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Is Fungal Count Acceptable in Pharmaceutical Classified Area?


Know about the fungus limits in the controlled environment (classified area) in pharmaceutical manufacturing.
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.

Air Sampling
There are various regulatory guidelines for 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. It is important to follow these limits but it is not necessary to define an in-house limit for the fungus. Soybean casein digest agar (SCDA) or R2A plates are exposed or used in air sampler and incubated for five days. Colonies are count as cfu per plate or per cubic meter.

Following are some guidelines by different regulatory agencies showing the limit of the air sampling of controlled area as cfu. Limits in cfu shows that fungal colonies are acceptable in 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.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


3 Comments so far : Add yours...

Dr Nishodh Saxena said...

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.

If 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.

Unknown said...

if the fungal colony appear in clean room again validate the area free form of fungus

Unknown said...

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.
normal disinfectants are not considered to be adequate for the controlling of fungal growth so disinfectants having sporicidal action are used for the control

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