What is the recommended time for settle plate exposure in
clean rooms for environmental monitoring?
|
EU GMP annex 1
states that settle plates are required to be exposed for a minimum of 4 hours.
Recommended
limits for microbiological monitoring of clean areas during operation:
Recommended limits for microbial
contamination (a)
|
||||
Grade
|
air sample cfu/m3
|
settle plates (diameter 90 mm) cfu/4 hours (b)
|
Contact plates (diameter 55 mm) cfu/plate
|
glove print 5 fingers cfu/glove
|
A
|
˂ 1
|
˂ 1
|
˂ 1
|
˂ 1
|
B
|
10
|
5
|
5
|
5
|
C
|
100
|
50
|
25
|
-
|
D
|
200
|
100
|
50
|
-
|
(a) These are average values.
(b)
Individual settle plates may be exposed for less than 4 hours.
EU Guidelines to Good Manufacturing
Practice Medicinal Products for Human and Veterinary Use – Annexure - I
why settle plate is cariied 4 hrs during operation
ReplyDeleteThe advantage with
Deletethis approach is that exposing plates and inoculating them
after 4 hours is a greater challenge because a
microorganism is more likely to be deposited onto the
surface of a settle plate some time during exposure rather
than at the start of the exposure time. Furthermore, at the
end of 4 hours the plates will have undergone maximum
weight loss.
as per ISO guidelines
ReplyDeleteis i expose less than 4 hrs then that is valid or not
ReplyDeletehow to determine settle plate location is there any guidelines for that
ReplyDeleteNo guidelines regarding location in this method. It is only to monitor the quality of air. you can do this test at any loacation
ReplyDeleteHello sir this is really a very useful information but can you please let me know why only 4 hours and why not more than that or less than that??
ReplyDeleteAnd also the effects if exposed more than 4 hours or less than four hours.
I exposed email plates more than 4 hour this is right or wrong if it and.yes so why or ur ans no so why
ReplyDeleteI exposed EM PLATES More than 4 Hour this is right or wrong if is it Right so why or is it wrong so why
ReplyDelete