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.
if 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
Yes , 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