The Classified area is monitored for viable and non-viable particles in pharmaceutical manufacturing. Fungus and bacteria both are found in the environment. Both are determined by the air sampling using the growth medium by settle plate and active air sampling methods.
There are various regulatory guidelines for the microbial sampling of air. All have their own limits for the microbial contamination in air but none of them have a separate limit for the fungus. A general limit of the colony forming unit (cfu) is given in all guidelines.
Following are some guidelines by different regulatory agencies showing the limit of the air sampling of the controlled area as cfu. Limits in cfu show that fungal colonies are acceptable in the classified area.
Colony Forming Unit (cfu) in Controlled Environment according to USP.
Class
|
cfu per cubic meter of air
|
cfu per cubic feet of air
|
|
SI
|
U.S. Customary
|
||
M3.5
|
100
|
Less than 3
|
Less than 0.1
|
M5.5
|
10,000
|
Less than 20
|
Less than 0.5
|
M6.5
|
1,00,000
|
Less than 100
|
Less than 2.5
|
Colony Forming Unit (cfu) in Controlled Environment according to WHO.
Grade
|
Air Sample
(cfu/m3)
|
Settle Plates
(diameter 90 mm)
(cfu/4 hours)
|
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
|
-
|
Colony Forming Unit (cfu) in Controlled Environment according to Schedule M.
Grade
|
Air Sample
(cfu/m3)
|
Settle Plates
(diameter 90 mm)
(cfu/2 hours)
|
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
|
500
|
100
|
50
|
-
|
This shows that these guidelines do not say to count colonies separately as bacteria and fungus.
I agree that there is no mention of fungal count in any of the guidelines, However it is must to have internal specifications of fungal count as NIL.
ReplyDeleteIf some one has no specification for fungal contamination, his facility will be found out of control one or the other day as fungi are spore forming and hard to sanitize by common fumigation agent. Hence it should be monitored on daily basis so that any contamination be controlled at the very initial stage.
if the fungal colony appear in clean room again validate the area free form of fungus
ReplyDeleteif in the area there is fungal count it is considered to be contaminated to a very high action level as the fungal growth occurs in the form of spores which is very difficult to control and remove from the area.
ReplyDeletenormal disinfectants are not considered to be adequate for the controlling of fungal growth so disinfectants having sporicidal action are used for the control
There are no guidelines to describe fungal limit in the clean rooms. How can we fix internal limit of fungal count in the Grade D area?
ReplyDeleteYou can set the limit of fungus in your area on the basis of trend.
DeleteI am talking about MLT area, specifically C and D areas. What is the issue, if 1 or 2 fungi observed? Even my products have an acceptance limit of 100 cfu/g.
ReplyDeleteOK sir, your product acceptance limit can be 100cfu/gm bacterial not fungal, if your products limit is 100cfu /gm fungal than you can accept 2or3 fungus in your area, but after some time you can not control fungal population in your area
DeleteYes , limits are for bacteria If you have single mould colony that's already action level. Nothing allowed at all due to amount of spores
ReplyDeleteNo fungus allowed at all, limits are for bacteria.
ReplyDelete