Learn 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. 
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 Schedule M.
Grade |
Air Sample(cfu/m3) |
Settle Platesdiameter 90mm)(cfu/2 hours) |
Contact Plates(diameter 55mm)(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 |
– |
Colony Forming Unit (cfu) in Controlled Environment according to WHO.
Grade |
Air Sample(cfu/m3) |
Settle Platesdiameter 90mm)(cfu/4 hours) |
Contact Plates(diameter 55mm)(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 |
– |
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 |