I just wonder.

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(Wendy Jimenez) #4

Hello, yes the standard is available.
You can send to me the room spaces in square meters and I can help you. (Remember to send the spaces per room for example, gowning entering square meters, gowning exiting, production room, transfer room square meters, etc)
After sampling points calculated and selected you must document the locations in a drawing to reflect the room space and points distribution (this is about air sampling viable and nom viable).
You can purchase the ISO on the portal.

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