Is Fungal Count Acceptable in Pharmaceutical Classified Area?

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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. ph
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 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
          –
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
    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
The above up data shows that these guidelines do not say to count colonies separately as bacteria and fungus.

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